FDA Recalls Cummor Male Enhancement Supplement for Undeclared Prescription Drugs
Organic Herbal Supply is recalling Cummor Natural Male Enhancement capsules because FDA analysis found undeclared prescription drugs, including tadalafil and sildenafil.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The agency classification is FDA Class I, which indicates a reasonable probability that use of the product will cause serious adverse health consequences or death. The presence of undeclared prescription drugs in a dietary supplement is a severe hazard.
Plain-English summary
Organic Herbal Supply is voluntarily recalling Cummor Natural Male Enhancement, Herbal Dietary Supplement Capsules, 500 mg. The product is supplied in 2, 4, and 10 count packages and was distributed nationwide via the internet. The recall covers all lots and package sizes.
The FDA is recalling the product because it was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA). FDA analysis detected the presence of undeclared tadalafil, sildenafil, and/or their analogues, as well as Flibanserin. These are prescription medications that can have serious side effects, particularly for individuals taking certain heart medications.
Consumers who have purchased this product should stop using it immediately. They should contact the distributor, Naturally Hard Supplements, in Reno, NV, for a refund or further information. The product was made in Malaysia and distributed by Naturally Hard Supplements.
The recalled product
- Product
- Cummor Natural Male Enhancement, Herbal Dietary Supplement Capsules, 500 mg, supplied in 2, 4 and 10 count packages, Made in Malaysia, Distributed by Naturally Hard Supplements, Reno, NV --- UPC code #680474229116
- Manufacturer
- Organic Herbal Supply
- Category
- Drug — Dietary Supplement
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All lots and package sizes
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 11 recalled by Organic Herbal Supply under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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