Ingredient record · Mucus thinner for cough
Ambroxol: 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
62 entries containing Ambroxol are on India's banned-drugs list, and 35 are banned today. 178 batches of medicines containing Ambroxol failed a government lab test between January 2019 and September 2026, from 143 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)
178
Batches failed a lab test
Sep 2026
Latest lab alert
Is it banned? Our answer pages
Not banned (LS/D) · old formulas banned
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 75 products by number of batches.
Most recent failed batches
| Product | Batch | Manufacturer | Reason declared NSQ | Tested by | Alert |
|---|---|---|---|---|---|
| Levosalbutamol, Guaiphenesin & Ambroxol Hydrochloride syrup | Batch UFL251248KMfg Dec 2025 · Exp Nov 2027 | Ultra Drugs Formulations Pvt LtdHimachal Pradesh | content- Ambroxol HydrochlorideOther | Drug Testing Laboratory, Madurai-19State lab | Sep 2026 |
| Levosalbutamol, Ambroxol Hydrochloride & Guaiphenesin Syrup | Batch TS-399Mfg Aug 2025 · Exp Jul 2027 | Trimedix Pharma (P) LtdPunjab | TESTS FOR ASSAY (CONTENT) OF AMBROXOL HYDROCHLORIDEAssay | DTL, DelhiState lab | Sep 2026 |
| Levosalbutamol Sulphate, Ambroxol Hydrochloride and Guaiphenesin Syrup | Batch AGL51232Mfg Dec 2025 · Exp Nov 2027 | Alventa Pharma LtdHimachal Pradesh | content - Levosalbutamol(in Levosalbutamol Sulphate) and Ambroxol HydrochlorideOther | Drug Testing Laboratory, Madurai-19State 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 |
| 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 |
| Ambroxol, Terbutaline & Guaiphenesin Cough Expectorant | Batch GRL600425Mfg Apr 2025 · Exp Mar 2027 | Guinness Remedies Pvt. Ltd | The sample does not conform to declared formula with respect to Identity test for Ambroxol Hydrochloride." Sample gives negative identity test for Diethylene Glycol (DEG) & Ethylene Glycol (EG).Other | LUCKNOW, Uttar PradeshState lab | Sep 2026 |
| Ambroxol Hydrochloride, Terbutaline Sulphate, Guaiphenesin & Menthol Syrup | Batch L15017AMfg Sep 2025 · Exp Aug 2027 | Navkar LifesciencesHimachal Pradesh | DescriptionDescription | DTL, Bengaluru, KarnatakaState lab | Sep 2026 |
| Ambroxol Hydrochloride, Terbutaline Sulphate & Guaiphenesin Syrup | Batch T3-13Mfg Apr 2025 · Exp Mar 2027 | Swiss India LaboratoriesHimachal Pradesh | TESTS FOR ASSAY (CONTENT) OF AMBROXOL HYDROCHLORIDEAssay | DTL, DelhiState lab | Sep 2026 |
| Levosalbutamol, Ambroxol Hydrochloride, Guaiphenesin & Menthol Syrup | Batch BL25-049AMfg May 2025 · Exp Apr 2027 | Biocore PharmaceuticalsHimachal Pradesh | Content - Levosalbutamol in Levosalbutamol Sulphate and Ambroxol HydrochlorideOther | DTL, Chennai-06State lab | Aug 2026 |
| Levosalbutamol Sulphate, Ambroxol Hydrochloride Guaiphenesin Syrup | Batch NBVL-07Mfg Aug 2025 · Exp Jul 2027 | Ntk PharmaaTamil Nadu | Content - Levosalbutamol in Levosalbutamol SulphateOther | DTL, Chennai-06State 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 |
| Guaiphenesin, Ambroxol Hydrochloride, Menthol and Terbutline Sulphate Syrup | Batch L260424Mfg Apr 2026 · Exp Mar 2028 | SGS Formulation Pvt LtdTamil Nadu | Content of Ambroxol Hydrochloride and Terbutline SulphateOther | DTL, Madurai-19State lab | Aug 2026 |
| Ambroxol Hydrochloride, levosalbutamol sulphate and Guaiphenesin Syrup | Batch BL-299Mfg Feb 2026 · Exp Jan 2028 | Bonn Stering Bio Science LLPPuducherry | Content - Ambroxol HydrochlorideOther | DTL, Chennai-06State lab | Aug 2026 |
| Ambroxol Hydrochloride, Terbutaline Sulphate, Guaiphenesin and menthol syrup | Batch AMS26D059Mfg Mar 2026 · Exp Feb 2028 | Alop Medi-Sciences Pvt. LtdHimachal Pradesh | Content of Terbutaline SulphateOther | DTL, Chennai-06State lab | Aug 2026 |
| Ambroxol Hcl, Terbutaline Sulphate, Guaiphenesin & Menthol Syrup I.P. | Batch LXR25-1Mfg May 2025 · Exp Apr 2027 | Leostar Healthcare Pvt. LtdTelangana | Sample Does not comply Description, Assay for Ambroxol HydrochlorideAssay | State Lab, DCL, TelanganaState lab | Aug 2026 |
Showing 15 of 178 records
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