Amoxicillin clavulanate oral suspension recalled as subpotent in the clavulanate component

Plain-English summary

Amoxicillin and Clavulanate Potassium for Oral Suspension USP, 200 mg/28.5 mg per 5 mL, 100 mL when reconstituted, manufactured in Canada by Teva Canada for Teva Pharmaceuticals USA, is being recalled as a subpotent drug in the clavulanate potassium component.

The recall covers 4,680 cartons from lot 100062316, expiring January 2026. The product was distributed in Mississippi, Ohio and California. The FDA has classified the recall as Class II.

Clavulanate is included to protect the amoxicillin from bacterial resistance mechanisms, so a subpotent clavulanate component means the medicine may not perform as prescribed. This is a paediatric oral suspension.

Patients and carers holding lot 100062316 should contact their pharmacy or prescriber about a replacement rather than stopping treatment on their own.

The recalled product

Product

Amoxicillin and Clavulanate Potassium for Oral Suspension USP, 200 mg/28.5 mg per 5mL, 100 mL (when reconstituted), Rx only, manufactured in Canada by: Teva Canada Limited, Toronto, Canada M1B 2K9; Manufactured For: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054 NDC 0093-22

Manufacturer

Teva Pharmaceuticals USA, Inc

Category

Drug — Antibiotic

Hazard

• subpotency
• out-of-specification
• antibiotic

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Distribution

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