CLASS III Drug recall · Reported 11 Apr 2018 · FDA Enforcement Report
Fabior (tazarotene) Foam recalled by Mayne Pharma
Mayne Pharma is recalling Fabior (tazarotene) Foam, 0.1%, distributed nationwide in the US. The recall was initiated on 21 Mar 2018 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0616-2018
- FDA event ID
- 79604
- Recalling firm
- Mayne Pharma, Greenville, NC
- Brand
- Fabior
- Manufacturer
- Mayne Pharma
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 21 Mar 2018
- FDA classified
- 30 Mar 2018
- Reported
- 11 Apr 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
Timeline
| 21 Mar 2018 | Recall initiated by company | |
| 30 Mar 2018 | Classified by FDA | +9 days |
| 11 Apr 2018 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Superpotent Drug: High out of specification results for tazarotene assay at the 9-month stability time point.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Fabior (tazarotene) Foam, 0.1%, 100 grams can, Rx only, Distributed by: Mayne Pharma, Greenville, NC 27834; NDC 51862-295-10.
Where it was distributed
Nationwide in the USA
Questions about this recall
Why was it recalled?
Superpotent Drug: High out of specification results for tazarotene assay at the 9-month stability time point.
Which lots are affected?
Lot: MBEB, Exp. 01/31/2019
Where was it sold?
Nationwide in the USA
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Mayne Pharma
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|---|---|---|---|---|---|
| Drug | CLASS II | Clonidine Transdermal System, USP 0.3 mg/day, 4 Patches recalledClonidine | Mayne Pharma | Potency & Assay | Nationwide |
| Drug | CLASS II | Lexette (halobetasol propionate) Topical Foam, 0.05% canisters recalled | Mayne Pharma | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Carbidopa and Levodopa Tablets, USP 25 mg/250mg recalled by Mayne Pharma | Mayne Pharma | Packaging Defects | Nationwide |
| Drug | CLASS III | Oxycodone and Acetaminophen Tablets, USP, 5 mg*/325 mg recalled | Mayne Pharma | Labeling Errors | Nationwide |
| Drug | CLASS II | Liothyronine Sodium Tablets, USP 25 mcg recalled by Mayne Pharma | Mayne Pharma | Potency & Assay | Nationwide |