Cystaran — Class III drug recall D-0683-2018
Terminated recall by LEADIANT BIOSCIENCES, INC, reported 2018-04-25. Subpotent drug: Out of specification for an active ingredient cysteamine hydrochloride.
| Recall number | D-0683-2018 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | LEADIANT BIOSCIENCES, INC, Gaithersburg, MD, United States |
| Recall initiated | 2018-04-09 |
| Classified | 2018-04-17 |
| Reported by FDA | 2018-04-25 |
| Terminated | 2018-11-29 |
| Countries outside the US | DE, IT |
| Quantity | 3,398 bottles |
| Reason classes | potency, specification failure |
| NDC | 54482-0020, 54482-0020-01, 54482-0020-02, 54482-0035, 54482-0035-02 |
| Lot numbers | 35866, 358663, 6/18, 7/18 |
Product
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
Reason for recall
Subpotent drug: Out of specification for an active ingredient cysteamine hydrochloride.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0683-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.