Ingredient record · Acid reducer (proton pump inhibitor)
Rabeprazole: 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
9 entries containing Rabeprazole are on India's banned-drugs list, and 4 are banned today. 171 batches of medicines containing Rabeprazole failed a government lab test between January 2019 and September 2026, from 110 manufacturers. A failed batch concerns that batch only, not the medicine or every brand.
4
Banned combinations in force
5
Other listed orders (stayed, restricted, quashed)
171
Batches failed a lab test
Sep 2026
Latest lab alert
On the banned-drugs list
Rabeprazole 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 |
|---|---|---|---|---|---|
| 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. |
| Aceclofenac + Paracetamol + RabeprazoleFixed-dose combination · painkillers | Quashed | S.O. 4379(E) | 7 September 2018 | 328 FDCs · Sep 2018 | Quashed by Delhi HC order dated 13.03.2019; CDSCO appealed, sub judice (CDSCO list as on 22.11.2021, note 5#). |
| Rabeprazole + ZinccarnosineFixed-dose combination · gi | Banned | S.O. 4496(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Rabeprazole + Zinc + DomperidoneFixed-dose combination · gi | Banned | S.O. 4502(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Rabeprazole + Diclofenac + ParacetamolFixed-dose combination · painkillers | Banned | S.O. 4508(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Aceclofenac + Paracetamol + RabeprazoleFixed-dose combination · painkillers | Quashed | S.O. 705(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Rabeprazole + Zinc CarnosineFixed-dose combination · gi | Quashed | S.O. 833(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Rabeprazole + Zinc + DomperidoneFixed-dose combination · gi | Quashed | S.O. 839(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Rabeprazole + Diclofenac + ParacetamolFixed-dose combination · painkillers | Quashed | S.O. 845(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 42 products by number of batches.
Most recent failed batches
| Product | Batch | Manufacturer | Reason declared NSQ | Tested by | Alert |
|---|---|---|---|---|---|
| Rabeprazole Sodium Enteric coated & Domperidone Sustained Release Capsules | Batch CF10008AMfg Oct 2025 · Exp Sep 2027 | Hetvi Lifesciences Pvt. LtdGujarat | The sample does not conform to claim with respect to the Assay of Rabeprazole Sodium.Assay | CDL, KolkataCDSCO lab | Sep 2026 |
| Rabeprazole Sodium (Enteric Coated) & Domperidone (Sustained Release) Capsules | Batch BCD-B0204GMfg Jan 2026 · Exp Dec 2027 | Broad Tab Pvt. LtdHaryana | The sample does not conforms to the claim with respect to Assay of Rabeprazole Sodium and Domperidone.Assay | DTL, JaipurState lab | Sep 2026 |
| Rabeprazole Sodium (EC) & Domperidone (SR) Capsules | Batch CE-25022Mfg May 2025 · Exp Apr 2027 | Horizon Bioceuticals Pvt. LtdHimachal Pradesh | The sample does not conform to declared formula, in respect of content of Rabeprazole sodiumOther | LUCKNOW, Uttar PradeshState lab | Sep 2026 |
| Rabeprazole Sodium (EC) & Domperidone (SR) Capsules | Batch LGQ01/199/01Mfg Jan 2026 · Exp Jun 2027 | Logos PharmaHimachal Pradesh | The sample does not conform to declared formula in respect of content of Rabeprazole and Domperidone.Other | VARANASI, Uttar PradeshState lab | Sep 2026 |
| Rabeprazole Gastro-Resistant Tablets IP | Batch SPA252793Mfg Dec 2025 · Exp Nov 2027 | Skymap Pharmaceuticals Pvt. LtdUttarakhand | The sample does not conform to claim as per IP 2022 and Addendum 2024 in respect to the Test of Dissolution (Buffer Stage)Dissolution | RDTL, ChandigarhCDSCO lab | Sep 2026 |
| Rabeprazole Gastro Resistant Tablets IP 20 mg | Batch GFTB25844Mfg Sep 2025 · Exp Aug 2027 | Genip Formulation Pvt LtdHimachal Pradesh | Assay & Dissolution Test of RabeprazoleAssay | SDTL, Andhra Pradesh, VijayawadaState lab | Sep 2026 |
| Rabeprazole Gastro Resistant Tablets IP | Batch GFTB26191Mfg Apr 2026 · Exp Mar 2028 | Genip Formulation Pvt LtdHimachal Pradesh | Dissolution Test of RabeprazoleDissolution | SDTL, Andhra Pradesh, VijayawadaState lab | Sep 2026 |
| RABEPRAZOLE SODIUM TABLETS IP | Batch MDT-4228Mfg Jul 2025 · Exp Jun 2027 | Mayasha LifesciencesHimachal Pradesh | Failed Description, Disintegration and AssayAssay | DTL, PuducherryState lab | Sep 2026 |
| Rabeprazole Sodium Tablets IP 20 mg | Batch N2600742Mfg Mar 2026 · Exp Feb 2028 | Intas Pharmaceuticals LtdSikkim | The sample does not conform to claim as per IP 2022 and Addendum 2024 in respect to the Test of Dissolution (Buffer Stage).Dissolution | RDTL, ChandigarhCDSCO lab | Aug 2026 |
| Rabeprazole Sodium Injection IP | Batch MD25A16Mfg Jan 2025 · Exp Dec 2026 | Martin & Brown Bio-Sciences Pvt. LtdHimachal Pradesh | The sample does not conform to I.P. with respect the tests of Description, Clarity of solution, Particulate matter, pH, Related substances and Assay of Rabeprazole Sodium.Assay | CDL, KolkataCDSCO lab | Aug 2026 |
| Rabeprazole Sodium Gastro Resistant and Domperidone Prolonged Release Capsules | Batch 2604209Mfg Apr 2026 · Exp Mar 2028 | Sai sarvaa Biotech Pvt. Ltd | The sample does not conform to claim as per Patent and Proprietary in respect to the Test of Dissolution of Domperidone (12th hours), Dissolution of Rabeprazole Sodium (buffer stage).Dissolution | RDTL, ChandigarhCDSCO lab | Aug 2026 |
| Rabeprazole Sodium (EC) & Domperidone (SR) Capsules | Batch PGC25-377EMfg Nov 2025 · Exp Oct 2027 | Plena RemediesHimachal Pradesh | The sample does not conform to declared formula in respect of content of Rabeprazole SodiumOther | GORAKHPUR LABState lab | Aug 2026 |
| Rabeprazole Sodium (EC) & Domperidone (SR) Capsules | Batch DC-10856Mfg Nov 2025 · Exp Oct 2027 | Dual HealthcareHimachal Pradesh | The sample does not conform to declared formula in respect of Identity test for Rabeprazole sodium & Domeperidone, Hence spurious.Spurious | LUCKNOW LABState lab | Aug 2026 |
| Rabeprazole Sodium & Domperidone Tablets | Batch SPT-41856Mfg Jan 2026 · Exp Dec 2027 | Shervotec PharmaceuticalsHimachal Pradesh | The sample does not comply with IP requirements fo the Disintegrarion Test for Enteric Coated TabletsOther | FDAL, MumbaiState lab | Aug 2026 |
| Rabeprazole Gastro-resistant Tablets IP | Batch TG25-1583LMfg Sep 2025 · Exp Aug 2027 | Athens Life SciencesHimachal Pradesh | Assay and DissolutionAssay | SDTL, RaipurState lab | Aug 2026 |
Showing 15 of 171 records
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