# FDA recall D-0167-2025

> **Lupin Pharmaceuticals Inc.** · Class II · drug recall initiated 2024-12-20.

## Product

Levothyroxine Sodium Tablets, Lupin, 75 mcg (0.075mg), 1000 Tablets, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 United States, Manufactured by: Lupin Limited, Pithampur (M.P)- 454 775 INDIA, NDC# 68180-967-03

## Reason for recall

Failed Impurities/Degradation Specifications: Out of specifications result observed in the drug substance for impurity test during 3-month long term stability study.

## Distribution

One US distributor in Ohio.

## Key facts

- **Recall number:** D-0167-2025
- **Recalling firm:** Lupin Pharmaceuticals Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2024-12-20
- **Report date:** 2025-01-08
- **Termination date:** 2026-02-17

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Baltimore, MD, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0167-2025

## Citation

> AI Analytics. FDA recall D-0167-2025. Retrieved 2026-07-20 from https://api.ai-analytics.org/recall/D-0167-2025. Source: US FDA. Licensed CC0.

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