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.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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: 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.
See all →- HighTobramycin Ophthalmic Solution Recalled Due to Incomplete Stability Studies
FDA (Drugs) · 2023-06-07
- HighGuaifenesin Oral Solution Recalled Due to Incomplete Stability Studies
FDA (Drugs) · 2023-06-07
- HighFDA Recalls Calcitriol Injection Due to Manufacturing Practice Violations
FDA (Drugs) · 2023-06-07
- HighAkorn Hydromorphone Hydrochloride Injection Recalled Due to CGMP Deviations
FDA (Drugs) · 2023-06-07
- HighMidazolam Injection Recalled Due to Manufacturing Compliance and Stability Study Issues
FDA (Drugs) · 2023-06-07
Same hazard · dispensing defect
See all →- ModerateLexette Topical Foam Recall Due to Dispensing Defects
FDA (Drugs) · 2022-01-26
Similar recalls
- HighFDA Recalls Calcipotriene Scalp Solution Due to Manufacturing Compliance Issues
FDA (Drugs) · 2023-06-07
- ModerateLidocaine Oral Topical Solution Recalled Due to Failed Viscosity Specification
FDA (Drugs) · 2022-05-11
- SevereAkorn Recalls Subpotent Hydrocortisone and Acetic Acid Otic Solution
FDA (Drugs) · 2020-02-19
- HighProparacaine Ophthalmic Solution Recalled for Manufacturing Quality Deviations
FDA (Drugs) · 2023-01-25
- ModerateDrug recall: Proparacaine eye solution due to manufacturing deviations
FDA (Drugs) · 2023-01-25
- ModerateAkorn Recalls Hydrocortisone and Acetic Acid Otic Solution Due to Low Potency
FDA (Drugs) · 2019-03-27