RecallRadar

FDA Drug recall D-0972-2022

Losartan Potassium Tablets, USP 25 mg, Rx only, Manufactured by: Vivimed Life Sciences Private Limited, Plot No., 101, 102, 107 & 108, SIDC…

On 2022-06-08 the FDA classified a Class II recall of Losartan Potassium Tablets, USP 25 mg, Rx only, Manufactured by: Vivimed Life Sciences Private Limited, Plot No., 101, 102, 107 & 108, SIDC… by Strides Pharma, citing CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-0972-2022
ClassificationClass II
Statusterminated
Initiated2022-05-18
Published2022-06-08
Last updated2026-09-13 11:52 UTC
CompanyStrides Pharma
DistributionUS

Product

Losartan Potassium Tablets, USP 25 mg, Rx only, Manufactured by: Vivimed Life Sciences Private Limited, Plot No., 101, 102, 107 & 108, SIDCO Pharmaceutical Complex, Alathur, Kanchipuram - 603 110, Tamilnadu, India, Distributed by: Strides Pharma Inc., East Brunswick, NJ 08816. 90 film coated tablets NDC 64380-933-05 1000 film coated tablets NDC 64380-933-08

Reason

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

Identifiers

ndc64380-933-04
ndc64380-933-05
ndc64380-933-08
ndc64380-934-04
ndc64380-934-05
ndc64380-934-08
ndc64380-935-04
ndc64380-935-05
ndc64380-935-08
code_info
NDC 64380-933-05 Lot 7901007A, Exp Date Jun-22; Lot 7901144A, 7901178A & 7901179A, Exp Date Sep-22; Lots 7901246A & 79…NDC 64380-933-05 Lot 7901007A, Exp Date Jun-22; Lot 7901144A, 7901178A & 7901179A, Exp Date Sep-22; Lots 7901246A & 7901247A, Exp Date Oct-22; Lot 7901343A, Exp Date Dec-22. NDC 64380-933-08 Lot 7901006A, Exp Date Jun-22; Lot 7901145A & 7901180A, Exp Date Sep-22; Lot 7901181A, Exp Date Oct-22.

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-0972-2022%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.