Fluocinonide recalls: 5 FDA reports
Recalls involving Fluocinonide. What was wrong with each batch, and how the FDA graded the risk.
5Reports
0Class I
3Ongoing
2026-04-22Most recent
What the classes mean
The FDA sorts every recall into one of three classes. The class is the whole story. It is also the part people skip.
Class II is the bulk of every list here. That matters. A long list of Class II says something different from one Class I.
By class
By year reported
Checking whether it affects you
The lot or code number is what matters. Not the product name. A recall covers
specific lots. Yours may not be one of them.
Check the code on your package against the report. The FDA keeps the current
list at fda.gov/safety/recalls.
The reports
The text below is quoted from the FDA record word for word.
Fluocinonide, USP, 0.05% Cream, 30g tube, Rx only, Mfd by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canad
D-0476-2026 · Class II · reported 2026-04-22 · Ongoing
- Why it was recalled
- Failed Viscosity Specifications: Out of Specification results, above the specification limit, in viscosity, noted during stability testing.
- Product
- Fluocinonide, USP, 0.05% Cream, 30g tube, Rx only, Mfd by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1, Dist. by: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532, NDC 51672-1386-2.
- Where it went
- Nationwide in the USA.
- How much
- 41,712 30g tubes
Fluocinonide, USP, 0.05% Cream, 60g tube, Rx only, Mfd by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canad
D-0477-2026 · Class II · reported 2026-04-22 · Ongoing
- Why it was recalled
- Failed Viscosity Specifications: Out of Specification results, above the specification limit, in viscosity, noted during stability testing.
- Product
- Fluocinonide, USP, 0.05% Cream, 60g tube, Rx only, Mfd by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1, Dist. by: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532, NDC 51672-1386-3.
- Where it went
- Nationwide in the USA.
- How much
- 2,640 60g tubes
Fluocinonide, USP, 0.05% Cream, 15g tube, Rx only, Mfd by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canad
D-0475-2026 · Class II · reported 2026-04-22 · Ongoing
- Why it was recalled
- Failed Viscosity Specifications: Out of Specification results, above the specification limit, in viscosity, noted during stability testing.
- Product
- Fluocinonide, USP, 0.05% Cream, 15g tube, Rx only, Mfd by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1, Dist. by: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532, NDC 51672-1386-1
- Where it went
- Nationwide in the USA.
- How much
- 24,672 15 g tubes
Fluocinonide Gel USP, 0.05%, 15 g tube, Rx Only, Mfd. by: Taro Pharmaceuticals Inc. Brampton Ontario Canada L
D-0146-2018 · Class III · reported 2017-11-01 · Terminated
- Why it was recalled
- Cross contamination with other products: traces of Dapsone were found in the finished product.
- Product
- Fluocinonide Gel USP, 0.05%, 15 g tube, Rx Only, Mfd. by: Taro Pharmaceuticals Inc. Brampton Ontario Canada L6T1C1, Dist. by: Taro Pharmaceuticals U.S.A . Inc. Hawthorne NY 10532, NDC 51672-1279-1
- Where it went
- Nationwide
- How much
- 16,944 tubes
Fluocinonide Cream UPS, 0.05% (Emulsified Base), packaged in 60 g tube, Rx only, Mfd. by: Taro Pharmaceuticals
D-0790-2017 · Class III · reported 2017-05-24 · Terminated
- Why it was recalled
- Cross contamination with other products: Certain lots of Fluocinonide Cream were found to be contaminated with a small quantity of hydrocortisone-17-valerate.
- Product
- Fluocinonide Cream UPS, 0.05% (Emulsified Base), packaged in 60 g tube, Rx only, Mfd. by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada, Dist. by Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532, NDC 51672-1254-3
- Where it went
- U.S. Nationwide
- How much
- 7,776 tubes
Read these counts with three things in mind
A firm with more recalls usually makes more products. A contract packer runs
hundreds of lines. It will out-recall a company with one product whatever either
does. This is not a safety ranking.
Most recalls here are voluntary. A firm found its own fault and pulled the stock.
That is the system working. It lands in this database looking the same as a recall
the FDA had to push for.
Terminated means the FDA considers the recall finished. It is not a verdict.
It does not mean anyone was harmed.
Source: openFDA enforcement reports, retrieved 2026-08-05. FDA dataset last updated 2026-07-29.
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