Mayne Pharma Fabior Foam Recall: High Tazarotene Levels Risk Serious Injury
Mayne Pharma recalls Fabior (tazarotene) foam due to high drug levels that could cause serious injury. This prescription-only product was distributed with specific lot and expiration details.
Use caution until it’s fixed
Superpotent Drug: High out of specification results for tazarotene assay at the 9-month stability time point.
Contact the company
What happened, in plain English
Mayne Pharma is recalling Fabior (tazarotene) foam because lab tests showed higher-than-expected levels of the drug at 9 months. This could lead to serious injury if used as directed. Read more at govinfonow.com/recall/40773-mayne-pharma-fabior-foam-recall-high-tazarotene-levels-risk-serious.
Source Summary by GovInfoNow · govinfonow.com/recall/40773-mayne-pharma-fabior-foam-recall-high-tazarotene-levels-risk-serious · Updated October 7, 2026 · FDA enforcement record: FDA #D-0616-2018
Cite this page
“Mayne Pharma Fabior Foam Recall: High Tazarotene Levels Risk Serious Injury.” GovInfoNow, updated October 7, 2026. https://govinfonow.com/recall/40773-mayne-pharma-fabior-foam-recall-high-tazarotene-levels-risk-serious. Based on FDA recall #D-0616-2018 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0616-2018%22&limit=1).
Why it’s dangerous
The foam contains higher-than-expected levels of tazarotene, a potent medication, which could cause serious skin injury if used incorrectly. This issue was detected during stability testing at 9 months.
Who’s affected
Prescription-only users who have the Fabior foam with lot number MBEB and expiration date 01/31/2019 are affected. Those using the product for skin conditions may be at higher risk.
How to tell if you have this one
Check for the Fabior foam with lot number MBEB and expiration date 01/31/2019. This product is prescription-only and distributed by Mayne Pharma in Greenville, NC.
- Brand
Mayne Pharma- Category
Drug
What to do — step by step
Check Product Details
Verify the lot number (MBEB) and expiration date (01/31/2019) on the Fabior foam packaging.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide in the USA” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 2.2 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-0616-2018 (March 21, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0616-2018 to see it in context.
- Plain-language summary written by qwen3:4b on October 7, 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.