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  1. FDA Recalls
  2. ›Drug Recalls

FDA Drug Recalls

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

Classification
AllClass IClass IIClass III
Status
AllOngoingCompletedTerminated
Date
All timePast 30 daysPast 12 months

Showing 81–100 of 1,000 recalls

Class IIICompleted

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 Pharmaceuticals: Kowa Pharmaceuticals America Inc., Montgomery, AL 36117 USA NDC 66869-404-90 HDPE Bottle, congregated into a shrink wrapped 6-pack further congregated into 24 6-packs in a cardboard case

Kowa Pharmaceuticals America

Presence of foreign tablets/capsules

February 24, 2025 · DrugView details →
Class IIIOngoing

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, NDC: 71384-733-05.

Imprimis NJOF, LLC

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.

February 24, 2025 · Drug
View details →
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 IIICompleted

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 →
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