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.
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: 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
- Hazard
- undeclared-sildenafil
- undeclared-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.
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