Medications & Supplements/Over-the-Counter

Walgreens Acetaminophen USP Caplets Recalled for Impurity and Discoloration

Agency Publication Date: May 24, 2023

Summary

Aurobindo Pharma USA Inc. is recalling 87,360 bottles of Walgreens brand Pain Reliever Acetaminophen USP Caplets (500 mg). The 225-count bottles, which are packaged in cardboard cartons, were found to have an impurity causing product discoloration. While no injuries or adverse reactions have been reported, the medication failed to meet safety and degradation specifications.

Risk

The product was found to be out of specification for an impurity, which was discovered following customer complaints regarding discoloration. Using medication that contains impurities or has degraded may result in unpredictable chemical reactions or reduced efficacy.

What You Should Do

This recall affects Walgreens brand Pain Reliever Acetaminophen USP Caplets (500 mg) sold in 225-count bottles with NDC 0363-9947-35.
Identify your product by checking for lot numbers P2200101 (Exp 11/2023), P2200178 (Exp 11/2023), or P2200230 (Exp 12/2023) printed on the bottle label or cardboard carton.
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 Aurobindo Pharma USA 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: Pain Reliever, Acetaminophen USP Caplets (225-count)

Variants: 500 mg, Caplets

Lot Numbers:

P2200101 (Exp 11/2023)

P2200178 (Exp 11/2023)

P2200230 (Exp 12/2023)

NDC:

0363-9947-35

Bottles are packaged in a cardboard carton.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 92380

Status: Resolved

Manufacturer: Aurobindo Pharma USA Inc.

Sold By: Walgreens

Manufactured In: United States

Units Affected: 87,360 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 Walgreens brand Pain Reliever Acetaminophen USP Caplets (500 mg) sold in 225-count bottles with NDC 0363-9947-35.

Identify your product by checking for lot numbers P2200101 (Exp 11/2023), P2200178 (Exp 11/2023), or P2200230 (Exp 12/2023) printed on the bottle label or cardboard carton.

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 Aurobindo Pharma USA Inc. for further instructions.

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