FDA Drug recall D-0221-2024
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…
- FDA Drug
- Class II
- terminated
- Published 2024-01-17
On 2024-01-17 the FDA classified a Class II recall of 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… by Lupin Pharmaceuticals, citing CGMP Deviations: N-Nitroso Desloratadine impurity result exceeded the acceptable intake limit.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0221-2024 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2023-12-20 |
| Published | 2024-01-17 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Lupin Pharmaceuticals |
| Distribution | US |
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
CGMP Deviations: N-Nitroso Desloratadine impurity result exceeded the acceptable intake limit.
Identifiers
| ndc | 68180-153-01 |
|---|---|
| ndc | 68180-153-03 |
| ndc | 68180-153-06 |
| ndc | 68180-153-02 |
| ndc | 68180-153-11 |
| ndc | 68180-153-12 |
| code_info | Lot # G201822, exp. date Jan 2024, 100 count G201823, exp. date Jan 2024, 100 count G201824, exp. date Jan 2024, 500 count |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
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All Lupin Pharmaceuticals recalls
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0221-2024%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.