Over 170,000 Bottles of Amoxicillin Recalled

Teva Pharmaceuticals USA is recalling more than 170,000 bottles of amoxicillin for oral suspension because assay results for the drug tested below specification limits, according to the April 24, 2019, US Food and Drug Administration (FDA) Enforcement Report.

The recall affects amoxicillin for oral suspension, 125 mg per 5 mL, packaged in: 

• 150-mL bottles (NDC 0093-4150-80) from lots 35436769A (Exp. 5/19), 35438389A and 35438390A (Exp. 1/20), and 35440838A (Exp. 10/20); and
• 80-mL bottles (NDC 0093-4150-79) from lots 35437491A and 35443574B (Exp. 9/21).

The recalled amoxicillin was distributed throughout the United States and in Puerto Rico.

Teva Pharmaceuticals USA voluntarily issued the recall April 12, 2019. The FDA designated it Class II on April 18, 2019. Under Class II recalls, use of the product could cause temporary or medically reversible adverse health consequences, or a remote possibility of serious harm. 

Amoxicillin for oral suspension is a prescription medicine used to treat bacterial infections. 

—Jolynn Tumolo