Clobetasol Propionate Emollient Cream 0.05%, a) 30 gram (NDC 50383-270-30) and b) 60 gram (NDC 50383-270-60) tubes, Rx only. Manufacturer: Akorn Inc. 369 Bayview Ave., Amityville, NY 117701.

Failed Stability Specification; out of specification (OOS) results for a preservative at 9 month stability study.

Recall #: D-0515-2019
Affected scope: a) 4896 tubes; b) 5064 tubes
Initiated: January 25, 2019

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

Akorn Inc recalled Clobetasol Propionate Emollient Cream 0.05%, a) 30 gram (NDC 50383-270-30) and b) 60 gram… - a low-severity action.

Clobetasol Propionate Emollient Cream 0.05%, a) 30 gram (NDC 50383-270-30) and b) 60 gram… was recalled by Akorn Inc in February 27, 2019. Reason: Failed Stability Specification; out of specification (OOS) results for a preservative at 9 month stability st…. Check the official notice for the remedy. Verify recall #D-0515-2019 with the FDA Drug before acting.

The recall

Akorn Inc issued this low-severity FDA Drug recall-Failed Stability Specification; out of specification (OOS) results for a preservative at 9 month stability st….

Low
severity level: Class III
classification: February 27, 2019
reported

Sourced from official FDA Drug enforcement records. Verify recall #D-0515-2019 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 low severity.

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

Product description

Clobetasol Propionate Emollient Cream 0.05%, a) 30 gram (NDC 50383-270-30) and b) 60 gram (NDC 50383-270-60) tubes, Rx only. Manufacturer: Akorn Inc. 369 Bayview Ave., Amityville, NY 117701.

Reason for recall

Failed Stability Specification; out of specification (OOS) results for a preservative at 9 month stability study.

Recall Profile

Structured summary of the FDA Drug recall record
Attribute	Value
Agency	U.S. Food and Drug Administration
Severity class	Low (Class III)
Status	Terminated
Recall number	D-0515-2019
Date reported	February 27, 2019
Date initiated	January 25, 2019
Recalling firm	Akorn Inc
Firm location	Lake Forest, IL
Affected scope	a) 4896 tubes; b) 5064 tubes
Distribution	Nationwide, including 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-0515-2019) 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? ▼

Clobetasol Propionate Emollient Cream 0.05%, a) 30 gram (NDC 50383-270-30) and b) 60 gram (NDC 50383-270-60) tubes, Rx only. Manufacturer: Akorn Inc. 369 Bayview Ave., Amityville, NY 117701.. Recalled by Akorn Inc. Units affected: a) 4896 tubes; b) 5064 tubes.

Why was this product recalled? ▼

Failed Stability Specification; out of specification (OOS) results for a preservative at 9 month stability study.

Which agency issued this recall? ▼

This recall was issued by the FDA Drug on February 27, 2019. Severity: Low. Recall number: D-0515-2019.

Where was the recalled product distributed? ▼

Distribution: Nationwide, including 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 (Low), closest by report date among other firms and states.

Oxytocin 10 Units added to NS 1000 mL (ox… 2019-02-27 Oxytocin 20 Units added to NS 1000 mL (ox… 2019-02-27 Oxytocin 30 Units added to NS 500 mL (oxy… 2019-02-27 Diltiazem HCl Extended-Release Capsules, … 2019-02-27

Similar Cosmetics & Personal Care · nearest report date

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

tubby todd Bath Co, 100% NATURAL DREAM CR… 2019-02-27 Mometasone Furoate Cream, 0.1%, 45 g tube… 2019-02-27 Prolact CR; Human Milk Caloric Fortifier … 2019-03-06 ATHLETICARE Anti-Bacterial Hand Soap AC 5… 2019-03-13

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 February 27, 2019. Severity classes follow each agency's own taxonomy; related-recall context is computed across the full archive.

Methodology · Corrections · Archive as of August 2026