Fluocinolone Acetonide recalls: 13 FDA reports
Recalls involving Fluocinolone Acetonide. What was wrong with each batch, and how the FDA graded the risk.
13Reports
0Class I
1Ongoing
2026-01-21Most 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.
Fluocinolone Acetonide Solution Topical Solution USP, 0.01%, 60-mL bottles, Rx only, Dist. by: Taro Pharmaceut
D-0256-2026 · Class III · reported 2026-01-21 · Ongoing
- Why it was recalled
- Failed Impurities/Degradation Specifications: Out of specification result was obtained for the known impurity D.
- Product
- Fluocinolone Acetonide Solution Topical Solution USP, 0.01%, 60-mL bottles, Rx only, Dist. by: Taro Pharmaceuticals Inc., Hawthorn, NY 10532. NDC 51672-1365-4
- Where it went
- Nationwide within the USA
- How much
- 24,624 bottles
Fluocinolone Acetonide Oil, 0.01% (Ear Drops), package in 1 Oz. (20 mL fill volume) bottle, Rx only, Manufactu
D-0259-2024 · Class II · reported 2024-01-31 · Terminated
- Why it was recalled
- Failed Excipient Specifications: OOS for assay of Isopropyl Alcohol
- Product
- Fluocinolone Acetonide Oil, 0.01% (Ear Drops), package in 1 Oz. (20 mL fill volume) bottle, Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd., Village: Kishanpura, Baddi Nalagarh Road, District: Solan, Himachal Pradesh - 173205, India, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, NDC 68462-185-56
- Where it went
- USA Nationwide
- How much
- 38,496 bottles
DermOtic Oil (fluocinolone acetonide oil) 0.01% Ear Drops 20 mL bottles, Rx only, Manufactured by: Hill Derm
D-0637-2021 · Class II · reported 2021-06-30 · Terminated
- Why it was recalled
- Presence of Foreign Substance: Potential for broken glass within the glass pipette of the dropper.
- Product
- DermOtic Oil (fluocinolone acetonide oil) 0.01% Ear Drops 20 mL bottles, Rx only, Manufactured by: Hill Dermaceuticals, Inc. Sanford, FL 32773 for: Royal Pharmaceuticals Manasquan, NJ 08736, NDC 68791-103-20
- Where it went
- Nationwide within the United States
- How much
- 34,561 bottles for sale; 773 bottles for samples
Fluocinolone Acetonide Topical Solution, USP, 0.01 %, 60 mL bottle, Rx Only, Manufactured for: Lupin Pharmaceu
D-0390-2019 · Class II · reported 2019-01-30 · Terminated
- Why it was recalled
- Failed Impurities/Degradation Specifications: Expansion of October 2018 recall due to elevated out of specification results for total impurities that have been chemically identified as oxidative degradation products of the fluocinolone active pharmaceutical ingredient.
- Product
- Fluocinolone Acetonide Topical Solution, USP, 0.01 %, 60 mL bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, MD 21202; Manufactured by: Novel Laboratories, Inc., Somerset, NJ 08873; NDC 43386-069-60.
- Where it went
- Nationwide in the USA and Puerto Rico
- How much
- 24,180 bottles
Fluocinolone Acetonide Topical Solution, USP 0.01%, 60ml Bottle, Manufactured for: Lupin Pharmaceutical, Inc.
D-0092-2019 · Class II · reported 2018-10-31 · Terminated
- Why it was recalled
- Failed Impurities/Degradation Specifications:Out of specification result noticed for total impurities observed during stability analysis
- Product
- Fluocinolone Acetonide Topical Solution, USP 0.01%, 60ml Bottle, Manufactured for: Lupin Pharmaceutical, Inc. Baltimore, MD 21202 Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873. NDC 43386-069-60
- Where it went
- Nationwide in the USA
- How much
- 2712 60-ml bottles
Fluocinolone Acetonide Topical Oil, 0.01% (Scalp Oil) 118.28 mL (4 fl.oz.) Rx Only, Manufactured by: Lyne Labo
D-0713-2018 · Class II · reported 2018-05-02 · Terminated
- Why it was recalled
- Subpotent Drug
- Product
- Fluocinolone Acetonide Topical Oil, 0.01% (Scalp Oil) 118.28 mL (4 fl.oz.) Rx Only, Manufactured by: Lyne Laboratories, Inc. Brockton, MA 02307 Manufactured for: Rising Pharmaceuticals, Inc. Allendale, NJ 07401, NDC 64980-330-04, UPC 364980330046
- Where it went
- to be entered
- How much
- 23453 units
Fluocinolone Acetonide Topical Oil, 0.01% (Ear Drops) 20 mL, Rx Only, Manufactured by: Lyne Laboratories, Inc.
D-0712-2018 · Class II · reported 2018-05-02 · Terminated
- Why it was recalled
- Subpotent Drug
- Product
- Fluocinolone Acetonide Topical Oil, 0.01% (Ear Drops) 20 mL, Rx Only, Manufactured by: Lyne Laboratories, Inc. Brockton, MA 02307 Manufactured for: Rising Pharmaceuticals, Inc. Allendale, NJ 07401, NDC 64980-329-20, UPC 364980329200
- Where it went
- to be entered
- How much
- 17939 units
Fluocinolone Acetonide Topical Oil, 0.01% (Body Oil) 118.28 mL (4 fl. oz.) Rx Only, Manufactured by: Lyne Labo
D-0711-2018 · Class II · reported 2018-05-02 · Terminated
- Why it was recalled
- Subpotent Drug
- Product
- Fluocinolone Acetonide Topical Oil, 0.01% (Body Oil) 118.28 mL (4 fl. oz.) Rx Only, Manufactured by: Lyne Laboratories, Inc. Brockton, MA 02307 Manufactured for: Rising Pharmaceuticals, Inc. Allendale, NJ 07401, NDC 64980-331-04, UPC 364980331043
- Where it went
- to be entered
- How much
- 12572 units
Fluocinolone Acetonide Topical Solution USP 0.01% For Topical Use Only, Not for Ophthalmic Use, 60 mL bottle,
D-0653-2017 · Class III · reported 2017-04-19 · Terminated
- Why it was recalled
- Chemical Contamination
- Product
- Fluocinolone Acetonide Topical Solution USP 0.01% For Topical Use Only, Not for Ophthalmic Use, 60 mL bottle, Rx Only, Manufactured for Gavis Pharmaceuticals, LLC, Somerset NJ 08873, Manufactured by Novel Laboratories, Inc. Somerset, NJ 08873, NDC 43386-069-60
- Where it went
- Nationwide
- How much
- 7,656 bottles
ROYAL PHARMACEUTICALS DermOtic Oil fluocinolone acetonide 0.01% (Ear Drops), 20 ml, Rx only Manufactured by:
D-1178-2014 · Class III · reported 2014-04-02 · Terminated
- Why it was recalled
- Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.
- Product
- ROYAL PHARMACEUTICALS DermOtic Oil fluocinolone acetonide 0.01% (Ear Drops), 20 ml, Rx only Manufactured by: Hill Dermaceuticalsfor: Royal Pharmaceuticals NDC 68791-103-20
- Where it went
- Nationwide and Puerto Rico
- How much
- 13,379 bottles
ROYAL PHARMACEUTICALS Derma-Smoothe/FS fluocinolone acetonide 0.01% Topical Oil (Body Oil) 4 fl. oz., Rx only
D-1176-2014 · Class III · reported 2014-04-02 · Terminated
- Why it was recalled
- Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.
- Product
- ROYAL PHARMACEUTICALS Derma-Smoothe/FS fluocinolone acetonide 0.01% Topical Oil (Body Oil) 4 fl. oz., Rx only Manufactured by: Hill Dermaceuticals, Inc. for: Royal Pharmaceuticals NDC 68791-101-04
- Where it went
- Nationwide and Puerto Rico
- How much
- 8,734 bottles
ROYAL PHARMACEUTICALS Derma-Smoothe/FS fluocinolone acetonide 0.01% (Scalp Oil), 4 fl.oz., Rx only Manufactur
D-1177-2014 · Class III · reported 2014-04-02 · Terminated
- Why it was recalled
- Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.
- Product
- ROYAL PHARMACEUTICALS Derma-Smoothe/FS fluocinolone acetonide 0.01% (Scalp Oil), 4 fl.oz., Rx only Manufactured by: Hill Dermaceuticals for: Royal Pharmaceuticals NDC 68791-102-04
- Where it went
- Nationwide and Puerto Rico
- How much
- 7,292 bottles
G & W Fluocinolone Acetonide Cream USP 0.025%, a) 15 gm (NDC 0713-0222-15), b) 60 gm (NDC 0713-0222-60 ), Rx O
D-391-2014 · Class III · reported 2014-01-08 · Terminated
- Why it was recalled
- Failed Content Uniformity Specifications; at the 18 month time point.
- Product
- G & W Fluocinolone Acetonide Cream USP 0.025%, a) 15 gm (NDC 0713-0222-15), b) 60 gm (NDC 0713-0222-60 ), Rx Only, Manufactured by: G&W Laboratories, Inc. 111 Coolidge Street, South Plainfield, NJ 07080
- Where it went
- Nationwide
- How much
- 187,368 metal 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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