Ingredient record · Bronchodilator for asthma
Salbutamol: 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
28 entries containing Salbutamol are on India's banned-drugs list, and 15 are banned today. 15 batches of medicines containing Salbutamol failed a government lab test between March 2020 and March 2026, from 14 manufacturers. A failed batch concerns that batch only, not the medicine or every brand.
15
Banned combinations in force
13
Other listed orders (stayed, restricted, quashed)
15
Batches failed a lab test
Mar 2026
Latest lab alert
Is it banned? Our answer pages
Not banned (LS/D) · old formulas banned
On the banned-drugs list
Salbutamol 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 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. |
| Salbutamol Sulphate + Bromhexine HCl + Guaifenesin + Ammonium Chloride + MentholFixed-dose combination · cough-cold | Banned | S.O. 3402(E) | 2 August 2024 | 156 FDCs · Aug 2024 | Prohibited under s.26A; notifications dated 02.08.2024, gazetted 21-22 Aug 2024. |
| Salbutamol + BromhexineFixed-dose combination · cough-cold | Banned | S.O. 2403(E) | 2 June 2023 | 14 FDCs · Jun 2023 | Prohibited under s.26A on DTAB/Expert Committee advice; these are 14 of the 15 'pre-1988' FDCs excluded from the 2018 re-ban (Imipramine + Diazepam not included). |
| Salbutamol + Hydroxyethyltheophylline (Etofylline) + BromhexineFixed-dose combination · cough-cold | Banned | S.O. 2407(E) | 2 June 2023 | 14 FDCs · Jun 2023 | Prohibited under s.26A on DTAB/Expert Committee advice; these are 14 of the 15 'pre-1988' FDCs excluded from the 2018 re-ban (Imipramine + Diazepam not included). |
| Salbutamol + Hydroxyethyl Theophylline (Etofylline) + BromhexineFixed-dose combination · cough-cold | Under examination | S.O. 4687(E) | 7 September 2018 | 328 FDCs · Sep 2018 | SC order 14.02.2019: claimed pre-1988 FDC; under examination with Expert Committee per CDSCO list as on 22.11.2021 (note 4#). Legally on sale pending examination. |
| Salbutamol + Bromhexine + Guaifenesin + MentholFixed-dose combination · cough-cold | Banned | S.O. 4593(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 |
| Salbutamol + Aminophylline + GuaifenesinFixed-dose combination · cough-cold | Banned | S.O. 4617(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Salbutamol + Theophylline + BromhexineFixed-dose combination · cough-cold | Banned | S.O. 4618(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 |
| Salbutamol + Choline Theophylinate + CarbocisteineFixed-dose combination · cough-cold | Banned | S.O. 4650(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Albuterol + Etofylline + Bromhexine + MentholFixed-dose combination · cough-cold | Banned | S.O. 4685(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Albuterol + Bromhexine + TheophyllineFixed-dose combination · cough-cold | Banned | S.O. 4686(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Salbutamol + Bromhexine + Guaifenesin + MentholFixed-dose combination · cough-cold | Quashed | S.O. 935(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 |
| Salbutamol + Aminophylline + GuaifenesinFixed-dose combination · cough-cold | Quashed | S.O. 960(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Salbutamol + Thoephylline + BromhexineFixed-dose combination · cough-cold | Quashed | S.O. 961(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 |
| Salbutamoll + BromhexineFixed-dose combination · cough-cold | Under examination | S.O. 978(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; SC order 15.12.2017 treated it as a pre-1988 FDC, under examination with Expert Committee per CDSCO list as on 22.11.2021 (note 3#). 14 of these 15 were re-prohibited on 02.06.2023 (wave 2023-14). |
| 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 |
| Salbutamol + Choline Theophylinate + CarbocisteineFixed-dose combination · cough-cold | Quashed | S.O. 996(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Albuterol + Etofylline + Bromhexine + MentholFixed-dose combination · cough-cold | Quashed | S.O. 1032(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Albuterol + Bromhexine + TheophyllineFixed-dose combination · cough-cold | Quashed | S.O. 1033(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Salbutamol + Hydroxyethyltheophylline (Etofylline) + BromhexineFixed-dose combination · cough-cold | Quashed | S.O. 1034(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Salbutamol or any other Bronchodilator with Centrally Acting Anti-Tussive And/or AntihistamineFixed-dose combination · cough-cold | Banned | GSR 290(E) | 16 April 2008 | Classic bans | Entry text as substituted vide GSR 290(E) dated 2008-04-16; original 1983/1988 notification superseded. |
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 |
|---|---|---|---|
| Salbutamol | 3 | 2 | Jan 2026 |
| Salbutamol Sulphate | 2 | 2 | Feb 2026 |
| Salbutamol Sulphate Bromhexine Hydrochloride Guaiphenesin Menthol | 1 | 1 | Mar 2026 |
| Ambroxol Hydrochloride Salubutamol Sulphate Equivalent To Salbutamol Guaiphenesin Menthol Sorbitol Base Q S Colour Sunset Yellow Fcf | 1 | 1 | Jan 2026 |
| Ambroxol Hcl Salbutamol Sulphate Guaiphenesin Liquid | 1 | 1 | Sep 2025 |
| Pulmonex As | 1 | 1 | Jun 2025 |
| Salbutamol Bromhexine Hci Guaifenesin Menthol | 1 | 1 | Aug 2024 |
| Salbutamol Nebuliser /ml | 1 | 1 | Jul 2024 |
| Salbutamol Nebuliser | 1 | 1 | Apr 2024 |
| Ambroxol Salbutamol Guaiphenesin Menthol | 1 | 1 | Mar 2024 |
| Asthalin | 1 | 1 | Mar 2020 |
| Salbetol | 1 | 1 | Mar 2020 |
Most recent failed batches
| Product | Batch | Manufacturer | Reason declared NSQ | Tested by | Alert |
|---|---|---|---|---|---|
| Salbutamol Sulphate, I.P (Equivalent to salbutamol) -2mg Bromhexine Hydrochloride, IP-4mg Guaiphenesin, IP-100mg Menthol, IP-1mg | PL-182Mfg 2025-09 · Exp 2027-08 | Panacea LaboratoriesWest Bengal | The sample does not conform to manufacturers specification with respect to the Assay of Bromhexine Hydrochloride.Assay | CDL, KolkataCDSCO lab | Mar 2026 |
| Salbutamol Sulphate Syrup IP | L-25075Mfg 2025-05 · Exp 2027-04 | Daffohils Laboratories Pvt. LtdUttarakhand | Sample fails the pH mentioned in the laboratory protocol as per IP.pH | DTL KonniState lab | Feb 2026 |
| Salbutamol Syrup IP | SVK 24049Mfg 2024-11 · Exp 2026-10 | Labinduss LtdKerala | sample fails the test pH as per IP .pH | RDTL ErnakulamState lab | Jan 2026 |
| Ambroxol Hydrochloride, I.P-15.0mg Salubutamol Sulphate Equivalent to Salbutamol, I.P-1mg Guaiphenesin, I.P- 50.0mg Menthol, I.P -1mg Sorbitol base -q.s. Colour: Sunset Yellow FCF | AS036-25Mfg 2025-01 · Exp 2026-12 | Harihar Pharmaceuticals Pvt.LtdOdisha | The sample does not conform to claim with respect to Assay of Menthol.Assay | CDL, KolkataCDSCO lab | Jan 2026 |
| Salbutamol Syrup IP | SVK 25040Mfg 2025-07 · Exp 2027-06 | Labinduss LtdKerala | Sample fails the test pH as per IP .pH | RDTL Ernakulam,KeralaState lab | Dec 2025 |
| Ambroxol HCl, Salbutamol Sulphate & Guaiphenesin Liquid | RSP3041Mfg 2023-05 · Exp 2026-04 | Naxpar Pharma Pvt. Ltd. 182Himachal Pradesh | sample does not conform to claim as per Manufacturer Specification with respect to the test for "Assay" of Ambroxol Hydrochloride and Salbutamol.Assay | RDTL, GuwahatiCDSCO lab | Sep 2025 |
| Pulmonex-AS (Ambroxol Salbutamol Guaiphenesin Syrup) | HTD-24109Mfg 2024-08 · Exp 2026-07 | Not applicable | Content of Salbutamol in Salbutamol Sulphate and Ambroxol Hydrochloride. Note: Manufacturer's Name is not stated on the label.Labelling | CDTL ChennaiCDSCO lab | Jun 2025 |
| Salbutamol, Bromhexine HCI, Guaifenesin and Menthol Syrup(Acozil Expectorant) | A-244003Mfg 2024-04 · Exp 2027-03 | Antila Lifesciences Pvt LtdGujarat | Not of Standard QualityOther | CDTL MumbaiCDSCO lab | Aug 2024 |
| Salbutamol Nebuliser Solution BP 5 mg/ml | CHS-3085Mfg 2023-06 · Exp 2025-05 | Cotec Healthcare Pvt. LtdUttarakhand | It fails the test ?pH? as per BPpH | DTL ThiruvananthapuramState lab | Jul 2024 |
| Salbutamol Nebuliser Solution BP | D 2259/23- 24Mfg 2023-06 · Exp 2025-05 | Supplied by M/s. Kerala Medical services Corporation LimitedKerala | It fails the test Acidity pH as per BPpH | SDTL ThiruvananthapuramState lab | Apr 2024 |
| Ambroxol, Salbutamol, Guaiphenesin and Menthol (Nokaff Expectorant) | 7709Mfg 2023-12 · Exp 2025-11 | Bidhan PharmaceuticalsWest Bengal | Assay of Ambroxol, & GuaiphenesinAssay | CDL KolkataCDSCO lab | Mar 2024 |
| Salbutamol Tablets IP 4mg. | 21112002Mfg 2021-05 · Exp 2024-04 | Mercury Laboratories LimitedGujarat | DisintegrationDisintegration | RDTL GuwahatiState lab | Jun 2022 |
| Salbutamol Sulphate Tablets I.P. | 7193Mfg 2018-12 · Exp 2020-11 | Adroit Pharmaceuticals Pvt. LtdMaharashtra | Related SubstancesRelated substances | CDL KolkataCDSCO lab | Apr 2020 |
| Salbetol -2 (Salbutamol Tablets IP 2 mg) | 469D005Mfg 2019-04 · Exp 2021-03 | FDC LimitedGoa | Related SubstancesRelated substances | CDL KolkataCDSCO lab | Mar 2020 |
| Asthalin - 4 (Salbutamol Sulphate Tablet I.P. 4 mg) | SA81637Mfg 2018-04 · Exp 2021-03 | Cipla LtdSikkim | Related SubstancesRelated substances | CDL KolkataCDSCO lab | Mar 2020 |
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.