ZapMax Capsules Recalled for Undeclared Sildenafil and Diclofenac
ZapMax Capsules, 500 mg are recalled for containing undeclared sildenafil and diclofenac without FDA approval. The product was distributed nationwide; consumers should stop using immediately and consult their healthcare provider.
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: This is an FDA Class I recall for a product containing undeclared prescription medications marketed without FDA approval. FDA Class I recalls indicate serious health risks from the use of the product.
Plain-English summary
ZapMax Capsules, 500 mg (Lot #YZM240406, expiring 04/05/2027) manufactured by Boulla LLC are being recalled.
The capsules were found to contain undeclared sildenafil and diclofenac and were marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA). Both sildenafil and diclofenac are prescription medications that require medical supervision and should not be distributed or used without proper healthcare provider oversight.
The product was distributed nationwide within the United States. Consumers who have purchased or used ZapMax Capsules should stop using them immediately and contact their healthcare provider, especially if they are taking other medications or have any underlying health conditions that could interact with these drugs.
The recalled product
- Product
- ZapMax Capsules, 500 mg, 10 count blisters in cartons, Distributed by: ZapMax, 2108 N St. Sacramento, CA 95816, www.zapmax.com
- Manufacturer
- Boulla LLC
- Category
- Drug
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.
See all 4 products in this recall →Related recalls
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