Antibiotic Pulled

Cardinal Healthcare pulled three units of amoxicillin for oral suspension because it was exposed to temperatures outside its labeled storage conditions. The recall was included in the January 3, 2024, US Food and Drug Administration (FDA) Enforcement Report.

The recall affected amoxicillin for oral suspension, 400 mg/5 mL, 100 mL when reconstituted (NDC 0093-4161-73), from batch 35447184A. The product was manufactured in Canada by Teva Canada, Toronto, Canada, for Teva Pharmaceuticals USA Inc., North Wales, Pennsylvania.

The recall was voluntarily initiated by Cardinal Healthcare on January 26, 2022. The FDA designated the recall Class II on December 26, 2023. Per the classification, use of the medication may cause temporary or medically reversible adverse health consequences. A remote possibility of serious harm also exists.

The recall has been completed, according to the FDA report.

Amoxicillin is a prescription penicillin-class antibiotic used in the treatment of patients with various infections and stomach ulcers.