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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Critical RiskFDA Drug
Medications & Supplements/Over-the-Counter

Acetaminophen Extra Strength Tablets Recalled for Label Mix-Up

Agency Publication Date: August 8, 2024
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Summary

A-S Medication Solutions LLC has recalled approximately 429 bottles of Acetaminophen Extra Strength Tablets (500 mg) because they were incorrectly labeled with the Drug Facts for Aspirin 81 mg. This labeling error means consumers may take the wrong medication or an incorrect dosage, which can lead to serious health risks. The recall affects 100-count bottles from a single lot distributed nationwide.

Risk

The label mix-up may cause consumers to inadvertently take acetaminophen instead of aspirin, potentially leading to accidental overdose, liver damage, or the omission of necessary aspirin therapy. No injuries or adverse events have been reported to date, but the risk of incorrect dosing is considered critical.

What You Should Do

  1. The recalled products are 100-count bottles of Acetaminophen Extra Strength Tablets (500 mg) packaged by A-S Medication Solutions LLC with NDC 50090-5313-2.
  2. Check your medicine for lot number 4138197 with an expiration date of 10/31/2025. These bottles may incorrectly display a Drug Facts label for Aspirin 81 mg tablets on the back.
  3. 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 A-S Medication Solutions LLC for further instructions.
  4. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls for additional information.

Your Remedy Options

You have 2 options:

๐Ÿ’ฐOption 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
๐Ÿ—‘๏ธ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: Acetaminophen Extra Strength Tablets (100 count)
Variants: 500 mg, Tablet
Lot Numbers:
4138197 (Exp 10/31/2025)
NDC:
50090-5313-2

Bottles were incorrectly labeled with the drug facts label for Aspirin 81 mg tablets.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 94873
Status: Resolved
Manufacturer: A-S Medication Solutions LLC
Manufactured In: United States
Units Affected: 429 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 ยท 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.