Recall: Health Essentials Kit Acetaminophen Label Mix-up
A-S Medication Solutions recalls Health Essentials Kits containing Acetaminophen bottles with incorrect prescription drug labels. Check your kit's lot numbers.
Use caution until it’s fixed
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.
Contact the company
What happened, in plain English
A-S Medication Solutions LLC is recalling certain Health Essentials Kits because the included bottle of over-the-counter Acetaminophen 500mg Extra Strength tablets was labeled incorrectly with a prescription drug label instead of an OTC drug label. This labeling error affects approximately 201,600 kits distributed nationwide in the USA. The record does not specify any injuries or provide a remedy for consumers. Read more at govinfonow.com/recall/36495-recall-health-essentials-kit-acetaminophen-label-mix-up.
Source Summary by GovInfoNow · govinfonow.com/recall/36495-recall-health-essentials-kit-acetaminophen-label-mix-up · Updated October 11, 2026 · FDA enforcement record: FDA #D-0358-2021
Cite this page
“Recall: Health Essentials Kit Acetaminophen Label Mix-up.” GovInfoNow, updated October 11, 2026. https://govinfonow.com/recall/36495-recall-health-essentials-kit-acetaminophen-label-mix-up. Based on FDA recall #D-0358-2021 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0358-2021%22&limit=1).
Why it’s dangerous
The hazard is a labeling mix-up where an over-the-counter drug bottle bears a prescription label. This could cause users to mistakenly believe they need a doctor's prescription for the medication, potentially leading to improper use or unnecessary medical visits, though no serious injury mechanism like toxicity is described.
Who’s affected
Consumers who purchased Health Essentials Kits containing A-S Medication Solutions Acetaminophen bottles between the production dates implied by the lot numbers and expiry dates of July and August 2022. Users are at risk of confusion regarding whether the medication is prescription-only or over-the-counter.
How to tell if you have this one
Check if you have a Health Essentials Kit containing a bottle of Acetaminophen, Extra Strength, Aspirin Free, 500 MG Tablets, 100-count. Look for Product # 6967-0 and NDC: 50090-5350-0 on the bottle. Affected lots include 323206 through 323224 (Expiry 8/31/2022) and 323209 through 323238, 335363 through 335377 (Expiry 8/31/2022), as well as lots 323206-323208, 335353-335362, 335395, 352116 (Expiry 7/31/2022).
- Brand
A-S Medication Solutions- Category
Drug
What to do — step by step
Check Your Kit
Verify if your Health Essentials Kit contains the affected Acetaminophen bottles by checking the lot numbers and expiry dates listed in the record.
Contact Manufacturer
Since the remedy is not stated in the record, contact A-S Medication Solutions LLC for instructions on how to proceed with the recalled item.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide in the USA” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 4.1 years after the firm started it.
- Firm started the recall
- FDA classified it Class I
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Questions people ask
Which lot numbers are affected by this recall?
Affected lots include 323206, 323207, 323208, 335353, 335354, 335355, 335356, 335358, 335359, 335360, 335361, 335362, 335395, 352116 (Expiry 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 (Expiry 8/31/2022).
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0358-2021 (March 2, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0358-2021 to see it in context.
- Plain-language summary written by qwen3.6:35b-a3b on October 11, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.