Class II Recall for Tramadol Hydrochloride Due to Nitrosamine Impurity Above Specifications

The US Food and Drug Administration (FDA) has classified a Class II recall for tramadol hydrochloride tablets, USP, 50 mg, packaged in 500-count bottles (NDC 60219-2348-5). The product was manufactured by Amneal Pharmaceuticals Pvt. Ltd. in Ahmedabad, India, and distributed in the US by Amneal Pharmaceuticals LLC, Glasgow, KY. The recall affects 29,542 bottles distributed nationwide, specifically Lot #AM230987 (Exp. 05/2026) and Lot #AR232387 (Exp. 12/2026). The recall was initiated on March 19, 2026.

The recall was prompted by out-of-specification impurity results identified during 24-month long-term stability testing (25°C/60%RH). The impurity, N-nitroso-desmethyl-tramadol (NDSRI)—a nitrosamine compound—was found above acceptable limits. Nitrosamines are classified as probable human carcinogens, raising concerns for long-term exposure. The FDA designated this as a Class II recall on March 30, 2026, indicating that use of the affected product may cause temporary or medically reversible adverse health consequences, with a low likelihood of serious harm. No press release has been issued; recall communication details were not specified.

Tramadol is a centrally acting opioid analgesic indicated for the management of moderate to moderately severe pain. It is widely used in both acute and chronic pain settings. Pharmacists should identify and quarantine the affected lots, ensure removal from inventory, and coordinate replacement supply. Patients should not abruptly discontinue opioid therapy without medical guidance; pharmacists should work with prescribers to ensure safe continuity of care while minimizing exposure to nitrosamine impurities.

Reference

FDA. Enforcement Report. April 8, 2026. Accessed April 9, 2026. https://www.accessdata.fda.gov/scripts/ires/index.cfm