Ingredient record · Bronchodilator for asthma and cough
Terbutaline: 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
15 entries containing Terbutaline are on India's banned-drugs list, and 9 are banned today. 109 batches of medicines containing Terbutaline failed a government lab test between January 2019 and September 2026, from 89 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)
109
Batches failed a lab test
Sep 2026
Latest lab alert
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 41 products by number of batches.
Most recent failed batches
| Product | Batch | Manufacturer | Reason declared NSQ | Tested by | Alert |
|---|---|---|---|---|---|
| Bromhexine Hydrochloride, Terbutaline Sulphate, Guaiphenesin & Menthol Syrup | Batch L-2507011Mfg Jul 2025 · Exp Jun 2027 | Rivpra Formulation Pvt. LtdUttarakhand | The sample does not conform to claim as per Patent and Proprietary in respect to the Assay of Bromhexine Hydrochloride, Terbutaline SulphateAssay | RDTL, ChandigarhCDSCO 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 |
| Choline Theophyllinate 50mg & Terbutaline Sulphate 1.25 mg Syrup | Batch KPD-2502Mfg Oct 2025 · Exp Sep 2027 | Aries Drugs Pvt. LtdUttarakhand | The sample does not conform to Manufacturer's specification with respect to Assay of Terbutaline Sulphate.Assay | CDL, KolkataCDSCO lab | Aug 2026 |
| Bromhexine, Terbutaline and Guaiphenesin Mentholated Syrup | Batch SL254444Mfg Feb 2026 · Exp Jan 2028 | Star Filteration SystemsHimachal Pradesh | Content - Terbutaline SulphateOther | 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 |
| Celltus-B (Ambroxol Hydrochloride, Terbutaline Sulphate, Guaiphenesin & Menthol Syrup) | Batch CLAM-2525Mfg Dec 2025 · Exp Nov 2027 | 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 | Batch FMX-030/26Mfg Mar 2026 · Exp Feb 2028 | 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 | Batch BGL250945Mfg Sep 2025 · Exp Aug 2027 | 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 | Batch EM1LF005Mfg Apr 2025 · Exp Mar 2027 | Unicure India LtdUttarakhand | ContentOther | DTL, Chennai-06State lab | Jun 2026 |
| Terbutaline Sulphate, Bromhexine HCl, Guaiphenesin & Menthol Syrup | Batch M24317Mfg Dec 2024 · Exp Nov 2026 | 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 | Batch JLI2586Mfg Sep 2025 · Exp Aug 2027 | Janveda Healthceutical Pvt. LtdGujarat | Ambroxol Hydrochloride contentOther | FDL, VadodaraState lab | Jun 2026 |
| Bromhexine Hydrochloride, Terbutaline Sulphate, Guaiphenesin & Menthol Syrup | Batch L-2601029Mfg Jan 2026 · Exp Dec 2027 | 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 |
Showing 15 of 109 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.