Benzodiazepine Tablets Recalled Over Label Strength Discrepancy
The US Food and Drug Administration (FDA) has announced a nationwide recall of clonazepam orally disintegrating tablets in various strengths distributed by PAR Pharmaceutical and manufactured by Endo USA, Inc. The recall involves multiple lot numbers across approximately 113 331 cartons due to a labeling error on the declared strength of the product cartons, although the blister strips inside the cartons are correctly labeled. This Class I recall—the most serious category—indicates a reasonable probability that the use of the product could cause adverse health consequences. The recall, initiated voluntarily by the firm on November 18, 2024, is still ongoing, with public notification provided via press releases.
The recall affects the following products:
- clonazepam orally disintegrating tablet, 2 mg, 60 tablets per carton (NDC 49884-310-02), 10 blister cards containing 6 tablets each (NDC 49884-310-52), from lots 550176501 and 550176601 (Exp. 02/28/2027);
- clonazepam orally disintegrating tablets, 0.125 mg, 60 tablets per carton (10 blister cards containing 6 tablets each), NDC 49884-306-02 (carton), NDC 49884-306-52 (blisters), from lot 550174101 (Exp. 01/31/2027);
- clonazepam orally disintegrating tablets, 0.25 mg, 60 tablets per carton (10 blister cards containing 6 tablets each), NDC 49884-307-02 (carton), NDC 49884-307-52 (blisters), from lots 550142801, 550142901, 550143001, 550143101, 550143201, 550143301, 550143401, 550147201, 550147401 (Exp. 08/31/2026);
- clonazepam orally disintegrating tablets, 1 mg, 60 tablets per carton (10 blister cards containing 6 tablets each), NDC 49884-309-02 (carton), NDC 49884-309-52 (blisters), from lot 550145201 (Exp. 08/31/2026) and lots 550175901, 550176001, 550176201 (Exp. 02/28/2027).
The affected products were distributed nationwide to pharmacies and health care providers. The recall was classified on January 3, 2025. Consumers and health care professionals are urged to inspect inventory for the specified lot numbers and cease distribution or use of the impacted products immediately. The recalling firm is Endo USA, Inc., headquartered in Malvern, Pennsylvania.
Clonazepam is a benzodiazepine commonly prescribed for managing seizure disorders, panic disorders, and certain anxiety conditions. The drug's potential for misuse and dependence, classified as a Schedule IV controlled substance, underscores the critical need for accurate labeling to prevent dosing errors. Pharmacists are encouraged to advise patients appropriately and facilitate returns or replacements through established recall procedures.
