Acetaminophen Extra Strength tablets recalled for incorrect imprinting
Akron Pharma is recalling 1,232 bottles of Acetaminophen Extra Strength tablets due to incorrect imprinting on the tablets. The product identification may be wrong on the affected tablets.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class III recall for a labeling defect involving incorrect tablet imprinting/identification. No illnesses, injuries, or deaths have been reported. Per the severity rubric, Class III recalls with labeling errors and no reported harm are scored as Moderate (2).
Plain-English summary
Akron Pharma, Inc. is recalling Acetaminophen Extra Strength 500 mg tablets sold in bottles of 1,000 tablets. The recall is due to incorrect imprinting of product identification on the tablets.
Approximately 1,232 bottles have been distributed nationwide in the United States. The affected lots are: Lot #KDT0224001B with expiration date 08/31/2026, and Lot #KDT0224002B with expiration date 09/30/2026. No illnesses or injuries have been reported in connection with this recall.
Consumers who have purchased the affected product should check the lot number on their bottle against the recall information. If the lot number matches one of those listed above, consumers should discontinue use. For information about product returns or replacement, contact Akron Pharma, Inc. at 373 US Route 46 W, Building E, Suite 117, Fairfield, NJ 07034, or contact the FDA.
The recalled product
- Product
- Acetaminophen Extra Strength 500 mg, 1000 Tablets per bottle, Akron Pharma, Manufactured for: Akron Pharma Inc., 373 US RT 46 W Building E, Suite 117, Fairfield, NJ 07034, NDC 71399-8022-02
- Manufacturer
- Akron Pharma, Inc.
- Category
- Drug — OTC Analgesic
- Hazard
- mis-labeling
- identification-error
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Lot #s: KDT0224001B
- Exp 08/31/2026
- KDT0224002B
- Exp 09/30/2026.
Distribution
Distributed nationwide across the United States.
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