FDA Drug recall D-0158-2024
THE ROCK, Male Sexual Performance Enhancement Capsules, 1200 mg, 1 count blister card, Distributed by Steele Productions: Hallandale, FL 33…
- FDA Drug
- Class I
- ongoing
- Published 2023-12-27
On 2023-12-27 the FDA classified a Class I recall of THE ROCK, Male Sexual Performance Enhancement Capsules, 1200 mg, 1 count blister card, Distributed by Steele Productions: Hallandale, FL 33… by Noah S Wholesale, citing marketed Without an Approved NDA/ANDA: FDA analysis found the product to be tainted with Sildenafil an ingredient found in an FDA approved product for the treatment of male sexual….
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0158-2024 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2023-10-16 |
| Published | 2023-12-27 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Noah S Wholesale |
| Distribution | FL |
Product
THE ROCK, Male Sexual Performance Enhancement Capsules, 1200 mg, 1 count blister card, Distributed by Steele Productions: Hallandale, FL 33008 UPC 6 61799 95052 7
Reason
Marketed Without an Approved NDA/ANDA: FDA analysis found the product to be tainted with Sildenafil an ingredient found in an FDA approved product for the treatment of male sexual enhancement, making this an unapproved drug.
Identifiers
| upc | 661799950527 |
|---|---|
| code_info | Lot# 03032021 Exp: 12/31/2027 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0158-2024%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.