Class III · Low risk Ongoing
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.
FDA Drug Recalls
164 recalls · Class III, newest first
Class III · Low risk Ongoing
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.
Class III · Low risk Ongoing
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.
Class III · Low risk Ongoing
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.
Class III · Low risk Ongoing
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…
Class III · Low risk Ongoing
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
Class III · Low risk Ongoing
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
Class III · Low risk Ongoing
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.
Class III · Low risk Ongoing
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.
Class III · Low risk Ongoing
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
Class III · Low risk Ongoing
Carboxymethylcellulose Sodium Ophthalmic Solution 0.5% Moisturizing Lubricant Eye Drops, 0.5 FL OZ (15 mL) bottles, Distributed…
Reason LABELING: LABEL MIX-UP
Class III · Low risk Ongoing
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.
Class III · Low risk Ongoing
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.
Class III · Low risk Ongoing
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.
Class III · Low risk Ongoing
Acetaminophen Extra Strength 500 mg, 1000 Tablets per bottle, Akron Pharma, Manufactured for: Akron Pharma Inc., 373 US RT 46 W…
Reason Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.
Class III · Low risk Ongoing
Acetaminophen, 325 mg Tablets, 100 Tablets per bottle, Akron Pharma, Manufactured for: Akron Pharma Inc., Fairfield, NJ 07034…
Reason Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.
Class III · Low risk Ongoing
Acetaminophen Regular Strength, 325 mg, 100 Tablets per bottle, Akron Pharma, Inc., 373 RT US 46 W Building E, Suite 117…
Reason Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.
Class III · Low risk Ongoing
Acetaminophen Extra Strength 500 mg, 100 Tablets per bottle, Akron Pharma, Inc., 373 RT US 46 W Building E, Suite 117, Fairfield…
Reason Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.
Class III · Low risk Ongoing
Javygtor (sapropterin dihydrochloride) Tablets 100mg, 120-count bottle, Rx Only, Distributor: Dr. Reddy's Laboratories Inc…
Reason Failed Impurities/Degradation Specifications
Class III · Low risk Ongoing
Esomeprazole Magnesium for Delayed-Release Oral Suspension 40 mg, 30 Single-Dose Packets, Rx Only, Manufactured by: Zydus…
Reason Labeling: Not Elsewhere Classified - Wrong NDC number
Class III · Low risk Ongoing
IBU (ibuprofen) 600 mg tablets, 500-count bottle, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made…
Reason Failed Tablet/Capsule Specifications
Class III · Low risk Ongoing
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…
Reason Defective Container: Firm received complaints of broken tube at the seal.
Class III · Low risk Ongoing
Kids' Cough and Chest Congestion (Dextromethorphan HBr, USP 5mg/ Guaifenesin, USP 100 mg), packaged in 4 oz bottles further…
Reason Crystallization: Lack of uniformity - a change in texture, chunky, grainy, and small crystal substances inside the bottles.
Class III · Low risk Ongoing
Adult Cough and Chest Congestion (Dextromethorphan HBr USP 20 mg, Guaifenesin USP 400mg), packaged in 4 oz bottles further…
Reason Crystallization: Lack of uniformity - a change in texture, chunky, grainy, and small crystal substances inside the bottles.
Class III · Low risk Ongoing
AcetaZOLAMIDE Tablets, USP, 125 mg, 100 count bottled, Rx Only, Distributed by: Advagen Pharma Limited, Plainsboro, NJ…
Reason Discoloration