LEO Pharma Recalls Calcipotriene Cream Due to Labeling Errors
LEO Pharma is recalling 272,062 tubes of Calcipotriene Cream because the label omitted a required excipient and a warning about contact dermatitis.
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: The recall is classified as FDA Class II due to labeling errors (omitted excipient and warning), which fits the rubric for minor labeling errors and low-risk contamination without reported injuries.
Plain-English summary
LEO Pharma Inc. is recalling 272,062 tubes of Calcipotriene Cream 0.0005% (NDC 66993-877-61 and 66993-877-78) distributed nationwide in the United States. The recall was initiated because the product labeling for the Authorized Generic version inadvertently omitted a drug excipient and failed to include a warning regarding contact dermatitis that is present in the brand product labeling.
The affected lots include EK8760, EL1115, EL2358, EL6143, EM0837, EM2088, A20899, A24492, EK8764, EL6145, EM2091, and A25206. These products were manufactured by LEO Pharma Inc. in Dublin, Ireland, and manufactured for Prasco Laboratories in Mason, Ohio. The recall is classified as FDA Class II, indicating a situation that might cause temporary or medically reversible adverse health consequences.
Consumers and healthcare providers should check their inventory for the specific lot numbers and expiration dates listed above. If the product is found, it should be returned to the pharmacy or point of purchase for a refund or replacement. Patients currently using the medication should consult their healthcare provider for guidance on continuing treatment or switching to an alternative product.
The recalled product
- Product
- CALCIPOTRIENE (CALCIPOTRIENE)
- Brand
- CALCIPOTRIENE
- Manufacturer
- LEO PHARMA INC
- Category
- Drug — Topical Prescription
- Affected units
- 272,062
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 (20)
- Lot #: a) EK8760
- Exp 2/17
- EL1115
- Exp 3/17
- EL2358
- Exp 4/17
- EL6143
- Exp 7/17
- EM0837
- Exp 10/17
- EM2088
- 12/17
- A20899
- Exp 5/18
- A24492
- Exp 6/18
- b) EK8764
- EL6145
- EM2091
- A25206
Distribution
Distributed nationwide across the United States.
Related recalls
Same manufacturer · LEO PHARMA INC
See all →- HighADBRY Injection Drug Recall for Particulate Contamination
FDA (Drugs) · 2026-03-04
- LowTaclonex Topical Suspension Recalled for Outdated Package Insert
FDA (Drugs) · 2017-02-22
Same hazard · mis labeling
See all →- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-10-14
- SevereBetter Bakehouse Recalls Donutful Chocolate Dipped Vanilla Cake Donuts for Undeclared Milk
FDA (Food) · 2026-10-14
- HighFreshPoint Recalls Cranberry Chicken Salad Wedges for Undeclared Egg Allergen
FDA (Food) · 2026-10-14
- HighJ K Patisserie & Bakery LLC Recalls Croissants for Undeclared Egg
FDA (Food) · 2026-10-14
- ModerateHalyard Laparoscopy Comprehensive Pack II Recalled for Latex Content
FDA (Devices) · 2026-10-14
Similar recalls
- LowTaclonex Topical Suspension Recalled for Outdated Package Insert
FDA (Drugs) · 2017-02-22
- LowUnichem Recalls Lamotrigine Tablets With Incorrect Imprint
FDA (Drugs) · 2016-10-05
- LowBuprenorphine Sublingual Tablets Recalled for Labeling Mix-up
FDA (Drugs) · 2026-09-09
- LowLupin Recalls Hydrocodone and Acetaminophen Tablets for Missing Labels
FDA (Drugs) · 2018-06-06
- LowG & W Laboratories Recalls Ciclopirox Olamine Cream Due to Outdated Insert
FDA (Drugs) · 2017-04-12
- ModerateAidapak Recalls CapsuleTOPRIL Tablets Due to Potential Labeling Error
FDA (Drugs) · 2014-01-29