CLASS I Drug recall · Reported 14 Aug 2024 · FDA Enforcement Report
Acetaminophen Extra Strength Tablets, 500 mg each recalled
A-S Medication Solutions is recalling Acetaminophen Extra Strength Tablets, 500 mg each, distributed nationwide in the US. The recall was initiated on 21 Jun 2024 and the FDA has classified it as Class I.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0631-2024
- FDA event ID
- 94873
- Recalling firm
- A-S Medication Solutions, Libertyville, IL
- Brand
- Acetaminophen
- Manufacturer
- A-S Medication Solutions
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 21 Jun 2024
- FDA classified
- 8 Aug 2024
- Reported
- 14 Aug 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Labeling Errors
- Drug class
- Pain Medication
Timeline
| 21 Jun 2024 | Recall initiated by company | |
| 8 Aug 2024 | Classified by FDA | +48 days |
| 14 Aug 2024 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Labeling: Label Mix-Up: Some bottles of Acetaminophen Extra Strength 500 mg tablets were incorrectly labeled with the drug facts label for Aspirin 81 mg tablets.
Product as listed by the FDA
Acetaminophen Extra Strength Tablets, 500 mg each, 100 count bottles, Packaged By: A-S Medication Solutions, Libertyville, IL 60048. NDC: 50090-5313-2
Where it was distributed
Nationwide within the United States.
Questions about this recall
Is Acetaminophen Extra Strength Tablets, 500 mg each recalled?
Yes. A-S Medication Solutions recalled Acetaminophen Extra Strength Tablets, 500 mg each on 21 Jun 2024. The recall is Class I and its status is Terminated. Recall number D-0631-2024.
Why was it recalled?
Labeling: Label Mix-Up: Some bottles of Acetaminophen Extra Strength 500 mg tablets were incorrectly labeled with the drug facts label for Aspirin 81 mg tablets.
Which lots are affected?
Lot: 4138197; Exp 10/31/2025
Where was it sold?
Nationwide within the United States.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from A-S Medication Solutions
All 9| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Metformin Hydrochloride Extended- Release 500mg recalledMetformin Hydrochloride | A-S Medication Solutions | Packaging Defects | Nationwide |
| Drug | CLASS III | Cetirizine hydrochloride recalled by A-S Medication SolutionsCetirizine | A-S Medication Solutions | Other | 4 states |
| Drug | CLASS I | Acetaminophen, Extra Strength, Aspirin Free, Mfr recalledAcetaminophen | A-S Medication Solutions | Packaging Defects | Nationwide |
| Drug | CLASS II | Valsartan Tablets, 160 MG bottle recalled by A-S Medication Solutions | A-S Medication Solutions | Potency & Assay | Nationwide |
| Drug | CLASS II | Valsartan and Hydrochlorothiazide Tablets recalled | A-S Medication Solutions | Potency & Assay | Nationwide |
Other Acetaminophen recalls
All 46| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Tylenol, Acetaminophen, Extra Strength, 24 Caplets, 500mg each recalledTylenol Extra Strength | Kenvue Brands | Other | Nationwide |
| Drug | CLASS II | Acetaminophen Injection 1000 mg/ (10 mg/mL) recalledAcetaminophen | Baxter Healthcare | Packaging Defects | Nationwide |
| Drug | CLASS II | Acetaminophen Tablets, 325 mg recalled by Aurobindo Pharma USAAmazon Basic Care Acetaminophen | Aurobindo Pharma USA | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS I | Acetaminophen Injection, 1,000 mg recalled by Hikma Pharmaceuticals USAAcetaminophen | Hikma Pharmaceuticals USA | Packaging Defects | OH, PR |
| Drug | CLASS II | Extra Strength Acetaminophen recalled by Contract PharmacalAcetaminophen | Contract Pharmacal | Other | MI |