The Recall Desk
HighFDA (Drugs)·D-0789-2023·Announced 2023-06-07

FDA Recalls Calcipotriene Scalp Solution Due to Manufacturing Compliance Issues

Akorn, Inc. is recalling all lots of Calcipotriene Topical Solution 0.005% due to manufacturing compliance failures and incomplete stability studies. The manufacturer ceased operations before completing required stability tests.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The incomplete stability studies represent a risk-of-harm situation where the drug's safety and efficacy cannot be verified. Although no illnesses or injuries have been reported, the inability to confirm the medication's stability throughout its shelf life poses a potential safety concern.

Plain-English summary

Akorn, Inc. is recalling all lots of Calcipotriene Topical Solution, 0.005% (Scalp Solution), 60 mL bottles, distributed nationwide in the USA and Puerto Rico. The recall is due to current Good Manufacturing Practice (CGMP) deviations and incomplete stability studies.

The firm went out of business and could no longer continue the required stability studies. Stability data is essential to verify that a medication maintains its safety and effectiveness throughout its shelf life. The incomplete data means the drug's quality cannot be fully assured.

Consumers currently using this medication should contact their healthcare provider or pharmacist for guidance on alternative treatments. Do not discard medication in household trash or water; ask your pharmacist about proper disposal options.

The recalled product

Product
Calcipotriene Topical Solution, 0.005% (Scalp Solution), 60 mL bottles, Rx Only, Distributed by: Akorn Operating Company, LLC., Gurnee, IL 60031. ALL NDCs
Manufacturer
Akorn, Inc.
Category
Drug — Topical medication
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 (1)

  • All Lots

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 86 recalled by Akorn, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 86 products in this recall →

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Same hazard · cgmp deviation

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