Acetaminophen Extra Strength 500 mg recall
FDA recall D-0193-2025 · initiated Dec 12, 2024
Akron Pharma, Inc. recalled Acetaminophen Extra Strength 500 mg in Dec 2024 — an FDA Class III recall (D-0193-2025) because Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.
Unlikely to cause harm but violates FDA labeling or manufacturing regulations.
Why it was recalled
Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.
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: 768 bottles
Details
- Product
- Acetaminophen Extra Strength 500 mg, 100 Tablets per bottle, Akron Pharma, Inc., 373 RT US 46 W Building E, Suite 117, Fairfield, NJ 07004, NDC 71399-8022-01.
- Recalling company
- Akron Pharma, Inc.
- Classification
- Class III
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide in the US
- Initiated
- Dec 12, 2024
- FDA report date
- Jan 22, 2025
Frequently asked
- Was Acetaminophen Extra Strength 500 mg recalled?
- Akron Pharma, Inc. recalled Acetaminophen Extra Strength 500 mg in Dec 2024 — an FDA Class III recall (D-0193-2025) because Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID. Unlikely to cause harm but violates FDA labeling or manufacturing regulations.
- Why was Acetaminophen Extra Strength 500 mg recalled?
- Per the FDA enforcement record, the reason for recall D-0193-2025 was: Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.
- Is a recalled Acetaminophen Extra Strength 500 mg 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. Unlikely to cause harm but violates FDA labeling or manufacturing regulations. 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 500 mg are affected?
- Distributed: Nationwide in the US. The recall covers these lots — Lot: KDT0224002A, Exp 09/30/2026. 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-0193-2025.