[pending] TRAMADOL HYDROCHLORIDE (TRAMADOL HYDROCHLORIDE)
Pending LLM rewrite. Source: FDA_DRUG D-0408-2026.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
Plain-English summary
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).
The recalled product
- Product
- TRAMADOL HYDROCHLORIDE (TRAMADOL HYDROCHLORIDE)
- Brand
- TRAMADOL HYDROCHLORIDE
- Manufacturer
- Amneal Pharmaceuticals, LLC
- Category
- Drug — Drugs
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Lot #: AM230987
- Exp. Date 05/2026
- AR232387
- Exp. Date 12/2026.
Distribution
Distributed nationwide across the United States.
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