Why it was recalled
Failed dissolution specifications: lower than specifications
Product description
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
Lot numbers, UPCs & expiration codes
Lot#: AVC24035, Exp 03/31/26
Where it was sold
U.S.A. nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0306-2025
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Mar 17, 2025
- FDA report date
- Apr 9, 2025
- Quantity
- 2184 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- BIOCON PHARMA INC
Original FDA data
Every field from FDA enforcement report D-0306-2025, exactly as published.
Show all FDA fields
- City
- ISELIN
- State
- NJ
- Status
- Ongoing
- Country
- United States
- Event ID
- 96496
- Address
- 485 HWY 1 (S)
- Code information
- Lot#: AVC24035, Exp 03/31/26
- Postal code
- 08830
- Report date
- Apr 9, 2025
- Product type
- Drugs
- Recall number
- D-0306-2025
- Classification
- Class II
- Recalling firm
- BIOCON PHARMA INC
- Product quantity
- 2184 bottles
- Reason for recall
- Failed dissolution specifications: lower than specifications
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- U.S.A. nationwide
- Recall initiation date
- Mar 17, 2025
- Center classification date
- Mar 28, 2025