FDA Drug recall D-0188-2024
Lisinopril and Hydrochlorothiazide Tablets USP, 10mg/12.5mg, Rx only, 100 Tablets per bottles, Manufactured for: Lupin Pharmaceuticals, Inc…
- FDA Drug
- Class II
- terminated
- Published 2024-01-03
On 2024-01-03 the FDA classified a Class II recall of Lisinopril and Hydrochlorothiazide Tablets USP, 10mg/12.5mg, Rx only, 100 Tablets per bottles, Manufactured for: Lupin Pharmaceuticals, Inc… by Cardinal Healthcare, citing CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0188-2024 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2022-01-26 |
| Published | 2024-01-03 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Cardinal Healthcare |
| Distribution | US |
Product
Lisinopril and Hydrochlorothiazide Tablets USP, 10mg/12.5mg, Rx only, 100 Tablets per bottles, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202; Manufactured by: Lupin Limited, Nagpur-441 108, India. NDC: 68180-518-01
Reason
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Identifiers
| ndc | 68180-518-02 |
|---|---|
| ndc | 68180-518-01 |
| ndc | 68180-518-30 |
| ndc | 68180-519-30 |
| ndc | 68180-519-01 |
| ndc | 68180-519-02 |
| ndc | 68180-520-02 |
| ndc | 68180-520-30 |
| ndc | 68180-520-01 |
| code_info | Batch Q101699, Q101981 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0188-2024%22
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