FDA Drug recall D-0085-2025
ZoomMax Capsules, 500 mg, 10 count blisters in cartons, Distributed by: ZoomMax, 2108 N St. Sacramento, CA 95816, www.zoommax.com
- FDA Drug
- Class I
- ongoing
- Published 2024-12-11
On 2024-12-11 the FDA classified a Class I recall of ZoomMax Capsules, 500 mg, 10 count blisters in cartons, Distributed by: ZoomMax, 2108 N St. Sacramento, CA 95816, www.zoommax.com by Boulla, citing marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and diclofenac.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0085-2025 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2024-11-04 |
| Published | 2024-12-11 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Boulla |
| Distribution | US |
Product
ZoomMax Capsules, 500 mg, 10 count blisters in cartons, Distributed by: ZoomMax, 2108 N St. Sacramento, CA 95816, www.zoommax.com
Reason
Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and diclofenac.
Identifiers
| code_info | Lot #: YZM240406, Exp: 04/05/2027 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0085-2025%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.