Ingredient record · Antihistamine for allergy
Levocetirizine: bans, restrictions and failed batches in India
Last checked 3 November 2026. Sources: CDSCO banned-drugs notifications and monthly NSQ alerts, Jan 2019 to Sep 2026
42 entries containing Levocetirizine are on India's banned-drugs list, and 23 are banned today. 149 batches of medicines containing Levocetirizine failed a government lab test between January 2019 and September 2026, from 109 manufacturers. A failed batch concerns that batch only, not the medicine or every brand.
23
Banned combinations in force
19
Other listed orders (stayed, restricted, quashed)
149
Batches failed a lab test
Sep 2026
Latest lab alert
Is it banned? Our answer pages
Not banned · some combos banned (2024)
Not banned
On the banned-drugs list
Levocetirizine on its own is not on CDSCO's banned list. The entries below are specific combinations that contain it. Status follows CDSCO's own notes on each entry.
| Drug / combination | Action | Notification | Date | Order | Status note |
|---|---|---|---|---|---|
| Phenylephrine HCl + Paracetamol + Levocetirizine HCl + MentholFixed-dose combination · cough-cold | Banned | S.O. 3389(E) | 2 August 2024 | 156 FDCs · Aug 2024 | Prohibited under s.26A; notifications dated 02.08.2024, gazetted 21-22 Aug 2024. |
| Diethylcarbamazine Citrate + Levocetirizine HClFixed-dose combination · cough-cold | Banned | S.O. 3393(E) | 2 August 2024 | 156 FDCs · Aug 2024 | Prohibited under s.26A; notifications dated 02.08.2024, gazetted 21-22 Aug 2024. |
| Dextromethorphan + Levocetirizine + Phenylephrine + ZincFixed-dose combination · cough-cold | Banned | S.O. 4522(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Nimesulide + Phenylephrine + Caffeine + LevocetirizineFixed-dose combination · cough-cold | Banned | S.O. 4527(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Levocetirizine + Ambroxol + Phenylephrine + GuaifenesinFixed-dose combination · cough-cold | Banned | S.O. 4536(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Levocetirizine + RanitidineFixed-dose combination · cough-cold | Banned | S.O. 4547(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Levocetirizine + Phenylephrine + Ambroxol + Guaifenesin + ParacetamolFixed-dose combination · cough-cold | Banned | S.O. 4548(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Codeine + Levocetirizine + MentholFixed-dose combination · cough-cold | Banned | S.O. 4563(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Levocetirizine + Montelukast + AcebrophyllineFixed-dose combination · cough-cold | Banned | S.O. 4573(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Nimesulide + Paracetamol + Levocetirizine + Phenylephrine + CaffeineFixed-dose combination · cough-cold | Banned | S.O. 4579(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Levocetirizine + Dextromethorphan + ZincFixed-dose combination · cough-cold | Banned | S.O. 4589(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Paracetamol + Phenylephrine + Levocetirizine + CaffeineFixed-dose combination · cough-cold | Banned | S.O. 4590(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Levocetirizine + Paracetamol + Phenylephrine + CaffeineFixed-dose combination · cough-cold | Banned | S.O. 4607(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Ketotifen + LevocetirizineFixed-dose combination · cough-cold | Banned | S.O. 4608(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Paracetamol + Levocetirizine + Phenylephrine + Zinc GluconateFixed-dose combination · cough-cold | Banned | S.O. 4609(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Ambroxol + Levocetirizine + Phenylephrine + Guaifenesin + MentholFixed-dose combination · cough-cold | Banned | S.O. 4613(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| N-Acetylcysteine + Ambroxol + Phenylephrine + LevocetirizineFixed-dose combination · cough-cold | Banned | S.O. 4628(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Calcium Gluconate + LevocetirizineFixed-dose combination · cough-cold | Banned | S.O. 4648(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Paracetamol + Levocetirizine + PseudoephedrineFixed-dose combination · cough-cold | Banned | S.O. 4649(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Levocetirizine + Ambroxol + Phenylephrine + ParacetamolFixed-dose combination · cough-cold | Banned | S.O. 4659(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Paracetamol + Phenylephrine + Levocetirizine + Sodium CitrateFixed-dose combination · cough-cold | Banned | S.O. 4688(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Nimesulide + LevocetirizineFixed-dose combination · cough-cold | Banned | S.O. 4702(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Nimesulide + LevocetirizineFixed-dose combination · cough-cold | Banned | S.O. 1851(E) | 8 June 2017 | Other orders | Five FDCs prohibited 08.06.2017 (S.O. 1851(E)-1855(E)); re-notified 07.09.2018 as S.O. 4702(E)-4706(E) after the SC-ordered DTAB review. Etodolac + Paracetamol (4706(E)) later quashed. |
| Dextromethorphan + Levocetirizine + Phenylephrine + ZincFixed-dose combination · cough-cold | Quashed | S.O. 859(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Nimesulide + Phenylephrine + Ceffeine + LevocetirizineFixed-dose combination · cough-cold | Quashed | S.O. 864(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Levocetirizine + Ambroxol + Phenylephrine + GuaifenesinFixed-dose combination · cough-cold | Quashed | S.O. 874(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Levocetirizine + RanitidineFixed-dose combination · cough-cold | Quashed | S.O. 885(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Levocetirizine + Phenylephrine + Ambroxol + Guaifenesin + ParacetamolFixed-dose combination · cough-cold | Quashed | S.O. 886(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Codeine + Levocetirizine + MentholFixed-dose combination · cough-cold | Quashed | S.O. 901(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Levocetirizine + Montelukast + AcebrophyllineFixed-dose combination · cough-cold | Quashed | S.O. 912(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Nimesulide + Paracetamol + Levocetirizine + Phenylephrine + CaffeineFixed-dose combination · cough-cold | Quashed | S.O. 918(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Levocetirizine + Dextromethorphan + ZincFixed-dose combination · cough-cold | Quashed | S.O. 931(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Paracetamol + Phenylephrine + Levocetirizine + CaffeineFixed-dose combination · cough-cold | Quashed | S.O. 932(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Levocetirizine + Paracetamol + Phenylephrine + CaffeineFixed-dose combination · cough-cold | Quashed | S.O. 949(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Ketotifen + LevocetirizineFixed-dose combination · cough-cold | Quashed | S.O. 951(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Paracetamol + Levocetirizine + Phenylephrine + Zinc GluconateFixed-dose combination · cough-cold | Quashed | S.O. 952(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Ambroxol + Levocetirizine + Phenylephrine + Guaifenesin + MentholFixed-dose combination · cough-cold | Quashed | S.O. 956(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| N-Acetylcysteine + Ambroxol + Phenylephrine + LevocetirizineFixed-dose combination · cough-cold | Quashed | S.O. 971(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Calcium Gluconate + LevocetirizineFixed-dose combination · cough-cold | Quashed | S.O. 994(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Paracetamol + Levocetirizine + PseudoephedrineFixed-dose combination · cough-cold | Quashed | S.O. 995(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Levocetirizine + Ambroxol + Phenylephrine + ParacetamolFixed-dose combination · cough-cold | Quashed | S.O. 1005(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Paracetamol + Phenylephrine + Levocetirizine + Sodium CitrateFixed-dose combination · cough-cold | Quashed | S.O. 1035(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
Products that failed lab tests
Product names as printed by the testing labs, grouped. Open a product to see every batch number.
Top 30 of 41 products by number of batches.
Most recent failed batches
| Product | Batch | Manufacturer | Reason declared NSQ | Tested by | Alert |
|---|---|---|---|---|---|
| Montelukast Sodium and Levocetirizine Hydrochloride Tablets IP | Batch FMT26015SLMfg Apr 2026 · Exp Mar 2028 | Shiva Biogenetic Laboratories Pvt. LtdHimachal Pradesh | The sample does not conform to IP in respect of DissolutionDissolution | LUCKNOW, Uttar PradeshState lab | Sep 2026 |
| Montelukast Sodium and Levocetirizine Hydrochloride Tablets | Batch ZDTY030Mfg Dec 2025 · Exp Nov 2027 | Pro-pharma Care Pvt. LtdUttarakhand | The sample dose not conform to I.P., in respect of Uniformity of content and DissolutionDissolution | LUCKNOW, Uttar PradeshState lab | Sep 2026 |
| Montelukast Sodium & Levocetirizine Hydrochloride Tablets IP | Batch T260356KMfg Mar 2026 · Exp Feb 2028 | Unispeed Pharmaceuticals Pvt. LtdHimachal Pradesh | The sample does not conform to IP in respect of DissolutionDissolution | LUCKNOW, Uttar PradeshState lab | Sep 2026 |
| Levocetirizine Tablets IP 5mg | Batch 0726A021Mfg Jan 2026 · Exp Dec 2027 | FDC LimitedGoa | The sample does not conform to IP in respect of DissolutionDissolution | LUCKNOW, Uttar PradeshState lab | Sep 2026 |
| Levocetirizine Hydrochloride, Ambroxol Hydrochlolride | Batch 26LK024Mfg Jan 2026 · Exp Jan 2028 | Kantil Pharmaceuticals Pvt. LtdHimachal Pradesh | The sample does not comply with the prescribed requirement for 'Description'Description | DTL, Dalgate Srinagar KashmirState lab | Sep 2026 |
| Levocetirizine Hydrochloride & Montelukast Sodium tablets IP | Batch UGT-25627LMfg May 2025 · Exp Apr 2027 | Ultra Drugs Pvt. LtdHimachal Pradesh | DescriptionDescription | DTL, Bengaluru, KarnatakaState lab | Sep 2026 |
| Levocetirizine Dihydrochloride 5mg Tablets IP | Batch MPR-251105Mfg Nov 2025 · Exp Oct 2027 | Preet Remedies LtdHimachal Pradesh | The sample is not of standard quality for the reason stated under "Description" of the tablets.Description | RDTL, GuwahatiCDSCO lab | Sep 2026 |
| Levocetirizine Dihydrochloride & Montelukast Tablets IP | Batch LGP12/303/37Mfg Dec 2025 · Exp Nov 2027 | Logos PharmaHimachal Pradesh | The sample does not conform to IP with respect to the DissolutionDissolution | SDTL, GuwahatiState lab | Sep 2026 |
| Montelukast sodium & Levocetirizine hydrochloride Tablets IP | Batch VRNT-933Mfg Mar 2025 · Exp Feb 2027 | Vrihaan Pharmaceuticals LLP | DissolutionDissolution | FDL, VadodaraState lab | Aug 2026 |
| Montelukast Sodium & Levocetirizine Hydrochloride Suspension | Batch DL508027Mfg Aug 2025 · Exp Jul 2027 | Renowed Life SciencesUttarakhand | Assay of Levocetirizine Hydrochloride.Assay | SFDTL, UttarakhandState lab | Aug 2026 |
| Montelukast & Levocetirizine Hydrochloride Syrup | Batch PTKLA004Mfg Nov 2025 · Exp Oct 2027 | Laborate Pharmaceuticals India Ltd (Unit-ii) 31Himachal Pradesh | Assay of Levocetirizine HydrochlorideAssay | SFDTL, UttarakhandState lab | Aug 2026 |
| Levocetirizine Hydrochloride and Montelukast Tablets | Batch 41046Mfg Nov 2025 · Exp Oct 2027 | Ronak Life Care Pvt. Ltd | The sample does not comply as per I.P. 2022 with respect to the test for Dissolution of Montelukast.Dissolution | RDTL, GuwahatiCDSCO lab | Aug 2026 |
| Levocetirizine Dihydrochloride,Montelukast Soidum & Ambroxol (SR) | Batch ITH002Mfg Aug 2025 · Exp Jul 2027 | Cis Life Care Pvt.Ltd.44-45 | The sample does not confom to IP 2022 requirements with respect to Uniformity of weightUniformity of weight/content | DTL,Dalgated Srinagar KashmirState lab | Aug 2026 |
| Levocetirizine Dihydrochloride Tablets I.P. | Batch B13225006Mfg Nov 2025 · Exp Oct 2027 | Torque Pharmaceuticals Pvt. Ltd | The sample does not conform to the I.P. with respect to Dissolution of Levocetirizine Dihydrochloride.Dissolution | DTL JodhpurState lab | Jul 2026 |
| Levocetirizine & Montelukast Sodium Dispersible tablets | Batch ABC04ABAMfg Dec 2025 · Exp Nov 2027 | Pure & Cure Healthcare Pvt. LtdUttarakhand | The sample does not conform to Label claim with respect to content of Montelukast in Montelukast sodium)Labelling | Drugs Testing Laboratory, Madurai-19State lab | Jul 2026 |
Showing 15 of 149 records
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