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FDA Drug Recalls

1,709 recalls · Class III, newest first

Class III · Low risk Completed Jul 9, 2025

Tropicamide-Proparacaine-Phenylephrine-Ketorolac, Sterile Ophthalmic Solution, 1% 0.5% 2.5% 0.5%, 5mL, 2x5ML vial per carton, Rx…

Reason Sub-Potent Drug: Subpotent assay results during stability testing.

Imprimis NJOF, LLC NDC 71384-733-05 D-0536-2025

Class III · Low risk Ongoing Jun 26, 2025

Pitavastatin Tablets, 2 mg, 90 Tablets per bottle, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478. NDC: 42291-906-90

Reason Failed Impurity/Degradation Specifications

AvKARE D-0529-2025

Class III · Low risk Ongoing Jun 26, 2025

Pitavastatin Tablets, 1 mg, 90 Tablets per bottle, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478. NDC: 42291-905-90

Reason Failed Impurity/Degradation Specifications

AvKARE D-0528-2025

Class III · Low risk Ongoing Jun 16, 2025

Testosterone 200 mg Pellet packaged in 1mL amber vials, Rx only, Compounded product. Qualgen 14844 Bristol Park Blvd Edmond OK…

Reason Labeling: Incorrect or Missing Lot and/or Exp. Date: A printing issue resulted in incorrect lot numbers on the label.

Qualgen, LLC NDC 69761-202-01 D-0517-2025

Class III · Low risk Ongoing Jun 11, 2025

Pitavastatin Tablets, 1 mg, Rx Only, 90 Tablets, Manufactured by: Orient Pharma Co., Ltd., 8 Kehu 1st Road, Huwei Chen, Yunlin…

Reason Failed Impurities/Degradation Specifications.

Orient Pharma Co., Ltd. Yunlin Plant NDC 0480-3631-98 D-0527-2025

Class III · Low risk Ongoing Jun 11, 2025

Pitavastatin Tablets, 2 mg, Rx Only, 90 Tablets, Manufactured by: Orient Pharma Co., Ltd., 8 Kehu 1st Road, Huwei Chen, Yunlin…

Reason Failed Impurities/Degradation Specifications.

Orient Pharma Co., Ltd. Yunlin Plant NDC 0480-3632-98 D-0526-2025

Class III · Low risk Ongoing Jun 11, 2025

Famciclovir Tablets, USP 500 mg, 30-count bottles, Rx Only, Manufactured for: Macleods Pharma USA, Inc., Manufactured by…

Reason Presence of Foreign Substance- Black hair strand found attached to a tablet in a sealed bottle.

Macleods Pharmaceuticals Ltd NDC 33342-026-07 D-0509-2025

Class III · Low risk Ongoing May 29, 2025

Levothyroxine Sodium Tablets, USP 112 mcg (0.112mg), 1000 tablets, Rx Only, Manufactured for: Macleods Pharma USA, Inc…

Reason Presence of a foreign substance: black hair found embedded in tablet.

Macleods Pharmaceuticals Ltd NDC 33342-398-44 D-0470-2025

Class III · Low risk Ongoing May 19, 2025

Ezetimibe and Simvastatin Tablets, 10mg/40mg, 90-count bottle, Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd., Plot No…

Reason Failed Impurities/Degradation Specifications: Out of Specification (OOS) for related substances test for Anhydro Simvastatin at the 06-month time…

Glenmark Pharmaceuticals Inc., USA NDC 68462-323-90 D-0462-2025

Class III · Low risk Terminated Apr 15, 2025

HYDROmorphone Hydrochloride 50mg/50mL (1mg/mL), packaged in a 50 mL Cassette, Rx Only, OurPharma, LLC, 2512 S. City Lake Rd…

Reason Superpotent Drug: Assay/potency result for hydromorphone HCl in the compounded stability lot was higher than specification..

OurPharma LLC NDC 73013-1040-01 D-0385-2025

Class III · Low risk Ongoing Mar 4, 2025

Gabapentin Capsules, USP 400 mg, Rx Only, Packaged in a) 500-count bottles, NDC 62756-139-05; b) 1000-count bottles, NDC…

Reason Cross Contamination

Sun Pharmaceutical Industries INC NDC 62756-139-05 D-0312-2025

Class III · Low risk Ongoing Mar 4, 2025

Gabapentin Capsules, USP 300 mg, Rx Only, Packaged in a) 500-count bottles, NDC 62756-138-05; b) 1000-count bottles, NDC…

Reason Cross Contamination

Sun Pharmaceutical Industries INC NDC 62756-138-05 D-0311-2025

Class III · Low risk Terminated Mar 4, 2025

Tolterodine Tartrate Extended-Release Capsules, 2 mg, 30 Capsules (3 x 10) Unit Dose carton, Rx only, Packaged and Distributed…

Reason Failed Dissolution Specifications: Out of specification results obtained during routine stability testing for dissolution.

The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories NDC 0904-6592-04 D-0304-2025

Class III · Low risk Ongoing Feb 24, 2025

Tropicamide - Proparacaine - Phenylephrine - Ketorolac Sterile Ophthalmic Solution, 1% 0.5% 2.5% 0.5%, 5 mL fill in 15 mL…

Reason 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.

Imprimis NJOF, LLC D-0305-2025

Class III · Low risk Completed Feb 24, 2025

Livalo (pitavatstatin) tablets, 4 mg, 90-count bottles, Rx only, Manufactured by: Patheon, Inc. Cincinnati, OH 45237 USA or by…

Reason Presence of foreign tablets/capsules

Kowa Pharmaceuticals America NDC 66869-404-90 D-0258-2025

Class III · Low risk Terminated Jan 17, 2025

BADGER 50, ADVENTURE SPORT MINERAL SUNSCREEN WITH CLEAR ZINC, (uncoated 25% zinc oxide), 2.4 oz., Tin, W.S. Badger Company, Inc…

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

The W.S. Badger Company, Inc. D-0209-2025

Class III · Low risk Completed Jan 16, 2025

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

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

Appco Pharma LLC NDC 43598-943-90 D-0208-2025

Class III · Low risk Terminated Jan 7, 2025

Guaifenesin and Codeine Phosphate Oral Solution USP, 100mg/10 mg per 5 mL, 16 fl oz (473 ml) bottles, PAI Pharmaceutical…

Reason Superpotent; sodium benzoate preservative

PAI Holdings, LLC. dba Pharmaceutical Associates Inc NDC 0121-0775-16 D-0222-2025

Class III · Low risk Ongoing Dec 19, 2024

Methadone Hydrochloride Tablets, USP, 5mg, 10x10 Unit-Dose Tablets, Rx Only, Distributed by: Hikma Pharmaceuticals USA Inc…

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

West-Ward Columbus Inc NDC 0054-0709-20 D-0183-2025

Class III · Low risk Ongoing Dec 18, 2024

Polyvinyl Alcohol Ophthalmic Solution 1.4%, Moisturizing Lubricant Eye Drops, 0.5 FL OZ (15 mL) bottles, Distributed by AvKARE…

Reason LABELING: LABEL MIX-UP

AvKARE NDC 50268-678-15 D-0176-2025

Class III · Low risk Ongoing Dec 18, 2024

Carboxymethylcellulose Sodium Ophthalmic Solution 0.5% Moisturizing Lubricant Eye Drops, 0.5 FL OZ (15 mL) bottles, Distributed…

Reason LABELING: LABEL MIX-UP

AvKARE NDC 50268-068-15 D-0175-2025

Class III · Low risk Terminated Dec 16, 2024

Atropine Sulfate Ophthalmic Solution, USP 1%, 5 mL bottles, Rx only, Manufactured for: Somerset Therapeutics, LLC. Somerset, NJ…

Reason Failed Impurities/Degradation Specifications

Somerset Therapeutics LLC NDC 70069-716-01 D-0169-2025

Class III · Low risk Ongoing Dec 12, 2024

Diphenhydramine HCl 50 mg, 1000 capsules per bottle, Akron Pharma, Manufactured for: Akron Pharma, Inc. 373 Route US 46, Building…

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

Akron Pharma, Inc. NDC 71399-8026-02 D-0199-2025

Class III · Low risk Ongoing Dec 12, 2024

Diphenhydramine HCl 25 mg, 1000 Capsules per bottle, Akron Pharma, Manufactured for: Akron Pharma, Inc., 373 RT US 46 W Building…

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

Akron Pharma, Inc. NDC 71399-8028-2 D-0198-2025

Class III · Low risk Ongoing Dec 12, 2024

Diphenhydramine HCl 25 mg, 100 capsules per bottle, Akron Pharma, Manufactured for: Akron Pharma, Inc., 373 RT US 46 W Building…

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

Akron Pharma, Inc. NDC 71399-8028-1 D-0197-2025