October 17, 2019
Amneal Pharmaceuticals Inc. is recalling 9720 bottles of benazepril hydrochloride tablets, 40 mg, after a foreign tablet was found in a bottle. According to the October 16, 2019, US Food and Drug Administration (FDA) Enforcement Report, the foreign tablet was promethazine hydrochloride, a prescription drug used to treat allergies and motion sickness.
The recall affects 100-count bottles of benazepril hydrochloride (NDC 65162-754-10) from lot BB02619A (Exp. 4/21). The bottles were sent throughout the United States to 13 major distributors that may have further distributed them.
Amneal Pharmaceuticals voluntarily initiated the recall September 24, 2019. The FDA designated the recall Class III on October 9, 2019. Under the recall classification, use of the affected tablets is not likely to cause harm.
Benazepril is a prescription ACE inhibitor used to treat hypertension.