Neoral soft gelatin capsules — Class II drug recall D-1543-2022
Terminated recall by Novartis Pharmaceuticals Corporation, reported 2022-10-05, distributed nationwide. CGMP deviations: Out of specification results obtained during routine stability testing for ethanol content.
| Recall number | D-1543-2022 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Novartis Pharmaceuticals Corporation, East Hanover, NJ, United States |
| Recall initiated | 2022-09-16 |
| Classified | 2022-09-26 |
| Reported by FDA | 2022-10-05 |
| Terminated | 2024-03-11 |
| Distributed | Nationwide (US) |
| Quantity | 132,999 cartons |
| Reason classes | cgmp, specification failure |
| NDC | 00078-0246, 00078-0246-15, 00078-0246-61, 00078-0248, 00078-0248-15, 00078-0248-61, 00078-0274, 00078-0274-22 |
| Lot numbers | APCD162 |
| Expiration dates | 2023-01 |
Product
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.
Reason for recall
CGMP deviations: Out of specification results obtained during routine stability testing for ethanol content.
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-1543-2022. 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.