ISELIN, NJ, United States
BIOCON PHARMA INC recalls
2 recalls recorded since 2018, most recently on 17 March 2025. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls2
Ongoing (FDA)1
Terminated or completed1
Class I (FDA)0
Ongoing Class II Drugs
- Recall started
- 17 March 2025
- Reason
- Failed dissolution specifications: lower than specifications
- Distribution
- U.S.A. nationwide
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0306-2025
- 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
Terminated Class II Drugs
- Recall started
- 31 January 2023
- Terminated
- 21 June 2024
- Reason
- Failed Impurities/Degradation Specifications: High Out Of Specification degradation results.
- Distribution
- Nationwide in the USA
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0268-2023
- Posaconazole Delayed-Release Tablets, 100 mg, 60-count bottle, Rx Only, Manufactured for: Biocon Pharma Inc., Iselin, NJ 08830-3009; Manufactured by: Biocon Pharma Limited, Bengaluru, India - 560 099, NDC 70377-038-11.
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.