Severity
Low
LowClass IIITerminated
FDA Drug recall · Reported April 11, 2018
Fabior (tazarotene) Foam, 0.1%, 100 grams can, Rx only, Distributed by: Mayne Pharma, Greenville, NC 27834; NDC 51862-295-10.
Superpotent Drug: High out of specification results for tazarotene assay at the 9-month stability time point.
Compiled from official public sources by the editorial team.
Verify with FDA Drug →
Mayne Pharma Inc recalled Fabior (tazarotene) Foam, 0.1%, 100 grams can, Rx only, Distributed by: Mayne Pharma, Gre… - a low-severity action.
Fabior (tazarotene) Foam, 0.1%, 100 grams can, Rx only, Distributed by: Mayne Pharma, Gre… was recalled by Mayne Pharma Inc in April 11, 2018. Reason: Superpotent Drug: High out of specification results for tazarotene assay at the 9-month stability time point.. Check the official notice for the remedy. Verify recall #D-0616-2018 with the FDA Drug before acting.
The recall
Mayne Pharma Inc issued this low-severity FDA Drug recall-Superpotent Drug: High out of specification results for tazarotene assay at the 9-month stability time point..
- Low
- severity level
- Class III
- classification
- April 11, 2018
- reported
Sourced from official FDA Drug enforcement records. Verify recall #D-0616-2018 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Drug action (record #D-0616-2018) was formally reported on April 11, 2018, with the manufacturer initiating the action on March 21, 2018. It is classified under Low severity (Class III), with a current status of Terminated. Mayne Pharma Inc is listed as the recalling firm, operating out of Greenville, NC. Federal records list the affected scope as 3312 cans.
The documented reason for this recall is: Superpotent Drug: High out of specification results for tazarotene assay at the 9-month stability time point. Distribution data in the federal record shows the product reached: Nationwide in the USA. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 5 from FDA Drug - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Drugs & Medications recalls over time
Where this recall sits in its category - 14,287 drugs & medications recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified low severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
3312 cans
Related Recalls
6
5 from same agency
Product description
Fabior (tazarotene) Foam, 0.1%, 100 grams can, Rx only, Distributed by: Mayne Pharma, Greenville, NC 27834; NDC 51862-295-10.
Reason for recall
Superpotent Drug: High out of specification results for tazarotene assay at the 9-month stability time point.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Low (Class III) |
| Status | Terminated |
| Recall number | D-0616-2018 |
| Date reported | April 11, 2018 |
| Date initiated | March 21, 2018 |
| Recalling firm | Mayne Pharma Inc |
| Firm location | Greenville, NC |
| Affected scope | 3312 cans |
| Distribution | Nationwide in the USA |
Profile values are sourced directly from the official FDA Drug enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (D-0616-2018) and product description against the item you own. Search the archive
- Confirm the current status with FDA Drug before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Drug record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
Fabior (tazarotene) Foam, 0.1%, 100 grams can, Rx only, Distributed by: Mayne Pharma, Greenville, NC 27834; NDC 51862-295-10.. Recalled by Mayne Pharma Inc. Units affected: 3312 cans.
Why was this product recalled? ▼
Superpotent Drug: High out of specification results for tazarotene assay at the 9-month stability time point.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on April 11, 2018. Severity: Low. Recall number: D-0616-2018.
Where was the recalled product distributed? ▼
Distribution: Nationwide in the USA.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (D-0616-2018) against your product. Visit the official FDA Drug website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
Nearby Recalls in This Category
Other recalls in the same product category, useful for spotting patterns across the same defect class or manufacturer.
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Compare this recall with PRED MILD, prednisolone acetate ophthalmic suspension, USP,… →
Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Drug, reported April 11, 2018. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.