CLASS III ONGOING Drug recall · Reported 22 Jan 2025 · FDA Enforcement Report
Acetaminophen Regular Strength, 325 mg per, Akron Pharma recalled
Akron Pharma is recalling Acetaminophen Regular Strength, 325 mg per, Akron Pharma, Inc., 373 RT US 46 W Building E, distributed nationwide in the US. The recall was initiated on 12 Dec 2024 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-0194-2025
- FDA event ID
- 95944
- Recalling firm
- Akron Pharma, Fairfield, NJ
- Classification
- Class III
- Status
- Ongoing
- Recall initiated
- 12 Dec 2024
- FDA classified
- 10 Jan 2025
- Reported
- 22 Jan 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Drug class
- Pain Medication
Timeline
| 12 Dec 2024 | Recall initiated by company | |
| 10 Jan 2025 | Classified by FDA | +29 days |
| 22 Jan 2025 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.
Product as listed by the FDA
Acetaminophen Regular Strength, 325 mg, 100 Tablets per bottle, Akron Pharma, Inc., 373 RT US 46 W Building E, Suite 117, Fairfield, NJ 07004, NDC 71399-8024-01 .
Where it was distributed
Nationwide in the US
Questions about this recall
Is Acetaminophen Regular Strength, 325 mg per, Akron Pharma, Inc., 373 RT US 46 W Building E recalled?
Yes. Akron Pharma recalled Acetaminophen Regular Strength, 325 mg per, Akron Pharma, Inc., 373 RT US 46 W Building E on 12 Dec 2024. The recall is Class III and its status is Ongoing. Recall number D-0194-2025.
Why was it recalled?
Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.
Which lots are affected?
Lot #: KDT0124001, Exp 08/31/2026
Where was it sold?
Nationwide in the US
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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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 | Diphenhydramine HCl 50 mg per, Akron Pharma recalled | Akron Pharma | Other | Nationwide |
| Drug | CLASS III | Diphenhydramine HCl 25 mg per, Akron Pharma recalled | Akron Pharma | Other | Nationwide |