RecallRadar

FDA Drug recall D-0638-2020

Blisovi Fe 1.5/30 (norethindrone acetate and ethinyl estradiol tablets USP and ferrous fumarate tablets 75mg), Rx Only, Distributed by: Lup…

On 2020-01-15 the FDA classified a Class II recall of Blisovi Fe 1.5/30 (norethindrone acetate and ethinyl estradiol tablets USP and ferrous fumarate tablets 75mg), Rx Only, Distributed by: Lup… by Lupin Pharmaceuticals, citing failed Tablet/Capsule Specifications: Complaints related to crumbling of tablets when popped out of the blister pack.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-0638-2020
ClassificationClass II
Statusterminated
Initiated2019-12-26
Published2020-01-15
Last updated2026-09-13 11:52 UTC
CompanyLupin Pharmaceuticals
DistributionUS

Product

Blisovi Fe 1.5/30 (norethindrone acetate and ethinyl estradiol tablets USP and ferrous fumarate tablets 75mg), Rx Only, Distributed by: Lupin Pharmaceuticals Inc Baltimore, MD 21202, Manufactured for: Lupin Limited Pithampur 454775 INDIA 240875, NDC 68180-866-11

Reason

Failed Tablet/Capsule Specifications: Complaints related to crumbling of tablets when popped out of the blister pack.

Identifiers

code_infoLot: H801227, Exp. Date January 2020

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-0638-2020%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.