Medications & Supplements/Prescription Drugs

Accord Healthcare Allopurinol Tablets Recalled for Plastic Contamination

Agency Publication Date: January 20, 2023

Summary

Accord Healthcare, Inc. is recalling 87,576 bottles of Allopurinol Tablets (100 mg), a prescription medication used to treat gout and kidney stones. The recall was issued because a small piece of green plastic was found embedded in the edge of a tablet. No injuries or medical incidents have been reported in connection with this issue.

Risk

Ingesting a tablet containing foreign plastic poses a potential risk of choking or physical injury to the mouth, throat, or digestive tract.

What You Should Do

This recall involves Allopurinol Tablets USP, 100 mg, packaged in 100-count bottles under the Accord Healthcare brand with NDC 16729-134-01.
Check your medication bottle for lot numbers R2200455 or R2200456, both featuring an expiration date of 03/2025.
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 Accord Healthcare, Inc. for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions 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: Allopurinol Tablets USP, 100 mg (100-count bottle)by Accord Healthcare

Variants: 100 mg, Tablet

Lot Numbers:

R2200455 (Exp. 03/2025)

R2200456 (Exp. 03/2025)

NDC:

16729-134-01

Manufactured by Intas Pharmaceuticals Limited for Accord Healthcare, Inc.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 91499

Status: Resolved

Manufacturer: Accord Healthcare, Inc.

Sold By: Pharmacies nationwide

Manufactured In: India, United States

Units Affected: 87,576 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 involves Allopurinol Tablets USP, 100 mg, packaged in 100-count bottles under the Accord Healthcare brand with NDC 16729-134-01.

Check your medication bottle for lot numbers R2200455 or R2200456, both featuring an expiration date of 03/2025.

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 Accord Healthcare, Inc. for further instructions.

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