Novacort Gel Recall: Subpotent Pramoxine Hazard
Novum Pharma recalls Novacort Gel sample packets due to subpotent pramoxine. Check lot numbers 8249 and 8250 for details.
Use caution until it’s fixed
Subpotent Drug: Out of specification result for pramoxine hydrochloride
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What happened, in plain English
Novum Pharma, LLC is recalling Novacort Gel Sample Packets because they contain less pramoxine hydrochloride than specified. This means the medication may not work as intended to relieve pain or itching. The recall affects specific lots distributed nationwide. Read more at govinfonow.com/recall/42137-novacort-gel-recall-subpotent-pramoxine-hazard.
Source Summary by GovInfoNow · govinfonow.com/recall/42137-novacort-gel-recall-subpotent-pramoxine-hazard · Updated October 11, 2026 · FDA enforcement record: FDA #D-0433-2017
Cite this page
“Novacort Gel Recall: Subpotent Pramoxine Hazard.” GovInfoNow, updated October 11, 2026. https://govinfonow.com/recall/42137-novacort-gel-recall-subpotent-pramoxine-hazard. Based on FDA recall #D-0433-2017 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0433-2017%22&limit=1).
Why it’s dangerous
The pramoxine hydrochloride in the gel is subpotent, meaning it does not meet the required strength specifications. This out-of-specification result could lead to inadequate pain or itch relief for users who depend on the medication's full potency.
Who’s affected
Patients who received these prescription sample packets from healthcare providers are affected. Individuals relying on this gel for symptom relief may find it ineffective due to the lower drug concentration.
How to tell if you have this one
Look for Novacort Gel Sample Packets (2% hydrocortisone acetate, 1% pramoxine HCl) in a 10-count carton of 1.0 g packets. Check for NDC 69646-704-38 or NDC 69646-704-01. Verify the lot number is either 8249 (Exp. Date: 03/18) or 8250 (Exp. Date: 06/18).
- Brand
Novum Pharma- Category
Drug
What to do — step by step
Check Your Lot Number
Verify if your sample packets match lot numbers 8249 or 8250 with expiration dates of 03/18 or 06/18.
Contact Your Provider
Speak with your healthcare provider or pharmacist about alternative treatments since the remedy details are not provided in the record.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 2.3 years after the firm started it.
- Firm started the recall
- FDA classified it Class III
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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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-0433-2017 (December 7, 2016) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0433-2017 to see it in context.
- Plain-language summary written by qwen3.6:35b-a3b on October 11, 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.