Home / Recalls / Akron Pharma, Inc. / D-0025-2025

D-0025-2025 Class II Ongoing

Recalled by Akron Pharma, Inc. — Fairfield, NJ

Recall Details

Product Type
Drugs
Report Date
October 30, 2024
Initiation Date
October 15, 2024
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
10845 bottles

Product Description

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.

Reason for Recall

CGMP Deviations

Distribution Pattern

Nationwide in the US

Code Information

Lot #ODS230001A, ODS230002A, Exp. 10/2025; ODS230003A, Exp. 11/2025.

Other recalls by Akron Pharma, Inc.

  • D-0195-2025 Class III — Acetaminophen, 325 mg Tablets, 100 Tablets per bottle, Akron Pharma, Manufacture (December 12, 2024)
  • D-0196-2025 Class III — Acetaminophen Extra Strength 500 mg, 1000 Tablets per bottle, Akron Pharma, Manu (December 12, 2024)
  • D-0198-2025 Class III — Diphenhydramine HCl 25 mg, 1000 Capsules per bottle, Akron Pharma, Manufactured (December 12, 2024)
  • D-0197-2025 Class III — Diphenhydramine HCl 25 mg, 100 capsules per bottle, Akron Pharma, Manufactured f (December 12, 2024)
  • D-0199-2025 Class III — Diphenhydramine HCl 50 mg, 1000 capsules per bottle, Akron Pharma, Manufactured (December 12, 2024)
  • D-0194-2025 Class III — Acetaminophen Regular Strength, 325 mg, 100 Tablets per bottle, Akron Pharma, In (December 12, 2024)
  • D-0193-2025 Class III — Acetaminophen Extra Strength 500 mg, 100 Tablets per bottle, Akron Pharma, Inc., (December 12, 2024)
  • D-0454-2023 Class III — DIBUCAINE 1% HEMORRHOIDAL OINTMENT, 1 oz. (28 gm), Manufactured for: Akron Pharm (February 17, 2023)
  • D-1352-2022 Class III — Acetaminophen 325 mg tablets, packaged in a) 100-count bottle (NDC 71399-8024-0 (August 4, 2022)
  • D-1353-2022 Class III — Acetaminophen 500 mg tablet, Extra Strength, packaged in a) 100-count bottle (ND (August 4, 2022)