iNDiGO capsules — Class I drug recall D-0978-2015
Terminated recall by Detox Transforms, reported 2015-05-13, distributed nationwide. Marketed Without An Approved NDA/ANDA: Product was found to contain undeclared phenolphthalein, making iNDiGO
| Recall number | D-0978-2015 |
|---|---|
| Product type | Drug |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Detox Transforms, Garner, NC, United States |
| Recall initiated | 2015-01-25 |
| Classified | 2015-05-04 |
| Reported by FDA | 2015-05-13 |
| Terminated | 2017-01-23 |
| Distributed | Nationwide (US) |
| Quantity | 175 bottles |
| Reason classes | undeclared allergen, unapproved product |
| UPC / GTIN / UDI-DI | 00852175004044 |
| Lot numbers | 000034 |
| Expiration dates | 2017-04-10 |
Product
iNDiGO capsules, 220 mg, 60-count bottle, Developed by Signature, 1027 Highway 70 W, Suite 227, Garner, NC 27529, UPC 8 52175 00404 4.
Reason for recall
Marketed Without An Approved NDA/ANDA: Product was found to contain undeclared phenolphthalein, making iNDiGO an unapproved drug.
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-0978-2015. 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.