Gentell Recalls Shield and Protect Moisture Barrier Cream Due to GMP Deviations
Gentell, Inc. recalls 65 gallons of Shield and Protect Moisture Barrier Cream due to Good Manufacturing Practice deviations. Check your product details.
Use caution until it’s fixed
GMP Deviations; product may not meet cGMP requirements
Contact the company
What happened, in plain English
Gentell, Inc. is recalling approximately 65 gallons of Shield and Protect Moisture Barrier Cream because the product may not meet current Good Manufacturing Practice (cGMP) requirements. This Class II recall affects products distributed nationwide and in Puerto Rico. The specific health risks associated with these deviations are not detailed in the provided record. Read more at govinfonow.com/recall/41656-gentell-recalls-shield-and-protect-moisture-barrier-cream-due-to.
Source Summary by GovInfoNow · govinfonow.com/recall/41656-gentell-recalls-shield-and-protect-moisture-barrier-cream-due-to · Updated October 11, 2026 · FDA enforcement record: FDA #D-0866-2017
Cite this page
“Gentell Recalls Shield and Protect Moisture Barrier Cream Due to GMP Deviations.” GovInfoNow, updated October 11, 2026. https://govinfonow.com/recall/41656-gentell-recalls-shield-and-protect-moisture-barrier-cream-due-to. Based on FDA recall #D-0866-2017 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0866-2017%22&limit=1).
Why it’s dangerous
The recall is due to deviations from current Good Manufacturing Practice (cGMP) requirements, meaning the manufacturing process did not consistently meet quality standards. While the exact consequences of these deviations are not specified, non-compliance can potentially affect product safety, efficacy, or purity.
Who’s affected
Consumers who purchased Shield and Protect Moisture Barrier Cream, specifically the 1.1% Clotrimazole Anti-Fungal variant, between the relevant distribution periods. Individuals using this product for moisture barrier or anti-fungal purposes are the primary group affected.
How to tell if you have this one
Look for the brand name 'Gentell' and the product name 'Shield and Protect Moisture Barrier Cream'. Verify the active ingredient is '1.1% Clotrimazole', the net weight is '4 oz - 115 g', and the NDC number is '61554-232-40'. The product code is 'GEN-23240'.
- Brand
Gentell- Category
Drug
What to do — step by step
Check Your Product Details
Verify if your cream matches the NDC 61554-232-40 and product code GEN-23240.
Contact Gentell for Instructions
Since no specific remedy is listed in the record, contact Gentell, Inc. directly for further guidance on what to do with your product.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide and Puerto Rico” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 10 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- 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-0866-2017 (April 19, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0866-2017 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.