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.

3
Banned combinations in force
2
Other listed orders (stayed, restricted, quashed)
190
Batches failed a lab test
Jul 2026
Latest lab alert

Is it banned? Our answer pages

Not banned · some combos banned
Not banned · spurious batches reported
Not banned · spurious batch (Dec 2025)

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 / combinationActionNotificationDateOrderStatus 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
Showing 15 of 190 records

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