Multi event Drug Recall Enforcement Report Class III voluntary initiated by Lupin Pharmaceuticals Inc., originally initiated on 04-06-2016 for the product Lisinopril Tablets USP, 30 mg, packaged in a) 500-count bottles (NDC 68180-516-02) and b) 100-count bottles (NDC 68180-516-01); Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, MD 21202, United States; Manufactured by: Lupin Limited, Pithampur (M.P.) 454 775, INDIA. The product was recalled due to cgmp deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.. The product was distributed in All Product Distributed Domestically In The Us. No Recalled Product Was Distributed To U.s. Government Agency Consignees Directly By Lupin. No Recalled Product Was Distributed To Any Foreign Consignees By Lupin. and the recall is currently terminated.
Recall Enforcement Reports
Recall Number |
Recall Initiation Date |
Report Date |
Recall Classification |
Quantity |
Product Description |
Recall Reason |
Status |
D-1502-2016 | 04-06-2016 | 09-28-2016 | Class III | 20,556 bottles | Lisinopril Tablets USP, 30 mg, packaged in a) 500-count bottles (NDC 68180-516-02) and b) 100-count bottles (NDC 68180-516-01); Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, MD 21202, United States; Manufactured by: Lupin Limited, Pithampur (M.P.) 454 775, INDIA. | CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications. | Terminated |
D-1503-2016 | 04-06-2016 | 09-28-2016 | Class III | 5,880 bottles | 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. | CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications. | Terminated |
Recalled Products
NDC |
Proprietary Name |
Non-Proprietary Name |
Dosage Form |
Route Name |
Company Name |
Product Type |
68180-512 | Lisinopril | Lisinopril | Tablet | Oral | Lupin Pharmaceuticals, Inc. | Human Prescription Drug |
68180-513 | Lisinopril | Lisinopril | Tablet | Oral | Lupin Pharmaceuticals, Inc. | Human Prescription Drug |
68180-514 | Lisinopril | Lisinopril | Tablet | Oral | Lupin Pharmaceuticals, Inc. | Human Prescription Drug |
68180-515 | Lisinopril | Lisinopril | Tablet | Oral | Lupin Pharmaceuticals, Inc. | Human Prescription Drug |
68180-516 | Lisinopril | Lisinopril | Tablet | Oral | Lupin Pharmaceuticals, Inc. | Human Prescription Drug |
68180-517 | Lisinopril | Lisinopril | Tablet | Oral | Lupin Pharmaceuticals, Inc. | Human Prescription Drug |
68180-979 | Lisinopril | Lisinopril | Tablet | Oral | Lupin Pharmaceuticals, Inc. | Human Prescription Drug |
68180-980 | Lisinopril | Lisinopril | Tablet | Oral | Lupin Pharmaceuticals, Inc. | Human Prescription Drug |
68180-981 | Lisinopril | Lisinopril | Tablet | Oral | Lupin Pharmaceuticals, Inc. | Human Prescription Drug |
68180-982 | Lisinopril | Lisinopril | Tablet | Oral | Lupin Pharmaceuticals, Inc. | Human Prescription Drug |