Acetaminophen Extra Strength Tablets recall
FDA recall D-0631-2024 · initiated Jun 21, 2024
A-S Medication Solutions LLC recalled Acetaminophen Extra Strength Tablets in Jun 2024 — an FDA Class I recall (D-0631-2024) because 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.
Most serious — a reasonable probability that use will cause serious harm or death.
Why it was 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.
Labelling, packaging or a product mix-up
The wrong information — or the wrong medicine — ended up in the pack. A mix-up is a manufacturing failure that can still be dangerous to swallow.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 429 bottles
Details
- Product
- Acetaminophen Extra Strength Tablets, 500 mg each, 100 count bottles, Packaged By: A-S Medication Solutions, Libertyville, IL 60048. NDC: 50090-5313-2
- Recalling company
- A-S Medication Solutions LLC
- Classification
- Class I
- Status
- Terminated
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide within the United States.
- Initiated
- Jun 21, 2024
- FDA report date
- Aug 14, 2024
Frequently asked
- Was Acetaminophen Extra Strength Tablets recalled?
- A-S Medication Solutions LLC recalled Acetaminophen Extra Strength Tablets in Jun 2024 — an FDA Class I recall (D-0631-2024) because 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. Most serious — a reasonable probability that use will cause serious harm or death.
- Why was Acetaminophen Extra Strength Tablets recalled?
- Per the FDA enforcement record, the reason for recall D-0631-2024 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.
- Is a recalled Acetaminophen Extra Strength Tablets dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. Most serious — a reasonable probability that use will cause serious harm or death. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Acetaminophen Extra Strength Tablets are affected?
- Distributed: Nationwide within the United States.. The recall covers these lots — Lot: 4138197; Exp 10/31/2025. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0631-2024.