The Recall Desk
Agency classClass IIIOur severity:ModerateFDA (Drugs)·D-0515-2019·Announced 2019-02-27

Akorn Recalls Clobetasol Propionate Cream Due to Preservative Stability Failure

Akorn Inc. is recalling specific lots of Clobetasol Propionate Emollient Cream 0.05% because stability testing revealed out-of-specification preservative levels.

The agency’s classification

FDA (Drugs): Class III

Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class III, which indicates a low probability of adverse health consequences. The issue is a stability specification failure regarding a preservative, which is a quality control issue rather than a direct acute hazard like contamination or mislabeling of a common allergen.

Plain-English summary

Akorn Inc. is voluntarily recalling Clobetasol Propionate Emollient Cream 0.05% in 30-gram and 60-gram tubes. The recall is due to failed stability specifications, specifically out-of-specification (OOS) results for a preservative found during a 9-month stability study.

The affected products are prescription-only and were distributed nationwide, including Puerto Rico. The specific lot numbers and expiration dates are: 357052 (exp 4/19/19), 356892 (exp 4/16/19), and 356927 (exp 4/15/19). The total quantity involved is 4,896 tubes of the 30-gram size and 5,064 tubes of the 60-gram size.

Consumers and healthcare providers should check their inventory for these specific lot numbers and expiration dates. If the product matches the recalled lots, it should be discontinued and returned to the pharmacy or supplier for disposal or credit. Patients should consult their healthcare provider for alternative treatment options if necessary.

The recalled product

Product
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.
Manufacturer
Akorn Inc
Category
Drug — Topical Corticosteroid
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (4)

  • a) 357052
  • exp 4/19/19 b) 356892
  • exp 4/16/19 and 356927
  • exp 4/15/19

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

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