# FDA recall D-0268-2023

> **BIOCON PHARMA INC** · Class II · drug recall initiated 2023-01-31.

## 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.

## Distribution

Nationwide in the USA

## Key facts

- **Recall number:** D-0268-2023
- **Recalling firm:** BIOCON PHARMA INC
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2023-01-31
- **Report date:** 2023-02-15
- **Termination date:** 2024-06-21

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** ISELIN, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0268-2023

## Citation

> AI Analytics. FDA recall D-0268-2023. Retrieved 2026-06-03 from https://api.ai-analytics.org/recall/D-0268-2023. Source: US FDA. Licensed CC0.

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