RecallRadar

FDA Drug recall D-1052-2016

Lisinopril & Hydrochlorothiazide Tables, USP 20mg/12.5mg, packaged in a)100-count bottles and b) 5000-count bottles, Rx only, Manufactured…

On 2016-07-06 the FDA classified a Class III recall of Lisinopril & Hydrochlorothiazide Tables, USP 20mg/12.5mg, packaged in a)100-count bottles and b) 5000-count bottles, Rx only, Manufactured… by Lupin Pharmaceuticals, citing CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-1052-2016
ClassificationClass III
Statusterminated
Initiated2016-04-04
Published2016-07-06
Last updated2026-09-13 11:51 UTC
CompanyLupin Pharmaceuticals
DistributionUS

Product

Lisinopril & Hydrochlorothiazide Tables, USP 20mg/12.5mg, packaged in a)100-count bottles and b) 5000-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, Manufactured by: Lupin Limited Pithampur (M.P.) 454 775 India, a) NDC 68180-519-01, b) 68180-519-30

Reason

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

Identifiers

ndc68180-518-02
ndc68180-518-01
ndc68180-518-30
ndc68180-519-30
ndc68180-519-01
ndc68180-519-02
ndc68180-520-02
ndc68180-520-30
ndc68180-520-01
code_infoLot #: a) H303459, b) H303460, Exp 09/2016

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-1052-2016%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.