Amoxicillin and Clavulanate Potassium for Oral Suspension USP, 200 mg/28.5 mg per 5mL, 100 mL (when reconstituted), Rx o
Summary
The FDA issued a Class II for Amoxicillin and Clavulanate Potassium for Oral Suspension USP, 200 mg/28.5 mg pe by Teva Pharmaceuticals USA, Inc. Reason: Subpotent drug; Clavulanate Potassium component.
Details
Source
Drug Recall
External ID
D-0151-2026
Action Date
2025-11-12
Status
Ongoing
Category
drug
Product Description
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 0093-2277-7.
Lot/Code Info: Lot # 100062316, Exp Date: 01/2026
Quantity Affected: 4680 cartons
Reason for Recall
Subpotent drug; Clavulanate Potassium component
Distribution
Distributed in three (3) States: MS, OH, CA.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-10-13
Company
Parsippany, NJ
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 83 drug recalls issued in the same week, part of 272 drug-related FDA actions this month.
Teva Pharmaceuticals USA, Inc has 50 FDA actions in our database, including 50 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Teva Pharmaceuticals USA, Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Teva Pharmaceuticals USA, Inc have FDA actions?
Teva Pharmaceuticals USA, Inc has 50 FDA actions in our database, including 50 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0151-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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