CLASS III Drug recall · Reported 21 Oct 2020 · FDA Enforcement Report
Cystaran (cysteamine ophthalmic solution) recalled
Leadiant Biosciences is recalling Cystaran (cysteamine ophthalmic solution) 0.44%, For Ophthalmic Use Only, Sterile, distributed in Pennsylvania. The recall was initiated on 24 Sep 2020 and the FDA has classified it as Class III.
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-0034-2021
- FDA event ID
- 86525
- Recalling firm
- Leadiant Biosciences, Gaithersburg, MD
- Brand
- Cystaran
- Manufacturer
- Leadiant Biosciences, Inc.
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 24 Sep 2020
- FDA classified
- 15 Oct 2020
- Reported
- 21 Oct 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Eye Drops
Timeline
| 24 Sep 2020 | Recall initiated by company | |
| 15 Oct 2020 | Classified by FDA | +21 days |
| 21 Oct 2020 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Subpotent Drug: Product testing identified a decreased level of the active ingredient, Cysteamine HCl.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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
Where it was distributed
PA and Italy
Questions about this recall
Why was it recalled?
Subpotent Drug: Product testing identified a decreased level of the active ingredient, Cysteamine HCl.
Which lots are affected?
Lot #: 370655, Exp. 10/31/2020
Where was it sold?
PA and Italy
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 III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
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 Leadiant Biosciences
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Abelcet (Amphotericin B Lipid Complex) Injection, 5 mg/mL recalled | Leadiant Biosciences | Sterility | Nationwide |
| Drug | CLASS III | Cystaran (cysteamine ophthalmic solution) recalledCystaran | Leadiant Biosciences | Potency & Assay | PA |
| Drug | CLASS III | Cystaran (cysteamine ophthalmic solution) recalledCystaran | Leadiant Biosciences | Potency & Assay | PA |
Other Cysteamine recalls
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Cystaran (cysteamine ophthalmic solution) recalledCystaran | Leadiant Biosciences | Potency & Assay | PA |
| Drug | CLASS III | Cystaran (cysteamine ophthalmic solution) recalledCystaran | Leadiant Biosciences | Potency & Assay | PA |