Antibiotic Recalled

Teva Pharmaceuticals USA is voluntarily recalling more than 100,000 bottles of penicillin V potassium due to subpotency, according to the December 29, 2021, US Food and Drug Administration (FDA) Enforcement Report.

The recall affects penicillin V potassium for oral solution, 125 mg (200,000 U) per 5 mL, packaged in:

• 100-mL (when mixed) bottles (NDC 00093-4125-73) from lots 35446365A (Exp. 3/22), 35447040A (Exp. 8/22), and 35447948B (Exp. 3/23); and
• 200-mL (when mixed) bottles (NDC 00093-4125-74) from lots 35446318B (Exp. 5/22) and 35447947A (Exp. 3/23).

Teva Pharmaceuticals USA initiated the recall December 16, 2021. On December 23, 2021, the FDA designated the recall Class II, signaling use of the product could cause temporary or medically reversible adverse health consequences. A remote possibility of serious harm also exists.

Penicillin V potassium is a prescription antibiotic used to prevent or treat a variety of bacterial infections.