BLUE PEARL capsules — Class I drug recall D-0247-2018
Terminated recall by Blue Fusion Natural, reported 2018-02-07, distributed nationwide. Marketed Without An Approved NDA/ANDA: FDA analysis found this product to contain undeclared sildenafil, an FD
| Recall number | D-0247-2018 |
|---|---|
| Product type | Drug |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Blue Fusion Natural, Orange, CA, United States |
| Recall initiated | 2017-11-29 |
| Classified | 2018-02-01 |
| Reported by FDA | 2018-02-07 |
| Terminated | 2018-12-06 |
| Distributed | Nationwide (US) |
| Quantity | 300 pill |
| Reason classes | undeclared allergen, unapproved product |
Product
BLUE PEARL capsules, 500mg, 1-count packets, Distributed by Blue Pearl Long Beach, CA UPC 8 4704600978 5
Reason for recall
Marketed Without An Approved NDA/ANDA: FDA analysis found this product to contain undeclared sildenafil, an FDA approved drug for the treatment of erectile dysfunction, making this an unapproved drug for which safety and efficacy have not been established and therefore, subject to recall.
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-0247-2018. 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.