Ingenus Pharmaceuticals Llc recalls Diclofenac Sodium Topical Solution, 1.5% w/w, 5 FL. OZ. (150 mL) bottle, Rx Only, Manufactured for: Ingenus
Ingenus Pharmaceuticals recalls 1.5% diclofenac topical solution bottles that may leak, causing product contamination. Affected lots manufactured between 2019-2020 in Orlando, FL. Consumers should check lot numbers on bottles.
Lower-risk recall
Defective Container: firm discovered samples stored horizontally as well as product quality complaints from customers for bottles leaking.
Contact the company & request your remedy
What happened, in plain English
Ingenus Pharmaceuticals is recalling diclofenac topical solution bottles that may leak. Leaking bottles could lead to product contamination, which might cause skin irritation or other issues if the medication comes into contact with other substances. Read more at govinfonow.com/recall/39079-ingenus-diclofenac-topical-solution-recall-leaking-bottles-risk-product-contamination.
Source Summary by GovInfoNow · govinfonow.com/recall/39079-ingenus-diclofenac-topical-solution-recall-leaking-bottles-risk-product-contamination · Updated October 5, 2026 · FDA enforcement record: FDA #D-1058-2019
Cite this page
“Ingenus Diclofenac Topical Solution Recall: Leaking Bottles Risk Product Contamination.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/39079-ingenus-diclofenac-topical-solution-recall-leaking-bottles-risk-product-contamination. Based on FDA recall #D-1058-2019 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1058-2019%22&limit=1).
Why it’s dangerous
The bottles may leak when stored horizontally or under normal conditions, leading to product contamination. This could cause skin irritation or other issues if the medication comes into contact with other substances.
Who’s affected
People who have the 1.5% diclofenac topical solution bottle with lot numbers 31804 through 32248 (manufactured 2019-2020) are affected. Those using the product for pain relief are most at risk if the bottle leaks.
How to tell if you have this one
Check the bottle for a lot number between 31804 and 32248. The product is a 5 fl. oz. (150 mL) bottle of diclofenac sodium topical solution, sold with a prescription.
- Brand
Ingenus- Category
Drug
What to do — step by step
Check Bottle Lot Number
Look for the lot number on the bottle, which should be between 31804 and 32248 for affected products.
Questions people ask
Why is this product being recalled?
The recall is due to defective containers that may leak, leading to potential product contamination.
How can I tell if my bottle is affected?
Check the lot number on the bottle; affected lots are 31804 through 32248 (manufactured 2019-2020).
What should I do if I have an affected bottle?
The recall does not specify a remedy, so contact Ingenus Pharmaceuticals for further instructions.
Contact Ingenus
We’ve drafted a message you can send Ingenus to request your refund or repair — edit it as you like.
Subject: Recall D-1058-2019 — Ingenus Ingenus Hello, I own a Ingenus that is covered by recall D-1058-2019 from Ingenus. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-1058-2019 (March 18, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1058-2019 to see it in context.
- Plain-language summary written by qwen3:4b on October 5, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.