Atorvastatin Calcium Tablets USP 40 mg — Class II drug recall D-0306-2025
Ongoing recall by BIOCON PHARMA INC, reported 2025-04-09, distributed nationwide. Failed dissolution specifications: lower than specifications
| Recall number | D-0306-2025 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | BIOCON PHARMA INC, ISELIN, NJ, United States |
| Recall initiated | 2025-03-17 |
| Classified | 2025-03-28 |
| Reported by FDA | 2025-04-09 |
| Distributed | Nationwide (US) |
| Quantity | 2,184 bottles |
| Reason classes | specification failure |
| NDC | 70377-0077, 70377-0077-11, 70377-0077-12, 70377-0077-13, 70377-0078, 70377-0078-11, 70377-0078-12, 70377-0078-13, 70377-0079, 70377-0079-11, 70377-0079-12, 70377-0079-13, 70377-0080, 70377-0080-11, 70377-0080-12, 70377-0080-13 |
| Lot numbers | AVC24035 |
| Expiration dates | 2026-03-31 |
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 for recall
Failed dissolution specifications: lower than specifications
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-0306-2025. 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.