FDA Recall Lisinopril

View Recall Number, Date, Reasons, Quantity

FDA Recall Enforcement Reports

The last Recall Enforcement Report for Lisinopril with NDC 68180-512 was initiated on 09-13-2022 as a Class II recall due to presence of foreign substance: foreign material (metal piece) embedded in one tablet. The latest recall number for this product is D-1536-2022 and the recall is currently terminated as of 01-31-2024 .

Recall Number Initiation Date Report Date Recall Classification Product Quantity Product Description Status
D-1536-202209-13-202209-21-2022Class II11,802 1000-count bottlesLisinopril Tablets USP, 10 mg, 1000-count bottles, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, Manufactured by: Lupin Limited, Nagpur- 441 108, India. NDC 68180-980-03Terminated
D-1290-202005-28-202006-17-2020Class II4,224 bottlesLisinopril Tablets, USP, 5 mg, Rx Only, 1000-count bottle, Manufactured for: Lupin Pharmaceuticals Inc., Baltimore, MD 21202, Manufactured by: Lupin Limited, Nagpur - 441 108, India, NDC 68180-513-03.Terminated
D-1079-202004-01-202004-08-2020Class II25,944 bottlesLisinopril Tablets USP, 30 mg, 100-count bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202, NDC 68180-982-01Terminated
D-1077-201808-13-201808-22-2018Class II11,706 bottlesLisinopril Tablets USP, 10mg, 1000-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals Inc. Baltimore, Maryland 21202, NDC 68180-980-03Terminated
D-1503-201604-06-201609-28-2016Class III5,880 bottlesLisinopril 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.Terminated
D-1502-201604-06-201609-28-2016Class III20,556 bottlesLisinopril 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.Terminated

What is the Enforcement Report?

All drug recalls are monitored by the Food and Drug Administration (FDA) and are included in the Enforcement Report once they are properly classified. The FDA will determine if a firm's removal or correction actions of a marked product meet the requirements to be considered a "recall". The FDA will also determine the public hazard assessment and a recall classification will be published in the Enforcement Report.