FDA Drug recall D-0858-2018
X-Jow (menthol USP) Pain Gel, 1.25%, packaged in a) 4 oz. (113g) bottles (UPC 850547 00502 6) and b) 8 oz. (226g) bottles (UPC 8 50547 0050…
- FDA Drug
- Class II
- terminated
- Published 2018-06-20
On 2018-06-20 the FDA classified a Class II recall of X-Jow (menthol USP) Pain Gel, 1.25%, packaged in a) 4 oz. (113g) bottles (UPC 850547 00502 6) and b) 8 oz. (226g) bottles (UPC 8 50547 0050… by Shadow Holdings, citing CGMP Deviations: products may be contaminated with bacteria.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0858-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-05-25 |
| Published | 2018-06-20 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Shadow Holdings |
| Distribution | US |
Product
X-Jow (menthol USP) Pain Gel, 1.25%, packaged in a) 4 oz. (113g) bottles (UPC 850547 00502 6) and b) 8 oz. (226g) bottles (UPC 8 50547 00503 3, Distributed by Herb-X Solutions, Inc., 3838 West Burbank Blvd., Burbank CA 91505.
Reason
CGMP Deviations: products may be contaminated with bacteria.
Identifiers
| upc | 850547005026 |
|---|---|
| upc | 850547005033 |
| code_info | All lots |
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-0858-2018%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.