Recall archive / FDA drug enforcement
Extended Phenytoin Sodium Capsules, USP, 100 mg, Rx Only, 100 capsules per bottle, Distributed by: Amneal Pharmaceuti... — FDA record D-0876-2023
Reported terminated
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date May 30, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- Extended Phenytoin Sodium Capsules, USP, 100 mg, Rx Only, 100 capsules per bottle, Distributed by: Amneal Pharmaceuticals LLC., Bridgewater, NJ 08807, NDC 65162-212-10.
- Reason
- Failed Dissolution Specifications: Out-of-specification results for dissolution (above specification)
- Classification
- Class II
- Recalling firm
- Amneal Pharmaceuticals of New York, LLC
- Quantity
- 9,056 bottles
- Agency-reported status
- Terminated
- Source record identifier
- D-0876-2023
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Lot # HL00721A, Exp. 12/2023 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
LA, PA and OH.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Jun 21, 2023
- Recall initiation date
- May 30, 2023
- Center classification date
- Jun 15, 2023
- Termination date
- Jun 10, 2025
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.