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Class I · Most seriousRecall completed

Acetaminophen

A reasonable chance it could cause serious harm or death.

Does this affect you?
Check your lot numberLots 323206, 323207, 323208, 335353, 335354, 335355, 335356, 335358, 335359,335360, 335361, 335362, 335395, 352116, Expiry 7/31/2022; 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, Expiry 8/31/2022
Where it was soldNationwide in the USA
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

Labeling: Label Mix-up; The bottle of over-the-counter Acetaminophen 500mg Extra Strength, 100 count, included in Health Essential Kits, labeled incorrectly with a prescription drug label instead of an OTC drug label.

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made byA-S Medication Solutions
Brand nameACETAMINOPHEN
Generic nameACETAMINOPHEN
Active ingredient(s)ACETAMINOPHEN
Distributed by / forA-S Medication Solutions LLC.
NDC50090-5350-0
Show the full FDA record
Full product labelAcetaminophen, Extra Strength, Aspirin Free, 500 MG Tablets, 100-count bottles, Mfr: Major Pharmaceuticals, Livonia, MI 48152; Packaged Exclusively By: A-S Medication Solutions LLC, Libertyville, IL 60048, Product # 6967-0; NDC: 50090-5350-0; contained within Health Essentials Kit, Kit Contains: 1 bottle hand sanitzer, 1 reusable face mask, 1 bottle Acetaminophen 500 mg, 1 bag cough drops, 1 digital thermometer, 50 disposable gloves.
Recalling firmA-S Medication Solutions LLC.
DistributionNationwide in the USA
Quantity201,600 kits
Recall initiated2021-03-02
Report date2021-05-12
Recall completed2025-04-23
Recall numberD-0358-2021
ClassificationClass I
FDA statusTerminated
Origin on fileLibertyville IL United States

Related

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Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.