CLASS I ONGOING Drug recall · Reported 27 Dec 2023 · FDA Enforcement Report
THE ROCK, Male Sexual Performance Enhancement Capsules recalled
Noah's Wholesale is recalling THE ROCK, Male Sexual Performance Enhancement Capsules, 1200 mg blister card, distributed in Florida. The recall was initiated on 16 Oct 2023 and the FDA has classified it as Class I.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0158-2024
- FDA event ID
- 93231
- Recalling firm
- Noah's Wholesale, Miami Lakes, FL
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- 16 Oct 2023
- FDA classified
- 21 Dec 2023
- Reported
- 27 Dec 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Hidden Drug Ingredients
Timeline
| 16 Oct 2023 | Recall initiated by company | |
| 21 Dec 2023 | Classified by FDA | +66 days |
| 27 Dec 2023 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
Products marketed as supplements sometimes contain undeclared prescription drug ingredients such as sildenafil or sibutramine. These can interact dangerously with other medicines.
Product as listed by the FDA
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
Where it was distributed
Florida, Bahamas, Turks & Caicos Islands
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
Lot# 03032021 Exp: 12/31/2027
Where was it sold?
Florida, Bahamas, Turks & Caicos Islands
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.