Medications & Supplements/Prescription Drugs

Teva Pharmaceuticals USA: Amoxicillin Oral Suspension Recalled for Subpotency

Agency Publication Date: August 21, 2018

Summary

Teva Pharmaceuticals USA is recalling approximately 133,601 bottles of Amoxicillin for Oral Suspension USP (125 mg per 5 mL) because the medication may be less effective than intended. Testing discovered the drug was "subpotent," meaning it does not contain the required amount of active ingredient to properly treat infections. This recall affects 100 mL bottles sold across the United States and Puerto Rico.

Risk

If the medication is subpotent, it may fail to treat the underlying bacterial infection effectively. This can lead to prolonged illness or the development of antibiotic-resistant bacteria because the dose is too low to kill the target germs.

What You Should Do

Check your medication bottle for the product name 'Amoxicillin for Oral Suspension USP, 125 mg per 5 mL' in a 100 mL bottle with NDC 0093-4150-73.
Verify if your bottle matches one of the following lot numbers: 35432507A, 35434914A, 35435798A, or 35437490A, all with an expiration date of 9/19.
Contact your healthcare provider or pharmacist immediately to discuss your treatment and obtain a replacement prescription if necessary.
Return any unused portion of the recalled medication to the pharmacy where you purchased it for a refund.
Contact Teva Pharmaceuticals USA for further instructions regarding this recall.
For additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

Full Refund

Drug recall refund and medical guidance

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Amoxicillin for Oral Suspension USP, 125 mg per 5 mL (100 mL bottle)

Model:

NDC 0093-4150-73

Recall #: D-0440-2017

Lot Numbers:

35432507A (Exp 9/19)

35434914A (Exp 9/19)

35435798A (Exp 9/19)

35437490A (Exp 9/19)

Date Ranges: Expiration 9/19

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 76038

Status: Resolved

Manufacturer: Teva Pharmaceuticals USA

Sold By: Pharmacies

Manufactured In: United States

Units Affected: 133,601 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

Check your medication bottle for the product name 'Amoxicillin for Oral Suspension USP, 125 mg per 5 mL' in a 100 mL bottle with NDC 0093-4150-73.

Verify if your bottle matches one of the following lot numbers: 35432507A, 35434914A, 35435798A, or 35437490A, all with an expiration date of 9/19.

Contact your healthcare provider or pharmacist immediately to discuss your treatment and obtain a replacement prescription if necessary.

Return any unused portion of the recalled medication to the pharmacy where you purchased it for a refund.

Contact Teva Pharmaceuticals USA for further instructions regarding this recall.

For additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.