Recalls / Class I
Class ID-0180-2025
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences or death.
Product
Clonazepam Orally Disintegrating Tablets, USP, 0.25 mg, C-IV, Rx Only, 60 tablets per carton (10 blister cards containing 6 tablets each), Distributed by: PAR Pharmaceutical, Chestnut Ridge, NY 10977, NDC#: 49884-307-02 (carton), NDC #: 49884-307-52 (blisters).
- Brand name
- Clonazepam
- Generic name
- Clonazepam
- Active ingredient
- Clonazepam
- Route
- Oral
- NDCs
- 49884-306, 49884-307, 49884-308, 49884-309, 49884-310
- FDA application
- ANDA077171
- Affected lot / code info
- Lot #s: 550142801, 550142901, 550143001, 550143101, 550143201, 550143301, 550143401, 550147201, 550147401, Exp. 08/31/2026.
Why it was recalled
Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. The blister strips inside the product carton reflect the correct strength.
Recalling firm
- Firm
- Endo USA, Inc.
- Manufacturer
- Par Health USA, LLC
- Notification channel
- Press Release
- Type
- Voluntary: Firm initiated
- Address
- 1400 Atwater Dr, Malvern, Pennsylvania 19355-8701
Distribution
- Quantity
- 72,973 cartons
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2024-11-18
- FDA classified
- 2025-01-03
- Posted by FDA
- 2025-01-15
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0180-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.