Fagron Zinc Oxide Paste 25% Recall: Labeling Error in Prescription Compounding
Fagron recalls 500g Zinc Oxide Paste 25% for prescription compounding due to labeling error in drug facts panel. Correct strength shown on primary container. No action needed per recall.
Lower-risk recall
Labeling: Error on Declared Strength: Error is due to an incorrect value in the Drug Facts Panel. The correct strength is displayed on the primary container.
Contact the company
What happened, in plain English
Fagron is recalling 500g Zinc Oxide Paste 25% for prescription compounding because the labeling shows an incorrect strength. The correct strength is displayed on the primary container, so no action is needed. Read more at govinfonow.com/recall/41750-fagron-zinc-oxide-paste-25-recall-labeling-error-in-prescription.
Source Summary by GovInfoNow · govinfonow.com/recall/41750-fagron-zinc-oxide-paste-25-recall-labeling-error-in-prescription · Updated October 8, 2026 · FDA enforcement record: FDA #D-0695-2017
Cite this page
“Fagron Zinc Oxide Paste 25% Recall: Labeling Error in Prescription Compounding.” GovInfoNow, updated October 8, 2026. https://govinfonow.com/recall/41750-fagron-zinc-oxide-paste-25-recall-labeling-error-in-prescription. Based on FDA recall #D-0695-2017 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0695-2017%22&limit=1).
Why it’s dangerous
The labeling error shows an incorrect strength value in the Drug Facts Panel. However, the correct strength is displayed on the primary container, so the error does not pose a safety risk.
Who’s affected
Prescription compounding pharmacies and healthcare providers using this product. No specific individuals are at risk as the error does not affect safety.
How to tell if you have this one
Check for the product name 'Zinc Oxide Paste 25%, 500 g' for prescription compounding. The lot number 17C01-U07-036096 and expiration date 5/1/2020 are associated with this recall.
- Brand
Fagron- Category
Drug
What to do — step by step
Check Label
Verify the product name and lot number on the container to confirm if it matches the recalled item.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide within US” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 4 months 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-0695-2017 (April 17, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0695-2017 to see it in context.
- Plain-language summary written by qwen3:4b on October 8, 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.