Life-Line DOCUSATE CALCIUM Sodium Free STOOL SOFTENER 240 mg each — Class III drug recall D-0568-2016
Terminated recall by National Vitamin Co Inc, reported 2016-01-20, distributed nationwide. Labeling: Label mix-up. Docusate Sodium 100mg Softgels were mislabeled as Docusate Calcium 240mg.
| Recall number | D-0568-2016 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | National Vitamin Co Inc, Casa Grande, AZ, United States |
| Recall initiated | 2015-12-18 |
| Classified | 2016-01-12 |
| Reported by FDA | 2016-01-20 |
| Terminated | 2016-05-03 |
| Distributed | Nationwide (US) |
| Quantity | 29,827 bottles |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 00079854950052 |
| NDC | 54629-0640-01 |
| Lot numbers | 02/17, 5EA46 |
Product
Life-Line DOCUSATE CALCIUM Sodium Free STOOL SOFTENER 240 mg each, 100 softgels per bottle. UPC 0-79854-95005-2 Manufactured and Distributed by: NATIONAL VITAMIN COMPANY Casa Grande, AZ 85122. NDC 54629-0640-01
Reason for recall
Labeling: Label mix-up. Docusate Sodium 100mg Softgels were mislabeled as Docusate Calcium 240mg.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0568-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.