FDA Recall D-0306-2025
BIOCON PHARMA INC · ISELIN, NJ
Class II Ongoing 423 days on record
Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.
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
Recall record
- Recall number
D-0306-2025- Classification
- Class II
- Status
- Ongoing
- Voluntary or mandated
- Voluntary: Firm initiated
- Distribution
- U.S.A. nationwide
- Recall initiated
- 2025-03-17
- Classified by FDA Center
- 2025-03-28
- FDA published
- 2025-04-09
- Recalling firm
- BIOCON PHARMA INC
- Firm location
- ISELIN, NJ
Drug identification
- Brand name(s)
- ATORVASTATIN CALCIUM
- Generic name(s)
- ATORVASTATIN CALCIUM
- Manufacturer(s)
- Biocon Pharma Inc.
- NDC(s)
70377-077, 70377-078, 70377-079, 70377-080- Route(s)
- ORAL
Operational response
Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.
For the official FDA enforcement record, see FDA's Recall Search.