Drug Recalls

2,059 drug recalls from federal enforcement feeds.

MedicalFood Drug Device

ConsumerProduct Vehicle

Showing 1,851–1,900 of 2,059

Drug Recall · February 1, 2024
Amerisource Health Services LLC
HydrALAZINE Hydrochloride Tablets, USP, 10 mg, 100-count (10 x 10) per unit dose carton, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC Carton: 68084-447-01; NDC Unit
Failed Impurities/Degradation Specifications: Out of Specification (OOS) result in the repackaged product for Related Compounds (Impurities) at the 6-month time point.
Class III
Drug Recall · February 1, 2024
Integrity Products
To the Moon Capsules, Horny Goat Weed, 1000 mg, packaged in a box containing a 10-count blister card, Distributed By: Integrity Products, 1710 Fenpark Dr., Fenton, MO 63026
Marketed Without an Approved NDA/ANDA: Products contain undeclared sildenafil.
Class I
Drug Recall · February 1, 2024
Integrity Products
RAM IT, Horny Goat Weed, dietary supplement capsules, 1000 mg, packaged in a box containing a 10-count blister card, Distributed By: Integrity Products, 1710 Fenpark Dr., Fenton, MO 63026
Marketed Without an Approved NDA/ANDA: Products contain undeclared sildenafil.
Class I
Drug Recall · January 30, 2024
Brassica Pharma Pvt Ltd
Equate Lubricant Eye Ointment (Mineral Oil 42.5%, White Petrolatum 57.3%), Packaged in 3.5 gram tubes, Distributed by Walmart Inc., Bentonville, AR 72716, NDC 79903-026-35, UPC 681131395298
Lack of Assurance of Sterility
Class II
Drug Recall · January 30, 2024
Brassica Pharma Pvt Ltd
CVS Health Lubricant Eye Ointment (Mineral oil 31.9% Emollient, White petrolatum 57.7% Emollient), Packaged in in 3.5 gram tubes, Distributed by: CVS Pharmacy, Inc. One CVS Drive Woonsocket, RI 02895
Lack of Assurance of Sterility
Class II
Drug Recall · January 30, 2024
Brassica Pharma Pvt Ltd
Lubricant PM Ointment (Mineral Oil 42.5% and White Petrolatum 57.3%), Packaged in 3.5 gram tubes, Distributed by: AACE Pharmaceuticals, Inc., Fairfield, NJ 07004, NDC 71406-124-35, UPC 371406124356
Lack of Assurance of Sterility
Class II
Drug Recall · January 30, 2024
Brassica Pharma Pvt Ltd
Equate Stye Lubricant Eye Ointment (Mineral Oil 31.9%, White Petrolatum 57.7%), Packaged in 3.5 g tubes, Distributed by Walmart Inc., Bentonville, AR 72716, NDC 79903-028-35, UPC 681131395304
Lack of Assurance of Sterility
Class II
Drug Recall · January 25, 2024
Teva Pharmaceuticals USA, Inc
Nortrel (norethindrone and ethinyl estradiol tablets USP) 0.5/35, packaged in cartons, each carton contains 3 blister cards, each card contains 28 tablets, Rx only, TEVA PHARMACEUTICALS USA, INC., Nor
Discoloration: discolored tablets (shades of blue) mixed in with the white inert remainder tablets.
Class III
Drug Recall · January 25, 2024
Amerisource Health Services LLC
Febuxostat Tablets, 40 mg, 30 Tablets (3 x 10) per carton, Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC Carton: 60687-538-21, NDC Unit dose 60687-538-11
CGMP Deviations
Class II
Drug Recall · January 25, 2024
Teva Pharmaceuticals USA, Inc
Nortrel 7/7/7 (norethindrone and ethinyl estradiol tablets USP- triphasic regimen), packaged in cartons, each carton contains 6 blister cards, each card contains 28 tablets, Rx only, TEVA PHARMACEUTIC
Discoloration: discolored tablets (shades of blue) mixed in with the white inert remainder tablets.
Class III
Drug Recall · January 25, 2024
Alpha Aromatics
Pure Care Foaming Mint Hand Sanitizer 62%, Distributed by: Air Scent International, 290 Alpha Drive, RIDC Industrial Park, Pittsburg, PA 15238 USA, www.airscent.com, NDC 75009-562.
CGMP Deviations
Class II
Drug Recall · January 23, 2024
Baxter Healthcare Corporation
Norepinephrine Bitartrate in 5% Dextrose Injection, 8 mg/ 250 mL (32 mcg/mL), For Intravenous Infusion Only, 250 mL vial, Rx Only, Baxter Healthcare Corporation, Deerfield, IL 60015. Made in Ireland.
Incorrect product concentration on the overwrap label: The overwrap label incorrectly identified the product strength as 4 mg / 250 mL; however, the primary bag label correctly identified the product strength as 8 mg / 250 mL.
Class II
Drug Recall · January 22, 2024
IntegraDose Compounding Services LLC
Vasopressin 2 Units/2 mL in 0.9% Sodium Chloride Sterile Syringe for Injection, Concentration: 1 Unit/mL, 2 mL Syringe, Rx Only, 719 Kasota Ave SE, Minneapolis, MN, Compounded Drug Not for Resale. Off
Sub-potent drug: failure to maintain potency through the duration of the labeled expiration/beyond-use date.
Class II
Drug Recall · January 19, 2024
Bestco LLC
Family Wellness Cherry Cough Drops Menthol cough suppressant/Oral Anesthetic, 80 drops per bag, item number 20001187, Bestco, 288 Mazeppa Road, Mooresville, NC 28115
CGMP Deviations: Potential Glass and Silicone particulates in product
Class II
Drug Recall · January 19, 2024
Bestco LLC
CVS Health Cherry Cough Drops, Menthol cough suppressant/Oral Anesthetic, 160 drops per bag, item number 20001089, Bestco, 288 Mazeppa Road, Mooresville, NC 28115
CGMP Deviations: Potential Glass and Silicone particulates in product
Class II
Drug Recall · January 19, 2024
OMEZA LLC
Omeza Lidocaine Lavage pain relief oil 10*2mL VIALS
CGMP Deviations
Class II
Drug Recall · January 19, 2024
Bestco LLC
Meijer Cherry Cough Drops, Menthol cough suppressant/Oral Anesthetic, 200 drops per bag, item number 20000345, Bestco, 288 Mazeppa Road, Mooresville, NC 28115
CGMP Deviations: Potential Glass and Silicone particulates in product
Class II
Drug Recall · January 19, 2024
Bestco LLC
Equate Cherry Cough Drops, Menthol cough suppressant/Oral Anesthetic, a) 30 drops per bag, item number 20000462, b) 160 drops per bag, item number 20000463, Bestco, 288 Mazeppa Road, Mooresville, NC 2
CGMP Deviations: Potential Glass and Silicone particulates in product
Class II
Drug Recall · January 19, 2024
Bestco LLC
Kroger Cherry Cough Drops, Menthol cough suppressant/Oral Anesthetic, 200 drops per bag, item number 20000064, Bestco, 288 Mazeppa Road, Mooresville, NC 28115
CGMP Deviations: Potential Glass and Silicone particulates in product
Class II
Drug Recall · January 19, 2024
OMEZA LLC
Omeza Skin Protectant, Skin Protectant Gel 10*2mL Vials
CGMP Deviations
Class II
Drug Recall · January 18, 2024
SUN PHARMACEUTICAL INDUSTRIES INC
Zolpidem Tartrate Extended-Release Tablets, USP 12.5mg, Rx Only, 100 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical In
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Class II
Drug Recall · January 18, 2024
SUN PHARMACEUTICAL INDUSTRIES INC
Zolpidem Tartrate Extended-Release Tablets, USP 6.25 mg, Rx Only, 100 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical I
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Class II
Drug Recall · January 18, 2024
Dr. Reddy's Laboratories, Inc.
Glimepiride Tablets, USP 1mg, 500-count bottles, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Srikakulam-532 409 INDIA, NDC: 55111-320-05
Misprint on tablet
Class III
Drug Recall · January 18, 2024
SUN PHARMACEUTICAL INDUSTRIES INC
Fexofenadine Hydrochloride Tablets, USP 180mg, Antihistamine, Allergy, 24 hour, a) 30 Tablets per bottle, NDC 51660-998-30; Distributed by: Ohm Laboratories Inc., New Brunswick, NJ 08901, Made in Indi
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Class II
Drug Recall · January 18, 2024
SUN PHARMACEUTICAL INDUSTRIES INC
Mesalamine Delayed-Release Tablets, USP 1.2 g per tablet, Rx Only, 120 Tablets per bottle, Once Daily, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pha
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Class II
Drug Recall · January 18, 2024
SUN PHARMACEUTICAL INDUSTRIES INC
Niacin Extended-Release Tablets, USP 1000mg, Rx Only, 90 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Lim
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Class II
Drug Recall · January 18, 2024
Dr. Reddy's Laboratories, Inc.
Glimepiride Tablets, USP 1mg, 100-count bottles, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Srikakulam-532 409 INDIA, NDC: 55111-320-01
Misprint on tablet
Class III
Drug Recall · January 18, 2024
SUN PHARMACEUTICAL INDUSTRIES INC
Cinacalcet Tablets 60mg, Rx Only, 30 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Limited Survey No. 259/
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Class II
Drug Recall · January 18, 2024
SUN PHARMACEUTICAL INDUSTRIES INC
Lurasidone Hydrochloride Tablets 120mg, Rx Only, 30 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Ltd., S
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Class II
Drug Recall · January 18, 2024
SUN PHARMACEUTICAL INDUSTRIES INC
Lurasidone Hydrochloride Tablets 60mg, Rx Only, 30 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Ltd., Su
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Class II
Drug Recall · January 18, 2024
SUN PHARMACEUTICAL INDUSTRIES INC
Niacin Extended-Release Tablets, USP 500mg, Rx Only, 90 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Limi
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Class II
Drug Recall · January 18, 2024
SUN PHARMACEUTICAL INDUSTRIES INC
Febuxostat Tablets 80 mg, Rx Only, 30 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Ltd., Survey No. 259/1
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Class II
Drug Recall · January 18, 2024
SUN PHARMACEUTICAL INDUSTRIES INC
Febuxostat Tablets 40mg, Rx Only, 30 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Ltd., Survey No. 259/15
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Class II
Drug Recall · January 17, 2024
Henry Schein Inc. and Glove Club HSI Gloves Inc.
Adrenalin (epinephrine) Injection 1mg/mL, 1mL single dose vial, Rx only, Packaged By: Henry Schein, Inc., 80 Summit View Lane, Bastian, VA 24314, Original NDC 42023-159-25 Repack NDC 0404-9810-01
Labeling: Incorrect or Missing Lot and/or Exp Date. The expiration date listed on the Repack Pouch Label is incorrect.
Class II
Drug Recall · January 16, 2024
Den-Mat Holdings, LLC
Hydrogen Peroxide Oral Rinse, Significantly Reduces Bacteria, Fresh Mint Flavor, Alcohol Free, a)16 fl. oz. (473 mL) bottle, NDC 59883-202-16, UPC 3 59883 00009 7); b) 64 fl. oz. (1.89 L) bottle, NDC
CGMP Deviations: products may not conform to the labeled specifications.
Class II
Drug Recall · January 16, 2024
Ascend Laboratories, LLC
Fosfomycin Tromethamine Granules for Oral Solution, (equivalent to 3 grams of fosfomycin), single-dose sachet, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA. Distributed by: Ascend Laborato
Failed Impurities/Degradation Specification: Out of specification for organic impurities
Class II
Drug Recall · January 16, 2024
Den-Mat Holdings, LLC
OralProCare medicated lip treatment, Net Wt 9.9 g (0.35 oz) tube, Ethyl alcohol 6.0% Antibacterial, Manufactured by: Den-Mat Holdings, LLC, Lompoc, CA, 93436, USA, NDC 59883-500-01, UPC: 3 59883 00000
CGMP Deviations: products may not conform to the labeled specifications.
Class II
Drug Recall · January 15, 2024
Amneal Pharmaceuticals of New York, LLC
Phenoxybenzamine Hydrochloride Capsules, USP 10mg, 100-count bottle, Rx only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd, Oral Solid Dosage Unit, Ahmedabad 382213, India, Distributed by: Amneal
Failed Impurities/Degradation Specifications: Out of specification for unknown impurity.
Class II
Drug Recall · January 12, 2024
Golden State Medical Supply Inc.
Budesonide Extended-Release Tablets, 9 mg, 30-count bottles, Rx only, Marketed by: GSMS, Incorporated, Camarillo, CA, UPC 5140782430, NDC 51407-824-30
Failed Dissolution Specifications
Class II
Drug Recall · January 12, 2024
Neptune Resources, LLC
Neptune's Fix, Tianeptine Extra Strength Elixir, 0.338 fl oz (10 mL) bottle, Distributed By Neptune Resources, LLC, 30 N. Gould Street, Ste R, Sheridan, WY 82801.
Marketed without an approved NDA/ANDA: Product contains tianeptine, a substance not FDA-approved for any medical use in the United States.
Class I
Drug Recall · January 12, 2024
Neptune Resources, LLC
Neptune's Fix, Tianeptine Tablets Extended Relief, Twenty Tablets per Box, Wide Awake, 3000 mg (150 mg Per Tablet), Distributed By Neptune Resources, LLC, 30 N. Gould Street, Ste R, Sheridan, WY 82801
Marketed without an approved NDA/ANDA: Product contains tianeptine, a substance not FDA-approved for any medical use in the United States.
Class I
Drug Recall · January 12, 2024
Neptune Resources, LLC
Neptune's Fix, Tianeptine Elixir, Fast Acting, 0.338 fl oz (10 mL) bottle, Distributed By Neptune Resources, LLC, 30 N. Gould Street, Ste R, Sheridan, WY 82801.
Marketed without an approved NDA/ANDA: Product contains tianeptine, a substance not FDA-approved for any medical use in the United States.
Class I
Drug Recall · January 12, 2024
IntegraDose Compounding Services LLC
Vasopressin 2 Unit/2 mL in 0.9% Sodium Chloride, 2 mL per syringe, Rx Only, 719 Kasota Ave SE, Minneapolis, MN. NDC 71139-0190-1
Subpotent Drug
Class II
Drug Recall · January 11, 2024
Amerisource Health Services LLC
Rifampin Capsules USP, 150 mg, 30 Capsules (3 x 10) unit doses per carton, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC Carton: 60687-575-21; NDC Unit Dose: 60687-575-
Failed Impurities/Degradation Specification.
Class II
Drug Recall · January 11, 2024
Par Sterile Products LLC
Vasostrict (vasopressin in 5% Dextrose) Injection, 20 units per 100 mL (0.2 units per mL), 100 mL x 10 Single Dose Vials per carton, Ready to Use, For Intravenous Infusion, Rx Only, Distributed by: Pa
Superpotent Drug: Assay from the 3-month and 6-month stability intervals exceeded the upper specification limit.
Class II
Drug Recall · January 10, 2024
BE PHARMACEUTICALS AG
Fosaprepitant for Injection 150 mg per vial, Sterile lyophilized powder for Intravenous use only after reconstitution and dilution, Single Dose Vial, Rx Only, Distributed by BE Pharmaceuticals Inc. 20
Lack of Sterility Assurance: Aseptic process simulation failure.
Class II
Drug Recall · January 10, 2024
MEDLINE INDUSTRIES, LP - Northfield
Medline Remedy Clinical TREAT Antifungal Cream, 2% Miconazole Nitrate, Paraben Free, 4 FL OZ (118 mL) tube, Manufactured for Medline Industries, LP Three Lakes Drive, Northfield, IL 60093. NDC: 5332
Labeling: Not Elsewhere Classified; Product labeling contains the claim of 'Paraben Free' while the product does in fact contain parabens as part of the formulation/ ingredient list.
Class II
Drug Recall · January 8, 2024
Teva Pharmaceuticals USA, Inc
Budesonide Extended-Release Tablets 9mg, 30-count bottle, Rx Only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314 USA, Distributed by: Actavis Pharma, Inc., Parsippany, NJ
Failed Dissolution Specifications
Class II
Drug Recall · January 5, 2024
Lupin Pharmaceuticals Inc.
Rifampin Capsules USP 300mg, 30-count bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 United States, Manufactured Lupin Limited, Aurangabad 431 210 INDIA, NDC
Subpotent Drug and Failed Impurities/Degradation Specifications
Class II
Drug Recall · January 5, 2024
Lupin Pharmaceuticals Inc.
Rifampin Capsules USP 150mg, 30-count bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 United States, Manufactured Lupin Limited, Aurangabad 431 210 INDIA, ND
Subpotent Drug and Failed Impurities/Degradation Specifications
Class II