Amoxicillin clavulanate oral suspension recalled as subpotent in the clavulanate component
Teva Pharmaceuticals USA is recalling 4,680 cartons of Amoxicillin and Clavulanate Potassium for Oral Suspension 200 mg/28.5 mg per 5 mL because the clavulanate component is subpotent.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Scored 3 under the risk-of-harm criterion: subpotency means the antibiotic may not deliver its prescribed effect, and no injuries are reported.
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…
- Manufacturer
- Teva Pharmaceuticals USA, Inc
- Category
- Drug — Antibiotic
- Affected units
- 4,680
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot # 100062316
- Exp Date: 01/2026
Distribution
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