Ingredient record · Acid reducer (proton pump inhibitor)
Rabeprazole: 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
9 entries containing Rabeprazole are on India's banned-drugs list, and 4 are banned today. 154 batches of medicines containing Rabeprazole failed a government lab test between January 2019 and July 2026, from 98 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)
154
Batches failed a lab test
Jul 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 40 products by number of batches.
Most recent failed batches
| Product | Batch | Manufacturer | Reason declared NSQ | Tested by | Alert |
|---|---|---|---|---|---|
| Rabeprazole Sodium Injection I.P. 20 mg/vial | MD24K17Mfg 2024-11 · Exp 2026-10 | Martin & Brown Bio-Sciences Pvt. LtdHimachal Pradesh | The sample does not conform to I.P. with respect to the Description, pH, Clarity of solution, Particulate matter and Assay of Rabeprazole SodiumAssay | CDL, KolkataCDSCO lab | Jul 2026 |
| Rabeprazole Sodium Gastro-Resistant Tablets I.P. | BLT-25798AMfg 2025-11 · Exp 2027-10 | Brit Lifescience V.P.O. MoginandHimachal Pradesh | MISBRANDED In the composition the label should be mentioned as Rabeprazoe sodium IP. But the label is mentioned as Rabeprazole Sodium equivalent to Rabeprazole. Hence it is misbranded drug as per section 17 of Drugs and Cosmetics Act 1940.Misbranded | DCL, TelanganaState lab | Jul 2026 |
| Rabeprazole Sodium (EC) & Domperidone (SR) Capsules | CG24-0548MMfg 2024-10 · Exp 2026-09 | Humankind Pharmaceuticals Lunia MohallaUttarakhand | Content of Rabeprazole SodiumOther | GORAKHPUR LAB, UPState lab | Jul 2026 |
| Rabepra zole Gastro Resistant Tablets IP 20 mg | T-2611 36Mfg 2025-11 · Exp 2027-10 | Merril Pharma Pvt. LtdUttarakhand | Dissolution TestDissolution | SDTL,Andhra Pradesh, VijayawadaState lab | Jul 2026 |
| Aceclofenac Sustained Release and Enteric Coated Rabeprazole Sodium Capsules | C50200BMfg 2025-12 · Exp 2027-11 | Samson Laboratories Pvt. LtdHimachal Pradesh | The sample received does not conform to manufacturers specification with respect to the test for Assay of rabeprazole sodium content only.Assay | CDTL, HyderabadCDSCO lab | Jul 2026 |
| Rabeprazole Sodium Tablet IP | ATG5H619Mfg 2025-08 · Exp 2027-07 | Anrose pharma 147Himachal Pradesh | Test For Assay (Content) Of Rabeprazole SodiumAssay | DelhiState lab | Jun 2026 |
| Rabeprazole Gastro resistant Tablets IP 20 m | UA01493Mfg 2024-06 · Exp 2026-05 | LUPIN LtdSikkim | Dissolution test (Buffer stage)Dissolution | SDT&RL, BhubaneswarState lab | Jun 2026 |
| Enteric Coated Rabeprazole Sodium & Domperidone Sustained Release Capsules | RDAA24009Mfg 2024-10 · Exp 2026-09 | Signova Healthcare Pvt. Ltd (Unit-II)Assam | The sample does not conform to I.P. w.r.to the tests for Dissolution & AssayAssay | SDTL, GuwahatiState lab | Jun 2026 |
| Enteric Coated Rabeprazole Sodium & Domperidone (SR) Capsules | VDR24002Mfg 2024-09 · Exp 2026-08 | Windlas Biotech Limited Plain-2Uttarakhand | Uniformity of WeightUniformity of weight/content | SDTL, PunjabState lab | Jun 2026 |
| Rabeprazole sodium IP 40mg | JKFP25002Mfg 2025-10 · Exp 2027-09 | Cadila pharmaceuticlas Limited | The sample does not conform to IP 2022 requirements w.r.t Dissolution TestDissolution | DTL,Dalgate Srinagar kashmirState lab | May 2026 |
| Rabeprazole Sodium Injection IP | MD25C11Mfg 2025-03 · Exp 2027-02 | Martin & Brown Bio-Sciences Pvt. LtdHimachal Pradesh | The sample does not conform to I.P with respect to the tests of Particulate matter, Clarity of Solution, Uniformity of weight and for the reason stated under DescriptionDescription | CDL, KolkataCDSCO lab | May 2026 |
| Rabeprazole Sodium (Enteric-Coated) & Domperidone (SR) Capsules. | IGC-0044Mfg 2025-01 · Exp 2027-10 | I.G. Pharma LtdUttarakhand | The content of Rabeprazole Sodium found to be 16.22mg/Capsule against labelled claim of 20.0mg/CapsuleLabelling | SDTL, PunjabState lab | May 2026 |
| Rabeprazole Sodium & Domperidone Capsules | HPC-5116Mfg 2025-09 · Exp 2027-08 | Helpzyn PharmaceuticalsHimachal Pradesh | Assay of Rabeprazole and DomperidoneAssay | SDTL, Andhra Pradesh, VijayawadaState lab | May 2026 |
| Rabeprazole Gastro Resistant Tablets IP | UT-240943BMfg 2024-06 · Exp 2026-05 | Ultra Drugs Pvt. Ltd. (Unit-II) HS No. 211Himachal Pradesh | Dissolution test (Buffer Stage)Dissolution | SDT&RL, BhubaneswarState lab | May 2026 |
| Aceclofenac (SR) & Rabeprazole Sodium (EC) Capsules | YC337AMfg 2025-07 · Exp 2027-06 | Saphnix Life SciencesHimachal Pradesh | The sample does not conform to Manufacturer's Specification with respect to the test of Dissolution of Rabeprazole Sodium in buffer stageDissolution | CDL, KolkataCDSCO lab | May 2026 |
Showing 15 of 154 records
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