# FDA recall D-0001-2025

> **Nivagen Pharmaceuticals Inc** · Class II · drug recall initiated 2024-09-24.

## Product

Atorvastatin Calcium Tablets, USP, 40mg, Rx only, 1000 Tablets per bottle, Manufactured for: Nivagen Pharmaceuticals, Inc. Sacramento, CA 95827, USA, Manufactured by: Umedica Laboratories Pvt Ltd., Vapi Gujarat 396195, India, NDC: 75834-257-01.

## Reason for recall

Presence of Foreign Tablets/Capsules: A Carbamazepine Extended-Release 400 mg tablet was found in a 1000-count bottle of Atorvastatin Calcium Tablets, USP 40 mg.

## Distribution

Nationwide within the U.S

## Key facts

- **Recall number:** D-0001-2025
- **Recalling firm:** Nivagen Pharmaceuticals Inc
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2024-09-24
- **Report date:** 2024-10-09

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Sacramento, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0001-2025

## Citation

> AI Analytics. FDA recall D-0001-2025. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/D-0001-2025. Source: US FDA. Licensed CC0.

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*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*