Cystaran — Class III drug recall D-0034-2021
Terminated recall by Leadiant Biosciences, Inc., reported 2020-10-21. Subpotent Drug: Product testing identified a decreased level of the active ingredient, Cysteamine HCl.
| Recall number | D-0034-2021 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Leadiant Biosciences, Inc., Gaithersburg, MD, United States |
| Recall initiated | 2020-09-24 |
| Classified | 2020-10-15 |
| Reported by FDA | 2020-10-21 |
| Terminated | 2021-11-10 |
| Countries outside the US | IT |
| Quantity | 1,380 bottles |
| Reason classes | potency |
| NDC | 54482-0020, 54482-0020-01, 54482-0020-02, 54482-0035, 54482-0035-02 |
| Lot numbers | 370655 |
| Expiration dates | 2020-10-31 |
Product
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
Reason for recall
Subpotent Drug: Product testing identified a decreased level of the active ingredient, Cysteamine HCl.
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-0034-2021. 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.