Ingredient record · Acid reducer (proton pump inhibitor)
Omeprazole: 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
6 entries containing Omeprazole are on India's banned-drugs list, and 5 are banned today. 45 batches of medicines containing Omeprazole failed a government lab test between February 2019 and July 2026, from 34 manufacturers. A failed batch concerns that batch only, not the medicine or every brand.
5
Banned combinations in force
1
Other listed orders (stayed, restricted, quashed)
45
Batches failed a lab test
Jul 2026
Latest lab alert
Is it banned? Our answer pages
Not banned
On the banned-drugs list
Omeprazole 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 |
|---|---|---|---|---|---|
| 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. |
| Ranitidine + OmeprazoleFixed-dose combination · gi | Banned | S.O. 208(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. |
| Drotaverine + OmeprazoleFixed-dose combination · gi | Banned | S.O. 223(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. |
| Ondansetron + OmeprazoleFixed-dose combination · gi | Banned | S.O. 258(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. |
| Omeprazole + Paracetamol + DiclofenacFixed-dose combination · painkillers | Banned | S.O. 4392(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Omeprazole + Paracetamol + DiclofenacFixed-dose combination · painkillers | Quashed | S.O. 720(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 |
|---|---|---|---|
| Omeprazole | 20 | 15 | May 2026 |
| Omeprazole Domperidone | 6 | 6 | Jul 2026 |
| Omeprazole Gastro Resistant | 6 | 5 | Jul 2026 |
| Parazim | 2 | 1 | Jul 2019 |
| Coolfresh D | 1 | 1 | Feb 2026 |
| Omeprazole Lyophilized | 1 | 1 | Dec 2024 |
| Cozol D | 1 | 1 | Jun 2024 |
| Softom D Omeprazole Domperidone | 1 | 1 | Jun 2024 |
| Omeprazole Magnesium Domperidone Tables | 1 | 1 | Mar 2024 |
| Spasom Omeprazole | 1 | 1 | May 2023 |
| Omicerr | 1 | 1 | Feb 2023 |
| Omirid | 1 | 1 | Dec 2022 |
| Omzole | 1 | 1 | Oct 2022 |
| Omecap | 1 | 1 | Sep 2022 |
| Omep | 1 | 1 | Nov 2019 |
Most recent failed batches
| Product | Batch | Manufacturer | Reason declared NSQ | Tested by | Alert |
|---|---|---|---|---|---|
| Omeprazole Gastro-resistant Capsules IP 20 mg | GC108503Mfg 2025-03 · Exp 2027-02 | Bengal Chemicals & Pharmaceuticals LtdHimachal Pradesh | The sample does not conform to IP standards with respect to the test for Dissolution.Dissolution | DTL, ThrissurState lab | Jul 2026 |
| Omeprazole & Domperidone Capsules | AC25/211Mfg 2026-01 · Exp 2027-12 | Accuwell Medics Private Ltd. Suvery No.-414Gujarat | Content of Omeprazole & DomperidoneOther | Lucknow LabState lab | Jul 2026 |
| Omeprazole Capsules IP | B251266Mfg 2025-08 · Exp 2027-07 | Bochem Healthcare Pvt. Ltd | Dissolution (Acid Satge)Dissolution | FDL, VadodaraState lab | May 2026 |
| Omeprazole Capsules IP 20mg | HCN460GMfg 2024-07 · Exp 2026-06 | Himalaya Meditek Pvt. LtdUttarakhand | Dissolution.Dissolution | DTL, Chennai-06State lab | Feb 2026 |
| Coolfresh-D (Omeprazole and Domperidone Capsules IP) | C032506Mfg 2025-03 · Exp 2027-02 | Swefn Pharmaceuticals Pvt. Ltd. 7 Sopan Kesar Indl. HubGujarat | Assay of Domperidone IPAssay | FDTL,UttarakhandState lab | Feb 2026 |
| Omeprazole Gastro-resistant Capsules IP 20 mg | JDC-1592Mfg 2025-04 · Exp 2027-03 | Jpee DrugsUttarakhand | Test for DissolutionDissolution | RDTL, Hubli, KarnatakaState lab | Jan 2026 |
| Omeprazole Capsules 40 mg | JDC-1452Mfg 2024-10 · Exp 2026-09 | Jpee DrugsUttarakhand | The sample does not conform to claim as per I.P. 2022 in respect to The Test of Dissolution (Acid Stage), Dissolution (Buffer Stage)Dissolution | CDL, KolkataCDSCO lab | Dec 2025 |
| Omeprazole Capsule IP 20 mg | 153/25Mfg 2025-01 · Exp 2026-12 | Aban PharmaceuticalsKerala | Dissolution ( Buffer satage)Dissolution | Food & Drugs Laboratory, VadodaraState lab | Nov 2025 |
| Gastro-Resistant Omeprazole Capsules BP 10 mg | C-3023Mfg 2024-10 · Exp 2026-04 | Jackson Laboratories Pvt.Ltd 22-24Punjab | The sample does not conform to claim as per B.P. in respect to the Test of Dissolution (Final Stage, PH 6.8)Dissolution | CDL, KolkataCDSCO lab | Nov 2025 |
| Omeprazole | CT51891Mfg 2024-12 · Exp 2026-11 | Cosmas Pharmacis Ltd.Buranwala RoadHimachal Pradesh | DissolutionDissolution | DTL,Dalgate Srinagar Kashmir( J&K)State lab | Sep 2025 |
| Omeprazole & Domperidone Capsules | 25ACW0028Mfg 2025-01 · Exp 2026-12 | Whiz Laboratories (India) Pvt.Ltd | labelingLabelling | SDTL Raipur ChhattisgarhState lab | Aug 2025 |
| Omeprazole Capsules IP 20mg | HCN423FMfg 2024-06 · Exp 2026-05 | Himalaya Meditek Pvt. LtdUttarakhand | Sample does not conform to IP specification with respect to Uniformity of weightUniformity of weight/content | DTL MaduraiState lab | Apr 2025 |
| Omeprazole for Injection (Lyophilized) 40 mg (Fexona ) | 324-609Mfg 2024-05 · Exp 2027-04 | Zee Laboratories LtdHimachal Pradesh | Sterility of Water for InjectionSterility | CDL, KolkataCDSCO lab | Mar 2025 |
| Omeprazole for Injection (Lyophilized) 40 mg (Fexona ) | 324-608Mfg 2024-05 · Exp 2027-04 | Zee Laboratories LtdHimachal Pradesh | Sterility of Water for InjectionSterility | CDL, KolkataCDSCO lab | Mar 2025 |
| Omeprazole Lyophilized Powder for Injection (I.V) (OMERA 40mg Lyophilized Powder for Injection ) | 0ZI2415ACMfg 2024-06 · Exp 2026-05 | Celon Laboratories Pvt. LtdTelangana | Test of Water by KFWater content | CDL KolkataCDSCO lab | Dec 2024 |
Showing 15 of 45 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.