FLUOCINONIDE GEL USP, 0.05%, Rx only, For External Use Only, Not For Ophthalmic Use, a) NET WT 15 gram tubes and b) NET WT 60 grams tubes, E. FOUGERA & CO., A division of Fougera Pharmaceuticals Inc., Melville, New York 11747, NDC 0168-0135-15 (15 g) and NDC 0168-0135-60 (60 g)

Failed Stability Specifications: The lots of Fluocinonide Gel USP, 0.05% recalled, may not meet the requirements for residual solvents as outlined in USP <467>.

Recall #: D-0245-2015
Affected scope: a) 59,622 Tubes; b) 43,178 Tubes
Initiated: August 28, 2014

Compiled from official public sources by the publisher. · Updated September 2026

Verify with FDA Drug →

View my saved recalls

Fougera Pharmaceuticals Inc. recalled FLUOCINONIDE GEL USP, 0.05%, Rx only, For External Use Only, Not For Ophthalmic Use, a) N… - a moderate-severity action.

FLUOCINONIDE GEL USP, 0.05%, Rx only, For External Use Only, Not For Ophthalmic Use, a) N… was recalled by Fougera Pharmaceuticals Inc. in November 19, 2014. Reason: Failed Stability Specifications: The lots of Fluocinonide Gel USP, 0.05% recalled, may not meet the requireme…. Check the official notice for the remedy. Verify recall #D-0245-2015 with the FDA Drug before acting.

The recall

Fougera Pharmaceuticals Inc. issued this moderate-severity FDA Drug recall-Failed Stability Specifications: The lots of Fluocinonide Gel USP, 0.05% recalled, may not meet the requireme….

Moderate
severity level: Class II
classification: November 19, 2014
reported

Sourced from official FDA Drug enforcement records. Verify recall #D-0245-2015 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.

Recall Insight

This recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution scope (see Distribution below) 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, 6 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.

Where this agency-classified recall sits among FDA Class I/II/III notices

Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified moderate severity.

Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.

Product description

FLUOCINONIDE GEL USP, 0.05%, Rx only, For External Use Only, Not For Ophthalmic Use, a) NET WT 15 gram tubes and b) NET WT 60 grams tubes, E. FOUGERA & CO., A division of Fougera Pharmaceuticals Inc., Melville, New York 11747, NDC 0168-0135-15 (15 g) and NDC 0168-0135-60 (60 g)

Reason for recall

Failed Stability Specifications: The lots of Fluocinonide Gel USP, 0.05% recalled, may not meet the requirements for residual solvents as outlined in USP <467>.

Recall Profile

Structured summary of the FDA Drug recall record
Attribute	Value
Agency	U.S. Food and Drug Administration
Severity class	Moderate (Class II)
Status	Terminated
Recall number	D-0245-2015
Date reported	November 19, 2014
Date initiated	August 28, 2014
Recalling firm	Fougera Pharmaceuticals Inc.
Firm location	Melville, NY
Affected scope	a) 59,622 Tubes; b) 43,178 Tubes
Distribution	Nationwide and Puerto Rico

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-0245-2015) 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? ▼

Why was this product recalled? ▼

Failed Stability Specifications: The lots of Fluocinonide Gel USP, 0.05% recalled, may not meet the requirements for residual solvents as outlined in USP <467>.

Which agency issued this recall? ▼

This recall was issued by the FDA Drug on November 19, 2014. Severity: Moderate. Recall number: D-0245-2015.

Where was the recalled product distributed? ▼

Distribution: Nationwide and Puerto Rico.

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.

Nationwide recalls with similar severity or category timing

Drug and device notices outside this firm and state, matched by severity timing and product category.

Similar severity · nearest report date

Same archive severity grade (Moderate), closest by report date among other firms and states.

Pennsylvania Firm Recalls Pork Products D… 2014-11-19 TOYOTA 2005-2011: SEATS:FRONT ASSEMBLY:SE… 2014-11-19 Olympus Recalls Digital Audio Recorders D… 2014-11-19 AP Specialties Recalls Power Bank Chargers 2014-11-19

Similar Drugs & Medications · nearest report date

Same product category, closest by report date among other firms and states (deduped against the severity set).

HALOPERIDOL DECANOATE INJECTION, 50 mg/mL… 2014-11-19 Assured Naproxen Sodium Tablets, USP 220 … 2014-11-19 Calcium Chloride Preservative Free Steril… 2014-11-26 Lidocaine 18.18 mg/mL/Bupivacaine 2.27 mg… 2014-11-26

Compare this recall with Kian Pee Wan Capsules, 30-count bottles → · All Drugs & Medications recalls

This recall: FDA Drug, reported November 19, 2014. Severity classes follow each agency's own taxonomy; related-recall context is computed across the full archive.

Methodology · Corrections · Archive as of August 2026