FDA Drug recall D-0268-2023
Posaconazole Delayed-Release Tablets, 100 mg, 60-count bottle, Rx Only, Manufactured for: Biocon Pharma Inc., Iselin, NJ 08830-3009
- FDA Drug
- Class II
- terminated
- Published 2023-02-15
On 2023-02-15 the FDA classified a Class II recall of Posaconazole Delayed-Release Tablets, 100 mg, 60-count bottle, Rx Only, Manufactured for: Biocon Pharma Inc., Iselin, NJ 08830-3009 by Biocon Pharma, citing failed Impurities/Degradation Specifications: High Out Of Specification degradation results.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0268-2023 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2023-01-31 |
| Published | 2023-02-15 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Biocon Pharma |
| Distribution | US |
Product
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.
Reason
Failed Impurities/Degradation Specifications: High Out Of Specification degradation results.
Identifiers
| ndc | 70377-038-11 |
|---|---|
| code_info | Lot #: BF21003163, BF21003246, BF21003161, Exp. Sep-2023; BF21004742, Exp. Dec-2023; BF22003359, Exp. Sep-2025 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0268-2023%22
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