FDA Drug recall D-1503-2016
Lisinopril Tablets USP, 40 mg, 1000-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, MD 21202, United Stat…
- FDA Drug
- Class III
- terminated
- Published 2016-09-28
On 2016-09-28 the FDA classified a Class III recall of Lisinopril Tablets USP, 40 mg, 1000-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, MD 21202, United Stat… by Lupin Pharmaceuticals, citing CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1503-2016 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2016-04-06 |
| Published | 2016-09-28 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Lupin Pharmaceuticals |
| Distribution | n/a |
Product
Lisinopril Tablets USP, 40 mg, 1000-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, MD 21202, United States; Manufactured by: Lupin Limited, Pithampur (M.P.) 454 775, INDIA, NDC 68180-517-03.
Reason
CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.
Identifiers
| ndc | 68180-512-02 |
|---|---|
| ndc | 68180-512-30 |
| ndc | 68180-512-09 |
| ndc | 68180-512-01 |
| ndc | 68180-512-03 |
| ndc | 68180-513-30 |
| ndc | 68180-513-03 |
| ndc | 68180-513-01 |
| ndc | 68180-513-09 |
| ndc | 68180-513-02 |
| ndc | 68180-513-05 |
| ndc | 68180-517-03 |
| ndc | 68180-517-01 |
| ndc | 68180-517-30 |
| ndc | 68180-517-09 |
| ndc | 68180-517-04 |
| ndc | 68180-517-02 |
| ndc | 68180-980-03 |
| ndc | 68180-980-30 |
| ndc | 68180-980-01 |
| ndc | 68180-980-09 |
| ndc | 68180-980-05 |
| ndc | 68180-980-02 |
| ndc | 68180-981-01 |
| ndc | 68180-981-03 |
| ndc | 68180-981-30 |
| ndc | 68180-981-09 |
| ndc | 68180-981-02 |
| ndc | 68180-981-05 |
| ndc | 68180-982-01 |
| ndc | 68180-982-02 |
| ndc | 68180-982-30 |
| ndc | 68180-982-03 |
| ndc | 68180-982-09 |
| ndc | 68180-979-01 |
| ndc | 68180-979-03 |
| ndc | 68180-979-30 |
| ndc | 68180-979-09 |
| ndc | 68180-514-01 |
| ndc | 68180-514-02 |
| ndc | 68180-514-03 |
| ndc | 68180-514-09 |
| ndc | 68180-514-30 |
| ndc | 68180-514-05 |
| ndc | 68180-515-01 |
| ndc | 68180-515-02 |
| ndc | 68180-515-03 |
| ndc | 68180-515-09 |
| ndc | 68180-515-30 |
| ndc | 68180-515-05 |
| ndc | 68180-516-01 |
| ndc | 68180-516-02 |
| ndc | 68180-516-03 |
| ndc | 68180-516-09 |
| ndc | 68180-516-30 |
| code_info | Batch number: H303449, Exp 09/16 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1503-2016%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.