Recalls / Class II
Class IID-0306-2025
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
- Brand name
- Atorvastatin Calcium
- Generic name
- Atorvastatin Calcium
- Active ingredient
- Atorvastatin Calcium Trihydrate
- Route
- Oral
- NDCs
- 70377-077, 70377-078, 70377-079, 70377-080
- FDA application
- ANDA216436
- Affected lot / code info
- Lot#: AVC24035, Exp 03/31/26
Why it was recalled
Failed dissolution specifications: lower than specifications
Recalling firm
- Firm
- BIOCON PHARMA INC
- Manufacturer
- Biocon Pharma Inc.
- Type
- Voluntary: Firm initiated
- Address
- 485 HWY 1 (S), ISELIN, New Jersey 08830
Distribution
- Quantity
- 2184 bottles
- Distribution pattern
- U.S.A. nationwide
Timeline
- Recall initiated
- 2025-03-17
- FDA classified
- 2025-03-28
- Posted by FDA
- 2025-04-09
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0306-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.