RecallRadar

FDA Drug recall D-0839-2022

Losartan Potassium Tablets USP, 50 mg, a) 90-count bottles (NDC# 68180-377-03), b) 1000-count bottles (NDC# 68180-377-09), Rx Only, Manufac…

On 2022-05-11 the FDA classified a Class II recall of Losartan Potassium Tablets USP, 50 mg, a) 90-count bottles (NDC# 68180-377-03), b) 1000-count bottles (NDC# 68180-377-09), Rx Only, Manufac… by Lupin Pharmaceuticals, citing CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-0839-2022
ClassificationClass II
Statusterminated
Initiated2022-03-31
Published2022-05-11
Last updated2026-09-13 11:52 UTC
CompanyLupin Pharmaceuticals
DistributionUS

Product

Losartan Potassium Tablets USP, 50 mg, a) 90-count bottles (NDC# 68180-377-03), b) 1000-count bottles (NDC# 68180-377-09), Rx Only, Manufactured By: Lupin Limited, Pithampur, India, MFG For: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, USA.

Reason

CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits

Identifiers

ndc68180-210-09
ndc68180-210-03
ndc68180-210-01
ndc68180-210-06
ndc68180-211-06
ndc68180-211-09
ndc68180-211-03
ndc68180-211-01
ndc68180-212-06
ndc68180-212-03
ndc68180-212-09
ndc68180-212-01
ndc68180-376-03
ndc68180-376-06
ndc68180-376-01
ndc68180-376-09
ndc68180-377-03
ndc68180-377-01
ndc68180-377-09
ndc68180-377-06
ndc68180-378-09
ndc68180-378-03
ndc68180-378-06
ndc68180-378-01
ndc68180-307-01
ndc68180-307-02
ndc68180-307-09
ndc68180-307-06
ndc68180-308-06
ndc68180-308-09
ndc68180-308-02
ndc68180-308-01
ndc68180-309-06
ndc68180-309-09
ndc68180-309-02
ndc68180-309-01
code_info
H903720, exp. date Oct-22 H001876, exp. date Dec-22 H003002, exp. date Jan-23 H903774, exp. date Oct-22 H001877, ex…H903720, exp. date Oct-22 H001876, exp. date Dec-22 H003002, exp. date Jan-23 H903774, exp. date Oct-22 H001877, exp. date Dec-22 H003003, exp. date Feb-23 H000849, exp. date Nov-22 H002127, exp. date Dec-22 H003004, exp. date Feb-23 H001412, exp. date Nov-22 H002128, exp. date Dec-22 H003123, exp. date Feb-23 H001413, exp. date Nov-22 H002643, exp. date Jan-23 H003124, exp. date Feb-23 H001414, exp. date Nov-22 H002644, exp. date Jan-23 H101129, exp. date Feb-23 H001430, exp. date Nov-22 H002645, exp. date Jan-23 H101147, exp. date Mar-23 H001526, exp. date Dec-22 H002839, exp. date Jan-23 H102139, exp. date Mar-23 H001652, exp. date Dec-22 H002840, exp. date Jan-23 H102158, exp. date Mar-23 H000605, exp. date Jan-23 H001599, exp. date Dec-22 H100148, exp. date Feb-23 H001401, exp. date Nov-22 H001875, exp. date Dec-22 H102043, exp. date Mar-23 H001063, exp. date Nov-22 H002126, exp. date Dec-22 H101495, exp. date Mar-23 H001188, exp. date Nov-22 H

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-0839-2022%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.