Ingredient record · Antispasmodic for stomach cramps
Dicyclomine: 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
25 entries containing Dicyclomine are on India's banned-drugs list, and 21 are banned today. 21 batches of medicines containing Dicyclomine failed a government lab test between February 2020 and July 2026, from 16 manufacturers. A failed batch concerns that batch only, not the medicine or every brand.
21
Banned combinations in force
4
Other listed orders (stayed, restricted, quashed)
21
Batches failed a lab test
Jul 2026
Latest lab alert
Is it banned? Our answer pages
Not banned · confirm (being verified)
Not banned · some combos banned
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 |
|---|---|---|---|
| Mefenamic Acid Dicyclomine Hydrochloride | 6 | 4 | Feb 2026 |
| Dicyclomine Hydrochloride | 6 | 5 | May 2025 |
| Dicyclomine | 4 | 2 | Jun 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 |
|---|---|---|---|---|---|
| Spasmore (Acetaminophen, Tramadol HCl & Dicyclomine HCl Capsules). | SE026040Mfg 2026-04 · Exp 2028-03 | 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 | THY25005ALMfg 2025-04 · Exp 2028-03 | Hindustan Laboratories LimitedMaharashtra | Sample does not conform to IP standards with respect to Description.Description | RDTL ErnakulamState lab | Jun 2026 |
| Dicyclomine Tablets IP | THY25001ALMfg 2025-01 · Exp 2027-12 | Hindustan Laboratories LimitedMaharashtra | DescriptionDescription | RDTL, ErnakulamState lab | Mar 2026 |
| Mefenamic Acid IP 250 mg & Dicyclomine Hydrochloride IP 20 mg Tablets | ST251442Mfg 2025-07 · Exp 2027-06 | Star Filteration SystemHimachal Pradesh | DescriptionDescription | FDTL,UttarakhandState lab | Feb 2026 |
| Dicyclomine Tablets IP 10mg | DC24002Mfg 2024-11 · Exp 2026-10 | 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 | WT-1025Mfg 2025-08 · Exp 2027-07 | 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 | WT-1026Mfg 2025-08 · Exp 2027-07 | 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.. | QT0210Mfg 2024-06 · Exp 2026-05 | 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 | CYF-34Mfg 2025-05 · Exp 2027-04 | 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) | 10769Mfg 2025-01 · Exp 2026-12 | Oyster Labs Limited 81-82Haryana | Assay of Mefenamic Acid, Dicyclomine HydrochlorideAssay | RDTL, ChandigarhCDSCO lab | Jul 2025 |
| Dicyclomine Tablets IP | THY24010ALMfg 2024-08 · Exp 2026-07 | Hindustan Laboratories LimitedMaharashtra | Description.Description | DTL MaduraiState lab | Jun 2025 |
| Dicyclomine Hydrochloride Tablets IP 10 mg | TK24-08Mfg 2024-11 · Exp 2026-10 | Om Biomedic Pvt. LtdUttarakhand | DescriptionDescription | RDTL, GuwahatiCDSCO lab | May 2025 |
| Dicyclomine HCL Powder | DEH/24011RMfg 2025-07 · Exp 2029-06 | Palam Pharma Pvt. LtdGujarat | IdentificationTest- Found to be Negative. Assay of Paracetamol IP-NilAssay | State Food & Drug Testing Laboratory UttarakhandState lab | May 2025 |
| Mefifresh Tablets, Mefenamic Acid & Dicyclomine Hydrochloride Tablets, | T09243 9Mfg 2024-09 · Exp 2027-08 | Mfg By: M/s. Swefn Pharmaceuticals Pvt.LtdGujarat | MISBRANDED The drug product Mefenamic Acid and Dicyclomine HCL tablets is official in Indian Pharmacopoeia. But the letters IP is not mentioned on the strip after the product name Mefenamic Acid and Dicyclomine HCL tablets. Hence it is Misbranded drug under section 17 of Drugs and Cosmetics Act, 1940.Misbranded | State Lab, Drugs Control Laboratory, TelanganaState lab | Mar 2025 |
| Dicyclomine Hydrochloride Injection IP-2ML | 23BDK74Mfg 2023-11 · Exp 2025-10 | SVP Life SciencesUttarakhand | Sample does not conform to the requirement for AssayAssay | DTL ChennaiState lab | Nov 2024 |
Showing 15 of 21 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.