Mayne Pharma Recalls Fabior Foam Due to Stability Test Failures
Mayne Pharma is recalling 3,312 cans of Fabior (tazarotene) Foam, 0.1%, because stability testing showed high out-of-specification results for the active ingredient.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class III, which indicates a low risk of adverse health consequences. The issue is a quality control failure (assay out of specification) without reported injuries or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
Mayne Pharma Inc is voluntarily recalling 3,312 cans of Fabior (tazarotene) Foam, 0.1%, 100 grams. The recalled product is identified by Lot MBEB and an expiration date of 01/31/2019. The cans were distributed nationwide in the United States.
The recall was initiated because the product failed to meet quality standards during stability testing. Specifically, the tazarotene assay results at the 9-month stability time point were found to be high out of specification. This indicates that the concentration of the active ingredient may not be within the approved limits.
Consumers who have this specific lot of Fabior should stop using it and contact their healthcare provider or pharmacist for guidance. The product is a prescription-only topical medication used for the treatment of acne.
The recalled product
- Product
- FABIOR (TAZAROTENE)
- Brand
- FABIOR
- Manufacturer
- Mayne Pharma Inc
- Category
- Drug — Topical Prescription
- Affected units
- 3,312
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot: MBEB
- Exp. 01/31/2019
Distribution
Distributed nationwide across the United States.
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