Severity
Critical
CriticalClass ITerminated
FDA Drug recall · Reported May 12, 2021
Acetaminophen, 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.
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 dr…
Compiled from official public sources by the editorial team.
Verify with FDA Drug →
A-s Medication Solutions LLC. recalled Acetaminophen, Extra Strength, Aspirin Free, 500 MG Tablets, 100-count bottles, Mfr: Majo… - a critical-severity action.
Acetaminophen, Extra Strength, Aspirin Free, 500 MG Tablets, 100-count bottles, Mfr: Majo… was recalled by A-s Medication Solutions LLC. in May 12, 2021. Reason: Labeling: Label Mix-up; The bottle of over-the-counter Acetaminophen 500mg Extra Strength, 100 count, include…. Check the official notice for the remedy. Verify recall #D-0358-2021 with the FDA Drug before acting.
The recall
A-s Medication Solutions LLC. issued this critical-severity FDA Drug recall-Labeling: Label Mix-up; The bottle of over-the-counter Acetaminophen 500mg Extra Strength, 100 count, include….
- Critical
- severity level
- Class I
- classification
- May 12, 2021
- reported
Sourced from official FDA Drug enforcement records. Verify recall #D-0358-2021 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Drug action (record #D-0358-2021) was formally reported on May 12, 2021, with the manufacturer initiating the action on March 2, 2021. It is classified under Critical severity (Class I), with a current status of Terminated. A-s Medication Solutions LLC. is listed as the recalling firm, operating out of Libertyville, IL. Federal records list the affected scope as 201,600 kits.
The documented reason for this recall is: 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. Distribution data in the federal record shows the product reached: Nationwide in the USA. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 5 from FDA Drug - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Drugs & Medications recalls over time
Where this recall sits in its category - 14,287 drugs & medications recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified high severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
201,600 kits
Related Recalls
6
5 from same agency
Product description
Acetaminophen, 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.
Reason for recall
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Terminated |
| Recall number | D-0358-2021 |
| Date reported | May 12, 2021 |
| Date initiated | March 2, 2021 |
| Recalling firm | A-s Medication Solutions LLC. |
| Firm location | Libertyville, IL |
| Affected scope | 201,600 kits |
| Distribution | Nationwide in the USA |
Profile values are sourced directly from the official FDA Drug enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (D-0358-2021) and product description against the item you own. Search the archive
- Confirm the current status with FDA Drug before acting, recall details can be updated.
- This is a Class I (high-risk) recall, stop using the product immediately and follow the disposal or return instructions. What to do next
This page summarizes the official FDA Drug record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
Acetaminophen, 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.. Recalled by A-s Medication Solutions LLC.. Units affected: 201,600 kits.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on May 12, 2021. Severity: Critical. Recall number: D-0358-2021.
Where was the recalled product distributed? ▼
Distribution: Nationwide in the USA.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (D-0358-2021) against your product. Visit the official FDA Drug website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
Nearby Recalls in This Category
Other recalls in the same product category, useful for spotting patterns across the same defect class or manufacturer.
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Compare this recall with PRED MILD, prednisolone acetate ophthalmic suspension, USP,… →
Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Drug, reported May 12, 2021. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.