FDA Drug recall D-0856-2016
col-rite (docusate sodium) stool softener softgels, 50 mg, packaged in a) 30-count, item 351104, UPC 0 11822 51104 9
- FDA Drug
- Class III
- terminated
- Published 2016-05-25
On 2016-05-25 the FDA classified a Class III recall of col-rite (docusate sodium) stool softener softgels, 50 mg, packaged in a) 30-count, item 351104, UPC 0 11822 51104 9 by Allegiant Health, citing superpotent Drug: High out of specification results for assay at the 6 month time point interval.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0856-2016 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2016-02-29 |
| Published | 2016-05-25 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Allegiant Health |
| Distribution | US |
Product
col-rite (docusate sodium) stool softener softgels, 50 mg, packaged in a) 30-count, item 351104, UPC 0 11822 51104 9; and b) 60-count, item 357392, UPC 0 11822 57392 4; DISTRIBUTED BY: RITE AID, 30 HUNTER LANE, CAMP HILL , PA 17011.
Reason
Superpotent Drug: High out of specification results for assay at the 6 month time point interval.
Identifiers
| upc | 011822511049 |
|---|---|
| upc | 011822573924 |
| code_info | Lot #: 5C344105, Exp 02/17 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0856-2016%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.