Ingredient record · Antihistamine for allergy

Cetirizine: 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

78 entries containing Cetirizine are on India's banned-drugs list, and 43 are banned today. 31 batches of medicines containing Cetirizine failed a government lab test between March 2019 and September 2026, from 27 manufacturers. A failed batch concerns that batch only, not the medicine or every brand.

Not banned Is Cetirizine banned in India? Cetirizine legal · 39 combinations prohibited. Read the full status record

43
Banned combinations in force
35
Other listed orders (stayed, restricted, quashed)
31
Batches failed a lab test
Sep 2026
Latest lab alert

Is it banned? Our answer pages

Original formula banned (Aug 2024)
Cetirizine legal · 39 combinations prohibited

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 / combinationActionNotificationDateOrderStatus 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.

Most recent failed batches

Product Batch Manufacturer Reason declared NSQ Tested by Alert
Cetirizine Hydrocloride and Ambroxol Hydrochloride Syrup Batch P0126002LMfg Jan 2026 · Exp Dec 2027 Pharma Roots HealthcareHimachal Pradesh content - Ambroxol HydrochlorideOther Drug Testing Laboratory, Madurai-19State lab Sep 2026
Paracetamol, Phenylephrine HCL, Guaiphenesin, Cetirizine Hydrochloride & Ambroxol HCL Tablets Batch SBT-3351Mfg Jul 2025 · Exp Jun 2027 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 Batch CIZ-2604Mfg Mar 2026 · Exp Feb 2028 Apple Formulations Pvt. LtdUttarakhand pHpH SDTL, PunjabState lab Jun 2026
Dextromethorphan Hydrobromide, Cetirizine Dihydrochloride, Ambroxol Hydrochloride & Methol Syrup Batch DLS5271Mfg Aug 2025 · Exp Jul 2027 Dhwanilife Care Pvt LtdGujarat Ambroxol Hydrochloride contentOther FDL, VadodaraState lab May 2026
Aceclofenac, Paracetamol, Phenylephrine Hcl Cetirizine Hcl & Caffeine Batch GT-25294AMfg Aug 2025 · Exp Jul 2028 Not applicable MisbrandadMisbranded SDTL, ChhattisgarhState lab May 2026
Cetirizine Hydrochloride Tablets I.P. 10mg Batch LPT2425300Mfg Feb 2025 · Exp Jan 2027 Lannett Pharmaceuticals Pvt. Ltd DescriptionDescription DTL, Bengaluru, KarnatakaState lab Apr 2026
Ambroxol Hydrochloride, Guaiphenesin, Terbutaline Sulphate, Cetirizine Hydrochloride and Menthol Syrup Batch HLAC25001Mfg Nov 2025 · Exp Oct 2027 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 Batch L-25154Mfg Sep 2025 · Exp Aug 2027 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 Batch LC-2505Mfg Jun 2025 · Exp May 2027 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 Batch CTT-2416Mfg Oct 2024 · Exp Jan 2027 Suprex laboratories 11/CMadhya Pradesh DescriptionDescription DCL, TelanganaState lab Jan 2026
Cetirizine Chydrochloride Syrup IP Batch MGMP 0898Mfg Nov 2025 · Exp Apr 2027 Thorab Pharma and Research LaboratoryPuducherry Failed pHpH DTL, PuducherryState lab Jan 2026
Cetirizine Hydrochloride, Phenylephrine Hydrochloride and Dextromethorphan Hydrobromide Syrup Batch R25053101Mfg Feb 2025 · Exp Jan 2027 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. Batch LPT2425300Mfg Feb 2025 · Exp Jan 2027 Lannett Pharmaceuticals Hydrochloride Pvt.LtdUttarakhand DescriptionDescription DCL, TelanganaState lab Sep 2025
Curacet Tablets (Cetirizine Hydrochloride) Batch CHT23320Mfg Oct 2023 · Exp Sep 2025 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 Batch OKOL-009Mfg Jul 2024 · Exp Jun 2026 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
Showing 15 of 31 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.