Drug FDA Class III Ongoing Mislabeling
Acetaminophen Regular Strength, 325 mg, 100 Tablets per bottle, Akron Pharma, Inc., 373 RT US 46 W Building E, Suite 117, Fairfield, NJ 07004, NDC 71399-8024-01 .
Akron Pharma, Inc. Published Jan 22, 2025
Risk level
Class IIIUnlikely to cause harm, but violates labeling or manufacturing rules.
Severity score 40/100
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 Akron Pharma, Inc. or your place of purchase with questions, and see the source record below for full details.
Reason for recall
Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.
Hazards
Tablet imprint mismatch · primary
Affected products (1)
Acetaminophen Regular Strength, 325 mg, 100 Tablets per bottle, Akron Pharma, Inc., 373 RT US 46 W Building E, Suite 117, Fairfield, NJ 07004, NDC 71399-8024-01 .
6429 bottles
Code info: Lot #: KDT0124001, Exp 08/31/2026
Affected areas
Nationwide
Timeline
- InitiatedDec 12, 2024
- PublishedJan 22, 2025
- Recall number
- D-0194-2025
- Agency
- U.S. Food and Drug Administration
- Country
- US
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.