Class II · Moderate risk Ongoing
OneLAX Docusate Sodium Liquid (docusate sodium 50 mg/5 mL) Stool Softener Laxative, 16 FL OZ (473 mL) bottle, Akron Pharma…
Reason CGMP Deviations
Docusate Sodium 250 mg, 1 Softgel in blister card-foils, 100-count unit dose box…
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
cGMP Deviations: Observations were made that some blister card-foils were separating from the blister cavity.
What was recalled
Docusate Sodium 250 mg, 1 Softgel in blister card-foils, 100-count unit dose box, www.safecorhealth.com, NDC 48433-101-01
- Recalling firm
- Safecor Health, LLC
- NDC code
- 48433-101-01
- Origin
- MA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0060-2025
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Other Docusate recalls
See all
Class II · Moderate risk Ongoing
DOCU LIQUID (docusate sodium, 50 mg/5 mL), packaged in 473mL bottles and b)10mL Unit Dose cups, Distributed by: Akorn Operating…
Reason CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class III · Low risk Terminated
Sankaijo BOTANICAL LAXATIVE (docusate sodium 8.33 mg and sennosides 1.36 mg) tablets, 150-count bottles, Manufactured by SATO…
Reason Subpotent Drug: Formulated amount of sennosides component is less than labelled claim.
Class II · Moderate risk Terminated
Preferred Plus Dioctyl Liquid Stool Softener (Docusate Sodium), 50mg/5mL, 16 FL. Oz. (1 PT.) 473 mL, Manufactured by RIJ…
Reason cGMP Deviations: Products may have microbial contamination.
Class II · Moderate risk Terminated
Gericare Diocto Liquid Docusate Sodium Stool Softener, 50 mg/5mL, 16 FL OZ (473 ml), Dist. BY: Gericare Pharmaceuticals corp…
Reason cGMP Deviations: Products may have microbial contamination.
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