Product record

Montelukast: batches declared Not of Standard Quality

Last checked 3 November 2026. Source: CDSCO monthly NSQ alerts, Jan 2019 to Sep 2026

5 batches of products named "Montelukast" (as printed by the testing lab) failed a CDSCO or state drug-testing laboratory test between June 2022 and August 2026. This is a record of specific batches, it does not mean the molecule or every brand is unsafe.

Records by type

5 records linked to Montelukast in the datasets we hold. A zero means nothing is on record in those datasets, not that nothing ever happened. What the labels mean.

0Banned or prohibited
0Recalled or suspended
5Failed a lab test
0Regulatory notice
Primary government sourceTier 1: government primary source

CDSCO drug alerts: Not of Standard Quality and spurious drugs

CDSCO · CDSCO monthly NSQ alerts, Jun 2022 to Aug 2026

View original document

Scope. A failed batch is not a verdict on every pack of this product. Regulatory actions can apply to one batch, one formulation, one period or one state. Always check the linked government document for the current position, and tell us if something is out of date. How we label records.

5
NSQ batches
5
Manufacturers
Dissolution
Most common reason
Aug 2026
Latest alert

Flagged batches

Batch Manufacturer Reason declared NSQ Tested by Alert
Batch T251209Mfg Dec 2025 · Exp Nov 2027 Micron Pharmaceuticals The sample does not conform to IP standards with respect to the test DissolutionDissolution DTL, ThrissurState lab Aug 2026
Batch CRT-250217Mfg Feb 2025 · Exp Jan 2027 Civron PharmaceuticalsHimachal Pradesh The sample is found to be Not of Standard Quality for the reason stated under Description.Description CDL KolkataCDSCO lab Jun 2026
Batch F4E0425Mfg May 2024 · Exp Apr 2026 Morepan Laboratories Ltd It fails the test ?Dissolution? Specified in the Laboratory Protocol as per IPDissolution DTL ThiruvananthapuramState lab Oct 2024
Batch T2203068Mfg Mar 2022 · Exp Feb 2024 Rhydburg Pharmaceuticals LtdUttarakhand Related SubstancesRelated substances RDTL ChandigarhCDSCO lab Oct 2022
Batch C-1D0342Mfg Apr 2021 · Exp Mar 2023 Morepen Laboratories LtdHimachal Pradesh DissolutionDissolution RDTL ChandigarhCDSCO lab Jun 2022

How to use this. Match the batch number on your strip or bottle against the list. If your batch is listed, return it to the pharmacy and ask for a replacement; if not, the product is not on any alert as of September 2026. Check any batch number.