RecallRadar

FDA Drug recall 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 fo…

On 2024-10-30 the FDA classified a Class II recall of OneLAX Docusate Sodium Liquid (docusate sodium 50 mg/5 mL) Stool Softener Laxative, 16 FL OZ (473 mL) bottle, Akron Pharma, Manufactured fo… by Akron Pharma, citing CGMP Deviations.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-0025-2025
ClassificationClass II
Statusongoing
Initiated2024-10-15
Published2024-10-30
Last updated2026-09-13 11:52 UTC
CompanyAkron Pharma
DistributionUS

Product

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

CGMP Deviations

Identifiers

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

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0025-2025%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.