Amneal traMADol 50mg Tablets Recall: NDSRI Impurity Risk
Amneal Pharmaceuticals recalls 50mg traMADol hydrochloride tablets with NDSRI impurity exceeding stability limits. This may pose health risks if used beyond expiration.
Lower-risk 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).
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What happened, in plain English
Amneal Pharmaceuticals is recalling 50mg traMADol hydrochloride tablets that contain an impurity (NDSRI) exceeding safety limits. This could pose health risks if the tablets are used after the expiration date. Read more at govinfonow.com/recall/31415-amneal-tramadol-50mg-tablets-recall-ndsri-impurity-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/31415-amneal-tramadol-50mg-tablets-recall-ndsri-impurity-risk · Updated August 10, 2026 · FDA enforcement record: FDA #D-0408-2026
Cite this page
“Amneal traMADol 50mg Tablets Recall: NDSRI Impurity Risk.” GovInfoNow, updated August 10, 2026. https://govinfonow.com/recall/31415-amneal-tramadol-50mg-tablets-recall-ndsri-impurity-risk. Based on FDA recall #D-0408-2026 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0408-2026%22&limit=1).
Why it’s dangerous
The tablets contain an impurity (NDSRI) that exceeds the safety limits set for stability testing at 24 months. This impurity could potentially cause health issues if the tablets are used beyond their expiration date.
Who’s affected
Prescription patients who have received the recalled 500-count bottles of 50mg traMADol hydrochloride tablets from Amneal Pharmaceuticals. Those with specific medical conditions requiring this medication are most at risk.
How to tell if you have this one
Check for the 500-count bottles labeled 'traMADol Hydrochloride Tablets, USP, 50 mg' with NDC 60219-2348-5. The lot numbers AM230987 (expiring 05/2026) and AR232387 (expiring 12/2026) are associated with this recall.
- Brand
Amneal Pharmaceuticals- Category
Drug
What to do — step by step
Check Expiration Date
Verify the expiration date on the bottle; the recalled items expire by May 2026 or December 2026.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide within the USA” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 20 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0408-2026 (March 19, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0408-2026 to see it in context.
- Plain-language summary written by qwen3:4b on August 10, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.