Docusate recalls
The FDA has published 11 recalls involving Docusate since 2014. The latest was reported on 27 Nov 2024. Most were for labeling errors. Aidapak Services has the most recalls in this group. Recalls usually affect specific lots, not every bottle on the market. Check the lot number on each recall page before acting.
Total recalls 11 since 2014
Last 12 months 0 reported
Class I 1 9% of total
Ongoing 1 latest 27 Nov 2024
Recalls per month, last 24 months click a bar for that month Severity split
1 9%9 82%1 9%
Ongoing docusate recalls 1 active
All docusate recalls, newest first 11 total Reported Class Recall Company Reason Where 27 Nov 2024 Drug CLASS II Docusate Sodium 250 mg in blister card-foils unit dose recalled Safecor Health Manufacturing (CGMP) Deviations Nationwide 13 Nov 2019 Drug CLASS III Sankaijo Botanical Laxative (docusate sodium 8.33 mg recalled Sankaijo Sato Pharmaceutical Potency & Assay Nationwide 27 Mar 2019 Drug CLASS II Docusate Sodium, 100mg softgels recalled by Rx Pak Division of McKesson Rx Pak Division of McKesson Packaging Defects Nationwide 28 Dec 2016 Drug CLASS I Docusate Oral 10 mg/mL Oral Syringe recalled by US Compounding US Compounding Sterility TX 30 Jul 2014 Drug CLASS II Docusate Calcium Softgel Capsules, 240 mg recalled Shamrock Medical Solutions Group Packaging Defects 5 states 29 Jan 2014 Drug CLASS II Docusate Calcium, Capsule, 240 mg, Over The Counter recalled Aidapak Services Labeling Errors 4 states 29 Jan 2014 Drug CLASS II Docusate Sodium, Capsule, 250 mg, Over The Counter recalled Aidapak Services Labeling Errors 4 states 29 Jan 2014 Drug CLASS II Docusate Sodium, Capsule, 250 mg, Over The Counter recalled Aidapak Services Labeling Errors 4 states 22 Jan 2014 Drug CLASS II Docusate Sodium Capsule, 100 mg, Over The Counter recalled Aidapak Services Labeling Errors 4 states 22 Jan 2014 Drug CLASS II Docusate Sodium, Capsule, 250 mg, Over The Counter recalled Aidapak Services Labeling Errors 4 states 22 Jan 2014 Drug CLASS II Docusate Sodium, Capsule, 50 mg, Over The Counter recalled Aidapak Services Labeling Errors 4 states
Should you stop taking Docusate?
Not on your own. Most recalls affect specific lots from one manufacturer, and stopping a prescription suddenly can be riskier than the defect. Check your lot number and NDC against the recall, then call the pharmacy that dispensed it for a replacement.