CLASS II Drug recall · Reported 15 Mar 2017 · FDA Enforcement Report
Calcipotriene Cream recalled by Leo Pharma
LEO Pharma is recalling Calcipotriene Cream 0.0005%, distributed nationwide in the US. The recall was initiated on 19 Jan 2017 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-0510-2017
- FDA event ID
- 76467
- Recalling firm
- LEO Pharma, Madison, NJ
- Brand
- Calcipotriene
- Manufacturer
- Prasco Laboratories
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 19 Jan 2017
- FDA classified
- 3 Mar 2017
- Reported
- 15 Mar 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Labeling Errors
- Drug class
- Creams, Ointments & Gels
Timeline
| 19 Jan 2017 | Recall initiated by company | |
| 3 Mar 2017 | Classified by FDA | +43 days |
| 15 Mar 2017 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Incorrect/Undeclared excipients: inadvertent omission of a drug excipient from the the Authorized Generic label and also a warning regarding contact dermatitis from the brand product labeling not being incorporated into the Authorized Generic labeling.
Product as listed by the FDA
Calcipotriene Cream 0.0005%, packaged in a) 60g tube, (NDC 66993-877-61), b) 120g tube (NDC 66993-877-78), Rx Only, Manufactured by: LEO Pharma Inc., Dublin, Ireland, Manufactured for: Prasco Laboratories, Mason, OH, 45040
Where it was distributed
U.S. Nationwide
Questions about this recall
Why was it recalled?
Incorrect/Undeclared excipients: inadvertent omission of a drug excipient from the the Authorized Generic label and also a warning regarding contact dermatitis from the brand product labeling not being incorporated into the Authorized Generic labeling.
Which lots are affected?
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, Exp 2/17; EL6145, Exp 7/17; EM2091, Exp 2/17; A25206, Exp 6/18.
Where was it sold?
U.S. Nationwide
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 LEO Pharma
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Adbry, (tralokinumab-ldrm) injection, 300 mg recalled by Leo PharmaAdbry | LEO Pharma | Particulate Matter | Nationwide |
| Drug | CLASS III | Taclonex (calcipotriene and betamethasone dipropionate) recalledTaclonex | LEO Pharma | Packaging Defects | 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 Topical Solution, 0.005% (Scalp Solution) recalled | Akorn | Other | Nationwide |
| Drug | CLASS III | Taclonex (calcipotriene and betamethasone dipropionate) recalledTaclonex | LEO Pharma | Packaging Defects | Nationwide |