# FDA recall D-0306-2025

> **BIOCON PHARMA INC** · Class II · drug recall initiated 2025-03-17.

## Product

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

U.S.A. nationwide

## Key facts

- **Recall number:** D-0306-2025
- **Recalling firm:** BIOCON PHARMA INC
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2025-03-17
- **Report date:** 2025-04-09

- **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-0306-2025

## Citation

> AI Analytics. FDA recall D-0306-2025. Retrieved 2026-06-03 from https://api.ai-analytics.org/recall/D-0306-2025. Source: US FDA. Licensed CC0.

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