Ingredient record · Mucus thinner for cough
Ambroxol: 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
62 entries containing Ambroxol are on India's banned-drugs list, and 35 are banned today. 163 batches of medicines containing Ambroxol failed a government lab test between January 2019 and July 2026, from 132 manufacturers. A failed batch concerns that batch only, not the medicine or every brand.
35
Banned combinations in force
27
Other listed orders (stayed, restricted, quashed)
163
Batches failed a lab test
Jul 2026
Latest lab alert
Is it banned? Our answer pages
Not banned (LS/D) · old formulas banned
Not banned · two combos banned (2024)
Not banned · some combos banned (2024)
On the banned-drugs list
Ambroxol 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 |
|---|---|---|---|---|---|
| Ambroxol Hydrochloride 20mg + Dextromethorphan Hydrobromide 10mg + Chlorpheniramine Maleate 2mg per 5ml SyrupFixed-dose combination · cough-cold | Halted | CDSCO F.No. 4-01/2023-DC (Misc. 3) dated 11.04.2025, Annexure Sr. 33 | 11 April 2025 | 35 FDCs · Apr 2025 | CDSCO direction to state licensing authorities, 11 Apr 2025, not a Section 26A gazette ban |
| 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. |
| Ambroxol HCl + Phenylephrine HCl + GuaifenesinFixed-dose combination · cough-cold | Banned | S.O. 3394(E) | 2 August 2024 | 156 FDCs · Aug 2024 | Prohibited under s.26A; notifications dated 02.08.2024, gazetted 21-22 Aug 2024. |
| Etofylline + Theophylline Anhydrous eq. to Theophylline Hydrate + Ambroxol HClFixed-dose combination · cough-cold | Banned | S.O. 3396(E) | 2 August 2024 | 156 FDCs · Aug 2024 | Prohibited under s.26A; notifications dated 02.08.2024, gazetted 21-22 Aug 2024. |
| Ambroxol HCl + Terbutaline Sulphate + Ammonium Chloride + Guaifenesin + MentholFixed-dose combination · cough-cold | Banned | S.O. 3398(E) | 2 August 2024 | 156 FDCs · Aug 2024 | Prohibited under s.26A; notifications dated 02.08.2024, gazetted 21-22 Aug 2024. |
| Ambroxol HCl + Salbutamol Sulphate + Ammonium Chloride + Guaifenesin + MentholFixed-dose combination · cough-cold | Banned | S.O. 3399(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. |
| Azithromycin + AmbroxolFixed-dose combination · antibiotics | Banned | S.O. 4449(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Nimesulide + Loratadine + Phenylephrine + AmbroxolFixed-dose combination · cough-cold | Banned | S.O. 4523(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Ambroxol + Guaifenesin + Ammonium Chloride + Phenylephrine + Chlorpheniramine Maleate + MentholFixed-dose combination · cough-cold | Banned | S.O. 4534(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 |
| 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 |
| 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 |
| Ambroxol + Terbutaline + DextromethorphanFixed-dose combination · cough-cold | Banned | S.O. 4557(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Dextromethorphan + Ambroxol + Guaifenesin + Phenylephrine + ChlorpheniramineFixed-dose combination · cough-cold | Banned | S.O. 4564(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Paracetamol (Acetaminophen) + Loratadine + Ambroxol + PhenylephrineFixed-dose combination · cough-cold | Banned | S.O. 4568(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Paracetamol + Phenylephrine + Desloratadine + Zinc Gluconate + AmbroxolFixed-dose combination · cough-cold | Banned | S.O. 4572(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Terbutaline + Ambroxol + Guaifenesin + Zinc + MentholFixed-dose combination · cough-cold | Banned | S.O. 4580(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 |
| Ambroxol + Guaifenesin + Phenylephrine + ChlorpheniramineFixed-dose combination · cough-cold | Banned | S.O. 4586(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Ambroxol + Salbutamol + TheophyllineFixed-dose combination · cough-cold | Banned | S.O. 4600(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 |
| 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 |
| Terbutaline Sulphate + Etofylline + AmbroxolFixed-dose combination · cough-cold | Banned | S.O. 4624(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 |
| 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 |
| Salbutamol + Choline Theophylinate + AmbroxolFixed-dose combination · cough-cold | Banned | S.O. 4637(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Ambroxol + Salbutamol + Choline Theophyllinate + MentholFixed-dose combination · cough-cold | Banned | S.O. 4641(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Paracetamol + Chlorpheniramine + Ambroxol + Guaifenesin + PhenylephrineFixed-dose combination · cough-cold | Banned | S.O. 4642(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Dextromethorphan + Ambroxol + Ammonium Chloride + Chlorpheniramine + MentholFixed-dose combination · cough-cold | Banned | S.O. 4645(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 + Ambroxol + Phenylephrine + ChlorpheniramineFixed-dose combination · cough-cold | Banned | S.O. 4683(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Gemifloxacin + AmbroxolFixed-dose combination · antibiotics | Banned | S.O. 4704(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Gemifloxacin + AmbroxolFixed-dose combination · antibiotics | Banned | S.O. 1853(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. |
| Azithromycin + AmbroxolFixed-dose combination · antibiotics | Quashed | S.O. 781(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Nimesulide + Loratadine + Phenylephrine + AmbroxolFixed-dose combination · cough-cold | Quashed | S.O. 860(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Ambroxol + Guaifenesin + Ammonium Chloride + Phenylephrine + Chlorpheniramine Maleate + MentholFixed-dose combination · cough-cold | Quashed | S.O. 872(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 |
| 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 |
| 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 |
| Ambroxol + Terbutaline + DextromethorphanFixed-dose combination · cough-cold | Quashed | S.O. 895(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Dextromethorphan + Ambroxol + Guaifenesin + Phenylephrine + ChlorpheniramineFixed-dose combination · cough-cold | Quashed | S.O. 902(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Paracetamol (Acetaminophen) + Loratadine + Ambroxol + PhenylephrineFixed-dose combination · cough-cold | Quashed | S.O. 906(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Paracetamol + Phenylephrine + Desloratadine + Zinc Gluconate + AmbroxolFixed-dose combination · cough-cold | Quashed | S.O. 911(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Terbutaline + Ambroxol + Guaifenesin + Zinc + MentholFixed-dose combination · cough-cold | Quashed | S.O. 919(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 |
| Ambroxol + Guaifenesin + Phenylephrine + ChlorpheniramineFixed-dose combination · cough-cold | Quashed | S.O. 927(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Ambroxol + Salbutamol + TheophyllineFixed-dose combination · cough-cold | Quashed | S.O. 942(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Cetirizine + Phenylephrine + Paracetamol + Ambroxol + CaffeineFixed-dose combination · cough-cold | Quashed | S.O. 947(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 |
| Terbutalinesulphate + Etofylline + AmbroxolFixed-dose combination · cough-cold | Quashed | S.O. 967(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 |
| Salbutamol + Cetirizine + AmbroxolFixed-dose combination · cough-cold | Quashed | S.O. 973(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Salbutamol + Choline Theophylinate + AmbroxolFixed-dose combination · cough-cold | Quashed | S.O. 982(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Ambroxol + Salbutamol + Choline Theophyllinate + MentholFixed-dose combination · cough-cold | Quashed | S.O. 987(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Paracetamol + Chlorpheniramine + Ambroxol + Guaifenesin + PhenylephrineFixed-dose combination · cough-cold | Quashed | S.O. 988(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Dextromethorphan + Ambroxol + Ammonium Chloride + Chlorpheniramine + MentholFixed-dose combination · cough-cold | Quashed | S.O. 991(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 62. 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.
Top 30 of 69 products by number of batches.
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 |
| Celltus-B (Ambroxol Hydrochloride, Terbutaline Sulphate, Guaiphenesin & Menthol Syrup) | CLAM-2525Mfg 2025-12 · Exp 2027-11 | Comex Pharma | 01. ASSAY OF TERBUTALINE SULPHATE I.P. ?Less than prescribed limit.Assay | SFDTL UttarakhandState lab | Jul 2026 |
| Ambroxol Hydrochloride, Terbutaline Sulphate, Guiaphenesin & Menthol Syrup | FMX-030/26Mfg 2026-03 · Exp 2028-02 | Finemax Formulation Pvt. LtdTamil Nadu | The sample does not conform to label claim with respect to the content of Ambroxol Hydrochloride and Terbutaline Sulphate.Labelling | Drugs Testing Laboratory, Chennai-06State lab | Jul 2026 |
| Ambroxol Hydrochloride, Terbutaline Sulphate, Guaiphenesin & Menthol Syrup | BGL250945Mfg 2025-09 · Exp 2027-08 | Bestcare Formulation PvtPuducherry | Content of Ambroxol Hydrochloride(75.7%) and Terbutaline Sulphate (85.6%)Other | Drugs Testing Laboratory, Chennai-06State lab | Jul 2026 |
| Terbutaline Sulphate, Ambroxol Hydrochloride, Guaiphenesin & Menthol Expectorant | JLI2586Mfg 2025-09 · Exp 2027-08 | Janveda Healthceutical Pvt. LtdGujarat | Ambroxol Hydrochloride contentOther | FDL, VadodaraState lab | Jun 2026 |
| Levosalbutamol Sulphate, Ambroxol HCl & Guaiphenesin Syrup 60 ml | SD-1376CMfg 2025-07 · Exp 2027-06 | Sano-Cito Therapeutics IncHimachal Pradesh | The sample does not conform to claim as per Schedule V of Drugs and Cosmetic Acts and Rules 1945 with respect to Assay/content of Levosalbutamol sulphate Equivalent to Levosalbutamol.Assay | CDL KolkataCDSCO lab | Jun 2026 |
| Levosalbutamol Sulphate Ambroxol Hydrochloride and Guaiphenesin Expectorant. | 18253692AMfg 2025-09 · Exp 2027-08 | Macleods Pharmaceuticals LtdSikkim | Description as per Schedule V of Drugs and Cosmetics act 1940 & Rules 1945 thereunder.Description | DTL, Bengaluru, KarnatakaState lab | Jun 2026 |
| Ambroxol Hydrochloride, Terbutaline, Guaiphenesin & Menthol Syrup | KL08501Mfg 2025-03 · Exp 2027-02 | Kinesis Laboratories Pvt.LtdHimachal Pradesh | ContentOther | DTL, Chennai-06State lab | Jun 2026 |
| Ambroxol Hydrochloride Terbutaline Sulphate Guaiphenesin & Menthol Syrup | RG-043Mfg 2025-08 · Exp 2027-07 | Redner FormulationsPuducherry | ContentOther | DTL, Madurai-19State lab | Jun 2026 |
| Terbutaline Sulphate, Ambroxol Hydrochloride, Guaiphenesin and Menthol Syrup | SPL-1934Mfg 2025-11 · Exp 2027-10 | Sheen Pharmaceuticals Wariana Industrial Complex Jal. P.b. 144021 | The Sample does not confirm to claim as Patient & Propritary in respect to the Assay of MentholAssay | DTL , BaddiState lab | May 2026 |
| Dextromethorphan Hydrobromide,Ambroxol Hydrochloride,Chlorpheniramine Maleate , Phenylephrine Hydrochloride & Menthol Syrup | CLRA4004Mfg 2024-12 · Exp 2026-11 | Crest Lifesciences Pvt. LtdHimachal Pradesh | The sample does not conform to claim with respect to Assay of Phenylephrine Hydrochloride, Ambroxol Hydrochloride and MentholAssay | CDL, KolkataCDSCO lab | May 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 |
| Ambroxol, Terbutaline Guaiphenesin with Menthol Syrup | AL24-0611AMfg 2024-12 · Exp 2026-11 | Aspo Pharmaceuticals LLPHimachal Pradesh | The sample does not conform to Manufacturer's Specification with respect to Assay of Ambroxol Hydrochloride, Guaiphenesin, and Terbutaline SulphateAssay | CDL, KolkataCDSCO lab | May 2026 |
| Ambroxol Hydrochloride, Levosalbutamol Sulphate & Guaiphenesin Syrup | AGL1143Mfg 2026-03 · Exp 2027-02 | Revive Formulation India Pvt. Ltd. R.S.NoTamil Nadu | ContentOther | DTL, Chennai-06State lab | May 2026 |
| Terbutaline Sulphate, Ambroxol Hydrochloride Guaiphenesin & Menthol Syrup, | OL25629Mfg 2025-09 · Exp 2027-08 | Saintlife Pharmaceuticals Ltd AN ISO-9001 2015/QMS Cert.Co WHO & GMP Certified CompanyUttarakhand | The sample received does not conform to manufacturers specification with respect to the Description only.Description | CDTL,HyderabadCDSCO lab | Apr 2026 |
Showing 15 of 163 records
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