Ingredient record · Bronchodilator for asthma and cough
Terbutaline: 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
15 entries containing Terbutaline are on India's banned-drugs list, and 9 are banned today. 101 batches of medicines containing Terbutaline failed a government lab test between January 2019 and July 2026, from 84 manufacturers. A failed batch concerns that batch only, not the medicine or every brand.
9
Banned combinations in force
6
Other listed orders (stayed, restricted, quashed)
101
Batches failed a lab test
Jul 2026
Latest lab alert
Is it banned? Our answer pages
Not banned · two combos banned (2024)
On the banned-drugs list
Terbutaline 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 + 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. |
| 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. |
| Terbutaline Sulphate + Bromhexine HCl + Chlorpheniramine MaleateFixed-dose combination · cough-cold | Banned | S.O. 3403(E) | 2 August 2024 | 156 FDCs · Aug 2024 | Prohibited under s.26A; notifications dated 02.08.2024, gazetted 21-22 Aug 2024. |
| 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 |
| Terbutaline + Bromhexine + Guaifenesin + DextromethorphanFixed-dose combination · cough-cold | Banned | S.O. 4559(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 |
| Terbutaline + Bromhexine + EtofyllineFixed-dose combination · cough-cold | Banned | S.O. 4598(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 |
| Terbutaline + N-Acetylcysteine + GuaifenesinFixed-dose combination · cough-cold | Banned | S.O. 4647(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 | Quashed | S.O. 895(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Terbutaline + Bromhexine + Guaifenesin + DextromethorphanFixed-dose combination · cough-cold | Quashed | S.O. 897(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 |
| Terbutaline + Bromhexine + EtofyllineFixed-dose combination · cough-cold | Quashed | S.O. 940(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 |
| Terbutaline + N-Acetyl L-Cysteine + GuaifenesinFixed-dose combination · cough-cold | Quashed | S.O. 993(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
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 38 products by number of batches.
Most recent failed batches
| Product | Batch | Manufacturer | Reason declared NSQ | Tested by | Alert |
|---|---|---|---|---|---|
| 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, Bromhexine Hydrochloride, Guaiphenesin & Menthol Syrup | EM1LF005Mfg 2025-04 · Exp 2027-03 | Unicure India LtdUttarakhand | ContentOther | DTL, Chennai-06State lab | Jun 2026 |
| Terbutaline Sulphate, Bromhexine HCl, Guaiphenesin & Menthol Syrup | M24317Mfg 2024-12 · Exp 2026-11 | Healcure LifesciencesHimachal Pradesh | Assay for Bromhexine Hydrochloride and Description as per Schedule V of Drugs and Cosmetics Act 1940 & Rules 1945 thereunderAssay | DTL, Bengaluru, KarnatakaState lab | Jun 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 |
| Bromhexine Hydrochloride, Terbutaline Sulphate, Guaiphenesin & Menthol Syrup | L-2601029Mfg 2026-01 · Exp 2027-12 | Rivpra Formulation Pvt. LtdUttarakhand | The sample does not conform to claim as per Patent and Proprietary in respect to the Assay of Bromhexine Hydrochloride.Assay | RDTL, ChandigarhCDSCO 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, Bromhexine Hydrochloride Guaiphenesin & Menthol Syrup | ULD014Mfg 2025-04 · Exp 2027-03 | Haustus Biotech Pvt. Ltd. 44-45 | AssayAssay | RDTL, Bellary, KarnatakaState lab | May 2026 |
| Terbutaline Sulphate, Bromhexine HCL, Guaiphenesin & Menthol Syrup | AL25061Mfg 2025-06 · Exp 2027-05 | Cian Healthcare LtdUttarakhand | ContentOther | DTL, Chennai-06State lab | May 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 |
| 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 |
| 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 |
| Terbutaline ,Ambroxol,Guaiphenesin and Levomenthol Syrup | S122509Mfg 2025-12 · Exp 2028-11 | Aglowmed LtdUttarakhand | The sample does not conform to claim with respect to the Assay of Levomenthol.Assay | CDL, KolkataCDSCO lab | Apr 2026 |
Showing 15 of 101 records
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