Desloratadine Tablets USP 5mg a) 100 count — Class II drug recall D-0221-2024
Terminated recall by Lupin Pharmaceuticals Inc., reported 2024-01-17, distributed nationwide. CGMP Deviations: N-Nitroso Desloratadine impurity result exceeded the acceptable intake limit.
| Recall number | D-0221-2024 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Lupin Pharmaceuticals Inc., Baltimore, MD, United States |
| Recall initiated | 2023-12-20 |
| Classified | 2024-01-09 |
| Reported by FDA | 2024-01-17 |
| Terminated | 2025-04-04 |
| Distributed | Nationwide (US) |
| Reason classes | cgmp, specification failure |
| NDC | 68180-0153, 68180-0153-01, 68180-0153-02, 68180-0153-03, 68180-0153-06, 68180-0153-11, 68180-0153-12 |
| Lot numbers | 100, G201822 |
| Expiration dates | 2024-01-20 |
Product
Desloratadine Tablets USP 5mg a) 100 count (NDC 68180-153-01) and b) 500 count (NDC 68180-153-02) bottles, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202.
Reason for recall
CGMP Deviations: N-Nitroso Desloratadine impurity result exceeded the acceptable intake limit.
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-0221-2024. 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.