Diclofenac Sodium Topical Solution — Class III drug recall D-1058-2019
Terminated recall by Ingenus Pharmaceuticals Llc, reported 2019-04-03, distributed nationwide. Defective Container: firm discovered samples stored horizontally as well as product quality complaints from cu
| Recall number | D-1058-2019 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ingenus Pharmaceuticals Llc, Orlando, FL, United States |
| Recall initiated | 2019-03-18 |
| Classified | 2019-03-25 |
| Reported by FDA | 2019-04-03 |
| Terminated | 2020-03-06 |
| Distributed | Nationwide (US) |
| Quantity | 29,435 bottles |
| Reason classes | packaging |
| NDC | 50742-0308-05 |
| Lot numbers | 31804, 31911, 31917, 32067, 32072, 32084, 32248 |
| Expiration dates | 2019-11, 2020-02, 2020-06, 2020-10 |
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 for recall
Defective Container: firm discovered samples stored horizontally as well as product quality complaints from customers for bottles leaking.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-1058-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.