Medications & Supplements/Prescription Drugs

Teva Pharmaceuticals USA: Amoxicillin Oral Suspension Recalled for Subpotency

Agency Publication Date: April 18, 2019

Summary

Teva Pharmaceuticals USA has recalled approximately 171,488 bottles of Amoxicillin for Oral Suspension USP (125 mg per 5 mL), a prescription antibiotic used to treat bacterial infections. Testing revealed that certain batches of the medication were subpotent, meaning the concentration of Amoxicillin was below the required specification limits. This recall affects both 150 mL and 80 mL bottle sizes distributed nationwide across the United States and Puerto Rico. Because this medication may not contain the full labeled dose of the antibiotic, it could lead to ineffective treatment of infections.

Risk

Subpotent antibiotics may fail to effectively treat an infection, potentially allowing the condition to worsen or leading to antibiotic resistance. If the medication does not provide the intended therapeutic dose, the patient's recovery may be delayed or compromised.

What You Should Do

Check your prescription bottle for the product name 'Amoxicillin for Oral Suspension USP, 125 mg per 5 mL' and look for NDC codes 0093-4150-80 (150 mL bottle) or 0093-4150-79 (80 mL bottle).
If you have a 150 mL bottle (NDC 0093-4150-80), check for lot numbers 35436769A (Exp. 05/2019), 35438389A (Exp. 01/2020), 35438390A (Exp. 01/2020), or 35440838A (Exp. 10/2020).
If you have an 80 mL bottle (NDC 0093-4150-79), check for lot numbers 35437491A or 35443574B with an expiration date of 09/2021.
Contact your healthcare provider or pharmacist immediately for guidance on your treatment and to obtain a replacement prescription if necessary.
Return any unused portion of the recalled medication to the pharmacy where it was purchased for a refund.
Contact Teva Pharmaceuticals USA at their North Wales, PA location for further instructions or product questions.
For additional questions or to report a problem, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA).

Your Remedy Options

Full Refund

Product return and pharmacist consultation

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 (150 mL bottle)

Model:

NDC 0093-4150-80

Lot Numbers:

35436769A (Exp. 05/2019)

35438389A (Exp. 01/2020)

35438390A (Exp. 01/2020)

35440838A (Exp. 10/2020)

Date Ranges: 05/2019, 01/2020, 10/2020

Product: Amoxicillin for Oral Suspension USP, 125 mg per 5 mL (80 mL bottle)

Model:

NDC 0093-4150-79

Lot Numbers:

35437491A (Exp. 09/2021)

35443574B (Exp. 09/2021)

Date Ranges: 09/2021

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 82619

Status: Resolved

Manufacturer: Teva Pharmaceuticals USA

Manufactured In: Canada, United States

Units Affected: 171,488 150 mL and 80 mL 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 prescription bottle for the product name 'Amoxicillin for Oral Suspension USP, 125 mg per 5 mL' and look for NDC codes 0093-4150-80 (150 mL bottle) or 0093-4150-79 (80 mL bottle).

If you have a 150 mL bottle (NDC 0093-4150-80), check for lot numbers 35436769A (Exp. 05/2019), 35438389A (Exp. 01/2020), 35438390A (Exp. 01/2020), or 35440838A (Exp. 10/2020).

If you have an 80 mL bottle (NDC 0093-4150-79), check for lot numbers 35437491A or 35443574B with an expiration date of 09/2021.

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

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

Contact Teva Pharmaceuticals USA at their North Wales, PA location for further instructions or product questions.

For additional questions or to report a problem, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA).

Affected Products

Product: Amoxicillin for Oral Suspension USP, 125 mg per 5 mL (150 mL bottle)

Model:

NDC 0093-4150-80

Lot Numbers:

35436769A (Exp. 05/2019)

35438389A (Exp. 01/2020)

35438390A (Exp. 01/2020)

35440838A (Exp. 10/2020)

Date Ranges: 05/2019, 01/2020, 10/2020

Product: Amoxicillin for Oral Suspension USP, 125 mg per 5 mL (80 mL bottle)

Model:

NDC 0093-4150-79

Lot Numbers:

35437491A (Exp. 09/2021)

35443574B (Exp. 09/2021)

Date Ranges: 09/2021