ModerateClass IITerminated

FDA Drug recall · Reported November 9, 2016

Desoximetasone Cream USP, 0.25% 100 g, Rx only, mfd. by Taro Pharmaceuticals Inc. Brampton, Ontario, Canada L6T 1C1, Dist. by: Taro Pharmaceuticals U.S.A., Inc. Hawthorne, NY 10532; NDC 51672-1270-7

Q: Which agency issued this recall?

This recall was issued by the FDA Drug on November 9, 2016. Severity: Moderate. Recall number: D-0116-2017.

Q: Where was the recalled product distributed?

Distribution: US & Puerto Rico.

Q: 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.

Failed Stability Specifications: The subject lots exhibited OOS results for Homogeneity test (Moderate separation).

Recall #: D-0116-2017
Affected scope: 15,576 units
Initiated: September 13, 2016

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

Verify with FDA Drug →

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Taro Pharmaceuticals, Inc. recalled Desoximetasone Cream USP, 0.25% 100 g, Rx only, mfd. by Taro Pharmaceuticals Inc. Brampto… - a moderate-severity action.

Desoximetasone Cream USP, 0.25% 100 g, Rx only, mfd. by Taro Pharmaceuticals Inc. Brampto… was recalled by Taro Pharmaceuticals, Inc. in November 9, 2016. Reason: Failed Stability Specifications: The subject lots exhibited OOS results for Homogeneity test (Moderate separa…. Check the official notice for the remedy. Verify recall #D-0116-2017 with the FDA Drug before acting.

The recall

Taro Pharmaceuticals, Inc. issued this moderate-severity FDA Drug recall-Failed Stability Specifications: The subject lots exhibited OOS results for Homogeneity test (Moderate separa….

Moderate
severity level: 16K units
affected scope: Class II
classification: November 9, 2016
reported

Sourced from official FDA Drug enforcement records. Verify recall #D-0116-2017 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, 3 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

Desoximetasone Cream USP, 0.25% 100 g, Rx only, mfd. by Taro Pharmaceuticals Inc. Brampton, Ontario, Canada L6T 1C1, Dist. by: Taro Pharmaceuticals U.S.A., Inc. Hawthorne, NY 10532; NDC 51672-1270-7

Reason for recall

Failed Stability Specifications: The subject lots exhibited OOS results for Homogeneity test (Moderate separation).

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-0116-2017
Date reported	November 9, 2016
Date initiated	September 13, 2016
Recalling firm	Taro Pharmaceuticals, Inc.
Firm location	Brampton
Affected scope	15,576 units
Distribution	US & Puerto Rico

Profile values are sourced directly from the official FDA Drug enforcement record. Source: U.S. Food and Drug Administration.

Scale of Impact

15,576 units units affected - limited or regional distribution scale.

Regional (<10K units) -

Multi-state (10K – 100K units) ✓ This recall

Large-scale (100K – 1M units) -

Massive (≥1M units) -

Bracket cutoffs follow federal recall-disclosure conventions; bar widths scale linearly within each bracket. Source: PlainRecalls analysis of U.S. Food and Drug Administration filings.

What to do with this recall

Match your product against the recall record, then act on the agency remedy.

Check the recall number (D-0116-2017) 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? ▼

Desoximetasone Cream USP, 0.25% 100 g, Rx only, mfd. by Taro Pharmaceuticals Inc. Brampton, Ontario, Canada L6T 1C1, Dist. by: Taro Pharmaceuticals U.S.A., Inc. Hawthorne, NY 10532; NDC 51672-1270-7. Recalled by Taro Pharmaceuticals, Inc.. Units affected: 15,576 units.

Why was this product recalled? ▼

Failed Stability Specifications: The subject lots exhibited OOS results for Homogeneity test (Moderate separation).

Which agency issued this recall? ▼

This recall was issued by the FDA Drug on November 9, 2016. Severity: Moderate. Recall number: D-0116-2017.

Where was the recalled product distributed? ▼

Distribution: US & 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.

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Similar Cosmetics & Personal Care · nearest report date

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

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Compare this recall with Ice Pop, D'Dioses Cookies Cream, 1 Bar (81.7 g), with UPC 7… → · All Cosmetics & Personal Care recalls

This recall: FDA Drug, reported November 9, 2016. Severity classes follow each agency's own taxonomy; related-recall context is computed across the full archive.

Methodology · Corrections · Archive as of August 2026