Medications & Supplements/Prescription Drugs

AuroMedics Pharma LLC: Amoxicillin and Clavulanate Potassium Tablets Recalled for Foreign Substance

Agency Publication Date: February 14, 2020

Summary

AuroMedics Pharma LLC has voluntarily recalled 30,432 bottles of Amoxicillin and Clavulanate Potassium Tablets (875 mg/125 mg) because a customer reported finding a nylon cable tie inside a bottle. This prescription antibiotic, used to treat bacterial infections, was manufactured in India and distributed nationwide across the United States. Consumers who have these tablets should check their bottles for the specific lot number and expiration date listed in this recall. If you have an affected bottle, do not use the medication and contact your pharmacist or healthcare provider immediately for guidance.

Risk

The presence of a foreign substance like a nylon cable tie in medication bottles poses a choking hazard and could lead to accidental ingestion of non-medical material, potentially causing injury or interfering with the delivery of the correct drug dosage.

What You Should Do

Check your medicine cabinet for 20-count bottles of Amoxicillin and Clavulanate Potassium Tablets (875 mg/125 mg) with NDC 65862-503-20.
Identify if your bottle is affected by looking for Lot Number SM8719040-A with an expiration date of 02/2021.
If your bottle matches these details, stop using the medication immediately and do not discard it until you speak with your pharmacist.
Contact your healthcare provider or pharmacist for guidance on obtaining a replacement prescription and to report the affected product.
Return any unused portions of the recalled medication to the pharmacy where you purchased it for a refund.
Contact AuroMedics Pharma LLC directly at their East Windsor, New Jersey location if you have specific questions regarding this recall.
For additional questions or to report a side effect or injury, call 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

Healthcare provider consultation and pharmacy refund

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

Affected Products

Product: Amoxicillin and Clavulanate Potassium Tablets, USP, 875 mg/125 mg (20-count bottles)

Model:

NDC 65862-503-20

Recall #: D-0852-2020

Lot Numbers:

SM8719040-A (Exp. Date 02/2021)

Date Ranges: February 2021

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 84910

Status: Resolved

Manufacturer: AuroMedics Pharma LLC

Sold By: Aurobindo Pharma USA. Inc.

Manufactured In: India, United States

Units Affected: 30432 bottles

Distributed To: Nationwide

Agency Last Updated: February 19, 2020

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 medicine cabinet for 20-count bottles of Amoxicillin and Clavulanate Potassium Tablets (875 mg/125 mg) with NDC 65862-503-20.

Identify if your bottle is affected by looking for Lot Number SM8719040-A with an expiration date of 02/2021.

If your bottle matches these details, stop using the medication immediately and do not discard it until you speak with your pharmacist.

Contact your healthcare provider or pharmacist for guidance on obtaining a replacement prescription and to report the affected product.

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

Contact AuroMedics Pharma LLC directly at their East Windsor, New Jersey location if you have specific questions regarding this recall.

For additional questions or to report a side effect or injury, call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.