D-0306-2025 Class II Ongoing
FDA drug recall D-0306-2025 was initiated by BIOCON PHARMA INC on Mar 17, 2025 and is designated Class II. Reason for recall: Failed dissolution specifications: lower than specifications The recall status is ongoing. Affected quantity: 2184 bottles.
Recall details
- Product Type
- Drugs
- Report Date
- Apr 9, 2025
- Initiation Date
- Mar 17, 2025
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2184 bottles
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
Reason for recall
Failed dissolution specifications: lower than specifications
Distribution pattern
U.S.A. nationwide
Code information
Lot#: AVC24035, Exp 03/31/26
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0306-2025
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026