FDA Drug recall D-1150-2016
XCEL ADVANCED Capsules, 350mg, 60-count bottles, Manufactured for JNS Health
- FDA Drug
- Class I
- terminated
- Published 2016-07-13
On 2016-07-13 the FDA classified a Class I recall of XCEL ADVANCED Capsules, 350mg, 60-count bottles, Manufactured for JNS Health by Bee Extremely Amazed, citing marketed Without An Approved NDA/ANDA: tainted product marketed as a dietary supplement. Product found to be tainted with undeclared phenolphthalein, an ingredient found in over-t….
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1150-2016 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2015-12-15 |
| Published | 2016-07-13 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Bee Extremely Amazed |
| Distribution | US |
Product
XCEL ADVANCED Capsules, 350mg, 60-count bottles, Manufactured for JNS Health
Reason
Marketed Without An Approved NDA/ANDA: tainted product marketed as a dietary supplement. Product found to be tainted with undeclared phenolphthalein, an ingredient found in over-the-counter laxative products that was withdrawn from the US market due to concerns of carcinogenicity, making it an unapproved drug.
Identifiers
| code_info | All lots |
|---|
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-1150-2016%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.