Losartan Potassium Tablets — Class II drug recall D-0973-2022

Terminated recall by Strides Pharma Inc., reported 2022-06-08, distributed nationwide. CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits

Recall number	`D-0973-2022`
Product type	Drug
Classification	Class II
Status	Terminated
Voluntary or mandated	Voluntary
Recalling firm	Strides Pharma Inc., East Brunswick, NJ, United States
Recall initiated	2022-05-18
Classified	2022-05-28
Reported by FDA	2022-06-08
Terminated	2023-10-20
Distributed	Nationwide (US)
Quantity	381,456 bottles
Reason classes	cgmp, specification failure
NDC	`64380-0933`, `64380-0933-04`, `64380-0933-05`, `64380-0933-08`, `64380-0934`, `64380-0934-04`, `64380-0934-05`, `64380-0934-08`, `64380-0935`, `64380-0935-04`, `64380-0935-05`, `64380-0935-08`
Lot numbers	`64380-934-08`, `7901008A`, `7901009A`, `7901146A`, `7901147A`, `7901148A`, `7901149A`, `7901150A`, `7901151A`, `7901279A`, `7901280A`, `7901281A`, `7901282A`, `7901283A`, `7901284A`, `7901285B`, `7901286B`, `7901287A`, `7901288A`, `7901289A`, `7901290A`, `7901291A`, `7901292A`, `7901293A`, `7901294A`, `7901359A`, `7901360A`, `7901361A`, `7901362A`, `7901406A`, `7901407A`, `7901408A`, `7901409A`, `DEC-22`, `JAN-23`, `JUN-22`, `NOV-22`, `SEP-22`

Product

Losartan Potassium Tablets, USP, 50 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 64380-934-05 1000 film coated tablets NDC 64380-934-08

Reason for recall

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

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0973-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.