Drug Recalls

1,842 drug recalls from federal enforcement feeds.

MedicalFood Drug Device

ConsumerProduct Vehicle

Showing 1,051–1,100 of 1,842

Drug Recall · February 28, 2025
Breckenridge Pharmaceutical, Inc.
Duloxetine Delayed-Release Capsules, USP, 20mg, Rx Only, 500-count bottles, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Ber
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
Class II
Drug Recall · February 28, 2025
Glenmark Pharmaceuticals Inc., USA
Carvedilol Tablets USP 6.25 mg, a.)100-count bottle (NDC 68462-163-01), b.) 500-count bottle (NDC 68462-163-05) Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Manufactured for: Glenmark Phar
CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake limit
Class II
Drug Recall · February 28, 2025
Breckenridge Pharmaceutical, Inc.
Duloxetine Delayed-Release Capsules, USP, 30mg, Rx Only, 1000-count bottles, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Be
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
Class II
Drug Recall · February 28, 2025
Sigan Industries Group Inc.
Walgreens, Acne Control Cleanser, 10% Benzoyl Peroxide/Acne Treatment, NET WT 5 OZ (142g) Distributed by: Walgreen CO, 200 Wilmont RD, Deerfield, IL, Made in Canada. UPC#: 1 9560203602 8
Chemical Contamination: Presence of benzene
Class II
Drug Recall · February 27, 2025
Amgen, Inc.
Neupogen (filgrastim) For Injection, 300mcg/1 mL, 1 mL Single Dose Vials, Rx Only, For Subcutaneous or Intravenous Use Only, Sterile Solution - No Preservative, Amgen Inc., Thousand Oaks, CA 91320, ND
Stability data does not support expiry: the products have the potential to be out of specification at the time of expiry of 36-months.
Class II
Drug Recall · February 27, 2025
Amgen, Inc.
Neupogen (filgrastim) For Injection, 480 mcg/1.6 mL (300 mcg/1 mL), 1.6 mL single Dose Vial, Rx Only, For Subcutaneous or Intravenous Use Only, Sterile Solution - No Preservative, Amgen Inc. Thousand
Stability data does not support expiry: the products have the potential to be out of specification at the time of expiry of 36-months.
Class II
Drug Recall · February 25, 2025
MYLAN PHARMACEUTICALS INC
Prasugrel Tablets, USP, 5 mg, 30-count bottle, Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A., NDC 0378-5185-93
Failed Dissolution Specifications - low dissolution results
Class II
Drug Recall · February 25, 2025
A-S Medication Solutions LLC
METFORMIN HYDROCHLORIDE EXTENDED- RELEASE 500MG, 180 TABLETS, Packaged BY: A-S Medication Solutions, Libertyville, IL 60048 NDC 50090-1494-3.
Presence of Foreign Tablets/Capsules.
Class II
Drug Recall · February 24, 2025
Kowa Pharmaceuticals America
Livalo (pitavatstatin) tablets, 4 mg, 90-count bottles, Rx only, Manufactured by: Patheon, Inc. Cincinnati, OH 45237 USA or by Kowa Company, Ltd, Nagoya, 462-0024 Japan, Marketed by Kowa Pharmaceutica
Presence of foreign tablets/capsules
Class III
Drug Recall · February 24, 2025
Denison Pharmaceuticals, LLC
Zapzyt, Acne Treatment Gel, 10% benzoyl peroxide Gel, packaged in 1 oz (28.35g) tube, Distributed by: FOCUS CONSUMER HEALTHCARE, LLC., 801 Broad St Ste 200, Chattanooga, TN 37402. NDC 71687-0011-1
Chemical Contamination: Presence of benzene.
Class II
Drug Recall · February 24, 2025
Imprimis NJOF, LLC
Tropicamide - Proparacaine - Phenylephrine - Ketorolac Sterile Ophthalmic Solution, 1% 0.5% 2.5% 0.5%, 5 mL fill in 15 mL bottle, Imprimis NJOF, LLC, Route 46 West, Unit 6B, Ledgewood, NJ, 07852, ND
Sub-Potent Drug: The stability batch showed a subpotent result, which does not meet the product specifications of 90.0-110.0% of the label claim.
Class III
Drug Recall · February 20, 2025
Central Admixture Pharmacy Services, Inc.
PHENYLephrine added to 0.9% sodium chloride, 40 mg/250 mL* (160 mcg/mL), Rx Only, CAPS, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, 855-275-2270, NDC 7
Presence of Particulate Matter
Class I
Drug Recall · February 20, 2025
One Source Nutrition, Inc,
Vitality, Fast Acting Male Enhancement Product, Dietary Supplement, a) One Capsule per Packet, b) 6 capsules per bottle, Xtreme Potency.
Marketed without an approved NDA/ANDA: Product found to be tainted with undeclared sildenafil and tadalafil.
Class I
Drug Recall · February 18, 2025
Turbare Manufacturing
Avastin 1.25 mg/0.05 mL in 0.25 mL Syringe, For Intravitreal Injection Only, Office Use Only - Not for Resale - Single Use, This drug product was repackaged by Turbare Manufacturing, 925 Jeanette Driv
Lack of Assurance of Sterility: due to a quality control process deviation
Class II
Drug Recall · February 17, 2025
MEDLINE INDUSTRIES, LP - Northfield
Medline Alcohol Prep Pads, 70% Isopropyl Alcohol, 100 Sterile 2-Ply Pads, Single Use Only, Large, www.medline.com, Manufactured for Medline Industries, LP, Three Lakes Drive, Northfield, IL 60093 USA,
Subpotent Drug
Class II
Drug Recall · February 17, 2025
Safecor Health, LLC
Ergocalciferol - Vitamin D Supplement - 10 mcg (400 Units) per 0.05 mL Oral Syringe, Delivers: 0.05 mL Oral Solution, Mfg by: Westminster, Pkg by: Safecor Health, LLC, Columbus, OH 43204, NDC: 6936702
Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.
Class II
Drug Recall · February 17, 2025
Safecor Health, LLC
Simethicone 20 mg per 0.3 mL Oral Syringe, Delivers: 0.3 mL, Oral Drops, Mfg By: Rugby, Pkg by: Safecor Health, LLC, Columbus, OH 43204, NDC: 00536130375.
Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.
Class II
Drug Recall · February 17, 2025
Safecor Health, LLC
Lorazepam 0.5 mg per 0.25 mL Oral Syringe, Delivers: 0.25 mL, Oral Concentrate, Rx Only, Refrigerate, Mfg by: PAI, Pkg by: Safecor Health, LLC, Columbus, OH 43204, NDC: a) 00054353244, b) 00121077001,
Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.
Class II
Drug Recall · February 17, 2025
MEDLINE INDUSTRIES, LP - Northfield
CURAD Alcohol Prep Pads, Sterile, Medium, 2-Ply, Contents: 5 boxes per Carton, 30 Boxes per Case, Single Use Only, Manufactured for Medline Industries, LP, Three Lakes Drive, Northfield, IL 60093, USA
Subpotent Drug
Class II
Drug Recall · February 17, 2025
Safecor Health, LLC
Ferrous Sulfate 7.5 mg Iron/0.5 mL Oral Syringe, Delivers: 0.5 mL, Iron Supplement Drops, Mfg by: Akron Pharma, Pkg by: Safecor, Columbus, OH 43204. NDC: a) 71399748005, b) 39328055750, c) 6961800705
Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.
Class II
Drug Recall · February 17, 2025
Safecor Health, LLC
Morphine Sulfate 5 mg per 0.25 mL Oral Syringe, Delivers: 0.25 mL, Oral Solution, Rx Only, Mfg by: Hikma, Pkg by: Safecor Health, LLC, Columbus, OH 43204, NDC: a) 00406800312, b) 00406800330, c) 00054
Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.
Class II
Drug Recall · February 14, 2025
CareFusion 213, LLC
BD ChloraPrep Clear 1mL Applicators, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA), Patient Preoperative Skin Preparation, Sterile Solution, 0.03 fl. oz (1 mL) each, 60 Appl
Non-Sterility: contamination of Aspergillus penicillioides, due to breach in package lidding.
Class I
Drug Recall · February 13, 2025
Johnson, S C and Son, Inc
Kids by babyganics SPF 50 mineral sunscreen totally tropical (titanium dioxide 3/5%, zinc oxide 7.25%), packaged in 3 OZ spray bottles, Dist. by KAS Direct LLC, 1525 Howe St. Racine, WI 53403, UPC 813
Chemical Contamination
Class II
Drug Recall · February 13, 2025
ICU Medical, Inc.
POTASSIUM CHLORIDE Inj., 10 mEq total in 100 mL, 100 mEq/L flexible container, Rx Only, ICU Medical, Inc., Lake Forest, Illinois, 60045, USA, NDC# 0990-7074-26; Bar Code (01)00309907074269
Labeling: Label Error on Declared Strength. Overwrap labeled as Potassium Chloride Inj 10 mEq may contain flexible containers of Potassium Chloride Inj 20 mEq
Class I
Drug Recall · February 13, 2025
Zydus Pharmaceuticals (USA) Inc
Nelarabine Injection, 250mg/50mL, (5mg/mL), packaged in: a) 50 mL Single-Dose Vial, NDC 70710-1839-1; b) 6 x 50 mL Single-Dose Vial, NDC 70710-1839-8, Rx only, Manufactured by Zydus Lifesciences Ltd,
Failed Impurities/Degradation Specifications
Class II
Drug Recall · February 13, 2025
ICU Medical, Inc.
POTASSIUM CHLORIDE Inj., 20 mEq total in 100 mL flexible container 24 x case, 200 mEq/L, Rx Only, ICU Medical, Inc., Lake Forest, Illinois, 60045, USA, NDC# 0990-7075-26; Bar Code Flexible container (
Labeling: Label Error on Declared Strength. Cases labeled POTASSIUM CHLORIDE 20 mEq, may contain flexible containers with overwrap mislabeled as 10 mEq. The correct dosage strength of 20 mEq is printed on the labeling affixed to the product flexible container.
Class I
Drug Recall · February 13, 2025
Johnson, S C and Son, Inc
Kids by babyganics SPF 50 totally tropical (titanium dioxide 3/5%, zinc oxide 7.25%) packaged in a) 6 OZ (170 g) spray bottles UPC 813277019954 and UPC 813277019800; and b) Twinpack UPC 813277019930;
Chemical Contamination
Class II
Drug Recall · February 13, 2025
Zydus Pharmaceuticals (USA) Inc
Nelarabine Injection, 250mg/50mL, (5mg/mL), packaged in: a) 50 mL Single-Dose Vial, NDC 70710-1726-1; b) 6 x 50 mL Single-Dose Vial, NDC 70710-1726-8, Rx only, Manufactured by Zydus Lifesciences Ltd,
Failed Impurities/Degradation Specifications
Class II
Drug Recall · February 13, 2025
World Perfumes Inc.
Iodo Blanco Iodides, First Aid Antiseptic, Mercury Free, Iodine 2%, First Aid Antiseptic, Contains 1 fl. oz (30 ml) per bottle, Distributed by: Essential Products, www.essentialproductsusa.com, NDC: 7
Defective Container: broken or leaking bottles.
Class II
Drug Recall · February 12, 2025
Wuxi Medical lnstrument Factory Co., Ltd.
ViaMed Alcohol Prep Pads, For External Use Only, 70% Isopropyl Alcohol, Sterile, 100 pieces per Box, 100 boxes per Carton, Sterile, Manufactured by Wuxi Medical Instrument Factory Co., Ltd., Made in C
Lack of assurance of sterility and cGMP deviations observed at the manufacturing site.
Class II
Drug Recall · February 10, 2025
Nephron Sterile Compounding Center LLC
Sodium Chloride Injection 9%, USP, 500 mL, Single-Dose IV Bottle, Rx Only, nephron, 503B outsourcing facility, West Columbia, SC 29172, NDC: 69374-334-50
Lack of Assurance of Sterility: There is a potential for leakage at the IV bottle port.
Class II
Drug Recall · February 7, 2025
Aspen Biopharma Labs Pvt., Ltd.
Alprostadil Container Description: Amber color bottle
CGMP Deviations
Class II
Drug Recall · February 7, 2025
Aspen Biopharma Labs Pvt., Ltd.
Chlorambucil Container Description: The product packed in double self-seal cover and finally packed in Aluminum cover for shipping.
CGMP Deviations
Class II
Drug Recall · February 7, 2025
Aspen Biopharma Labs Pvt., Ltd.
Finasteride NDC# 82187-1003-1 Container Description: The product packed in white poly bag containing black poly bag and tied each individual finally packed in HDPE container for shipping.
CGMP Deviations
Class II
Drug Recall · February 7, 2025
Aspen Biopharma Labs Pvt., Ltd.
Bimatoprost NDC# 82187-1001-1 Container description: The product packed in double self-seal cover and finally packed in Aluminum cover for shipping.
CGMP Deviations
Class II
Drug Recall · February 7, 2025
Aspen Biopharma Labs Pvt., Ltd.
Latanoprost NDC# 82187-1002-1 Container Description: Amber colour bottle
CGMP Deviations
Class II
Drug Recall · February 7, 2025
Aspen Biopharma Labs Pvt., Ltd.
Voriconazole Container Description: voriconazole The product packed in white poly bag containing black poly bag and tied each individual finally packed in HDPE container for shipping.
CGMP Deviations
Class II
Drug Recall · February 6, 2025
SUN PHARMACEUTICAL INDUSTRIES INC
Morphine Sulfate Extended-Release Tablets, 100 mg, 100-count bottles, Rx Only, Manufactured by: Ohm Laboratories Inc., New Brunswick, NJ 08901. Distributed by: Sun Pharmaceutical Industries, Inc., Cr
Failed Dissolution Specifications
Class II
Drug Recall · February 6, 2025
Padagis US LLC
Estradiol Gel, 0.1%, 0.25 mg/g, 30 packets per carton, Rx Only, For Topical Use Only, Manufactured by Padagis, Yeruham, Israel, NDC: 45802-0134-30
Defective Container: Some packets may not be fully sealed, potentially allowing for loss of Ethanol from the product.
Class II
Drug Recall · February 4, 2025
AvKARE
Silodosin Capsules, 8mg, 90-count bottle, Rx only, Manufactured for: AvKare, Pulaski, TN 38478, Manufactured by: Amneal Pharmaceuticals of NY, LLC, NY 11719, NDC 42291-778-90
Subpotent Drug: Out of Specification (OOS) result for De hydro Impurity (0.654%) for 18 M Stability sample and low assay 94.9% (specification of NLT 95.0% NMT 105%)
Class II
Drug Recall · January 31, 2025
Direct Rx
CIPROFLOXACIN OPHTH SOLUTION, 0.3% 5mL bottle, Rx Only, Generic for CILOXAN, Packaged and Distributed by: DIRECT Rx, NDC 61919-795-05.
Defective Container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle
Class II
Drug Recall · January 31, 2025
Fagron Compounding Services
fentaNYL Citrate In Sodium Chloride 1600mcg/100mL (16 mcg per mL) CII, Single use 100mL IV Bag, Fagron Sterile Services, 8710 E 34th St N, Wichita, KS 67726 Bar Code 71266-5060-01
Lack of Assurance of Sterility
Class II
Drug Recall · January 31, 2025
Alvogen, Inc
Fentanyl Transdermal System CII, 25mcg/h, packaged in a pouch, further packaged in 5-count carton, Rx only, Distributed by: Alvogen, Inc., Pine Brook, NJ 07058, Manufactured by: Kindeva Drug Delivery
Defective delivery system - patches could be multi-stacked, adhered one on top of the other, in a single product pouch.
Class I
Drug Recall · January 30, 2025
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
Potassium Chloride Extended-Release Tablets, USP, 10 mEq (750 mg), 100 Tablets per carton (10 x 10 unit dose blisters), Rx Only, Distributed by: Aurobindo Pharma USA< INC., 279 Princeton-Hightstown Ro
Failed Dissolution Specifications.
Class II
Drug Recall · January 29, 2025
Glenmark Pharmaceuticals Inc., USA
Atomoxetine Capsules, USP, 100 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India, NDC 68462-271-30.
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Class II
Drug Recall · January 29, 2025
Glenmark Pharmaceuticals Inc., USA
Atomoxetine Capsules, USP, 18 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Glenmark Pharmaceuticals Ltd., Goa, India, NDC 16714-756-01.
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Class II
Drug Recall · January 29, 2025
Glenmark Pharmaceuticals Inc., USA
Atomoxetine Capsules, USP, 100 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Glenmark Pharmaceuticals Ltd., Goa, India, NDC 16714-761-01.
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Class II
Drug Recall · January 29, 2025
Glenmark Pharmaceuticals Inc., USA
Atomoxetine Capsules, USP, 60 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Glenmark Pharmaceuticals Ltd., Goa, India, NDC 16714-759-01.
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Class II
Drug Recall · January 29, 2025
Glenmark Pharmaceuticals Inc., USA
Atomoxetine Capsules, USP, 10 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India, NDC 68462-265-30.
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Class II
Drug Recall · January 29, 2025
Glenmark Pharmaceuticals Inc., USA
Atomoxetine Capsules, USP, 80 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Glenmark Pharmaceuticals Ltd., Goa, India, NDC 16714-760-01.
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Class II