CLASS III Drug recall · Reported 24 Aug 2022 · FDA Enforcement Report

Acetaminophen 325 mg tablets, packaged in a) 100-count bottle recalled

Akron Pharma is recalling Acetaminophen 325 mg tablets, packaged in a) 100-count bottle (. The recall was initiated on 4 Aug 2022 and the FDA has classified it as Class III.

Check your package

Lot, batch or date codesLot #: 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

Quantity recalled301,382 bottles

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

Recall details

Recall number: D-1352-2022
FDA event ID: 90682
Recalling firm: Akron Pharma, Fairfield, NJ
Classification: Class III
Status: Terminated
Recall initiated: 4 Aug 2022
FDA classified: 17 Aug 2022
Reported: 24 Aug 2022
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Packaging Defects
Drug class: Pain Medication

Timeline

4 Aug 2022	Recall initiated by company
17 Aug 2022	Classified by FDA	+13 days
24 Aug 2022	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

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

Where it was distributed

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

Questions about this recall

Why was it recalled?

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

Which lots are affected?

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

Where was it sold?

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

What should I do if I have it?

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

What does Class III mean?

Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

1 other product · FDA event 90682

This product is part of a recall event; the main page for the event is Acetaminophen, Extra Strength recalled by Akron Pharma.

Reported	Class	Recall	Company	Reason	Where
24 Aug 2022	CLASS III	Acetaminophen, Extra Strength recalled by Akron Pharma	Akron Pharma	Packaging Defects	NJ

More recalls from Akron Pharma

All 11

Reported	Class	Recall	Company	Reason	Where
22 Jan 2025Drug	CLASS III	Acetaminophen Extra Strength 500 mg per, Akron Pharma recalled	Akron Pharma	Other	Nationwide
22 Jan 2025Drug	CLASS III	Acetaminophen Extra Strength 500 mg per, Akron Pharma, Inc. recalled	Akron Pharma	Other	Nationwide
22 Jan 2025Drug	CLASS III	Diphenhydramine HCl 25 mg per, Akron Pharma recalled	Akron Pharma	Other	Nationwide
22 Jan 2025Drug	CLASS III	Acetaminophen Regular Strength, 325 mg per, Akron Pharma recalled	Akron Pharma	Other	Nationwide
22 Jan 2025Drug	CLASS III	Diphenhydramine HCl 50 mg per, Akron Pharma recalled	Akron Pharma	Other	Nationwide

Other Acetaminophen recalls

All 61

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3 Sep 2025Drug	CLASS II	Acetaminophen Injection 1000 mg/ (10 mg/mL) recalledAcetaminophen	Baxter Healthcare	Packaging Defects	Nationwide
25 Jun 2025Drug	CLASS II	Acetaminophen Tablets, 325 mg recalled by Aurobindo Pharma USAAmazon Basic Care Acetaminophen	Aurobindo Pharma USA	Manufacturing (CGMP) Deviations	Nationwide
16 Apr 2025Drug	CLASS II	Acetaminophen and Ibuprofen (Nsaid) Tablets, 250 mg/125 mg a) recalledAcetaminophen, Ibuprofen	Glenmark Pharmaceuticals Inc., USA	Manufacturing (CGMP) Deviations	Nationwide
18 Dec 2024Drug	CLASS II	Kirkland Severe Cold & Flu Plus Congestion: Day - 112 coated caplets recalledSevere Cold And Flu Plus Congestion	LNK International	Manufacturing (CGMP) Deviations	Nationwide