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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 90682

2 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
August 04, 2022
Product types
Drug
Classifications
Class III
Statuses
Terminated
Recalling firm wording
Akron Pharma, Inc.

Dossier provenance

Source snapshots represented here

  • openFDA Drug Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

2 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

drug · product 1 of 2

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

D-1352-2022
Recall number
D-1352-2022
Initiated
August 04, 2022
Classification
Class III
Status
Terminated
Recalling firm
Akron Pharma, Inc.
Quantity
301,382 bottles

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Failed Tablet/Capsule Specifications: Imprint "AP 325" is missing from the tablet.

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Failed Tablet/Capsule Specifications: Imprint "AP 325" is missing from the tablet.

Code information

Lot #: AXA2001, AXA2002, AXA2003, AXA2004, AXA2005, AXA2006, AXA2007, AXA2008, AXA2009, AXA2010, AXA2011, AXA2012, AXA2013, AXA2014, Exp Feb-23; AKK2021, AKK30421, AKK40421, AKK50421, AKK60421, AKK70421, AKK80421, AKK90421, Exp Mar-24; AKL10421, AKL20421, AKL10521, AKL20521, AKL30521, AKL40521, AKL50521, AKL60521, AKL70521, AKL80521, AKL90521, Exp Apr-24; AKM10521, Exp Apr-24; AKA10621, AKA20621, AKA30621, AKA40621, AKA50621, AKA60621, AKA70621, AKA80621, AKA90621, Exp May-24; AKB10621, Exp May-24

Distribution pattern

Product was distributed to 6 distributors/wholesalers who may have further distributed the product.

drug · product 2 of 2

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

D-1353-2022
Recall number
D-1353-2022
Initiated
August 04, 2022
Classification
Class III
Status
Terminated
Recalling firm
Akron Pharma, Inc.
Quantity
30,325 bottles

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Failed Tablet/Capsule Specifications: Imprint "AP 325" is missing from the tablet.

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Failed Tablet/Capsule Specifications: Imprint "AP 325" is missing from the tablet.

Code information

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, AXB2017, AXB2018, AXB2019, AXB2020, AXB2021, AXB2022, AXB2023, AXB2024, AXB2025, AXB2026, AXB2027, Exp Feb-23

Distribution pattern

Product was distributed to 6 distributors/wholesalers who may have further distributed the product.