Recall Register

Food, drugs, devices › Firms

LEO PHARMA INC

FDA recalling firm · 3 enforcement events · 3 product records · 2017–2026 · NJ

LEO PHARMA INC has 3 FDA enforcement events on this register (3 product records) between 2017 and 2026: 3 drug; the busiest year was 2017 with 2.

0% of its events are Class I; the most common class is Class II (2). 1 event is listed as ongoing; the recalling firm's address is in NJ.

Recall classification reflects the relative degree of health hazard. Event counts depend on a firm's size and product range; they are not a comparison of one firm with another.

Enforcement events

InitiatedProduct (first record)TypeClassRecordsStatus
10 Feb 2026Adbry, (tralokinumab-ldrm) injection, 300 mg/2mL, Packaged as a) 1 x Single dose Autoinjector, SAMPLE NOT FOR SALE, NDC 50222-350-91; b) 2 x Single dose Autoinjectors, NDC 50222-350-02; Rx only, Manufactured by: LEO Pharma A/S. Industriparken 55, DK-2750 Ballerup, Denmark, Distributed by: LEO Pharma Inc., Madison, NJ…DrugClass II1Ongoing
19 Jan 2017Calcipotriene 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, 45040DrugClass II1Terminated
16 Jan 2017Taclonex (calcipotriene and betamethasone dipropionate) Topical Suspension, 0.005%/0.064%, packaged in (a) 60 g (NDC 50222-501-06), and (b)120 g (50222-501-66) tubes, Rx Only, Manufactured by: LEO Laboratories Ltd., 285 Cashel Road, Dublin 12 Ireland, Distributed by: LEO Pharma Inc. 1 Sylvan Way, Parsippany, NJ 07054.DrugClass III1Terminated

By type and class

Drug3
Class II2
Class III1

Class I: 0% of this firm's events; 18% of all events on the register.

Events by year

17
18
19
20
21
22
23
24
25
26
Enforcement events for LEO PHARMA INC by year initiated.

Questions and answers

How many FDA recalls has LEO PHARMA INC had?

3 enforcement events (3 product records) on this register, 2017–2026: 3 drug.

Are any LEO PHARMA INC recalls ongoing?

1 event is listed as ongoing in the current openFDA export.

What class are LEO PHARMA INC recalls?

2 Class II, 1 Class III. 0% are Class I against 18% of all events on the register. Class reflects the relative degree of health hazard of the product, not the firm.

Where does this data come from?

openFDA food, drug and device enforcement reports (CC0), export dated 28 Sep 2026.

Provenance

Source: openFDA enforcement reports (CC0), export dated 28 Sep 2026. Firm names are grouped exactly as FDA spells them; the same company can appear under several spellings. Only organisations are shown. See the methodology.