Medications & Supplements/Prescription Drugs

Amoxicillin and Clavulanate Potassium Chewable Tablets Recalled for Subpotency

Agency Publication Date: June 18, 2024

Summary

Teva Pharmaceuticals USA, Inc. has recalled 34,448 bottles of Amoxicillin and Clavulanate Potassium Chewable Tablets (400mg/57mg) because the medication is subpotent. This means the drug may not contain the full amount of active ingredients required to effectively treat infections. This prescription antibiotic was distributed nationwide in 20-count bottles and manufactured in Canada.

Risk

A subpotent antibiotic may fail to treat the underlying bacterial infection, which could lead to the infection worsening or other medical complications.

What You Should Do

This recall affects Amoxicillin and Clavulanate Potassium Chewable Tablets (400mg/57mg) sold in 20-count bottles under the Teva Pharmaceuticals brand.
Check your prescription bottle for NDC 0093-2272-34 and lot numbers 100047634 (Expiration Date 4/2025) or 35449379A (Expiration Date 7/2024).
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.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional information regarding this recall.

Your Remedy Options

You have 2 options:

Option 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

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 Tablets USP, Chewable (20-count bottles)by Teva Pharmaceuticals

Variants: 400mg/57mg, Chewable Tablet

Lot Numbers:

100047634 (Exp 4/2025)

35449379A (Exp 7/2024)

NDC:

0093-2272-34

Rx only; Manufactured in Canada by Teva Canada Limited.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 94750

Status: Active

Manufacturer: Teva Pharmaceuticals USA, Inc

Sold By: Pharmacies

Manufactured In: Canada

Units Affected: 34,448 bottles

Distributed To: Nationwide

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 · 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.

Summary

What You Should Do

This recall affects Amoxicillin and Clavulanate Potassium Chewable Tablets (400mg/57mg) sold in 20-count bottles under the Teva Pharmaceuticals brand.

Check your prescription bottle for NDC 0093-2272-34 and lot numbers 100047634 (Expiration Date 4/2025) or 35449379A (Expiration Date 7/2024).

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.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional information regarding this recall.