Acetaminophen 500 mg tablet — Class III drug recall D-1353-2022
Terminated recall by Akron Pharma, Inc., reported 2022-08-24. Failed Tablet/Capsule Specifications: Imprint "AP 325" is missing from the tablet.
| Recall number | D-1353-2022 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Akron Pharma, Inc., Fairfield, NJ, United States |
| Recall initiated | 2022-08-04 |
| Classified | 2022-08-17 |
| Reported by FDA | 2022-08-24 |
| Terminated | 2023-12-04 |
| Quantity | 30,325 bottles |
| NDC | 71399-8022-01, 71399-8022-02 |
| Lot numbers | AXA2014, AXB2001, AXB2002, AXB2003, AXB2004, AXB2005, AXB2006, AXB2007, AXB2008, AXB2009, AXB2010, AXB2011, AXB2012, AXB2013, AXB2014, AXB2015, AXB2016, AXB2017, AXB2018, AXB2019, AXB2020, AXB2021, AXB2022, AXB2023, AXB2024, AXB2025, AXB2026, AXB2027, DEC-22, FEB-23, NOV-22 |
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 for recall
Failed Tablet/Capsule Specifications: Imprint "AP 325" is missing from the tablet.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-1353-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.