CLASS II Drug recall · Reported 6 Jul 2022 · FDA Enforcement Report
Calcipotriene Topical Solution, 0.005% (Scalp Solution) recalled
Akorn is recalling Calcipotriene Topical Solution, 0.005% (Scalp Solution), distributed nationwide in the US. The recall was initiated on 10 Jun 2022 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1170-2022
- FDA event ID
- 90442
- Recalling firm
- Akorn, Lake Forest, IL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 10 Jun 2022
- FDA classified
- 29 Jun 2022
- Reported
- 6 Jul 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Drug class
- Creams, Ointments & Gels
Timeline
| 10 Jun 2022 | Recall initiated by company | |
| 29 Jun 2022 | Classified by FDA | +19 days |
| 6 Jul 2022 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Defective Delivery System: Potential defect that could prevent the product from dispensing as intended.
Product as listed by the FDA
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
Where it was distributed
Nationwide in the U.S.
Questions about this recall
Why was it recalled?
Defective Delivery System: Potential defect that could prevent the product from dispensing as intended.
Which lots are affected?
Lot #: 378440, Exp. 07/31/2023
Where was it sold?
Nationwide in the U.S.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Akorn
All 192| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Timolol Maleate Ophthalmic Solution recalled by Akorn | Akorn | Potency & Assay | Nationwide |
| Drug | CLASS II | Calcipotriene Topical Solution, 0.005% (Scalp Solution) recalled | Akorn | Potency & Assay | Nationwide |
| Drug | CLASS II | Midazolam Injection, USP, 50 mg/ (5mg/mL) recalled by Akorn | Akorn | Potency & Assay | Nationwide |
| Drug | CLASS II | Lidocaine Ointment USP, 5%, 1 tubes recalled by Akorn | Akorn | Potency & Assay | Nationwide |
| Drug | CLASS II | Midazolam Injection, USP 2mg recalled by Akorn | Akorn | Potency & Assay | Nationwide |
Other Calcipotriene recalls
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Calcipotriene Topical Solution, 0.005% (Scalp Solution) recalled | Akorn | Potency & Assay | Nationwide |
| Drug | CLASS II | Calcipotriene Cream recalled by Leo PharmaCalcipotriene | LEO Pharma | Labeling Errors | Nationwide |
| Drug | CLASS III | Taclonex (calcipotriene and betamethasone dipropionate) recalledTaclonex | LEO Pharma | Packaging Defects | Nationwide |