# FDA recall D-0408-2026

> **Amneal Pharmaceuticals, LLC** · Class II · drug recall initiated 2026-03-19.

## Product

traMADol Hydrochloride Tablets, USP, 50 mg, 500-count bottles,  Rx only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Ahmedabad 382220, India, Distributed by: Amneal Pharmaceuticals LLC, Glasgow, KY 42141, NDC 60219-2348-5.

## Reason for recall

Failed Impurities/Degradation Specifications: N-nitroso-desmethyl-tramadol impurity (NDSRI) was found out of the specification at 24-month stability interval during Long term stability (25¿C/60%RH).

## Distribution

Nationwide within the USA

## Key facts

- **Recall number:** D-0408-2026
- **Recalling firm:** Amneal Pharmaceuticals, LLC
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2026-03-19
- **Report date:** 2026-04-08

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0408-2026

## Citation

> AI Analytics. FDA recall D-0408-2026. Retrieved 2026-07-01 from https://api.ai-analytics.org/recall/D-0408-2026. Source: US FDA. Licensed CC0.

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