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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 Tablets Recalled for Missing Brand Imprint

Agency Publication Date: August 17, 2022
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Summary

Akron Pharma, Inc. has recalled approximately 331,707 bottles of Acetaminophen 325 mg and 500 mg (Extra Strength) tablets because the tablets are missing the "AP 325" brand identification imprint. Without this imprint, consumers and healthcare providers cannot easily verify the medication if it is removed from its original packaging. No incidents or injuries related to this issue have been reported to date.

Risk

The absence of a brand imprint can lead to the misidentification of the drug, which may cause a consumer to take the wrong medication or an incorrect dosage. This is particularly dangerous if multiple medications are stored outside of their original bottles.

What You Should Do

  1. This recall affects Acetaminophen 325 mg and 500 mg (Extra Strength) tablets sold under the Akorn Pharma brand in 100-count and 1000-count bottles.
  2. Check your medication packaging for NDC codes 71399-8024-01, 71399-8024-02, 71399-8022-01, or 71399-8022-02. See the Affected Products section below for the full list of affected codes.
  3. If you have health concerns, contact your healthcare provider or pharmacist.
  4. Return any unused product to the place of purchase for a refund, throw it away, or contact Akron Pharma, Inc. for further instructions.
  5. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.

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: Acetaminophen 325 mg tabletsby Akorn Pharma
Variants: 100-count bottle, 1000-count bottle
Lot Numbers:
AXA2001 (Exp Feb-23)
AXA2002 (Exp Feb-23)
AXA2003 (Exp Feb-23)
AXA2004 (Exp Feb-23)
AXA2005 (Exp Feb-23)
AXA2006 (Exp Feb-23)
AXA2007 (Exp Feb-23)
AXA2008 (Exp Feb-23)
AXA2009 (Exp Feb-23)
AXA2010 (Exp Feb-23)
AXA2011 (Exp Feb-23)
AXA2012 (Exp Feb-23)
AXA2013 (Exp Feb-23)
AXA2014 (Exp Feb-23)
AKK2021 (Exp Mar-24)
AKK30421 (Exp Mar-24)
AKK40421 (Exp Mar-24)
AKK50421 (Exp Mar-24)
AKK60421 (Exp Mar-24)
AKK70421 (Exp Mar-24)
AKK80421 (Exp Mar-24)
AKK90421 (Exp Mar-24)
AKL10421 (Exp Apr-24)
AKL20421 (Exp Apr-24)
AKL10521 (Exp Apr-24)
AKL20521 (Exp Apr-24)
AKL30521 (Exp Apr-24)
AKL40521 (Exp Apr-24)
AKL50521 (Exp Apr-24)
AKL60521 (Exp Apr-24)
AKL70521 (Exp Apr-24)
AKL80521 (Exp Apr-24)
AKL90521 (Exp Apr-24)
AKM10521 (Exp Apr-24)
AKA10621 (Exp May-24)
AKA20621 (Exp May-24)
AKA30621 (Exp May-24)
AKA40621 (Exp May-24)
AKA50621 (Exp May-24)
AKA60621 (Exp May-24)
AKA70621 (Exp May-24)
AKA80621 (Exp May-24)
AKA90621 (Exp May-24)
AKB10621 (Exp May-24)
NDC:
71399-8024-01
71399-8024-02
Product: Acetaminophen 500 mg tablet, Extra Strengthby Akorn Pharma
Variants: 100-count bottle, 1000-count bottle
Lot Numbers:
AXA2014 (Exp Feb-23)
AXB2001 (Exp Nov-22)
AXB2002 (Exp Dec-22)
AXB2003 (Exp Dec-22)
AXB2004 (Exp Dec-22)
AXB2005 (Exp Dec-22)
AXB2006 (Exp Dec-22)
AXB2007 (Exp Dec-22)
AXB2008 (Exp Dec-22)
AXB2009 (Exp Dec-22)
AXB2010 (Exp Dec-22)
AXB2011 (Exp Dec-22)
AXB2012 (Exp Feb-23)
AXB2013 (Exp Feb-23)
AXB2014 (Exp Feb-23)
AXB2015 (Exp Feb-23)
AXB2016 (Exp Feb-23)
AXB2017 (Exp Feb-23)
AXB2018 (Exp Feb-23)
AXB2019 (Exp Feb-23)
AXB2020 (Exp Feb-23)
AXB2021 (Exp Feb-23)
AXB2022 (Exp Feb-23)
AXB2023 (Exp Feb-23)
AXB2024 (Exp Feb-23)
AXB2025 (Exp Feb-23)
AXB2026 (Exp Feb-23)
AXB2027 (Exp Feb-23)
NDC:
71399-8022-01
71399-8022-02

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 90682
Status: Resolved
Manufacturer: Akron Pharma, Inc.
Sold By: Distributors; Wholesalers
Manufactured In: United States
Units Affected: 2 products (301,382 bottles; 30,325 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.