Product record

Montelukast Sodium Levocetirizine Hydrochloride: batches declared Not of Standard Quality

Last checked 20 September 2026. Source: CDSCO monthly NSQ alerts, Jan 2019, Jul 2026

17 batches of products named "Montelukast Sodium Levocetirizine Hydrochloride" (as printed by the testing lab) failed a CDSCO or state drug-testing laboratory test between April 2020 and December 2025. This is a record of specific batches, it does not mean the molecule or every brand is unsafe.

Records by type

17 records linked to Montelukast Sodium Levocetirizine Hydrochloride 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
17Failed 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, Apr 2020 to Dec 2025

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 Always check the linked government document for the current position, and tell us if something is out of date.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.

17
NSQ batches
15
Manufacturers
Dissolution
Most common reason
Dec 2025
Latest alert

Flagged batches

Batch Manufacturer Reason declared NSQ Tested by Alert
GT240841Mfg 2024-04 · Exp 2026-03 Theon Pharmaceuticals LtdHimachal Pradesh The sample does not conform to Schedule V of Drugs Rules 1940 with respect to the test Disintegration as per IPDisintegration DTL Thrissur,KeralaState lab Dec 2025
SP240802Mfg 2024-04 · Exp 2026-03 Sotac Pharmaceuticals Pvt. LtdGujarat The sample does not conform as per IP 2022 in respect to the description, as out of 40 Tablets 15 were found moistened, bulged and crackedDescription Government Analyst, DTL, Baddi, Distt Solan, Himanchal PradeshState lab Jul 2025
FDMC-588Mfg 2024-07 · Exp 2026-06 Firstmed Therapeutics Pvt Ltd For the received sample Montelukast Sodium & Levocetirizine Hydrochloride Tablets IP (Moncube LC) ,Presence of Spots was observed which should not be presentOther State Lab PuducherryState lab Apr 2025
18RT2401Mfg 2024-04 · Exp 2026-09 Adnova Healthcare Pvt. Ltd. 156Gujarat Description and Uniformity of dispersionDescription CDTL IndoreCDSCO lab Jan 2025
MLHT-1022Mfg 2023-09 · Exp 2026-08 Wings Biotech LLPHimachal Pradesh It fails the test ?Dissolution? Specified in the Laboratory Protocol as per IPDissolution DTL ThiruvananthapuramState lab Oct 2024
ST23- 384DMfg 2023-05 · Exp 2025-04 Symbiosis Pharmaceuticals Pvt. LtdHimachal Pradesh Dissolution of Montelukast Levocetirizine hydrochlorideDissolution RDTL GuwahatiCDSCO lab Jun 2024
ATA-176Mfg 2023-02 · Exp 2025-01 Alliaance BiotechHimachal Pradesh The sample does not conform to I.P. with respect to the above tests only.Other RDTL GuwahatiCDSCO lab May 2024
TLL-2450Mfg 2022-12 · Exp 2024-11 Taksa LifesciencePunjab Assay of MontelukastAssay RDTL GuwahatiState lab Mar 2024
MAT22030Mfg 2022-06 · Exp 2024-05 Tirupati Medicare LimitedHimachal Pradesh Dissolution of MontelukastDissolution RDTL GuwahatiState lab Feb 2024
TXL012007Mfg 2022-11 · Exp 2024-10 DWD Pharmaceuticals LtdGujarat DesriptionOther CDL KolkataCDSCO lab Feb 2024
FPT-2067Mfg 2022-10 · Exp 2024-09 Forgo PharmaceuticalsHimachal Pradesh Assay/Content of MontelukastAssay RDTL GuwahatiState lab Jan 2024
MLCT1026Mfg 2023-02 · Exp 2025-01 Unicure India LtdUttar Pradesh DissolutionDissolution CDL KolkataCDSCO lab Nov 2023
MTZ2200 3Mfg 2022-12 · Exp 2024-11 Tirupati Medicare LimitedHimachal Pradesh Dissolution of MontelukastDissolution CDL KolkataCDSCO lab Aug 2023
TE2027AMfg 2022-05 · Exp 2024-04 Vivimed Labs LimitedTelangana DescriptionDescription CDL KolkataCDSCO lab Jan 2023
LMT21001MBMfg 2021-01 · Exp 2022-12 Sri Ram Healthcare Pvt. LtdHimachal Pradesh DissolutionDissolution RDTL GuwahatiState lab Apr 2022
TMNL-018Mfg 2019-01 · Exp 2020-12 Medipol Pharmaceuticals India Pvt. Ltd. 1199/3Himachal Pradesh DissolutionDissolution RDTL GuwahatiState lab Apr 2020
TMNL-018Mfg 2019-01 · Exp 2020-12 Medipol Pharmaceuticals India Pvt. Ltd. 1199/3Himachal Pradesh DissolutionDissolution RDTL GuwahatiState lab Apr 2020

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 July 2026. Check any batch number.