Safety Recalls

15,259 recalls across FDA food, drug, and medical device recalls, CPSC consumer products, and NHTSA vehicles.

Showing 4,951–5,000 of 15,259

• Consumer Product Recall · August 21, 2025

  IBC Technologies USA Inc., of Lawnside, New Jersey

  CX Series Combi Boiler

  A combi (or combination) boiler is a type of gas boiler that provides both a home's hot water and central heating. The hot water can exceed the temperature set on the control panel, posing a burn hazard to users.

  Unclassified

• Food Recall · August 20, 2025

  Itacate Foods LLC

  CAMPSITE LENTEJAS Hearty lentil soup with a tomato and cilantro base that takes no time to rehydrate. NET WT 4.0 OZ (115G) INGREDIENTS: *** VEGETABLE FLAVOR BASE (SALT, SUGAR, SOYBEAN OIL, ONION POWDE

  Undeclared Yellow #5 and Yellow #6.

  Class II

• Medical Device Recall · August 20, 2025

  Boston Scientific Corporation

  Model Number L101, ESSENTIO DR SL Pacemaker

  Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).

  Class I

• Food Recall · August 20, 2025

  The J.M. Smucker Company

  Hostess Ding Dongs CHOCOLATE CAKE WITH CREAMY FILLING 2.55 oz twin pack UPC 8 88109 01002 7; 10-1.28 oz carton (12.7 oz) UPC 8 88109 11061 1; 16-1.28 oz carton (20.31 oz) Individual selling unit - UPC

  Mold. The firm noticed an increase in customer complaints. They conducted a root cause investigation and discovered that one of their coolers had malfunctioning.

  Class II

• Food Recall · August 20, 2025

  Jessie Lord Bakery, LLC

  Lemon Meringue Pie, 8" round. Net Wt. 27 OZ; Refrigerate after opening Item Code 31811; UPC: 8 85523 31811 1;Jessie's Lemon Meringue Pie Sugar Free Item Code 30811; UPC: 8 85523 30811 2; Jessie's Lem

  Undeclared Yellow#5 in Lemon Meringue Pie

  Class II

• Medical Device Recall · August 20, 2025

  Boston Scientific Corporation

  Model Number U128, VALITUDE CRT-P EL MRI

  Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).

  Class I

• Medical Device Recall · August 20, 2025

  Boston Scientific Corporation

  Model Number L110, ESSENTIO SR SL MRI Pacemaker

  Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).

  Class I

• Medical Device Recall · August 20, 2025

  Boston Scientific Corporation

  ACCOLADE DR SL (Model L301)

  Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).

  Class I

• Medical Device Recall · August 20, 2025

  Boston Scientific Corporation

  Model Number L111, ESSENTIO DR SL MRI Pacemaker

  Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).

  Class I

• Medical Device Recall · August 20, 2025

  Boston Scientific Corporation

  ACCOLADE DR SL MRI (Model L311)

  Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).

  Class I

• Medical Device Recall · August 20, 2025

  Boston Scientific Corporation

  ACCOLADE DR EL (Model L321)

  Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).

  Class I

• Medical Device Recall · August 20, 2025

  Boston Scientific Corporation

  Model Number U125, VALITUDE CRT-P EL

  Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).

  Class I

• Food Recall · August 20, 2025

  Itacate Foods LLC

  CHARGE-UP CHILAQUILES Traditional Mexican breakfast consisting of tortilla chips smothered in a spicy tomatillo salsa and beans, topped with egg and cheese. NET WT 3.5 OZ (100G) INGREDIENTS: *** VEGET

  Undeclared Yellow #5 and Yellow #6.

  Class II

• Medical Device Recall · August 20, 2025

  Abiomed, Inc.

  Automated Impella Controller (AIC) with the below brands and product codes. Used with heart assist pump. 1. Impella Controller, Packaged, US; Product Code: 0042-0000-US. 2. Impella Controller, Pack

  Specific Automated Impella Controllers (AICs) that have a Pump Driver Circuit Assembly do not meet current specifications. This may lead to decreased pump performance or pump stop and trigger an Impella Failure or Impella Stopped Controller Failure alarm.

  Class I

• Medical Device Recall · August 20, 2025

  Boston Scientific Corporation

  ACCOLADE SR SL (Model L300)

  Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).

  Class I

• Medical Device Recall · August 20, 2025

  MicroSurgical Technology Inc

  MST ArcDUO 9mm, REF: ARC-0002, single-use, sterile ophthalmic knife, used with Suction Set, Part: 48-1000-01

  An ophthalmic knife has a suction set (not direct patient-contacting), which contains springs contaminated with an unidentified residue that may potentially cause eye irritation

  Class II

• Medical Device Recall · August 20, 2025

  Boston Scientific Corporation

  ACCOLADE SR SL MRI (Model L310)

  Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).

  Class I

• Drug Recall · August 20, 2025

  The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories

  Carvedilol Tablets USP, 12.5 mg, 100- Tablets, (10x10) cartons, Rx Only, Packaged and distributed by Major Pharmaceuticals, Indianapolis, IN, 46268, USA, NDC 0904-7307-61

  CGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above the FDA-recommended limit of NMT 4.0 ppm

  Class II

• Medical Device Recall · August 20, 2025

  Boston Scientific Corporation

  PROPONENT DR SL (Model L201)

  Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).

  Class I

• Medical Device Recall · August 20, 2025

  Boston Scientific Corporation

  Model Number S701 ALTRUA 2 SR SL Pacemaker

  Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).

  Class I

• Drug Recall · August 20, 2025

  Northwind Pharmaceuticals LLC

  Sulfamethoxazole and Trimethoprim Tablets, USP 800mg / 160mg Double Strength packaged in a) 6-count bottles (NDC 51655-307-87), b) 10-count bottles (NDC 51655-307-53), c) 14-count bottles (NDC 51655-3

  Presence of a Foreign Substance: A specific lot of auxiliary polyester coil, used in product packaging by manufacturer (Amneal Pharmaceuticals LLC) was detected with presence of a micro-organism. No micro-organism was detected on any tablets.

  Class II

• Medical Device Recall · August 20, 2025

  Boston Scientific Corporation

  Model Number L211 PROPONENT DR SL MRI Pacemaker

  Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).

  Class I

• Food Recall · August 20, 2025

  Toto Foods, Inc.

  Toto S'Mores Ooey Gooey Cookie; Gluten Free & Dairy Free; Net Wt. 2.25 OZ Rear panel: Packed with superfoods; Gluten, Dairy & Soy Free UPC: 860010409398

  Product label contains conflicting statements about inclusion and being free of Soy ingredient.

  Class II

• Medical Device Recall · August 20, 2025

  Boston Scientific Corporation

  Model Number S722, ALTRUA 2 DR EL Pacemaker

  Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).

  Class I

• Medical Device Recall · August 20, 2025

  Boston Scientific Corporation

  Model Number L100, ESSENTIO SR SL Pacemaker

  Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).

  Class I

• Drug Recall · August 20, 2025

  Baxter Healthcare Corporation

  Acetaminophen Injection 1000 mg/100 mL (10 mg/mL), packaged in 100 mL Viaflo container, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015, Made in Ireland, NDC 36000-306-60.

  Discoloration

  Class II

• Medical Device Recall · August 20, 2025

  Boston Scientific Corporation

  Model Number U228, VISIONIST CRT-P EL MRI

  Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).

  Class I

• Medical Device Recall · August 20, 2025

  Boston Scientific Corporation

  Model Number S702, ALTRUA 2 DR SL Pacemaker

  Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).

  Class I

• Medical Device Recall · August 20, 2025

  Boston Scientific Corporation

  Model Number L231, PROPONENT DR EL MRI Pacemaker

  Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).

  Class I

• Medical Device Recall · August 20, 2025

  Boston Scientific Corporation

  Model Number L209 PROPONENT DR (VDD) SL Pacemaker

  Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).

  Class I

• Medical Device Recall · August 20, 2025

  Boston Scientific Corporation

  Model Number U226, VISIONIST CRT-P EL

  Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).

  Class I

• Medical Device Recall · August 20, 2025

  Boston Scientific Corporation

  PROPONENT SR SL (Model L200)

  Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).

  Class I

• Medical Device Recall · August 20, 2025

  Boston Scientific Corporation

  Model Number L221 PROPONENT DR EL Pacemaker

  Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).

  Class I

• Medical Device Recall · August 20, 2025

  Boston Scientific Corporation

  Model Number L131, ESSENTIO DR EL MRI Pacemaker

  Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).

  Class I

• Medical Device Recall · August 20, 2025

  Boston Scientific Corporation

  ACCOLADE DR EL MRI (Model L331)

  Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).

  Class I

• Medical Device Recall · August 20, 2025

  Boston Scientific Corporation

  Model Number L121 ESSENTIO DR EL Pacemaker

  Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).

  Class I

• Medical Device Recall · August 20, 2025

  Boston Scientific Corporation

  Model Number U225 VISIONIST CRT-P EL

  Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).

  Class I

• Medical Device Recall · August 20, 2025

  Boston Scientific Corporation

  Model Number L210 PROPONENT SR SL Pacemaker

  Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).

  Class I

• Food Recall · August 19, 2025

  Southwind Foods LLC dba Great American Seafood Imports Co.

  Sand Bar; Great American; and First Street branded Frozen raw shrimp; 2 pound plastic bag; UPC#: 011110641182; 829944010612; 041512179471; 829944010698; 8299440106636

  Product manufactured under insanitary conditions whereby it may have been contaminated with Cesium-137 (Cs-137)

  Class II

• Food Recall · August 19, 2025

  Southwind Foods LLC dba Great American Seafood Imports Co.

  Best Yet; Arctic Shores; and Great American branded Frozen cooked shrimp; 1 Pound/ 12 OZ/ 6 OZ/ 2 Pound plastic bag; (Various Brands) UPC#: 042187002736; 042187002743; 041130812392; 041130810497; 0411

  Product manufactured under insanitary conditions whereby it may have been contaminated with Cesium-137 (Cs-137)

  Class II

• Medical Device Recall · August 19, 2025

  Greiner Bio-One North America, Inc.

  Brand Name: Vacuette Product Name: 8 ml CAT Serum Separator Clot Activator Model/Catalog Number: 455071P Product Description: Greiner VACUETTE Blood Collection Tube with Clot Activator and Gel Sepa

  Some of the Vacuette¿ CAT Serum Separator Clot Activator tubes were manufactured without gel separator, which could yield erroneous assay results and require the patient to return to the lab for recollection or repeat testing. This may result in delayed diagnosis, cause a delay in clinical decision-making or treatment and in some rare cases, yield incorrect results from less stable parameters.

  Class II

• Drug Recall · August 19, 2025

  Lannett Company Inc.

  Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, 10mg, 100 Tablets per bottle, Rx only, Distributed by: Lannett Company, Inc., Philadelph

  Presence of Foreign Tablet/Capsule: Two (2) bottles labeled as Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, 10mg, 100ct, contained one (1) tablet of Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, 5 mg.

  Class II

• Drug Recall · August 19, 2025

  Medline Industries, LP

  READYPREP PVP, Povidone-Iodine 10% Solution, Topical Antiseptic, Not Sterile, 1 Gallon (3.78 L) per bottle, Manufactured in USA by Medline Industries, LP., Three Lakes Drive, Northfield, IL 60093, NDC

  Subpotent drug

  Class III

• Food Recall · August 19, 2025

  HERSHEY CREAMERY CO.

  Hershey s Ice Cream, Green Mint Chip (GMC) Bulk, 3 gallons, 1 unit , bulk can- a cardboard tub with metal rings and cardboard lid

  Product tested elevated coliform counts during routine testing

  Class II

• Medical Device Recall · August 18, 2025

  Boston Scientific Corporation

  Preventive Maintenance (PM) Kit ICEFX, Material Number (UPN) SPRPM8000

  Certain desiccant tube subassemblies were built with end caps that were not correctly tightened.

  Class II

• Medical Device Recall · August 18, 2025

  Aesculap AG

  AESCULAP ELAN 4 FIXED DURAGUARD STANDARD. Model Number: GB942R.

  Mislabeling. The ELAN 4 FIXED DURAGUARD STANDARD was labeled as "Long" and the ELAN 4 FIXED DURAGUARD LONG was labeled as "Standard."

  Class II

• Drug Recall · August 18, 2025

  Amneal Pharmaceuticals, LLC

  chlorproMAZINE Hydrochloride Tablets, USP, 200 mg, 100-count bottles Rx only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Oral Solid Dosage Unit, Ahmedabad 382213, INDIA; Distributed by: Amneal

  Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. No micro-organism was detected on any tablets.

  Class II

• Drug Recall · August 18, 2025

  B BRAUN MEDICAL INC

  0.9% Sodium Chloride Injection USP, 1000 mL container, Rx only, B. Braun Medical, Inc., Bethlehem, PA 18018-3524 USA, NDC 0264-7800-09

  Presence of Particulate Matter.

  Class I

• Drug Recall · August 18, 2025

  Amneal Pharmaceuticals, LLC

  chlorproMAZINE Hydrochloride Tablets, USP, 100 mg, 100-count bottle, Rx Only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Oral Solid Dosage Unit, Ahmedabad 382213, INDIA; Distributed by: Amnea

  Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. No micro-organism was detected on any tablets.

  Class II

• Drug Recall · August 18, 2025

  Amneal Pharmaceuticals, LLC

  chlorproMAZINE Hydrochloride Tablets, USP, 25 mg, 100-count bottles, Rx Only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Oral Solid Dosage Unit, Ahmedabad 382213, INDIA, Distributed by: Amneal

  Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. No micro-organism was detected on any tablets.

  Class II