Ingredient record · Antihistamine for allergy
Cetirizine: 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
78 entries containing Cetirizine are on India's banned-drugs list, and 43 are banned today. 30 batches of medicines containing Cetirizine failed a government lab test between March 2019 and July 2026, from 26 manufacturers. A failed batch concerns that batch only, not the medicine or every brand.
43
Banned combinations in force
35
Other listed orders (stayed, restricted, quashed)
30
Batches failed a lab test
Jul 2026
Latest lab alert
Is it banned? Our answer pages
Not banned · two combos banned (2024)
Original formula banned (Aug 2024)
On the banned-drugs list
Cetirizine 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 |
|---|---|---|---|---|---|
| Cetirizine HCl + Paracetamol + Phenylephrine HClFixed-dose combination · cough-cold | Banned | S.O. 3385(E) | 2 August 2024 | 156 FDCs · Aug 2024 | Prohibited under s.26A; notifications dated 02.08.2024, gazetted 21-22 Aug 2024. |
| Cetirizine HCl + Phenylephrine HClFixed-dose combination · cough-cold | Banned | S.O. 3386(E) | 2 August 2024 | 156 FDCs · Aug 2024 | Prohibited under s.26A; notifications dated 02.08.2024, gazetted 21-22 Aug 2024. |
| Levo Cetirizine + Phenylephrine HClFixed-dose combination · cough-cold | Banned | S.O. 3387(E) | 2 August 2024 | 156 FDCs · Aug 2024 | Prohibited under s.26A; notifications dated 02.08.2024, gazetted 21-22 Aug 2024. |
| Levo Cetirizine + Phenylephrine HCl + ParacetamolFixed-dose combination · cough-cold | Banned | S.O. 3388(E) | 2 August 2024 | 156 FDCs · Aug 2024 | Prohibited under s.26A; notifications dated 02.08.2024, gazetted 21-22 Aug 2024. |
| Levo Cetirizine HCl + Ambroxol HCl + ParacetamolFixed-dose combination · cough-cold | Banned | S.O. 3390(E) | 2 August 2024 | 156 FDCs · Aug 2024 | Prohibited under s.26A; notifications dated 02.08.2024, gazetted 21-22 Aug 2024. |
| Levo Cetirizine HCl + Ambroxol HCl + Phenylephrine HClFixed-dose combination · cough-cold | Banned | S.O. 3391(E) | 2 August 2024 | 156 FDCs · Aug 2024 | Prohibited under s.26A; notifications dated 02.08.2024, gazetted 21-22 Aug 2024. |
| Cetirizine HCl + Terbutaline Sulphate + Ambroxol HCl + GuaifenesinFixed-dose combination · cough-cold | Banned | S.O. 3400(E) | 2 August 2024 | 156 FDCs · Aug 2024 | Prohibited under s.26A; notifications dated 02.08.2024, gazetted 21-22 Aug 2024. |
| Nimesulide + Pseudoephedrine + CetirizineFixed-dose combination · cough-cold | Banned | S.O. 256(E) | 11 January 2019 | Other orders | One of 80 FDCs prohibited vide S.O. 180(E)-259(E) dated 11.01.2019 (CDSCO letter 22.01.2019). In force per CDSCO list as on 22.11.2021. |
| Nimesulide + Cetirizine + CaffeineFixed-dose combination · painkillers | Banned | S.O. 4381(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Paracetamol + Cetirizine + CaffeineFixed-dose combination · painkillers | Banned | S.O. 4383(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Paracetamol + Pseudoephedrine + CetirizineFixed-dose combination · cough-cold | Banned | S.O. 4398(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Cetirizine + Diethyl CarbamazineFixed-dose combination · antibiotics | Banned | S.O. 4459(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Nimesulide + Paracetamol + Cetirizine + PhenylephrineFixed-dose combination · cough-cold | Banned | S.O. 4530(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Cetirizine + Phenylephrine + Paracetamol + Zinc GluconateFixed-dose combination · cough-cold | Banned | S.O. 4533(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Cetirizine + Ambroxol + Guaifenesin + Ammonium Chloride + Phenylephrine + MentholFixed-dose combination · cough-cold | Banned | S.O. 4538(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Cetirizine + Dextromethorphan + Phenylephrine + Zinc Gluconate + Paracetamol + MentholFixed-dose combination · cough-cold | Banned | S.O. 4549(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Paracetamol + Pseudoephedrine + Dextromethorphan + CetirizineFixed-dose combination · cough-cold | Banned | S.O. 4550(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Diethylcabamazine Citrate + Cetirizine + GuaifenesinFixed-dose combination · cough-cold | Banned | S.O. 4554(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Pseudoephedrine + Dextromethorphan + CetirizineFixed-dose combination · cough-cold | Banned | S.O. 4555(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Cetirizine + Phenylephrine + Dextromethorphan + MentholFixed-dose combination · cough-cold | Banned | S.O. 4565(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Cetirizine + Paracetamol (Acetaminophen) + Dextromethorphan + Phenylephrine + Zinc GluconateFixed-dose combination · cough-cold | Banned | S.O. 4569(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Cetirizine + Dextromethorphan + Zinc Gluconate + MentholFixed-dose combination · cough-cold | Banned | S.O. 4571(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Dextromethorphan + CetirizineFixed-dose combination · cough-cold | Banned | S.O. 4578(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Diethylcarbamazine + Cetirizine + AmbroxolFixed-dose combination · cough-cold | Banned | S.O. 4583(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Cetirizine + Dextromethorphan + AmbroxolFixed-dose combination · cough-cold | Banned | S.O. 4585(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Dextromethorphan + Phenylephrine + Cetirizine + Paracetamol + CaffeineFixed-dose combination · cough-cold | Banned | S.O. 4588(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Cetirizine + Dextromethorphan + Bromhexine + GuaifenesinFixed-dose combination · cough-cold | Banned | S.O. 4595(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Ketotifen + CetirizineFixed-dose combination · cough-cold | Banned | S.O. 4597(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Cetirizine + Nimesulide + PhenylephrineFixed-dose combination · cough-cold | Banned | S.O. 4601(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Cetirizine + Dextromethorphan + Phenylephrine + TulsiFixed-dose combination · cough-cold | Banned | S.O. 4604(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Cetirizine + Phenylephrine + Paracetamol + Ambroxol + CaffeineFixed-dose combination · cough-cold | Banned | S.O. 4605(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Caffeine + Paracetamol + Phenylephrine + CetirizineFixed-dose combination · cough-cold | Banned | S.O. 4611(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Pseudoephedrine + CetirizineFixed-dose combination · cough-cold | Banned | S.O. 4614(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Ammonium Chloride + Dextromethorphan + Cetirizine + MentholFixed-dose combination · cough-cold | Banned | S.O. 4621(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Dextromethorphan + Paracetamol + Cetirizine + PhenylephrineFixed-dose combination · cough-cold | Banned | S.O. 4622(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Paracetamol + Pseudoephedrine + Cetirizine + CaffeineFixed-dose combination · cough-cold | Banned | S.O. 4626(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Salbutamol + Cetirizine + AmbroxolFixed-dose combination · cough-cold | Banned | S.O. 4630(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Nimesulide + Cetirizine + PhenylephrineFixed-dose combination · cough-cold | Banned | S.O. 4632(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Dextromethorphan + Phenylephrine + Guaifenesin + Cetirizine + Paracetamol (Acetaminophen)Fixed-dose combination · cough-cold | Banned | S.O. 4634(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Cetirizine + Phenylephrine + Paracetamol + Caffeine + NimesulideFixed-dose combination · painkillers | Banned | S.O. 4639(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Dextromethorphan + Cetirizine + Guaifenesin + Ammonium ChlorideFixed-dose combination · cough-cold | Banned | S.O. 4640(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Bromhexine + Cetirizine + Phenylephrine + Guaifenesin + MentholFixed-dose combination · cough-cold | Banned | S.O. 4644(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Dextromethorphan + Phenylephrine + Cetirizine + Zinc + MentholFixed-dose combination · cough-cold | Banned | S.O. 4646(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Nimesulide + Cetirizine + CaffeineFixed-dose combination · painkillers | Quashed | S.O. 707(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Paracetamol + Cetirizine + CaffeineFixed-dose combination · painkillers | Quashed | S.O. 709(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Paracetamol + Pseudoephedrine + CetirizineFixed-dose combination · cough-cold | Quashed | S.O. 726(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Cetirizine Dihydrochloride + Diethyl CarbamazineFixed-dose combination · antibiotics | Quashed | S.O. 792(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Nimesulide + Paracetamol + Cetirizine + PhenylephrineFixed-dose combination · cough-cold | Quashed | S.O. 867(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Cetirizine + Phenylephrine + Paracetamol + Zinc GluconateFixed-dose combination · cough-cold | Quashed | S.O. 871(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Cetirizine + Ambroxol + Guaifenesin + Ammonium Chloride + Phenylephrine + MentholFixed-dose combination · cough-cold | Quashed | S.O. 876(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Cetirizine + Dextromethorphan + Phenylephrine + Zinc Gluconate + Paracetamol + MentholFixed-dose combination · cough-cold | Quashed | S.O. 887(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Paracetamol + Pseudoephedrine + Dextromethorphan + CetirizineFixed-dose combination · cough-cold | Quashed | S.O. 888(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Diethylcabamazine + Cetirizine + GuaifenesinFixed-dose combination · cough-cold | Quashed | S.O. 892(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Pseudoephedrine + Dextromethorphan + CetirizineFixed-dose combination · cough-cold | Quashed | S.O. 893(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Cetirizine + Phenylephrine + Dextromethorphan + MentholFixed-dose combination · cough-cold | Quashed | S.O. 903(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Cetirizine + Paracetamol (Acetaminophen) + Dextromethorphan + Phenylephrine + Zinc GluconateFixed-dose combination · cough-cold | Quashed | S.O. 907(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Cetirizine + Dextromethorphan + Zinc Gluconate + MentholFixed-dose combination · cough-cold | Quashed | S.O. 910(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Dextromethorphan + CetirizineFixed-dose combination · cough-cold | Quashed | S.O. 917(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Diethylcarbamazine + Cetirizine + AmbroxolFixed-dose combination · cough-cold | Quashed | S.O. 923(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Cetirizine + Dextromethorphan + AmbroxolFixed-dose combination · cough-cold | Quashed | S.O. 925(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
Showing the 60 most recent of 78. The full list and CSV have the rest.
Products that failed lab tests
Product names as printed by the testing labs, grouped. Open a product to see every batch number.
| Product | Batches | Makers | Latest |
|---|---|---|---|
| Cetirizine | 8 | 5 | Jun 2026 |
| Cetirizine Hydrochloride | 3 | 3 | Apr 2026 |
| Cetirizine Dihydrochloride | 2 | 2 | Jan 2026 |
| Dextromethorphan Hydrobromide Phenylephrine Hydrochloride Cetirizine | 2 | 2 | Jan 2026 |
| Paracetamol Phenylephrine Hydrochloride Cetirizine | 2 | 2 | Aug 2024 |
| Paracetamol Phenylephrine Hcl Guaiphenesin Cetirizine Hydrochloride Ambroxol | 1 | 1 | Jul 2026 |
| Aceclofenac Paracetamol Phenylephrine Hcl Cetirizine Caffeine | 1 | 1 | May 2026 |
| Dextromethorphan Hydrobromide Cetirizine Dihydrochloride Ambroxol Hydrochloride Methol | 1 | 1 | May 2026 |
| Ambroxol Hydrochloride Guaiphenesin Terbutaline Sulphate Cetirizine Menthol | 1 | 1 | Feb 2026 |
| Cetirizine Chydrochloride | 1 | 1 | Jan 2026 |
| Dextromethorphan Hydrobromide Cetirizine Dihydrochloride Zinc Ammonium Chloride | 1 | 1 | Jan 2026 |
| Curacet | 1 | 1 | Jun 2025 |
| Merocet | 1 | 1 | Apr 2025 |
| Paracetamol Phenylephrine Hcl Cetrizine | 1 | 1 | Apr 2025 |
| Paracetamo L Cetirizine Hydrochlori De Phenylephri Ne | 1 | 1 | Jan 2025 |
| Warcetiz | 1 | 1 | Sep 2022 |
| Mdzime | 1 | 1 | Nov 2019 |
| Cetfast | 1 | 1 | Sep 2019 |
Most recent failed batches
| Product | Batch | Manufacturer | Reason declared NSQ | Tested by | Alert |
|---|---|---|---|---|---|
| Paracetamol, Phenylephrine HCL, Guaiphenesin, Cetirizine Hydrochloride & Ambroxol HCL Tablets | SBT-3351Mfg 2025-07 · Exp 2027-06 | Supercure Biotech Pvt. LtdHaryana | The sample is found to be Not of Standard Quality for the reason stated under Description.Description | CDL, KolkataCDSCO lab | Jul 2026 |
| Cetirizine Syrup IP | CIZ-2604Mfg 2026-03 · Exp 2028-02 | Apple Formulations Pvt. LtdUttarakhand | pHpH | SDTL, PunjabState lab | Jun 2026 |
| Dextromethorphan Hydrobromide, Cetirizine Dihydrochloride, Ambroxol Hydrochloride & Methol Syrup | DLS5271Mfg 2025-08 · Exp 2027-07 | Dhwanilife Care Pvt LtdGujarat | Ambroxol Hydrochloride contentOther | FDL, VadodaraState lab | May 2026 |
| Aceclofenac, Paracetamol, Phenylephrine Hcl Cetirizine Hcl & Caffeine | GT-25294AMfg 2025-08 · Exp 2028-07 | Not applicable | MisbrandadMisbranded | SDTL, ChhattisgarhState lab | May 2026 |
| Cetirizine Hydrochloride Tablets I.P. 10mg | LPT2425300Mfg 2025-02 · Exp 2027-01 | Lannett Pharmaceuticals Pvt. Ltd | DescriptionDescription | DTL, Bengaluru, KarnatakaState lab | Apr 2026 |
| Ambroxol Hydrochloride, Guaiphenesin, Terbutaline Sulphate, Cetirizine Hydrochloride and Menthol Syrup | HLAC25001Mfg 2025-11 · Exp 2027-10 | Health Biotech LtdHimachal Pradesh | The sample does not conform to claim as per Patent and Proprietary in respect to the Assay of Ambroxol HydrochlorideAssay | RDTL, ChandigarhCDSCO lab | Feb 2026 |
| Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride & Cetirizine Hydrochloride Syrup | L-25154Mfg 2025-09 · Exp 2027-08 | Apco Pharma LtdUttarakhand | The sample does not conform to Manufacturers specification with respect to test for Assay of Phenylephrine Hydrochloride.Assay | CDTL, MumbaiCDSCO lab | Jan 2026 |
| Dextromethorphan Hydrobromide, Cetirizine Dihydrochloride, Zinc and Ammonium Chloride Syrup | LC-2505Mfg 2025-06 · Exp 2027-05 | Frontline Pharmaceuticals Pvt. LtdMaharashtra | The sample received does not conform to I.P. 2022 with respect to the test for Assay for Cetrizine Dihydrochloride.Assay | CDTL, MumbaiCDSCO lab | Jan 2026 |
| Cetirizine Dihydrochloride Tablets IP 10 mg | CTT-2416Mfg 2024-10 · Exp 2027-01 | Suprex laboratories 11/CMadhya Pradesh | DescriptionDescription | DCL, TelanganaState lab | Jan 2026 |
| Cetirizine Chydrochloride Syrup IP | MGMP 0898Mfg 2025-11 · Exp 2027-04 | Thorab Pharma and Research LaboratoryPuducherry | Failed pHpH | DTL, PuducherryState lab | Jan 2026 |
| Cetirizine Hydrochloride, Phenylephrine Hydrochloride and Dextromethorphan Hydrobromide Syrup | R25053101Mfg 2025-02 · Exp 2027-01 | Shreya Lifesciences Pvt. Ltd. 13Uttarakhand | The sample does not conform as per I.P. 2022 with respect to the test for Diethylene Glycol (DEG).Other | RDTL, GuwahatiCDSCO lab | Nov 2025 |
| Cetirizine Hydrochloride Tablets, I.P. | LPT2425300Mfg 2025-02 · Exp 2027-01 | Lannett Pharmaceuticals Hydrochloride Pvt.LtdUttarakhand | DescriptionDescription | DCL, TelanganaState lab | Sep 2025 |
| Curacet Tablets (Cetirizine Hydrochloride) | CHT23320Mfg 2023-10 · Exp 2025-09 | Cureza Healthcare pvt. Ltd. A.B.Road Girwai | Almost all the tablets received for analysis show Grey coloured spots all over the surface of the tablet, when observed in normal day light with unaided eyes.Description | FDA Lab , MumbaiCDSCO lab | Jun 2025 |
| Paracetamol, Phenylephrine HCL & Cetrizine HCL Suspension | OKOL-009Mfg 2024-07 · Exp 2026-06 | Laborate Pharmaceuticals India Ltd | The sample does not conform to claim as per Patent and Proprietary in respect of the assay of Phenylephrine Hydrochloride.Assay | DTL BaddiState lab | Apr 2025 |
| Merocet (Cetirizine Hydrochloride Syrup) | 1124192Mfg 2024-11 · Exp 2026-10 | Kite Formulation | Sample does not conform to IP specification with respect to the PH.pH | DTL MaduraiState lab | Apr 2025 |
Showing 15 of 30 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.