ZoomMax Capsules contain undeclared sildenafil and diclofenac
ZoomMax Capsules have been recalled by the FDA due to containing undeclared sildenafil and diclofenac. The product was marketed without FDA approval.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I recall for an unapproved product containing undeclared prescription medications. Meets Class I criterion requiring minimum Severe classification. No illnesses reported, therefore 4 rather than 5.
Plain-English summary
ZoomMax Capsules, 500 mg, sold by ZoomMax (2108 N St. Sacramento, CA 95816), have been recalled by the FDA. These capsules were marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).
The product was found to contain undeclared sildenafil and diclofenac. The recall affects nationwide distribution, with Lot #YZM240406 expiring 04/05/2027.
Consumers who purchased this product should stop using it immediately and consult a healthcare provider if they have taken these capsules. The product should be disposed of properly or returned to the point of purchase.
The recalled product
- Product
- ZoomMax Capsules, 500 mg, 10 count blisters in cartons, Distributed by: ZoomMax, 2108 N St. Sacramento, CA 95816, www.zoommax.com
- Manufacturer
- Boulla LLC
- Category
- Drug
- Hazard
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 (2)
- Lot #: YZM240406
- Exp: 04/05/2027
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 recalled by Boulla LLC 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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