FDA Drug recall D-0835-2018
screamin' menthol (menthol) Pain Relieving Gel, 4%, packaged in a) 2 OZ (57g) tubes, UPC 7 50263 80062 5
- FDA Drug
- Class II
- terminated
- Published 2018-05-30
On 2018-05-30 the FDA classified a Class II recall of screamin' menthol (menthol) Pain Relieving Gel, 4%, packaged in a) 2 OZ (57g) tubes, UPC 7 50263 80062 5 by Ideaz, citing CGMP Deviations: Products manufactured with an ingredient that exceed the benzene levels allowed in drug products.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0835-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-05-16 |
| Published | 2018-05-30 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Ideaz |
| Distribution | US |
Product
screamin' menthol (menthol) Pain Relieving Gel, 4%, packaged in a) 2 OZ (57g) tubes, UPC 7 50263 80062 5; b) 5 oz. (141g) tubes, UPC 7 50263 80006 9; and c) 16 oz. (454g) bottles, UPC 7 50263 80066 3; MFD FOR: Toast Products, 400 Sproul Street, Pittsburgh, PA 15136; NDC 52099-8010.
Reason
CGMP Deviations: Products manufactured with an ingredient that exceed the benzene levels allowed in drug products.
Identifiers
| upc | 750263800625 |
|---|---|
| upc | 750263800069 |
| upc | 750263800663 |
| code_info | Lot #: 1015019, Exp 10/18; 1116011, Exp 11/19 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0835-2018%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.