Col-Rite Docusate Sodium Recall: High Assay Results
Allegiant Health recalls Col-Rite stool softener softgels due to high out-of-specification assay results. Check lot numbers and expiration dates.
Use caution until it’s fixed
Superpotent Drug: High out of specification results for assay at the 6 month time point interval.
Contact the company
What happened, in plain English
Allegiant Health is recalling Col-Rite (docusate sodium) stool softener softgels because they have high out-of-specification assay results at the six-month interval. This means the drug may contain more active ingredient than labeled, potentially leading to unintended effects. The recall affects specific lots distributed by Rite Aid. Read more at govinfonow.com/recall/43135-col-rite-docusate-sodium-recall-high-assay-results.
Source Summary by GovInfoNow · govinfonow.com/recall/43135-col-rite-docusate-sodium-recall-high-assay-results · Updated October 11, 2026 · FDA enforcement record: FDA #D-0856-2016
Cite this page
“Col-Rite Docusate Sodium Recall: High Assay Results.” GovInfoNow, updated October 11, 2026. https://govinfonow.com/recall/43135-col-rite-docusate-sodium-recall-high-assay-results. Based on FDA recall #D-0856-2016 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0856-2016%22&limit=1).
Why it’s dangerous
The hazard is that the assay results were high out of specification, meaning the concentration of docusate sodium may be higher than the labeled 50 mg. This deviation could alter the expected therapeutic effect or safety profile of the stool softener.
Who’s affected
Consumers who purchased Col-Rite stool softener softgels from Rite Aid stores nationwide are affected. Individuals taking this medication for constipation relief should check their bottles immediately.
How to tell if you have this one
Look for Col-Rite (docusate sodium) stool softener softgels, 50 mg, in either 30-count bottles (Item 351104, UPC 0 11822 51104 9) or 60-count bottles (Item 357392, UPC 0 11822 57392 4). Check the lot number for 5C344105 and the expiration date of 02/17.
- Brand
Col-Rite- Product
col-rite (docusate sodium) stool softener softgels, 50 mg, packaged in a) 30-count, item 351104, UPC 0 11822 51104 9- Category
Drug
What to do — step by step
Check Your Bottle
Verify if your product matches the recalled item numbers, UPCs, lot number 5C344105, or expiration date 02/17.
Stop Using Recalled Items
If your bottle matches the details above, discontinue use immediately due to the high assay results.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 2.3 years after the firm started it.
- Firm started the recall
- FDA classified it Class III
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0856-2016 (February 29, 2016) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0856-2016 to see it in context.
- Plain-language summary written by qwen3.6:35b-a3b on October 11, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.