U.S. Food and Drug Administration

SEP 2, 2026 · SAFETY RECALL

Class II recall: Levothyroxine Sodium Tablets, USP, 137 mcg (0.137 mg), packaged in a) 90-count bottles (NDC 16729-454-15) b) 1000-count bottles (NDC 16729-454-17), Rx Only, Man

U.S. Food and Drug Administration

FDA Class II recall of levothyroxine sodium tablets for subpotent drug distribution; a safety action requiring immediate attention but not a clinical trial.

SEP 2, 2026 · SAFETY RECALL

Class II recall: Levothyroxine Sodium Tablets, USP, 75 mcg (0.075 mg), 1000-count bottles, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by

U.S. Food and Drug Administration

FDA Class II recall of levothyroxine sodium tablets for subpotency; affects patients nationwide and requires immediate clinical attention to dosing adequacy.

SEP 2, 2026 · SAFETY RECALL

Class II recall: Acthar Gel (repository corticotropin injection), 5 mL multiple-dose vial, Rx Only, Mfd. for: Mallinckrodt ARD LLC, Bridgewater, NJ 08807, NDC 63004-8710-1 & NDC

U.S. Food and Drug Administration

FDA Class II recall of Acthar Gel due to presence of particulate matter (glass and stopper fragments) affecting product safety and integrity.

SEP 2, 2026 · SAFETY RECALL

Class II recall: Clobetasol Propionate Cream USP, 0.05%, 60 g tube, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc., Naples, FL 34108, United States, Manufactured by: Lup

U.S. Food and Drug Administration

FDA Class II recall for failed content uniformity in clobetasol propionate cream; affects drug safety and product integrity nationwide.

SEP 2, 2026 · SAFETY RECALL

Class II recall: Paxil CR, Paroxetine, Extended-Release Tablets, 37.5mg, 30 count bottle, Rx only, Manufactured by: Apotex Inc., Toronto, Ontario, Canada M9L 1T9, Manufactured f

U.S. Food and Drug Administration

FDA Class II recall of Paxil CR 37.5 mg due to failed dissolution specifications and stability testing; affects product quality and bioavailability but does not report clinical outcomes.

SEP 2, 2026 · SAFETY RECALL

Class II recall: Levothyroxine Sodium Tablets, USP, 125 mcg (0.125 mg), 1000-count bottles, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured b

U.S. Food and Drug Administration

FDA Class II recall of levothyroxine sodium tablets for subpotent drug distribution; affects patients nationwide who may receive ineffective thyroid replacement therapy.

SEP 2, 2026 · SAFETY RECALL

Class II recall: Levothyroxine Sodium Tablets, USP, 175 mcg (0.175 mg), packaged in a) 90-count bottles (NDC 16729-456-15), and b) 1000-count bottles (NDC 16729-456-17), Rx Only

U.S. Food and Drug Administration

FDA Class II recall of levothyroxine sodium tablets due to subpotency, affecting drug distribution nationwide and requiring clinical awareness of affected batches.

SEP 2, 2026 · SAFETY RECALL

Class II recall: Levothyroxine Sodium Tablets, USP, 50 mcg (0.05 mg), 1000-count bottles, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by:

U.S. Food and Drug Administration

FDA Class II recall of levothyroxine sodium tablets for subpotency; a safety action affecting drug quality and patient safety nationwide.