FDA Drug recall D-0001-2025
Atorvastatin Calcium Tablets, USP, 40mg, Rx only, 1000 Tablets per bottle, Manufactured for: Nivagen Pharmaceuticals, Inc
- FDA Drug
- Class II
- terminated
- Published 2024-10-09
On 2024-10-09 the FDA classified a Class II recall of Atorvastatin Calcium Tablets, USP, 40mg, Rx only, 1000 Tablets per bottle, Manufactured for: Nivagen Pharmaceuticals, Inc by Nivagen Pharmaceuticals, citing 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.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0001-2025 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2024-09-24 |
| Published | 2024-10-09 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Nivagen Pharmaceuticals |
| Distribution | US |
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
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.
Identifiers
| ndc | 75834-256-90 |
|---|---|
| ndc | 75834-256-01 |
| ndc | 75834-256-05 |
| ndc | 75834-256-50 |
| ndc | 75834-255-90 |
| ndc | 75834-255-01 |
| ndc | 75834-255-05 |
| ndc | 75834-255-50 |
| ndc | 75834-257-90 |
| ndc | 75834-257-50 |
| ndc | 75834-257-25 |
| ndc | 75834-257-01 |
| ndc | 75834-258-90 |
| ndc | 75834-258-50 |
| ndc | 75834-258-02 |
| ndc | 75834-258-01 |
| code_info | Lot #: U24T0408A, Exp: 03/31/2026 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0001-2025%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.