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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

Teva Amoxicillin and Clavulanate Potassium Recalled for Subpotency

Agency Publication Date: November 3, 2025
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Summary

Teva Pharmaceuticals USA, Inc. has recalled 4,680 cartons of Amoxicillin and Clavulanate Potassium for Oral Suspension USP (200 mg/28.5 mg per 5mL) because the Clavulanate Potassium component was found to be subpotent. This medication is a prescription antibiotic used to treat various bacterial infections. The recall affects 100 mL bottles manufactured in Canada and distributed to Mississippi, Ohio, and California.

Risk

A subpotent drug may not provide the full intended dose of the antibiotic, which could lead to ineffective treatment of an infection and potentially contribute to antibiotic resistance. No injuries or illnesses have been reported to date.

What You Should Do

  1. Check your medication carton and bottle for Amoxicillin and Clavulanate Potassium for Oral Suspension USP, 200 mg/28.5 mg per 5mL (100 mL when reconstituted).
  2. Look for lot number 100062316 with an expiration date of 01/2026 and NDC 0093-2277-7 printed on the packaging.
  3. If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.
  4. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.

Your Remedy Options

You have 2 options:

๐Ÿ’ฐOption 1: Full Refund
How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund
๐Ÿ—‘๏ธOption 2: Dispose of Product
How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Amoxicillin and Clavulanate Potassium for Oral Suspension USP (100 mL when reconstituted)by Teva
Variants: 200 mg/28.5 mg per 5mL, Rx only
Lot Numbers:
100062316 (Exp 01/2026)
NDC:
0093-2277-7

Recall #: D-0151-2026; Manufactured by Teva Canada Limited for Teva Pharmaceuticals USA, Inc.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 97795
Status: Active
Manufacturer: Teva Pharmaceuticals USA, Inc
Sold By: Retail pharmacies
Manufactured In: Canada
Units Affected: 4680 cartons
Distributed To: Mississippi, Ohio, California

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.