Ingredient record · Antihistamine for allergy
Levocetirizine: bans, restrictions and failed batches in India
Last checked 20 September 2026. Sources: CDSCO banned-drugs notifications and monthly NSQ alerts, Jan 2019 to Jul 2026
42 entries containing Levocetirizine are on India's banned-drugs list, and 23 are banned today. 136 batches of medicines containing Levocetirizine failed a government lab test between January 2019 and July 2026, from 98 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)
136
Batches failed a lab test
Jul 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 39 products by number of batches.
Most recent failed batches
| Product | Batch | Manufacturer | Reason declared NSQ | Tested by | Alert |
|---|---|---|---|---|---|
| Levocetirizine Dihydrochloride Tablets I.P. | B13225006Mfg 2025-11 · Exp 2027-10 | 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 | ABC04ABAMfg 2025-12 · Exp 2027-11 | 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 |
| Levocetirizine HCl & Montelukast Sodium Syrup. | SL-151Mfg 2025-06 · Exp 2027-05 | Shivam Enterprises (Pharma Division)Himachal Pradesh | Assay Of Montelukast Sodium I.P. ? Less than prescribed limit.Assay | SDFTL US Nagar,UKState lab | Jun 2026 |
| Levocetirizine Dihydrochloride Tablets IP 5mg | PRT2501-149Mfg 2025-01 · Exp 2026-12 | Regent Ajanta BiotechUttarakhand | The sample does not conform to standard quality in respect of the test for Description performed.Description | SDTL, Tripura, AgartalaState lab | Jun 2026 |
| Levocetirizine Tablets IP | PGT25-2392GMfg 2025-09 · Exp 2027-08 | Plena RemediesHimachal Pradesh | The sample does not conforms to the IP with respect to Assay of Levocetirizine Hydrochloride.Assay | DTL JaipurState lab | May 2026 |
| Levocetirizine Hydrochloride & Montelukast Syrup | JLH2523Mfg 2025-08 · Exp 2027-07 | Janveda Healthceuticals Pvt. LtdGujarat | Content of Levocetirizine Hydrochloride & MontelukastOther | FDL, VadodaraState lab | May 2026 |
| Levocetirizine Dihydrochloride Syrup | 1C0149Mfg 2026-03 · Exp 2028-02 | Deep PharmaGujarat | The sample does not conform to Manufacturers specification with respect to the test of Microbial contamination (Total aerobic viable count).Microbial limits | CDTL, MumbaiCDSCO lab | May 2026 |
| Montelukast Sodium and Levocetirizine Dihydrochloride Syrup | SP25990Mfg 2025-10 · Exp 2027-09 | Seejar Pharmaceuticalls | Assay for MontelukastAssay | DTL, Bengaluru, KarnatakaState lab | Apr 2026 |
| Levocetirizine Hydrochloride and Montelukast Sodium Tablets IP (5 mg/10 mg) | 310225017Mfg 2025-05 · Exp 2027-04 | Ravenbhel Healthcare Pvt. LtdJammu & Kashmir | DescriptionDescription | DTL, Bengaluru, KarnatakaState lab | Apr 2026 |
| Paracetamol, Levocetirizine Hydrochloride & Phenyleprine Hydrochloride Tablets | AMT-0309Mfg 2024-04 · Exp 2026-03 | Avalon Medicines Pvt. LtdHaryana | DescriptionDescription | DTL, Bengaluru, KarnatakaState lab | Mar 2026 |
| Levocetirizine Dihydrochloride and Montelukast Syrup | LR25J006Mfg 2025-10 · Exp 2027-09 | Rhombus Pharma Pvt. LtdGujarat | The sample received does not conform to I.P. 2022 with respect to the test for pHpH | CDTL, MumbaiCDSCO lab | Mar 2026 |
| Levocetirizine Dihydrochloride Tablets I.P | ATGI4259Mfg 2024-09 · Exp 2026-08 | Actinova Pvt. LtdHimachal Pradesh | Content of Levocetirizine DihydrochlorideOther | SDTL, PunjabState lab | Mar 2026 |
| Montelukast & Levocetirizine Dihydrochloride | E9AIY029Mfg 2025-08 · Exp 2027-07 | Pharma Force Lab (Unit-II)Himachal Pradesh | Assay of Montelukast Sodium IP & Levocetirizine Dihydrochloride IPAssay | FDTL,UttarakhandState lab | Feb 2026 |
| Levocetirizine Tablets IP 5 mg | R25021Mfg 2025-01 · Exp 2026-12 | Ripcord Pharmaceuticals Pvt. LtdMaharashtra | Failed DescriptionDescription | DTL, PuducherryState lab | Feb 2026 |
| Levocetirizine Hydrochloride and Montelukast Sodium Tablets IP | UGT-25293LMfg 2025-03 · Exp 2027-02 | Ultra Drugs Pvt. LtdHimachal Pradesh | The sample does not conform to I.P.w.r.t. the test for DissolutionDissolution | SDTL, AssamState lab | Feb 2026 |
Showing 15 of 136 records
Holding a strip or bottle? The batch number is printed after "B. No." Check it against every alert. If it matches, return it to the pharmacy. What the labels mean: status guide.