Ingredient record · Antispasmodic for stomach cramps
Dicyclomine: 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
25 entries containing Dicyclomine are on India's banned-drugs list, and 21 are banned today. 23 batches of medicines containing Dicyclomine failed a government lab test between February 2020 and September 2026, from 17 manufacturers. A failed batch concerns that batch only, not the medicine or every brand.
Is it banned? Our answer pages
On the banned-drugs list
Dicyclomine 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 |
|---|---|---|---|---|---|
| Dicyclomine + Paracetamol + Clidinium Bromide + ChlordiazepoxideFixed-dose combination · gi | Banned | S.O. 3071(E) | 11 June 2026 | 16 FDCs · Jun 2026 | Prohibited under s.26A with immediate effect, 11.06.2026 (CDSCO list published 21.07.2026). |
| Dicyclomine + Paracetamol + Clidinium BromideFixed-dose combination · gi | Banned | S.O. 3078(E) | 11 June 2026 | 16 FDCs · Jun 2026 | Prohibited under s.26A with immediate effect, 11.06.2026 (CDSCO list published 21.07.2026). |
| Rabeprazole Sodium (as Enteric Coated Tablet) + Clidinium Bromide + Dicyclomine HCl + ChlordiazepoxideFixed-dose combination · gi | Banned | S.O. 3291(E) | 2 August 2024 | 156 FDCs · Aug 2024 | Prohibited under s.26A; notifications dated 02.08.2024, gazetted 21-22 Aug 2024. |
| Omeprazole Magnesium + Dicyclomine HClFixed-dose combination · gi | Banned | S.O. 3294(E) | 2 August 2024 | 156 FDCs · Aug 2024 | Prohibited under s.26A; notifications dated 02.08.2024, gazetted 21-22 Aug 2024. |
| Tramadol HCl + Dicyclomine HCl + DomperidoneFixed-dose combination · gi | Banned | S.O. 3439(E) | 2 August 2024 | 156 FDCs · Aug 2024 | Prohibited under s.26A; notifications dated 02.08.2024, gazetted 21-22 Aug 2024. |
| Ciprofloxacin + Tinidazole + DicyclomineFixed-dose combination · antibiotics | Banned | S.O. 189(E) | 11 January 2019 | Other orders | One of 80 FDCs prohibited vide S.O. 180(E)-259(E) dated 11.01.2019 (CDSCO letter 22.01.2019). In force per CDSCO list as on 22.11.2021. |
| Dicyclomine + Dextromethorphan + ParacetamolFixed-dose combination · gi | Banned | S.O. 190(E) | 11 January 2019 | Other orders | One of 80 FDCs prohibited vide S.O. 180(E)-259(E) dated 11.01.2019 (CDSCO letter 22.01.2019). In force per CDSCO list as on 22.11.2021. |
| Dicyclomine + Paracetamol + ChlordiazepoxideFixed-dose combination · gi | Banned | S.O. 191(E) | 11 January 2019 | Other orders | One of 80 FDCs prohibited vide S.O. 180(E)-259(E) dated 11.01.2019 (CDSCO letter 22.01.2019). In force per CDSCO list as on 22.11.2021. |
| Dicyclomine + Paracetamol + Phenylisopropyl PyrazoloneFixed-dose combination · painkillers | Banned | S.O. 192(E) | 11 January 2019 | Other orders | One of 80 FDCs prohibited vide S.O. 180(E)-259(E) dated 11.01.2019 (CDSCO letter 22.01.2019). In force per CDSCO list as on 22.11.2021. |
| Dicyclomine + SerratiopeptidaseFixed-dose combination · gi | Banned | S.O. 193(E) | 11 January 2019 | Other orders | One of 80 FDCs prohibited vide S.O. 180(E)-259(E) dated 11.01.2019 (CDSCO letter 22.01.2019). In force per CDSCO list as on 22.11.2021. |
| Norfloxacin + Tinidazole + DicyclomineFixed-dose combination · antibiotics | Banned | S.O. 200(E) | 11 January 2019 | Other orders | One of 80 FDCs prohibited vide S.O. 180(E)-259(E) dated 11.01.2019 (CDSCO letter 22.01.2019). In force per CDSCO list as on 22.11.2021. |
| Ranitidine + Dicyclomine + Clidinium BromideFixed-dose combination · gi | Banned | S.O. 207(E) | 11 January 2019 | Other orders | One of 80 FDCs prohibited vide S.O. 180(E)-259(E) dated 11.01.2019 (CDSCO letter 22.01.2019). In force per CDSCO list as on 22.11.2021. |
| Dicyclomine + Paracetamol + Dextropropoxyphene + ChlordiazepoxideFixed-dose combination · painkillers | Banned | S.O. 219(E) | 11 January 2019 | Other orders | One of 80 FDCs prohibited vide S.O. 180(E)-259(E) dated 11.01.2019 (CDSCO letter 22.01.2019). In force per CDSCO list as on 22.11.2021. |
| Dicyclomine + Paracetamol + DimethylpolysiloxaneFixed-dose combination · gi | Banned | S.O. 220(E) | 11 January 2019 | Other orders | One of 80 FDCs prohibited vide S.O. 180(E)-259(E) dated 11.01.2019 (CDSCO letter 22.01.2019). In force per CDSCO list as on 22.11.2021. |
| Dicyclomine + Paracetamol + SimethiconeFixed-dose combination · gi | Banned | S.O. 221(E) | 11 January 2019 | Other orders | One of 80 FDCs prohibited vide S.O. 180(E)-259(E) dated 11.01.2019 (CDSCO letter 22.01.2019). In force per CDSCO list as on 22.11.2021. |
| Ranitidine + Dicyclomine + NimesulideFixed-dose combination · gi | Banned | S.O. 249(E) | 11 January 2019 | Other orders | One of 80 FDCs prohibited vide S.O. 180(E)-259(E) dated 11.01.2019 (CDSCO letter 22.01.2019). In force per CDSCO list as on 22.11.2021. |
| Ranitidine + Dicycloverine + SimethiconeFixed-dose combination · gi | Banned | S.O. 250(E) | 11 January 2019 | Other orders | One of 80 FDCs prohibited vide S.O. 180(E)-259(E) dated 11.01.2019 (CDSCO letter 22.01.2019). In force per CDSCO list as on 22.11.2021. |
| Dicyclomine + Paracetamol + DomperidoneFixed-dose combination · gi | Banned | S.O. 4385(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Paracetamol + Mefenamic Acid + Ranitidine + DicyclomineFixed-dose combination · gi | Banned | S.O. 4401(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Nimesulide + DicyclomineFixed-dose combination · gi | Banned | S.O. 4402(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Clidinium + Paracetamol + Dicyclomine + Activated DimethiconeFixed-dose combination · gi | Banned | S.O. 4506(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Dicyclomine + Paracetamol + DomperidoneFixed-dose combination · gi | Quashed | S.O. 711(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Paracetamol + Mefenamic Acid + Ranitidine + DicyclomineFixed-dose combination · gi | Quashed | S.O. 729(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Nimesulide + DicyclomineFixed-dose combination · gi | Quashed | S.O. 730(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Clidinium + Paracetamol + Dicyclomine + Activated DimethiconeFixed-dose combination · gi | Quashed | S.O. 843(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.
| Product | Batches | Makers | Latest |
|---|---|---|---|
| Dicyclomine Hydrochloride | 7 | 6 | Sep 2026 |
| Mefenamic Acid Dicyclomine Hydrochloride | 6 | 4 | Feb 2026 |
| Dicyclomine | 5 | 2 | Sep 2026 |
| Spasmore | 1 | 1 | Jul 2026 |
| Calxia Dicyclomine Hydrochloride | 1 | 1 | Sep 2025 |
| Dicyclomine Hcl Mefenamic Acid Paracetamol | 1 | 1 | Jul 2025 |
| Mefifresh Mefenamic Acid Dicyclomine Hydrochloride | 1 | 1 | Mar 2025 |
| Myspas | 1 | 1 | Dec 2023 |
Most recent failed batches
| Product | Batch | Manufacturer | Reason declared NSQ | Tested by | Alert |
|---|---|---|---|---|---|
| Dicyclomine Tablets I.P 10 mg | Batch THY25008AMfg May 2025 · Exp Apr 2027 | Hindustan Laboratories LimitedMaharashtra | DescriptionDescription | RDTL, Hubli, KarnatakaState lab | Sep 2026 |
| Dicyclomine Hydrochloride Tablets IP 20 mg | Batch BGT-2601Mfg Mar 2026 · Exp Feb 2029 | Suprex Laboratories | Assay for Dicyclomine HydrochlorideAssay | RDTL, Bellary, KarnatakaState lab | Sep 2026 |
| Spasmore (Acetaminophen, Tramadol HCl & Dicyclomine HCl Capsules). | Batch SE026040Mfg Apr 2026 · Exp Mar 2028 | Danish Health Care (P) Ltd | 01. ASSAY OF TRAMADOL HCL I.P. & DICYCLOMINE HCL I.P. ?Less than prescribed limit.Assay | SFDTL UttarakhandState lab | Jul 2026 |
| Dicyclomine Tablets IP 10 mg | Batch THY25005ALMfg Apr 2025 · Exp Mar 2028 | Hindustan Laboratories LimitedMaharashtra | Sample does not conform to IP standards with respect to Description.Description | RDTL ErnakulamState lab | Jun 2026 |
| Dicyclomine Tablets IP | Batch THY25001ALMfg Jan 2025 · Exp Dec 2027 | Hindustan Laboratories LimitedMaharashtra | DescriptionDescription | RDTL, ErnakulamState lab | Mar 2026 |
| Mefenamic Acid IP 250 mg & Dicyclomine Hydrochloride IP 20 mg Tablets | Batch ST251442Mfg Jul 2025 · Exp Jun 2027 | Star Filteration SystemHimachal Pradesh | DescriptionDescription | FDTL,UttarakhandState lab | Feb 2026 |
| Dicyclomine Tablets IP 10mg | Batch DC24002Mfg Nov 2024 · Exp Oct 2026 | EUROKEM Laboratories Pvt.Ltd. C-25Tamil Nadu | Tablets are not intact condition. when strip is opended, tablets found to be in powdered state. Hence Dicyclomine tablets does not meet the Specifications Wrt. DescriptionDescription | DCL TelanganaState lab | Nov 2025 |
| Dicyclomine hydrochloride & Mefenamic Acid Tablets IP | Batch WT-1025Mfg Aug 2025 · Exp Jul 2027 | Wilcure Remedies Pvt LtdMadhya Pradesh | The cited product is official in I.P which is not printed on the strips of above refered sample.Other | SDTL, PunjabState lab | Oct 2025 |
| Dicyclomine hydrochloride & Mefenamic Acid Tablets | Batch WT-1026Mfg Aug 2025 · Exp Jul 2027 | Wilcure Remedies Pvt LtdMadhya Pradesh | The cited product is official in I.P which is not Printed on the strips of above refered sample.Other | SDTL, PunjabState lab | Oct 2025 |
| CALXIA Dicyclomine Hydrochloride Tablets IP 10 mg.. | Batch QT0210Mfg Jun 2024 · Exp May 2026 | Quest Laboratories Pvt. LtdMadhya Pradesh | sample does not conform to IP with respect to the Test of Description.Description | CDL, KolkataCDSCO lab | Sep 2025 |
| Mefenamic acid & Dicyclomine Hydrochloride tablets IP 250mg/10 mg | Batch CYF-34Mfg May 2025 · Exp Apr 2027 | Not Mentioned | Manufactured by not mentioned anywhere on the label.Labelling | State Drugs Laboratory, PunjabState lab | Jul 2025 |
| Dicyclomine HCl, Mefenamic Acid and Paracetamol Tablets (MEFEN-SPAS TABLETS) | Batch 10769Mfg Jan 2025 · Exp Dec 2026 | Oyster Labs Limited 81-82Haryana | Assay of Mefenamic Acid, Dicyclomine HydrochlorideAssay | RDTL, ChandigarhCDSCO lab | Jul 2025 |
| Dicyclomine Tablets IP | Batch THY24010ALMfg Aug 2024 · Exp Jul 2026 | Hindustan Laboratories LimitedMaharashtra | Description.Description | DTL MaduraiState lab | Jun 2025 |
| Dicyclomine Hydrochloride Tablets IP 10 mg | Batch TK24-08Mfg Nov 2024 · Exp Oct 2026 | Om Biomedic Pvt. LtdUttarakhand | DescriptionDescription | RDTL, GuwahatiCDSCO lab | May 2025 |
| Dicyclomine HCL Powder | Batch DEH/24011RMfg Jul 2025 · Exp Jun 2029 | Palam Pharma Pvt. LtdGujarat | IdentificationTest- Found to be Negative. Assay of Paracetamol IP-NilAssay | State Food & Drug Testing Laboratory UttarakhandState lab | May 2025 |
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.