Atorvastatin Calcium Tablets — Class II drug recall D-0001-2025
Terminated recall by Nivagen Pharmaceuticals Inc, reported 2024-10-09, distributed nationwide. Presence of Foreign Tablets/Capsules: A Carbamazepine Extended-Release 400 mg tablet was found in a 1000-count
| Recall number | D-0001-2025 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Nivagen Pharmaceuticals Inc, Sacramento, CA, United States |
| Recall initiated | 2024-09-24 |
| Classified | 2024-10-02 |
| Reported by FDA | 2024-10-09 |
| Terminated | 2026-07-01 |
| Distributed | Nationwide (US) |
| Quantity | 2,328 bottles |
| NDC | 75834-0255, 75834-0255-01, 75834-0255-05, 75834-0255-50, 75834-0255-90, 75834-0256, 75834-0256-01, 75834-0256-05, 75834-0256-50, 75834-0256-90, 75834-0257, 75834-0257-01, 75834-0257-25, 75834-0257-50, 75834-0257-90, 75834-0258, 75834-0258-01, 75834-0258-02, 75834-0258-50, 75834-0258-90 |
| Lot numbers | U24T0408A |
| Expiration dates | 2026-03-31 |
Product
Atorvastatin Calcium Tablets, USP, 40mg, Rx only, 1000 Tablets per bottle, Manufactured for: Nivagen Pharmaceuticals, Inc. Sacramento, CA 95827, USA, Manufactured by: Umedica Laboratories Pvt Ltd., Vapi Gujarat 396195, India, NDC: 75834-257-01.
Reason for recall
Presence of Foreign Tablets/Capsules: A Carbamazepine Extended-Release 400 mg tablet was found in a 1000-count bottle of Atorvastatin Calcium Tablets, USP 40 mg.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0001-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.