Akron Pharma, Inc.

FDA Regulatory Profile

Summary

Total Recalls
11
510(k) Clearances
0
Inspections
1
Compliance Actions
0

Recent Recalls

NumberClassProductDate
D-0195-2025Class IIIAcetaminophen, 325 mg Tablets, 100 Tablets per bottle, Akron Pharma, Manufactured for: Akron Pharma December 12, 2024
D-0196-2025Class IIIAcetaminophen Extra Strength 500 mg, 1000 Tablets per bottle, Akron Pharma, Manufactured for: AkronDecember 12, 2024
D-0198-2025Class IIIDiphenhydramine HCl 25 mg, 1000 Capsules per bottle, Akron Pharma, Manufactured for: Akron Pharma, IDecember 12, 2024
D-0197-2025Class IIIDiphenhydramine HCl 25 mg, 100 capsules per bottle, Akron Pharma, Manufactured for: Akron Pharma, InDecember 12, 2024
D-0199-2025Class IIIDiphenhydramine HCl 50 mg, 1000 capsules per bottle, Akron Pharma, Manufactured for: Akron Pharma, IDecember 12, 2024
D-0194-2025Class IIIAcetaminophen Regular Strength, 325 mg, 100 Tablets per bottle, Akron Pharma, Inc., 373 RT US 46 W BDecember 12, 2024
D-0193-2025Class IIIAcetaminophen Extra Strength 500 mg, 100 Tablets per bottle, Akron Pharma, Inc., 373 RT US 46 W BuilDecember 12, 2024
D-0025-2025Class IIOneLAX Docusate Sodium Liquid (docusate sodium 50 mg/5 mL) Stool Softener Laxative, 16 FL OZ (473 mLOctober 15, 2024
D-0454-2023Class IIIDIBUCAINE 1% HEMORRHOIDAL OINTMENT, 1 oz. (28 gm), Manufactured for: Akron Pharma Inc. Fairfield NJ February 17, 2023
D-1352-2022Class IIIAcetaminophen 325 mg tablets, packaged in a) 100-count bottle (NDC 71399-8024-01); b) 1000-count boAugust 4, 2022
D-1353-2022Class IIIAcetaminophen 500 mg tablet, Extra Strength, packaged in a) 100-count bottle (NDC 71399-8022-01), b)August 4, 2022