Recalls / Class II
Class IID-0201-2025
Product
Clobazam Tablets, 10 mg, packaged in 30 tablets per carton (3x10 blister cards each), Rx Only, Amneal Pharmaceuticals LLC, Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC 60687-423-11
- Brand name
- Clobazam
- Generic name
- Clobazam
- Active ingredient
- Clobazam
- Route
- Oral
- NDC
- 60687-423
- FDA application
- ANDA209718
- Affected lot / code info
- Lot #: 1018598, Exp. Date 10/31/2025
Why it was recalled
Presence of Foreign Tablets/Capsules
Recalling firm
- Firm
- Amerisource Health Services LLC
- Manufacturer
- American Health Packaging
- Type
- Voluntary: Firm initiated
- Address
- 2550 John Glenn Ave Ste A, Columbus, Ohio 43217-1188
Distribution
- Quantity
- 4640 units
- Distribution pattern
- Nationwide within the United States
Timeline
- Recall initiated
- 2025-01-07
- FDA classified
- 2025-01-14
- Posted by FDA
- 2025-01-22
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0201-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.