OMEZA LLC recalls Omeza Skin Protectant, Skin Protectant Gel 10*2mL Vials
Omeza recalls 10*2mL Skin Protectant Vials due to CGMP deviations. Affected lots may not meet safety standards. Consumers should check lot numbers and contact Omeza for details.
Recall notice
CGMP Deviations
Contact the company & request your remedy
What happened, in plain English
Omeza is recalling its Skin Protectant and Skin Protectant Gel 10*2mL vials because of manufacturing quality control issues. This recall affects products with specific lot numbers that may not meet safety standards. Read more at govinfonow.com/recall/32858-omeza-skin-protectant-vials-recall-cgmp-deviations-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/32858-omeza-skin-protectant-vials-recall-cgmp-deviations-risk · Updated September 23, 2026 · FDA enforcement record: FDA #D-0289-2024
Cite this page
“Omeza Skin Protectant Vials Recall: CGMP Deviations Risk.” GovInfoNow, updated September 23, 2026. https://govinfonow.com/recall/32858-omeza-skin-protectant-vials-recall-cgmp-deviations-risk. Based on FDA recall #D-0289-2024 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0289-2024%22&limit=1).
Why it’s dangerous
CGMP deviations refer to failures in the manufacturing process that could lead to products not meeting safety and quality standards. This means the recalled vials might have issues that could affect their intended use, especially for medical applications.
Who’s affected
People who own or use Omeza Skin Protectant or Skin Protectant Gel 10*2mL vials with lot number 19123 4-1 are affected. Those using the product for medical purposes may be at higher risk due to potential quality issues.
How to tell if you have this one
Check the lot number on the vial, which is 19123 4-1 for the recalled items. The expiration date is May 11, 2024. These vials were sold with the product name 'Omeza Skin Protectant' or 'Skin Protectant Gel'.
- Brand
Omeza- Category
Drug
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Terminated- Distribution
US Nationwide
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| D-0288-2024 | Omeza Lidocaine Lavage pain relief oil 10*2mL VIALS; Lots: 28622 2-1, Exp. 04/24/2024 286222-3, Exp. 1/25/2024 or 04/25/2024 | 4390 vials |
| D-0289-2024 | Omeza Skin Protectant, Skin Protectant Gel 10*2mL Vials; Lot: 19123 4-1, Exp. 05/11/2024 | 1210 vials |
What to do — step by step
Check Lot Number
Look for the lot number 19123 4-1 on the vial to confirm if it is affected.
Questions people ask
What is the recall for?
Omeza is recalling Skin Protectant and Skin Protectant Gel 10*2mL vials with lot number 19123 4-1 due to CGMP deviations.
How can I check if my vial is affected?
Check the lot number on the vial; affected items have lot number 19123 4-1 with expiration date May 11, 2024.
What should I do if I have the recalled vials?
The recall record does not specify a remedy, so contact Omeza directly for further instructions.
Contact Omeza
We’ve drafted a message you can send Omeza to request your refund or repair — edit it as you like.
Subject: Recall D-0289-2024 — Omeza Omeza Hello, I own a Omeza that is covered by recall D-0289-2024 from Omeza. 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-0289-2024 (January 19, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0289-2024 to see it in context.
- Plain-language summary written by qwen3:4b on September 23, 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.