The Recall Desk
ModerateFDA (Drugs)·D-1352-2022·Announced 2022-08-24

Acetaminophen 325 mg tablets recalled for missing imprint

Akorn Pharma is recalling 301,382 bottles of Acetaminophen 325 mg tablets because the tablets lack the required "AP 325" imprint marking.

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 minor labeling defect (missing tablet imprint) with no reported illnesses or injuries. This falls under 'minor labeling errors' per the agency classification guidance.

Plain-English summary

Akorn Pharma, Inc. is recalling 301,382 bottles of Acetaminophen 325 mg tablets due to a manufacturing defect. The tablets are missing the required "AP 325" imprint that identifies the medication.

The recalled products include 100-count bottles (NDC 71399-8024-01) and 1000-count bottles (NDC 71399-8024-02). Multiple lot numbers are affected with expiration dates ranging from February 2023 through May 2024.

The products were distributed to six distributors and wholesalers, who may have further distributed them. No illnesses or injuries related to these tablets have been reported.

The recalled product

Product
Acetaminophen 325 mg tablets, packaged in a) 100-count bottle (NDC 71399-8024-01); b) 1000-count bottle (NDC 71399-8024-02), Akorn Pharma Manufactured for: Akorn Pharma, Inc., Fairfield, NJ
Manufacturer
Akron Pharma, Inc.
Category
Drug
Hazard
Affected units
301,382

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 #: AXA2001
  • AXA2002
  • AXA2003
  • AXA2004
  • AXA2005
  • AXA2006
  • AXA2007
  • AXA2008
  • AXA2009
  • AXA2010
  • AXA2011
  • AXA2012
  • AXA2013
  • AXA2014
  • Exp Feb-23
  • AKK2021
  • AKK30421
  • AKK40421
  • AKK50421
  • AKK60421

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 →

Related recalls

Same manufacturer · Akron Pharma, Inc.

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Same hazard · missing imprint

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