The Recall Desk
SevereFDA (Drugs)·D-0085-2025·Announced 2024-12-11

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.

What this means for you

Illness, injury, or structural failure has been reported. 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
  • sildenafil
  • diclofenac

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.

Related recalls

Same category