Lisinopril Tablets USP — Class III drug recall D-1502-2016

Terminated recall by Lupin Pharmaceuticals Inc., reported 2016-09-28. CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates fa

Recall number	`D-1502-2016`
Product type	Drug
Classification	Class III
Status	Terminated
Voluntary or mandated	Voluntary
Recalling firm	Lupin Pharmaceuticals Inc., Baltimore, MD, United States
Recall initiated	2016-04-06
Classified	2016-09-16
Reported by FDA	2016-09-28
Terminated	2017-08-07
Quantity	20,556 bottles
Reason classes	cgmp, specification failure
NDC	`68180-0512`, `68180-0512-01`, `68180-0512-02`, `68180-0512-03`, `68180-0512-09`, `68180-0512-30`, `68180-0513`, `68180-0513-01`, `68180-0513-02`, `68180-0513-03`, `68180-0513-05`, `68180-0513-09`, `68180-0513-30`, `68180-0514`, `68180-0514-01`, `68180-0514-02`, `68180-0514-03`, `68180-0514-05`, `68180-0514-09`, `68180-0514-30`, `68180-0515`, `68180-0515-01`, `68180-0515-02`, `68180-0515-03`, `68180-0515-05` and 40 more
Lot numbers	`09/16`, `H303487`, `H303488`, `H303489`

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.

Reason for recall

CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-1502-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.