Amoxicillin and Clavulanate Potassium Recalled for Oral Suspension Due to Subpotency

Key Clinical Summary

• Teva USA recalled amoxicillin and clavulanate potassium for oral suspension USP due to low Clavulanate levels (Lot #100062316, Exp. 01/2026).
• 4680 cartons distributed in MS, OH, and CA; classified as Class II, voluntary, ongoing as of November 2025.
• Used to treat bacterial infections; reduced potency could decrease efficacy and promote resistance.

Teva Pharmaceuticals USA, Inc has voluntarily initiated a Class II recall of amoxicillin and clavulanate potassium for oral suspension USP (200 mg/28.5 mg per 5 mL, 100 mL when reconstituted) after identifying subpotency in the clavulanate potassium component. The affected lot—#100062316 (Exp. 01/2026)—was manufactured by Teva Canada Limited in Toronto and distributed across Mississippi, Ohio, and California. Approximately 4680 cartons are included in the recall, which was officially classified by the US Food and Drug Administration (FDA) on November 3, 2025.

This recall is categorized as Class II, indicating that use of or exposure to the affected product may cause temporary or medically reversible adverse health consequences. The company initiated the recall voluntarily and notified consignees via direct mail correspondence. No press release has been issued at this time, and the recall remains ongoing as of November 2025. The FDA has not reported any adverse events related to the issue.

Amoxicillin and clavulanate potassium is a commonly prescribed antibiotic used to treat bacterial infections, including otitis media, sinusitis, pneumonia, and skin or urinary tract infections. Pharmacists are advised to verify inventory for the affected lot and follow standard recall return procedures to ensure patient safety.