Ingredient record · Acid reducer (proton pump inhibitor)
Pantoprazole: 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
5 entries containing Pantoprazole are on India's banned-drugs list, and 3 are banned today. 190 batches of medicines containing Pantoprazole failed a government lab test between January 2019 and July 2026, from 132 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
Pantoprazole 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 |
|---|---|---|---|---|---|
| Naproxen IP 250/500mg + Pantoprazole IP 20mg Hard Gelatin Capsules or TabletsFixed-dose combination · gi | Restricted | S.O. 3267(E) | 12 August 2024 | Other orders | Restricted (regulated with conditions), not prohibited, CDSCO 'List of 02 Restricted FDC drugs dated 12.08.2024'. |
| Sucralfate + Pantoprazole Sodium + Zinc Gluconate + Light Magnesium CarbonateFixed-dose combination · gi | Banned | S.O. 3306(E) | 2 August 2024 | 156 FDCs · Aug 2024 | Prohibited under s.26A; notifications dated 02.08.2024, gazetted 21-22 Aug 2024. |
| Paracetamol + Diclofenac Sodium + Amoxicillin + Cloxacillin + Pantoprazole + Lactic Acid Bacillus + SerratiopeptidaseFixed-dose combination · antibiotics | Banned | S.O. 204(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. |
| Pantoprazole (as Enteric Coated Tablet) + Zinc Carnosine (as Film Coated Tablets)Fixed-dose combination · gi | Banned | S.O. 4513(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Pantoprazole (as Enteric Coated Tablet) + Zinc Carnosine (as Film Coated Tablets)Fixed-dose combination · gi | Quashed | S.O. 850(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 57 products by number of batches.
Most recent failed batches
| Product | Batch | Manufacturer | Reason declared NSQ | Tested by | Alert |
|---|---|---|---|---|---|
| Pantoprazole and Domperidone Tablets | T-241215Mfg 2024-12 · Exp 2026-11 | Medirose Drugs & Pharmaceuticals | The sample does not conform to claim with respect to above tests and The sample is not of standard quality for the reason stated under Description.Description | CDL, KolkataCDSCO lab | Jul 2026 |
| Pantoprazole and Domperidone Tablets | AN-06-25Mfg 2025-10 · Exp 2027-09 | Anchor Pharma Pvt. LtdDaman & Diu | TEST FOR DISINTEGRATION TIMEDisintegration | DTL, DelhiState lab | Jul 2026 |
| Pantoprazole Tablets IP | PEP5001Mfg 2025-02 · Exp 2027-01 | Finecure Pharmaceuticals Ltd. PF-5 & 6Gujarat | Dissolution testDissolution | SDT&RL, BhubaneswarState lab | Jul 2026 |
| Pantoprazole Tablets IP | AGW01AKAMfg 2025-09 · Exp 2027-08 | Pure & Cure Healthcare Pvt. LtdUttarakhand | The sample does not conform to IP standards. It fails the test Dissolution.Dissolution | DTL, KonniState lab | Jul 2026 |
| Pantoprazole Gastro-resistant Tablets IP 40 mg | SPK251470Mfg 2025-10 · Exp 2028-03 | Aristo Pharmaceuticals Pvt. LtdSikkim | Identification - Doesn't conforms to I.P.Identification | Lucknow LabState lab | Jul 2026 |
| Pantoprazole Gastro-resistant Tablets IP 40 mg | 25444650Mfg 2025-12 · Exp 2028-05 | Alkem Health ScienceSikkim | Identification - Doesn't conforms to I.P.Identification | Lucknow LabState lab | Jul 2026 |
| Pantoprazole Gastro-resistant Tablets IP | AT-1952AMfg 2025-06 · Exp 2027-05 | Azot Life SciencesHimachal Pradesh | Content of Pantoprazole (84.7%)Other | Drugs Testing Laboratory, Madurai-19State lab | Jul 2026 |
| Pantoprazole Gastro-resistant and Domperidone Prolonged- released Capsules IP | 25441645Mfg 2025-05 · Exp 2027-04 | Alkem Health ScienceSikkim | TESTS FOR ASSAY (CONTENT) OF PANTOPRAZOLE & UNIFORMITY OF WEIGHTAssay | DTL, DelhiState lab | Jul 2026 |
| Pantoprazole Gastro-resistant Tablets IP | GD25214Mfg 2025-12 · Exp 2027-11 | Skymap Pharmaceuticals Pvt. LtdUttarakhand | TEST FOR DISSOLUTIONDissolution | DTL, DelhiState lab | Jul 2026 |
| Pantoprazole Gastro-Resistant Tablets IP | R2516403JMfg 2025-10 · Exp 2027-09 | Reltsen Healthcare SplPuducherry | Sample Does not meets the Specifications wrt, Dissolution (All 6 Tablets dissolved in acid stage) as per IPDissolution | DCL, TelanganaState lab | Jul 2026 |
| Pantoprazole Gastro- Resistant & Domperidone Prologed Release Capsules I.P. | CG26-0049RMfg 2026-03 · Exp 2028-02 | Athens Life Sciences Mauza Rampur JattanHimachal Pradesh | 01. ASSAY OF PANTOPRAZOLE SODIUM I.P. & DOMPERIDONE I.P. ? Less than prescribed limit.Assay | SFDTL UttarakhandState lab | Jul 2026 |
| Pantoprazole Gastro-resistant Tablets IP | TG25-03290Mfg 2025-02 · Exp 2027-01 | Athens Life SciencesHimachal Pradesh | The sample does not comply as per I.P. 2022 with respect to the test for Dissolution in Acid Stage for Pantoprazole and Description.Dissolution | RDTL, GuwahatiCDSCO lab | Jun 2026 |
| Pantoprazole Gastro-Resistant Tablets IP 40 mg | MMPT9348Mfg 2026-01 · Exp 2027-12 | Middle Mist Pharmaceuticals PvtTamil Nadu | ContentOther | DTL, Madurai-19State lab | Jun 2026 |
| Pantoprazole Gastro Resistant Tablets IP 40 mg | ZTC-165Mfg 2025-03 · Exp 2027-02 | Zoic Biotech Pvt .LtdPunjab | The sample does not conform to the IP standards with respect to the test for DissolutionDissolution | DTL, ThrissurState lab | Jun 2026 |
| Pantoprazole Gastro Resistant Tablets IP 40mg | T-3423Mfg 2024-11 · Exp 2026-10 | Jackson Laboratories Pvt. LtdPunjab | Does not conform to IP Standards with respect to Description and Dissolution TestDissolution | FDL, Bambolim GoaState lab | Jun 2026 |
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.