CLASS II Drug recall · Reported 5 Oct 2022 · FDA Enforcement Report
Neoral soft gelatin capsules (cyclosporine capsules recalled
Novartis Pharmaceuticals is recalling Neoral soft gelatin capsules (cyclosporine capsules, USP) Modified, 25 mg, distributed nationwide in the US. The recall was initiated on 16 Sep 2022 and the FDA has classified it as Class II.
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-1543-2022
- FDA event ID
- 90862
- Recalling firm
- Novartis Pharmaceuticals, East Hanover, NJ
- Brand
- Neoral
- Manufacturer
- Novartis Pharmaceuticals Corporation
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 16 Sep 2022
- FDA classified
- 26 Sep 2022
- Reported
- 5 Oct 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
Timeline
| 16 Sep 2022 | Recall initiated by company | |
| 26 Sep 2022 | Classified by FDA | +10 days |
| 5 Oct 2022 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
CGMP deviations: Out of specification results obtained during routine stability testing for ethanol content.
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
Neoral soft gelatin capsules (cyclosporine capsules, USP) Modified, 25 mg, Rx Only, 30 Soft Gelatin Capsules per carton, Mfg by: Novartis Pharmaceuticals Corporation, East Hanover, NJ 07936, NDC # 0078-0246-15.
Where it was distributed
Nationwide and Puerto Rico
Questions about this recall
Why was it recalled?
CGMP deviations: Out of specification results obtained during routine stability testing for ethanol content.
Which lots are affected?
Lot # APCD162, Exp. 01/2023
Where was it sold?
Nationwide and Puerto Rico
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 II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
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 Novartis Pharmaceuticals
All 33| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Diovan (valsartan) 160 mg recalled by Novartis PharmaceuticalsDiovan | Novartis Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS I | Sandimmune Oral Solution (cyclosporine oral solution, USP) 100 mg/mL recalled | Novartis Pharmaceuticals | Other | Nationwide |
| Drug | CLASS I | Sandimmune Oral Solution (cyclosporine oral solution, USP) 100 mg/mL recalled | Novartis Pharmaceuticals | Other | Nationwide |
| Drug | CLASS III | Xiidra (lifitegrast ophthalmic solution) recalledXiidra | Novartis Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS III | Xiidra (lifitegrast ophthalmic solution) recalled | Novartis Pharmaceuticals | Potency & Assay | Nationwide |
Other Cyclosporine recalls
All 13| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Cequa (cyclosporine ophthalmic solution) 0.09%-Use Vials recalledCequa | SUN Pharmaceutical Industries | Potency & Assay | Nationwide |
| Drug | CLASS III | Cequa (cyclosporine ophthalmic solution) recalledCequa | SUN Pharmaceutical Industries | Particulate Matter | Nationwide |
| Drug | CLASS III | Cequa (cyclosporine ophthalmic solution) 0.09%-Use Vials recalledCequa | SUN Pharmaceutical Industries | Particulate Matter | Nationwide |
| Drug | CLASS III | Cequa (cyclosporine ophthalmic solution) 0.09%-Use Vials recalledCequa | SUN Pharmaceutical Industries | Potency & Assay | Nationwide |
| Drug | CLASS II | Cyclosporine USP, for prescription compounding recalled | American Pharmaceutical Ingredients | Potency & Assay | Nationwide |