Fairfield, NJ, United States
Akron Pharma, Inc. recalls
4 recalls recorded since 2018, most recently on 12 December 2024. 2 are listed as ongoing. Status and classification are as published by the FDA.
Recalls4
Ongoing (FDA)2
Terminated or completed2
Class I (FDA)0
Ongoing Class III Drugs
- Recall started
- 12 December 2024
- Reason
- Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.
- Distribution
- Nationwide in the US
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-0195-2025, D-0198-2025, D-0199-2025, D-0194-2025, D-0197-2025, D-0193-2025, D-0196-2025
- Acetaminophen, 325 mg Tablets, 100 Tablets per bottle, Akron Pharma, Manufactured for: Akron Pharma Inc., Fairfield, NJ 07034, NDC 71399-8014-01.
- Diphenhydramine HCl 25 mg, 1000 Capsules per bottle, Akron Pharma, Manufactured for: Akron Pharma, Inc., 373 RT US 46 W Building E., Suite 117, Fairfield, NJ 07004, NDC 71399-8028-2.
- Diphenhydramine HCl 50 mg, 1000 capsules per bottle, Akron Pharma, Manufactured for: Akron Pharma, Inc. 373 Route US 46, Building E, Suite 117, Fairfield, NJ 07004, NDC 71399-8026-02.
- 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 .
- Diphenhydramine HCl 25 mg, 100 capsules per bottle, Akron Pharma, Manufactured for: Akron Pharma, Inc., 373 RT US 46 W Building E, Suite 117, Fairfield, NJ 07004, NDC 71399-8028-1.
- Acetaminophen Extra Strength 500 mg, 100 Tablets per bottle, Akron Pharma, Inc., 373 RT US 46 W Building E, Suite 117, Fairfield, NJ 07004, NDC 71399-8022-01.
- Acetaminophen Extra Strength 500 mg, 1000 Tablets per bottle, Akron Pharma, Manufactured for: Akron Pharma Inc., 373 US RT 46 W Building E, Suite 117, Fairfield, NJ 07034, NDC 71399-8022-02
Ongoing Class II Drugs
- Recall started
- 15 October 2024
- Reason
- CGMP Deviations
- Distribution
- Nationwide in the US
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0025-2025
- OneLAX Docusate Sodium Liquid (docusate sodium 50 mg/5 mL) Stool Softener Laxative, 16 FL OZ (473 mL) bottle, Akron Pharma, Manufactured for: Akron Pharma, Inc., Fairfield, NJ 07004, NDC 71399-0039-06.
Terminated Class III Drugs
- Recall started
- 17 February 2023
- Terminated
- 9 September 2024
- Reason
- Labeling: Incorrect or Missing Lot and/or Exp Date
- Distribution
- Nationwide within the United States
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0454-2023
- DIBUCAINE 1% HEMORRHOIDAL OINTMENT, 1 oz. (28 gm), Manufactured for: Akron Pharma Inc. Fairfield NJ 07004, NDC 71399-2829-1
Terminated Class III Drugs
- Recall started
- 4 August 2022
- Terminated
- 4 December 2023
- Reason
- Failed Tablet/Capsule Specifications: Imprint "AP 325" is missing from the tablet.
- Distribution
- Product was distributed to 6 distributors/wholesalers who may have further distributed the product.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-1353-2022, D-1352-2022
- 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
- Acetaminophen 325 mg tablets, packaged in a) 100-count bottle (NDC 71399-8024-01); b) 1000-count bottle (NDC 71399-8024-02), Akorn Pharma Manufactured for: Akorn Pharma, Inc., Fairfield, NJ
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.