RecallRadar

FDA Drug recall D-1720-2019

Lisinopril and Hydrochlorothiazide Tablets USP, 10 mg/12.5 mg, 100 tablet bottle, Rx only, Manufactured by for: Lupin Pharmaceuticals, Inc.…

On 2019-08-21 the FDA classified a Class II recall of Lisinopril and Hydrochlorothiazide Tablets USP, 10 mg/12.5 mg, 100 tablet bottle, Rx only, Manufactured by for: Lupin Pharmaceuticals, Inc.… by Lupin Pharmaceuticals, citing presence of Foreign Substance; Product complaints received related to brownish/blackish stains on the tablets and brownish/blackish powder observed inside the bottles.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-1720-2019
ClassificationClass II
Statusterminated
Initiated2019-07-17
Published2019-08-21
Last updated2026-09-13 11:52 UTC
CompanyLupin Pharmaceuticals
DistributionUS

Product

Lisinopril and Hydrochlorothiazide Tablets USP, 10 mg/12.5 mg, 100 tablet bottle, Rx only, Manufactured by for: Lupin Pharmaceuticals, Inc., Baltimore, MD, Manufactured by: Lupin Limited, Pithampur, INDIA NDC 68180-518-01

Reason

Presence of Foreign Substance; Product complaints received related to brownish/blackish stains on the tablets and brownish/blackish powder observed inside the bottles.

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_infoBatch# H900575, exp. date 01/2022

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1720-2019%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.