Lower risk Drug recall · FDA · Published June 10, 2022

Akorn Calcipotriene Topical Solution Recall: Defective Delivery System

Akorn recalls 0.005% Calcipotriene Topical Solution (Scalp Solution) due to potential delivery system defect preventing proper dispensing. Rx only, 60mL bottles manufactured by HI-TECH.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #D-1170-2022Drug Akorn ›

Lower-risk recall

Defective Delivery System: Potential defect that could prevent the product from dispensing as intended.

Take action

Contact the company

Recalling firmAkorn, Inc.1925 W Field Ct Ste 300 · Lake Forest, IL 60045-4862

✎ GovInfoNow plain-language explainer

Akorn is recalling 0.005% Calcipotriene Topical Solution (Scalp Solution) because the delivery system might not work properly. This could mean the medication doesn't dispense as intended, which is important for people using it under a doctor's supervision. Read more at govinfonow.com/recall/34628-akorn-calcipotriene-topical-solution-recall-defective-delivery-system.

Source Summary by GovInfoNow · govinfonow.com/recall/34628-akorn-calcipotriene-topical-solution-recall-defective-delivery-system · Updated August 18, 2026 · FDA enforcement record: FDA #D-1170-2022

Cite this page

“Akorn Calcipotriene Topical Solution Recall: Defective Delivery System.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/34628-akorn-calcipotriene-topical-solution-recall-defective-delivery-system. Based on FDA recall #D-1170-2022 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1170-2022%22&limit=1).

The FDA announced on June 10, 2022, that Akorn, Inc. is recalling Calcipotriene Topical Solution due to a defective delivery system that may prevent dispensing. The recall affects 2,736 bottles distributed nationwide.

How to tell if you have it

Brand: Akorn
Product: Calcipotriene Topical Solution, 0.005% (Scalp Solution), Rx only, 60 mL (2 fl. oz.) bottle
Manufacturer: HI-TECH PHARMACAL CO., INC.
NDC: 50383-732-02
Lot #: 378440
Expiration Date: 07/31/2023

The hazard

The product has a potential defect that could prevent it from dispensing as intended, according to the FDA.

Context

GovInfoNow's records show Akorn, Inc. has had 64 other recalls on record since August 5, 2014. Other recent recalls of similar products include Rifampin Capsules 300mg (April 26, 2023), Atropine Sulfate Ophthalmic Solution 1% (January 30, 2023), and Levofloxacin Ophthalmic Solution 0.5% (October 13, 2022).

How to tell if you have this one

Check for the 60 mL (2 fl. oz.) bottle labeled 'Calcipotriene Topical Solution, 0.005% (Scalp Solution), Rx only'. The product was manufactured by HI-TECH PHARMACAL CO., INC. in Amityville, N.Y. with NDC 50383-732-02 and lot number 378440.

Brand
Akorn
Category
Drug

Based on the official FDA remedy

What to do — step by step

Check Product Details
Verify the product label matches the description: 60 mL (2 fl. oz.) bottle, 'Calcipotriene Topical Solution, 0.005% (Scalp Solution), Rx only'.

Where it went and when

Where it was distributed

Distributed nationwide.

FDA distribution: “Nationwide in the U.S.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA terminated this recall 16 months after the firm started it.

Jun 10, 2022Firm started the recall
Jun 29, 2022FDA classified it Class II
Jul 6, 2022Published in FDA’s Enforcement Report
Sep 28, 2023FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/34628-akorn-calcipotriene-topical-solution-recall-defective-delivery-system">Akorn Calcipotriene Topical Solution Recall: Defective Delivery System (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #D-1170-2022 (June 10, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1170-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.