FDA Drug recall D-0532-2025
Lisinopril and Hydrochlorothiazide Tablets USP 20mg/12.5mg, 100-count bottles, Rx only, Mfg for: Lupin Pharmaceuticals, Inc
- FDA Drug
- Class II
- ongoing
- Published 2025-07-23
On 2025-07-23 the FDA classified a Class II recall of Lisinopril and Hydrochlorothiazide Tablets USP 20mg/12.5mg, 100-count bottles, Rx only, Mfg for: Lupin Pharmaceuticals, Inc by Lupin Pharmaceuticals, citing product Mix Up: This product is being recalled because of a complaint received that a sealed bottle of lisinopril and hydrochlorothiazide tablets 20mg/12.5 mg had a foreign tablet….
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0532-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-06-20 |
| Published | 2025-07-23 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Lupin Pharmaceuticals |
| Distribution | US |
Product
Lisinopril and Hydrochlorothiazide Tablets USP 20mg/12.5mg, 100-count bottles, Rx only, Mfg for: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202, Manufactured by: Lupin Limited Nagpur-441 108, INDIA, NDC 68180-519-01
Reason
Product Mix Up: This product is being recalled because of a complaint received that a sealed bottle of lisinopril and hydrochlorothiazide tablets 20mg/12.5 mg had a foreign tablet identified as atazanavir and ritonavir tablet 300mg/100mg.
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 | Lot #: QA01081, Exp. Date April 2027 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0532-2025%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.