CLASS III Drug recall · Reported 24 Aug 2022 · FDA Enforcement Report
Acetaminophen, Extra Strength recalled by Akron Pharma
Akron Pharma is recalling Acetaminophen, Extra Strength. The recall was initiated on 4 Aug 2022 and the FDA has classified it as Class III.
Check your package
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-1353-2022
- 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 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
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#: 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
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| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS III | Acetaminophen 325 mg tablets, packaged in a) 100-count bottle recalled | Akron Pharma | Packaging Defects | NJ |
More recalls from Akron Pharma
All 11| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Acetaminophen Extra Strength 500 mg per, Akron Pharma recalled | Akron Pharma | Other | Nationwide |
| Drug | CLASS III | Acetaminophen Extra Strength 500 mg per, Akron Pharma, Inc. recalled | Akron Pharma | Other | Nationwide |
| Drug | CLASS III | Diphenhydramine HCl 25 mg per, Akron Pharma recalled | Akron Pharma | Other | Nationwide |
| Drug | CLASS III | Acetaminophen Regular Strength, 325 mg per, Akron Pharma recalled | Akron Pharma | Other | Nationwide |
| Drug | CLASS III | Diphenhydramine HCl 50 mg per, Akron Pharma recalled | Akron Pharma | Other | Nationwide |