ZapMax Capsules recall
FDA recall D-0086-2025 · initiated Nov 4, 2024
Boulla LLC recalled ZapMax Capsules in Nov 2024 — an FDA Class I recall (D-0086-2025) because Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and diclofenac.
Most serious — a reasonable probability that use will cause serious harm or death.
Why it was recalled
Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and diclofenac.
Sold unapproved, or found to contain something undeclared
The product should not have been on sale in this form — often a supplement found to contain a hidden prescription drug.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: Unknown
Details
- Product
- ZapMax Capsules, 500 mg, 10 count blisters in cartons, Distributed by: ZapMax, 2108 N St. Sacramento, CA 95816, www.zapmax.com
- Recalling company
- Boulla LLC
- Classification
- Class I
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide within the United States
- Initiated
- Nov 4, 2024
- FDA report date
- Dec 11, 2024
Frequently asked
- Was ZapMax Capsules recalled?
- Boulla LLC recalled ZapMax Capsules in Nov 2024 — an FDA Class I recall (D-0086-2025) because Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and diclofenac. Most serious — a reasonable probability that use will cause serious harm or death.
- Why was ZapMax Capsules recalled?
- Per the FDA enforcement record, the reason for recall D-0086-2025 was: Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and diclofenac.
- Is a recalled ZapMax Capsules dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. Most serious — a reasonable probability that use will cause serious harm or death. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of ZapMax Capsules are affected?
- Distributed: Nationwide within the United States. The recall covers these lots — Lot #: YZM240406, Exp: 04/05/2027. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0086-2025.