Medications & Supplements/Over-the-Counter

Spirit Pharmaceuticals: Regular Strength Acetaminophen 325 mg Tablets Recalled for Discoloration

Agency Publication Date: August 16, 2021

Summary

Spirit Pharmaceuticals has recalled one lot of Regular Strength Pain Reliever (acetaminophen) 325 mg tablets sold in 100-count bottles. This recall was initiated due to discoloration of the tablets, which indicates deviations from current Good Manufacturing Practices (cGMP). The affected bottles were distributed nationwide to Walmart stores.

Risk

The discoloration of the acetaminophen tablets suggests a quality failure or potential degradation of the medication. Using products that do not meet manufacturing quality standards can lead to unpredictable drug effectiveness or potential exposure to unintended substances.

What You Should Do

Check your medicine cabinet for 100-count bottles of Regular Strength Pain Reliever (Acetaminophen 325 mg) distributed by Walmart Inc. with NDC 79903-052-10.
Verify the lot number and expiration date on the bottle label to see if it matches lot number S210240 with an expiration date of 03/2023.
Immediately stop using any tablets from the affected lot.
Contact your healthcare provider or pharmacist for guidance regarding alternative pain relief and to discuss any health concerns.
Return any unused product to the place of purchase for a refund and contact Spirit Pharmaceuticals for further instructions regarding the disposal of the affected medication.
For additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA).

Your Remedy Options

Full Refund

Healthcare consultation and refund

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

Affected Products

Product: Acetaminophen 325 mg tablets, Regular Strength Pain Reliever (100-count bottle)

Model:

NDC 79903-052-10

D-0729-2021

Lot Numbers:

S210240 (Exp. 03/2023)

Date Ranges: 03/2023

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 88322

Status: Resolved

Manufacturer: Spirit Pharmaceuticals

Sold By: Walmart

Manufactured In: United States

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 medicine cabinet for 100-count bottles of Regular Strength Pain Reliever (Acetaminophen 325 mg) distributed by Walmart Inc. with NDC 79903-052-10.

Verify the lot number and expiration date on the bottle label to see if it matches lot number S210240 with an expiration date of 03/2023.

Immediately stop using any tablets from the affected lot.

Contact your healthcare provider or pharmacist for guidance regarding alternative pain relief and to discuss any health concerns.

Return any unused product to the place of purchase for a refund and contact Spirit Pharmaceuticals for further instructions regarding the disposal of the affected medication.

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