Leadiant Biosciences, Inc.

FDA recalling firm · 4 enforcement events · 4 product records · 2018–2023 · MD

Leadiant Biosciences, Inc. has 4 FDA enforcement events on this register (4 product records) between 2018 and 2023: 4 drug; the busiest year was 2018 with 2.

0% of its events are Class I; the most common class is Class III (3). 0 events are listed as ongoing; the recalling firm's address is in MD.

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

Initiated	Product (first record)	Type	Class	Records	Status
3 Feb 2023	Abelcet (Amphotericin B Lipid Complex) Injection, 5 mg/mL, 100 mg vial, Rx only, Manufactured by Exelead, Inc., Indianapolis, IN 46268; Distributed by Leadiant Biosciences, Inc., Gaithersburg, MD 20878, NDC 57665-101-41	Drug	Class II	1	Terminated
24 Sep 2020	Cystaran (cysteamine ophthalmic solution) 0.44%, For Ophthalmic Use Only, 15 mL bottle, Sterile, Rx Only, Manufactured by Hi-Tech Pharmacal Co Inc., Amityville, NY 11701 for Leadiant Biosciences, Inc., Gaithersburg, MD 20878, NDC 54482-020-01	Drug	Class III	1	Terminated
9 Apr 2018	Cystaran (cysteamine ophthalmic solution) 0.44%, 15 mL bottle, Rx only, Manufactured by Hi-Tech Pharmacal Co. Inc. Amityville, NY 11701 for Leadiant Biosciences, Inc. Gaithersburg, MD 20878, NDC 54482-020-01	Drug	Class III	1	Terminated
14 Feb 2018	Cystaran (cysteamine ophthalmic solution) 0.44%, 15 mL bottle, Rx only, Manufactured by Hi-Tech Pharmacal Co. Inc., Amityville, NY 11701 for Leadiant Biosciences, Inc., Gaithersburg, MD 20878, NDC 54482-020-01	Drug	Class III	1	Terminated

By type and class

Drug4

Class III3

Class II1

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

Events by year

Enforcement events for Leadiant Biosciences, Inc. by year initiated.

Questions and answers

How many FDA recalls has Leadiant Biosciences, Inc. had?

4 enforcement events (4 product records) on this register, 2018–2023: 4 drug.

Are any Leadiant Biosciences, Inc. recalls ongoing?

0 events are listed as ongoing in the current openFDA export.

What class are Leadiant Biosciences, Inc. recalls?

3 Class III, 1 Class II. 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.