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FDA Recalls
›Drug Recalls

FDA Drug Recalls

Recalls of prescription drugs, over-the-counter medications, and compounded pharmaceuticals.

Classification

All Class I Class II Class III

Status

All Ongoing Completed Terminated

Date

All time Past 30 days Past 12 months

Showing 101–120 of 1,000 recalls

Class IIITerminated

BADGER 50, ADVENTURE SPORT MINERAL SUNSCREEN WITH CLEAR ZINC, (uncoated 25% zinc oxide), 2.4 oz., Tin, W.S. Badger Company, Inc, 768 Route 10, Gilsum NH, 03448 UPC 6 34084 47150 2

The W.S. Badger Company, Inc.

Labeling: Missing Label: The finished product potentially missing the labeling with the drug facts panel, bar code and directions for use.

January 17, 2025 · DrugView details →

Class IIICompleted

Venlafaxine Extended-Release Tablets, 150mg, Rx only, 90 Tablets, Manufactured by Appco Pharma. LLC, NDC 43598-943-90.

Appco Pharma LLC

Failed Tablet/Capsule Specifications: Missing tab ID on either side of the tablet

January 16, 2025 · DrugView details →

Class IIITerminated

Guaifenesin and Codeine Phosphate Oral Solution USP, 100mg/10 mg per 5 mL, 16 fl oz (473 ml) bottles, PAI Pharmaceutical Associates, Inc., Greenville, SC 29605, NDC 0121-0775-16

PAI Holdings, LLC. dba Pharmaceutical Associates Inc

Superpotent; sodium benzoate preservative

January 7, 2025 · DrugView details →

Class IIIOngoing

Methadone Hydrochloride Tablets, USP, 5mg, 10x10 Unit-Dose Tablets, Rx Only, Distributed by: Hikma Pharmaceuticals USA Inc., Berkeley Heights, NJ 07922, NDC 0054-0709-20

West-Ward Columbus Inc

Failed Tablet/Capsule Specifications: Illegible product identification for the unit dose configuration only.

December 19, 2024 · DrugView details →

Class IIIOngoing

Carboxymethylcellulose Sodium Ophthalmic Solution 0.5% Moisturizing Lubricant Eye Drops, 0.5 FL OZ (15 mL) bottles, Distributed by: AvKARE, Pulaski, TN, 38478, NDC 50268-068-15.

AvKARE

LABELING: LABEL MIX-UP

December 18, 2024 · DrugView details →

Class IIIOngoing

Polyvinyl Alcohol Ophthalmic Solution 1.4%, Moisturizing Lubricant Eye Drops, 0.5 FL OZ (15 mL) bottles, Distributed by AvKARE, Pulaski, TN 38478, www.avkare.com, NDC 50268-678-15

AvKARE

LABELING: LABEL MIX-UP

December 18, 2024 · DrugView details →

Class IIITerminated

Atropine Sulfate Ophthalmic Solution, USP 1%, 5 mL bottles, Rx only, Manufactured for: Somerset Therapeutics, LLC. Somerset, NJ 08873, NDC 70069-716-01

SOMERSET THERAPEUTICS LLC

Failed Impurities/Degradation Specifications

December 16, 2024 · DrugView details →

Class IIIOngoing

Acetaminophen, 325 mg Tablets, 100 Tablets per bottle, Akron Pharma, Manufactured for: Akron Pharma Inc., Fairfield, NJ 07034, NDC 71399-8014-01.

Akron Pharma, Inc.

Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.

December 12, 2024 · DrugView details →

Class IIIOngoing

Diphenhydramine HCl 25 mg, 1000 Capsules per bottle, Akron Pharma, Manufactured for: Akron Pharma, Inc., 373 RT US 46 W Building E., Suite 117, Fairfield, NJ 07004, NDC 71399-8028-2.

Akron Pharma, Inc.

Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.

December 12, 2024 · DrugView details →

Class IIIOngoing

Diphenhydramine HCl 50 mg, 1000 capsules per bottle, Akron Pharma, Manufactured for: Akron Pharma, Inc. 373 Route US 46, Building E, Suite 117, Fairfield, NJ 07004, NDC 71399-8026-02.

Akron Pharma, Inc.

Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.

December 12, 2024 · DrugView details →

Class IIIOngoing

Acetaminophen Regular Strength, 325 mg, 100 Tablets per bottle, Akron Pharma, Inc., 373 RT US 46 W Building E, Suite 117, Fairfield, NJ 07004, NDC 71399-8024-01 .

Akron Pharma, Inc.

Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.

December 12, 2024 · DrugView details →

Class IIIOngoing

Diphenhydramine HCl 25 mg, 100 capsules per bottle, Akron Pharma, Manufactured for: Akron Pharma, Inc., 373 RT US 46 W Building E, Suite 117, Fairfield, NJ 07004, NDC 71399-8028-1.

Akron Pharma, Inc.

Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.

December 12, 2024 · DrugView details →

Class IIIOngoing

Acetaminophen Extra Strength 500 mg, 100 Tablets per bottle, Akron Pharma, Inc., 373 RT US 46 W Building E, Suite 117, Fairfield, NJ 07004, NDC 71399-8022-01.

Akron Pharma, Inc.

Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.

December 12, 2024 · DrugView details →

Class IIIOngoing

Acetaminophen Extra Strength 500 mg, 1000 Tablets per bottle, Akron Pharma, Manufactured for: Akron Pharma Inc., 373 US RT 46 W Building E, Suite 117, Fairfield, NJ 07034, NDC 71399-8022-02

Akron Pharma, Inc.

Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.

December 12, 2024 · DrugView details →

Class IIIOngoing

Javygtor (sapropterin dihydrochloride) Tablets 100mg, 120-count bottle, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540 Made in India, NDC 43598-096-04.

Dr. Reddy's Laboratories, Inc.

Failed Impurities/Degradation Specifications

November 22, 2024 · DrugView details →

Class IIIOngoing

Esomeprazole Magnesium for Delayed-Release Oral Suspension 40 mg, 30 Single-Dose Packets, Rx Only, Manufactured by: Zydus Lifesciences Ltd. Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-849-94. Packaged in sachets

Zydus Pharmaceuticals (USA) Inc

Labeling: Not Elsewhere Classified - Wrong NDC number

November 14, 2024 · DrugView details →

Class IIITerminated

Hydralazine HCl Tablets, USP, 25mg, Rx only, 100 tablets per carton, Distributed by: Avet Pharmaceuticals Inc., East Brunswick, NJ 08816, Distributed by: MAJOR Pharmaceuticals, Livonia, MI, 48152, USA, NDC 0904-6441-61.

The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories

Failed Impurities/Degradation Specifications; during routine stability testing for impurities.

November 5, 2024 · DrugView details →

Class IIIOngoing

IBU (ibuprofen) 600 mg tablets, 500-count bottle, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, NDC 55111-683-05

Dr. Reddy's Laboratories, Inc.

Failed Tablet/Capsule Specifications

October 29, 2024 · DrugView details →

Class IIITerminated

Triamcinolone Acetonide Cream USP, 0.025%, 1 LB (454 g) per jar, Rx Only, Manufactured By Padagis, Minneapolis, MN 55427. NDC: 45802-0063-05

Padagis US LLC

Subpotent and Superpotent Drug. Out of specification assay results recorded as part of Uniformity of Container test during long-term stability testing.

October 11, 2024 · DrugView details →

Class IIIOngoing

Ciclopirox Gel 0.77%, For Dermatologic Use Only, Not for Use in Eyes, Rx Only, a) 30 gm Tube, NDC 68462-0455-35; b) 45 gm Tube, NDC 68462-0455-47; c) 100 gm Tube, NDC 68462-0455-94, Manufactured by: Glenmark Pharmaceuticals, Ltd., Colvale-Bardez, Goa 403513, India, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430.

Glenmark Pharmaceuticals Inc., USA

Defective Container: Firm received complaints of broken tube at the seal.

September 30, 2024 · DrugView details →

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