Posaconazole Delayed-Release Tablets — Class II drug recall D-0268-2023
Terminated recall by BIOCON PHARMA INC, reported 2023-02-15, distributed nationwide. Failed Impurities/Degradation Specifications: High Out Of Specification degradation results.
| Recall number | D-0268-2023 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | BIOCON PHARMA INC, ISELIN, NJ, United States |
| Recall initiated | 2023-01-31 |
| Classified | 2023-02-14 |
| Reported by FDA | 2023-02-15 |
| Terminated | 2024-06-21 |
| Distributed | Nationwide (US) |
| Quantity | 3,665 bottles |
| Reason classes | specification failure |
| NDC | 70377-0038, 70377-0038-11 |
| Lot numbers | BF21003161, BF21003163, BF21003246, BF21004742, BF22003359, DEC-2023, SEP-2023, SEP-2025 |
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 for recall
Failed Impurities/Degradation Specifications: High Out Of Specification degradation results.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0268-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.