Recall archive / FDA company announcement

Boulla LLC: Marketed as Dietary Supplement — FDA announcement Nov 5, 2024

Published notice; closure not supplied

A company announcement posted by FDA. The listing date can differ from the original announcement date. The absence of a termination marker does not prove the recall is currently ongoing.

Source date Nov 5, 2024. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

What the record says

Product: Marketed as Dietary Supplement
Reason: Undeclared Sildenafil and Diclofenac
Classification: Not supplied
Recalling firm: Boulla LLC
Quantity: Not supplied
Agency-reported status: Company recall announcement
Source record identifier: a84e424b711133e3

Open the official record

Lot and product identifiers

Label field	Details supplied by the agency
Lot, code or applicability	FOR IMMEDIATE RELEASE – 11/04/24 – Sacramento, CA, Boulla LLC is voluntarily recalling lot YZM240406, Exp 04/05/27, of ZoomMax Capsules and ZapMax Capsules packaged in 10-count blisters in a cardboard carton to the consumer level. The products were found to be tainted with sildenafil via testing by the FDA, an ingredient in FDA approved products for treatment of male erectile dysfunction in the family of drugs known as phosphodiesterase (PDE-5) inhibitors and diclofenac, an FDA approved drug known as a nonsteroidal anti-inflammatory drug (NSAID) used to treat pain and inflammation. Products containing sildenafil and diclofenac cannot be marketed as dietary supplements. ZoomMax and ZapMax capsules are unapproved new drugs for which safety and efficacy have not been established and, therefore, subject to recall.; ZoomMax capsules and ZapMax capsules are marketed as dietary supplements for male performance and energy and are packaged in 10-count blisters packaged in an (ZoomMax - Orange and White Carton) and (ZapMax in Purple and White carton) with Lot#: YZM240406. The products can be identified by the labels below.; Boulla LLC is notifying its distributors and customers by this press announcement and is arranging for return of all recalled products by using the return product option on the Amazon platform. Consumers that have ZoomMax or ZapMax capsules lot number YZM240406 should stop using the product. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Label field

Details supplied by the agency

Lot, code or applicability

FOR IMMEDIATE RELEASE – 11/04/24 – Sacramento, CA, Boulla LLC is voluntarily recalling lot YZM240406, Exp 04/05/27, of ZoomMax Capsules and ZapMax Capsules packaged in 10-count blisters in a cardboard carton to the consumer level. The products were found to be tainted with sildenafil via testing by the FDA, an ingredient in FDA approved products for treatment of male erectile dysfunction in the family of drugs known as phosphodiesterase (PDE-5) inhibitors and diclofenac, an FDA approved drug known as a nonsteroidal anti-inflammatory drug (NSAID) used to treat pain and inflammation. Products containing sildenafil and diclofenac cannot be marketed as dietary supplements. ZoomMax and ZapMax capsules are unapproved new drugs for which safety and efficacy have not been established and, therefore, subject to recall.; ZoomMax capsules and ZapMax capsules are marketed as dietary supplements for male performance and energy and are packaged in 10-count blisters packaged in an (ZoomMax - Orange and White Carton) and (ZapMax in Purple and White carton) with Lot#: YZM240406. The products can be identified by the labels below.; Boulla LLC is notifying its distributors and customers by this press announcement and is arranging for return of all recalled products by using the return product option on the Amazon platform. Consumers that have ZoomMax or ZapMax capsules lot number YZM240406 should stop using the product. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Match all identifying details in the current notice. A brand name alone is not enough.

Distribution

The product was distributed via the internet on Amazon.com in the USA.

No US distribution state could be established from this record. Check the official notice.

Dates in the source

Fda listing date: Nov 5, 2024
Company announcement date: Nov 4, 2024

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.