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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

A-S Medication Solutions LLC.: Acetaminophen 500mg Extra Strength Recalled for Labeling Mix-up

Agency Publication Date: April 30, 2021
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Summary

A-S Medication Solutions LLC is recalling approximately 201,600 Health Essentials Kits containing Acetaminophen Extra Strength (aspirin-free) 500 mg tablets in 100-count bottles. These over-the-counter (OTC) medication bottles were mistakenly labeled with a prescription drug label instead of the required OTC drug label. This labeling error means consumers do not have access to critical dosage instructions, warnings, and ingredient information necessary for safe use. The kits were distributed nationwide across the United States.

Risk

The incorrect labeling may cause consumers to take the medication without following proper dosage limits or understanding specific health warnings. Taking too much acetaminophen or failing to follow safety warnings can lead to severe liver damage or other adverse health reactions.

What You Should Do

  1. Check your Health Essentials Kit for a 100-count bottle of Acetaminophen Extra Strength (500 mg tablets) packaged by A-S Medication Solutions LLC.
  2. Verify the lot number and expiration date on your bottle. Affected lots include: 323206, 323207, 323208, 335353, 335354, 335355, 335356, 335358, 335359, 335360, 335361, 335362, 335395, 352116 (Exp 7/31/2022); and 323209, 323210, 323211, 323212, 323213, 323214, 323215, 323216, 323218, 323219, 323220, 323222, 323223, 323224, 323238, 335363, 335364, 335365, 335366, 335367, 335368, 335369, 335370, 335371, 335372, 335373, 335374, 335375, 335376, 335377 (Exp 8/31/2022).
  3. Look for National Drug Code (NDC) 50090-5350-0 and Product # 6967-0 on the bottle label.
  4. Immediately stop using the medication if it has a prescription-style label instead of the standard over-the-counter 'Drug Facts' label.
  5. Contact your healthcare provider or pharmacist for guidance regarding your medication and return any unused product to the place of purchase for a refund.
  6. Contact A-S Medication Solutions LLC at their Libertyville, IL location for further instructions or replacement information.
  7. For additional questions, contact 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

Drug Recall Baseline Remedy

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

Affected Products

Product: Acetaminophen, Extra Strength, Aspirin Free, 500 MG Tablets (100-count bottles)
Model:
NDC: 50090-5350-0
Product # 6967-0
Lot Numbers:
323206 (Exp 7/31/2022)
323207 (Exp 7/31/2022)
323208 (Exp 7/31/2022)
335353 (Exp 7/31/2022)
335354 (Exp 7/31/2022)
335355 (Exp 7/31/2022)
335356 (Exp 7/31/2022)
335358 (Exp 7/31/2022)
335359 (Exp 7/31/2022)
335360 (Exp 7/31/2022)
335361 (Exp 7/31/2022)
335362 (Exp 7/31/2022)
335395 (Exp 7/31/2022)
352116 (Exp 7/31/2022)
323209 (Exp 8/31/2022)
323210 (Exp 8/31/2022)
323211 (Exp 8/31/2022)
323212 (Exp 8/31/2022)
323213 (Exp 8/31/2022)
323214 (Exp 8/31/2022)
323215 (Exp 8/31/2022)
323216 (Exp 8/31/2022)
323218 (Exp 8/31/2022)
323219 (Exp 8/31/2022)
323220 (Exp 8/31/2022)
323222 (Exp 8/31/2022)
323223 (Exp 8/31/2022)
323224 (Exp 8/31/2022)
323238 (Exp 8/31/2022)
335363 (Exp 8/31/2022)
335364 (Exp 8/31/2022)
335365 (Exp 8/31/2022)
335366 (Exp 8/31/2022)
335367 (Exp 8/31/2022)
335368 (Exp 8/31/2022)
335369 (Exp 8/31/2022)
335370 (Exp 8/31/2022)
335371 (Exp 8/31/2022)
335372 (Exp 8/31/2022)
335373 (Exp 8/31/2022)
335374 (Exp 8/31/2022)
335375 (Exp 8/31/2022)
335376 (Exp 8/31/2022)
335377 (Exp 8/31/2022)
Date Ranges: Expiry 7/31/2022, Expiry 8/31/2022

Product Images

Image 1 - Picture of Health Essentials Kit containing Acetaminophen

Image 1 - Picture of Health Essentials Kit containing Acetaminophen

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 87436
Status: Resolved
Manufacturer: A-S Medication Solutions LLC.
Sold By: Health Essential Kits
Manufactured In: United States
Units Affected: 201,600 kits
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 · FDA Press Release · 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.