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Drug FDA Class I Terminated Mislabeling

Acetaminophen Extra Strength Tablets, 500 mg each, 100 count bottles, Packaged By: A-S Medication Solutions, Libertyville, IL 60048. NDC: 50090-5313-2

A-S Medication Solutions LLC Published Aug 14, 2024

Risk level

Class I

Dangerous or defective — could cause serious health problems or death.

Severity score 80/100

What should you do?

  • Check whether you have this product, using the lot codes, UPCs, and dates listed below.
  • Do not eat, serve, or sell the affected product.
  • Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
  • Contact A-S Medication Solutions LLC or your place of purchase with questions, and see the source record below for full details.
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.

Affected products (1)

Acetaminophen Extra Strength Tablets, 500 mg each, 100 count bottles, Packaged By: A-S Medication Solutions, Libertyville, IL 60048. NDC: 50090-5313-2

ACETAMINOPHEN · 429 bottles

NDC: 50090-5313, 50090-5313-1, 50090-5313-2, 50090-5313-3, 50090-5313-4, 50090-5313-5
Lot codes: 4138197
Code info: Lot: 4138197; Exp 10/31/2025

Affected areas

Nationwide

Timeline

  1. Initiated
    Jun 21, 2024
  2. Published
    Aug 14, 2024
  3. Terminated
    May 7, 2025
Recall number
D-0631-2024
Agency
U.S. Food and Drug Administration
Country
US
Source data (openFDA JSON) About FDA enforcement reports

FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.