Acetaminophen Tablet
FDA Recall NDC 50090-5313
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Acetaminophen (NDC 50090-5313). A significant event, classified as Class I, was initiated on Jun 21, 2024 by A-s Medication Solutions. The reported reason for this action was: "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."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class I Terminated
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.
Jun 21, 2024
Aug 14, 2024
429 bottles
Recall Profile & Regulatory Data
Event ID
94873
Classification
Class I
Enforcement Status
Terminated
Recalling Firm
A-S Medication Solutions LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide within the United States.
Termination Date
May 07, 2025
Product Description
Acetaminophen Extra Strength Tablets, 500 mg each, 100 count bottles, Packaged By: A-S Medication Solutions, Libertyville, IL 60048. NDC: 50090-5313-2
Batch or Lot Expiration Information
Lot# Lot: 4138197; Exp 10/31/2025
Affected Packages Involved in this Recall
50090-5313-1Product
50090-5313-2Product
50090-5313-3Product
50090-5313-4Product
50090-5313-5Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
