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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Low RiskFDA Drug
Medications & Supplements/Over-the-Counter

Akron Pharma Acetaminophen and Diphenhydramine Recalled for Wrong Imprint

Agency Publication Date: January 10, 2025
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Summary

Akron Pharma, Inc. is recalling 31,232 bottles of Acetaminophen and Diphenhydramine HCl because the tablets and capsules were manufactured with the incorrect identification code imprinted on them. The recall affects several strengths of these medications, including 325 mg and 500 mg Acetaminophen and 25 mg and 50 mg Diphenhydramine. Consumers should consult their pharmacist or doctor if they have concerns about their medication.

Risk

The medications are marked with an incorrect identification code, which can make it difficult for consumers or healthcare providers to identify the drug correctly. This labeling error could lead to confusion or the improper use of the medication.

What You Should Do

  1. This recall affects Akron Pharma Acetaminophen tablets (325 mg and 500 mg) and Diphenhydramine HCl capsules (25 mg and 50 mg) in various bottle sizes.
  2. Check the bottle label for NDC codes 71399-8028-1, 71399-8028-2, 71399-8026-02, 71399-8022-01, 71399-8024-01, 71399-8014-01, or 71399-8022-02.
  3. Identify the lot number on your bottle; affected lots include KDC0124001A, KDC0124002B, KDC0224001B, KDT0224002A, KDT0124001, KDT0124004, KDT0124005, KDT0124006, KDT0224001B, and KDT0224002B. See the Affected Products section below for the full list of affected codes.
  4. If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.
  5. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions regarding this recall.

Your Remedy Options

You have 2 options:

๐Ÿ’ฐOption 1: Full Refund
How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund
๐Ÿ—‘๏ธOption 2: Dispose of Product
How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Diphenhydramine HCl (100 capsules per bottle)by Akron Pharma
Variants: 25 mg, Capsule
Lot Numbers:
KDC0124001A (Exp 09/30/2026)
NDC:
71399-8028-1

Quantity: 7198 bottles

Product: Diphenhydramine HCl (1000 capsules per bottle)by Akron Pharma
Variants: 25 mg, Capsule
Lot Numbers:
KDC0124002B (Exp 09/30/2026)
NDC:
71399-8028-2

Quantity: 456 bottles

Product: Diphenhydramine HCl (1000 capsules per bottle)by Akron Pharma
Variants: 50 mg, Capsule
Lot Numbers:
KDC0224001B (Exp 09/30/2026)
NDC:
71399-8026-02

Quantity: 324 bottles

Product: Acetaminophen Extra Strength (100 tablets per bottle)by Akron Pharma, Inc.
Variants: 500 mg, Tablet
Lot Numbers:
KDT0224002A (Exp 09/30/2026)
NDC:
71399-8022-01

Quantity: 768 bottles

Product: Acetaminophen Regular Strength (100 tablets per bottle)by Akron Pharma, Inc.
Variants: 325 mg, Tablet
Lot Numbers:
KDT0124001 (Exp 08/31/2026)
NDC:
71399-8024-01

Quantity: 6429 bottles

Product: Acetaminophen (100 tablets per bottle)by Akron Pharma
Variants: 325 mg, Tablet
Lot Numbers:
KDT0124004 (Exp 08/31/2026)
KDT0124005 (Exp 08/31/2026)
KDT0124006 (Exp 08/31/2026)
NDC:
71399-8014-01

Quantity: 14825 bottles

Product: Acetaminophen Extra Strength (1000 tablets per bottle)by Akron Pharma
Variants: 500 mg, Tablet
Lot Numbers:
KDT0224001B (Exp 08/31/2026)
KDT0224002B (Exp 09/30/2026)
NDC:
71399-8022-02

Quantity: 1232 bottles

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 95944
Status: Active
Manufacturer: Akron Pharma, Inc.
Manufactured In: United States
Units Affected: 7 products (768 bottles; 6429 bottles; 14825 bottles; 1232 bottles; 7198 bottles; 456 bottles; 324 bottles)
Distributed To: Nationwide

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.