Recall archive / 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. Source coverage and dates.
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
What the recall classes mean. 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.