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
  • dispensing-defect

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 category