Amneal tramadol tablets failed nitrosamine impurity specification at stability
Amneal Pharmaceuticals is recalling two lots of Tramadol Hydrochloride Tablets 50 mg after a nitrosamine impurity was found out of specification at the 24-month stability interval.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: Rubric level 3 covers risk-of-harm products where injury has not yet been reported: a nitrosamine impurity was found above specification in a prescription medicine, and no injuries are stated in the source.
Plain-English summary
Amneal Pharmaceuticals, LLC is recalling Tramadol Hydrochloride Tablets USP, 50 mg, in 500-count bottles, prescription only, manufactured in Ahmedabad, India, NDC 60219-2348-5. About 29,542 bottles were distributed nationwide within the United States. The FDA has classified this recall as Class II.
The recall was initiated for failed impurities and degradation specifications: the N-nitroso-desmethyl-tramadol impurity, a nitrosamine drug substance related impurity, was found out of specification at the 24-month interval during long term stability testing at 25°C and 60% relative humidity.
Affected product covers lot AM230987 (expiry 05/2026) and lot AR232387 (expiry 12/2026).
Patients and pharmacies can identify affected product by the NDC and lot numbers above, and may contact Amneal Pharmaceuticals, LLC for further information.
The recalled product
- Product
- TRAMADOL HYDROCHLORIDE (TRAMADOL HYDROCHLORIDE)
- Brand
- TRAMADOL HYDROCHLORIDE
- Manufacturer
- Amneal Pharmaceuticals, LLC
- Category
- Drug — Prescription tablet
- Affected units
- 29,542
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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