FDA Drug recall D-1058-2019
Diclofenac Sodium Topical Solution, 1.5% w/w, 5 FL. OZ. (150 mL) bottle, Rx Only, Manufactured for: Ingenus Pharmaceuticals, LLC, Orlando,…
- FDA Drug
- Class III
- terminated
- Published 2019-04-03
On 2019-04-03 the FDA classified a Class III recall of Diclofenac Sodium Topical Solution, 1.5% w/w, 5 FL. OZ. (150 mL) bottle, Rx Only, Manufactured for: Ingenus Pharmaceuticals, LLC, Orlando,… by Ingenus Pharmaceuticals, citing defective Container: firm discovered samples stored horizontally as well as product quality complaints from customers for bottles leaking.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1058-2019 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2019-03-18 |
| Published | 2019-04-03 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Ingenus Pharmaceuticals |
| Distribution | US |
Product
Diclofenac Sodium Topical Solution, 1.5% w/w, 5 FL. OZ. (150 mL) bottle, Rx Only, Manufactured for: Ingenus Pharmaceuticals, LLC, Orlando, FL 32839-6408, NDC 50742-308-05.
Reason
Defective Container: firm discovered samples stored horizontally as well as product quality complaints from customers for bottles leaking.
Identifiers
| code_info | Lot #: 31804, Exp 11/2019; 31911, 31917, Exp 02/2020; 32067, 32072, 32084, Exp 06/2020; 32248, Exp 10/2020 |
|---|
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-1058-2019%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.