FDA Drug recall D-0306-2025
Atorvastatin Calcium Tablets USP 40 mg, 1000-count bottle, Rx Only, Manufactured for: Biocon Pharma Inc., Iselin, NJ 08830-3009 USA, Manufa…
- FDA Drug
- Class II
- ongoing
- Published 2025-04-09
On 2025-04-09 the FDA classified a Class II recall of Atorvastatin Calcium Tablets USP 40 mg, 1000-count bottle, Rx Only, Manufactured for: Biocon Pharma Inc., Iselin, NJ 08830-3009 USA, Manufa… by Biocon Pharma, citing failed dissolution specifications: lower than specifications.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0306-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-03-17 |
| Published | 2025-04-09 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Biocon Pharma |
| Distribution | US |
Product
Atorvastatin Calcium Tablets USP 40 mg, 1000-count bottle, Rx Only, Manufactured for: Biocon Pharma Inc., Iselin, NJ 08830-3009 USA, Manufactured by: Recipharm Pharmaservices PVT, Ltd Bengaluru, INDIA -562-123, NDC 70377-079-13
Reason
Failed dissolution specifications: lower than specifications
Identifiers
| ndc | 70377-077-11 |
|---|---|
| ndc | 70377-077-13 |
| ndc | 70377-077-12 |
| ndc | 70377-078-11 |
| ndc | 70377-078-13 |
| ndc | 70377-078-12 |
| ndc | 70377-079-11 |
| ndc | 70377-079-12 |
| ndc | 70377-079-13 |
| ndc | 70377-080-11 |
| ndc | 70377-080-12 |
| ndc | 70377-080-13 |
| code_info | Lot#: AVC24035, Exp 03/31/26 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0306-2025%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.