---
title: "Acetaminophen 500 mg tablet, Extra Strength, packaged in a) 100-count bottle ... — FDA record D-1353-2022 | Is It on Recall"
description: "Failed Tablet/Capsule Specifications: Imprint \"AP 325\" is missing from the tablet."
url: https://isitonrecall.com/recall/fda-drug-d-1353-2022-acetaminophen-500-mg-tablet-extra-strength-packaged-in-a-100-count-bottle-ndc-71399-8022-01-b-1000-c/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

[Recall archive](https://isitonrecall.com/archives/) / FDA drug enforcement

# Acetaminophen 500 mg tablet, Extra Strength, packaged in a) 100-count bottle (NDC 71399-8022-01), b) 1000-count bottl... — FDA record D-1353-2022

Reported terminated

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Aug 4, 2022. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/).

## What the record says

- **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
- **Reason**: Failed Tablet/Capsule Specifications: Imprint "AP 325" is missing from the tablet.
- **Classification**: Class III
- **Recalling firm**: Akron Pharma, Inc.
- **Quantity**: 30,325 bottles
- **Agency-reported status**: Terminated
- **Source record identifier**: D-1353-2022

[Open the official record](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-1353-2022%22)

[What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). Classification is an agency assessment, not individual medical advice.

## Lot and product identifiers

| Label field | Details supplied by the agency |
| --- | --- |
| Lot, code or applicability | 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 |

Match all identifying details in the current notice. A brand name alone is not enough.

## Distribution

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

No US distribution state could be established from this record. Check the official notice.

## Dates in the source

- **Report date**: Aug 24, 2022
- **Recall initiation date**: Aug 4, 2022
- **Center classification date**: Aug 17, 2022
- **Termination date**: Dec 4, 2023

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

## What to do next

Read the official notice for the action that applies to your exact product.

[Read the current instructions](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-1353-2022%22)

## Before changing a medicine

Follow urgent instructions in the current official recall notice. Speak to your pharmacist or prescriber before stopping or changing a prescribed medicine.

Talk to your doctor or pharmacist if you have questions or concerns about your medicine. [FDA medication recall guidance](https://www.fda.gov/drugs/drug-recalls/understanding-drug-recalls-what-know-and-what-do)

## Related records

[Acetaminophen records](https://isitonrecall.com/drug/acetaminophen/) [Medications records](https://isitonrecall.com/category/medications/) [Akron Pharma, Inc. records](https://isitonrecall.com/brand/akron-pharma-inc/)