Opioid Analgesic Recalled

The Harvard Drug Group is recalling 3876 cartons of tramadol hydrochloride tablets because of a packaging defect. According to the July 5, 2023, US Food and Drug Administration (FDA) Enforcement Report, the product’s blister packaging is inadequately sealed.

The recall affects tramadol hydrochloride tablets, 50 mg, unit dose 100-count tablets (NDC 0904-7179-61), from lot M04343 (Exp 4/24). The tablets were manufactured by Sun Pharmaceutical Industries Ltd, Dadra, India, and distributed by Sun Pharmaceutical Industries Inc, Cranbury, New Jersey, and Major Pharmaceuticals, Livonia, Michigan, throughout the United States.  

The Harvard Drug Group voluntarily initiated the recall June 16, 2023. The FDA designated the recall Class II on June 26, 2023. Products affected by Class II recalls may cause temporary or medically reversible adverse health consequences if used. A remote possibility of serious harm also exists.

Tramadol hydrochloride is a controlled substance available with a prescription for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are not adequate.