Clonazepam Orally Disintegrating Tablets, USP (C-IV) 0.125mg, 60 tablets per carton (10 blister cards containing 6 tablets each), Rx Only, Distributed by: Par Pharmaceutical, Chestnut Ridge, NY 10977, NDC# 49884-306-02.

FDA recall notice · announced August 7, 2024 · Endo Pharmaceuticals

Class I FDA/FSIS Class I: reasonable probability that use will cause serious adverse health consequences or death.

The product

Clonazepam Orally Disintegrating Tablets, USP (C-IV) 0.125mg, 60 tablets per carton (10 blister cards containing 6 tablets each), Rx Only, Distributed by: Par Pharmaceutical, Chestnut Ridge, NY 10977, NDC# 49884-306-02.

Reason for recall

Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled as 0.125 mg instead of 0.25 mg. The blister strips inside the product carton reflect the correct strength of 0.25 mg.

Notes

Distribution: Nationwide in the USA and Puerto Rico
Lot/code information: Lot 550147301, Exp. 08/31/2026
Quantity: 8,139 cartons
Status: Terminated
Products in this recall event:
- Clonazepam Orally Disintegrating Tablets, USP (C-IV) 0.125mg, 60 tablets per carton (10 blister cards containing 6 tablets each), Rx Only, Distributed by: Par Pharmaceutical, Chestnut Ridge, NY 10977, (D-0622-2024)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.