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
- missing-imprint
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.
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