TRAMADOL HYDROCHLORIDE
Recalling Firm / Manufacturer: Amneal Pharmaceuticals, LLC
(Bridgewater, NJ, United States)
FDA Recall Number: D-0408-2026
Source Authority Disclaimer: This drug recall notice is published by Questo using official enforcement reports issued by the U.S. Food & Drug Administration (FDA). It is provided for informational, academic, and clinical research purposes only. Patients should not discontinue prescribed treatments without consulting their physician or pharmacist.
Product & Identification Information
Brand, active ingredients, NDC codes, and manufacturer details
Brand / Trade Name
TRAMADOL HYDROCHLORIDE
Generic Name
TRAMADOL HYDROCHLORIDE
Active Substance(s)
Tramadol Hydrochloride
Administration Route
Oral
National Drug Code (NDC)
60219-2348
Total Quantity Recalled
29,542 bottles
Official Reason for Recall
Specific hazard or quality defect cited by the FDA
According to the official FDA enforcement report:
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).
Full Product Description
Packaging specifications and labeling details
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.
Enforcement & Regulatory Details
FDA classification, report dates, and initiation authority
Health Hazard Classification
Class II
Current Action Status
Ongoing
FDA Enforcement Report Date
April 08, 2026
Firm Initiation Date
March 19, 2026
FDA Classification Date
Mar 30, 2026
Initiation Type
Voluntary: Firm initiated
Affected Lots & Batch Numbers
Product codes, lot numbers, and expiration dates
Lot #: AM230987, Exp. Date 05/2026; AR232387, Exp. Date 12/2026.
Distribution Information
Geographic scope of affected shipments
Nationwide within the USA
Safety Guidance & Actions
Standard FDA protocol for patients and healthcare providers
Patient Advisory
Check your prescription bottle or packaging against the affected lot numbers listed above. If your medication matches a recalled lot, contact your pharmacist for replacement guidance.
Healthcare Provider Guidance
Audit pharmacy stock and return affected lots to the distributor per manufacturer instructions. Notify patients where clinically indicated.
Official Source Provenance
Verified regulatory citation from U.S. FDA OpenFDA
Primary Data Source: U.S. Food & Drug Administration (FDA) OpenFDA API
Recall Number: D-0408-2026
Questo Retrieval Date: July 31, 2026 14:36 1785508604UTCC