Obstetric Drug Recalled for Subpotency

Amneal Pharmaceuticals of New York is recalling 2784 bottles of methylergonovine maleate tablets because they are subpotent, according to the May 8, 2024, US Food and Drug Administration (FDA) Enforcement Report.

The recall affects 12-count bottles of methylergonovine maleate tablets, 0.2 mg (NDC 69238-1605-2), from lot BJ01922A (Exp. 3/24). Amneal Pharmaceuticals, Bridgewater, New Jersey, distributed the drug throughout the United States.

Amneal Pharmaceuticals voluntarily initiated the recall on March 25, 2024. The FDA designated it Class II on April 29, 2024. Per the classification, use of the affected drug could cause temporary or medically reversible adverse health consequences. A remote possibility of serious harm also exists.

Methylergonovine maleate is a semi-synthetic ergot alkaloid used for the prevention and control of postpartum hemorrhage.