The Recall Desk
ModerateFDA (Drugs)·D-0193-2025·Announced 2025-01-22

Acetaminophen Extra Strength tablets recalled for incorrect product imprint identification

Akron Pharma recalls 768 bottles of Acetaminophen Extra Strength 500 mg due to incorrect identification imprinted on the tablets nationwide.

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 involving a labeling error with tablets imprinted with incorrect identification. No illnesses or injuries have been reported. Per the severity rubric, minor labeling errors without reported harm are classified as Moderate (2).

Plain-English summary

Akron Pharma, Inc. is recalling Acetaminophen Extra Strength 500 mg tablets due to incorrect product identification imprinted on the tablets. The recalled product includes 768 bottles of 100-tablet bottles (NDC 71399-8022-01, Lot KDT0224002A, Expiration 09/30/2026) distributed nationwide in the United States.

The tablets are imprinted with incorrect product identification information, which is a labeling error. This defect could affect the ability to correctly identify the medication.

Consumers with the affected lot should consult with their pharmacist or healthcare provider about whether they have the recalled product and appropriate next steps.

The recalled product

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.
Manufacturer
Akron Pharma, Inc.
Category
Drug
Hazard
  • mis-labeling
  • wrong-identification

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 (2)

  • Lot: KDT0224002A
  • Exp 09/30/2026

Distribution

Distributed nationwide across the United States.

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