The Recall Desk
ModerateFDA (Drugs)·D-1353-2022·Announced 2022-08-24

Akorn Pharma recalls Acetaminophen 500 mg tablets with missing imprints

Akorn Pharma, Inc. is recalling Acetaminophen 500 mg Extra Strength tablets because the imprint identification marking is missing from the tablets. The recall affects 30,325 bottles distributed to wholesalers.

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: FDA Class III recall for a labeling specification defect. The missing imprint constitutes a minor labeling error. The rubric specifies that FDA Class III recalls are typically scored 1 or 2. This qualifies as Score 2 - Moderate due to the labeling/identification nature of the defect.

Plain-English summary

Akorn Pharma, Inc. is recalling Acetaminophen 500 mg Extra Strength tablets due to failed tablet specifications. The imprint 'AP 325' is missing from the affected tablets.

The affected product was distributed to six distributors and wholesalers. Approximately 30,325 bottles are subject to this recall, available in two package sizes: 100-count bottles (NDC 71399-8022-01) and 1000-count bottles (NDC 71399-8022-02).

The recall affects multiple lot numbers with expiration dates ranging from November 2022 through February 2023. Consumers who may have purchased the recalled product should contact their pharmacist or healthcare provider with questions about identification or replacement.

The recalled product

Product
Acetaminophen 500 mg tablet, Extra Strength, packaged in a) 100-count bottle (NDC 71399-8022-01), b) 1000-count bottle (NDC 71399-8022-02), Akorn Pharma Manufactured for: Akorn Pharma, Inc., Fairfield, NJ
Manufacturer
Akron Pharma, Inc.
Category
Drug — Over-the-Counter Pain Reliever
Hazard
Affected units
30,325

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 (20)

  • Lot#: AXA2014
  • Exp Feb-23
  • AXB2001
  • Exp Nov-22
  • AXB2002
  • AXB2003
  • AXB2004
  • AXB2005
  • AXB2006
  • AXB2007
  • AXB2008
  • AXB2009
  • AXB2010
  • AXB2011
  • Exp Dec-22
  • AXB2012
  • AXB2013
  • AXB2014
  • AXB2015
  • AXB2016

Distribution

Distribution scope not specified by the agency.

Part of a larger recall action

This product is one of 2 recalled by Akron Pharma, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

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Same hazard · missing imprint

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