The Recall Desk
ModerateFDA (Drugs)·D-1170-2022·Announced 2022-07-06

Calcipotriene Scalp Solution Recalled Due to Defective Delivery System

Akorn, Inc. is recalling Calcipotriene Topical Solution 0.005% (Scalp Solution) nationwide due to a defective delivery system that could prevent the product from dispensing properly.

What this means for you

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: This is an FDA Class II recall for a defective delivery system with no reported illnesses, injuries, or hospitalizations. The hazard is functional—the product may not dispense as intended—without evidence of actual patient harm.

Plain-English summary

Akorn, Inc. is recalling Calcipotriene Topical Solution, 0.005% (Scalp Solution) due to a defective delivery system. The recalled product is a prescription topical medication distributed nationwide in the United States, supplied in 60 mL (2 fl. oz.) bottles manufactured by HI-TECH PHARMACAL CO., INC., Amityville, N.Y.

The defect could prevent the product from dispensing as intended. The affected lot number is 378440 with an expiration date of 07/31/2023, and approximately 2,736 bottles have been distributed.

The recalled product

Product
Calcipotriene Topical Solution, 0.005% (Scalp Solution), Rx only, 60 mL (2 fl. oz.) bottle, Manufactured by: HI-TECH PHARMACAL CO., INC., Amityville, N.Y. 11701. NDC: 50383-732-02
Manufacturer
Akorn, Inc.
Category
Drug — Topical / Scalp Solution
Hazard
Affected units
2,736

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 (2)

  • Lot #: 378440
  • Exp. 07/31/2023

Distribution

Distributed nationwide across the United States.

Related recalls

Same manufacturer · Akorn, Inc.

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Same hazard · dispensing defect

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