Ingredient record · Acid reducer (proton pump inhibitor)
Pantoprazole: 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
5 entries containing Pantoprazole are on India's banned-drugs list, and 3 are banned today. 201 batches of medicines containing Pantoprazole failed a government lab test between January 2019 and September 2026, from 141 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 for Injection IP | Batch YMC-2534Mfg Sep 2025 · Exp Aug 2027 | Park PharmaceuticalsHimachal Pradesh | The sample does not conform to claim as per I.P. Addendum 2024 in respect to the Test of SterilitySterility | RDTL, GuwahatiCDSCO lab | Sep 2026 |
| Pantoprazole Sodium Gastro-resistant Tablets IP' | Batch 26KHT-0255Mfg Feb 2026 · Exp Jan 2028 | Kaalinga Health CareHimachal Pradesh | The Sample does not conform to the IP standards with respect to the tests Dissolution and Assay.Assay | DTL, ThrissurState lab | Sep 2026 |
| Pantoprazole Sodium Gastro Resistant tablets IP 40 mg | Batch OM-12884Mfg Apr 2026 · Exp Mar 2025 | D.D. Pharmaceutical Pvt. Ltd. G-1/583Rajasthan | The sample does not conform to IP with respect to the DissolutionDissolution | SDTL, GuwahatiState lab | Sep 2026 |
| Pantoprazole Gastro-resistant Tablets IP 40 mg | Batch ACTD-05Mfg Jan 2026 · Exp Dec 2027 | Nestor Pharmaceuticals LimitedHaryana | The sample received does not conform to i.p. 2022, i.p. addendum 2024 specification with respect to the test for Dissolution (acid stage) onlyDissolution | CDTL, HyderabadCDSCO lab | Sep 2026 |
| Pantoprazole Gastro Resistant Tablets IP 40 mg | Batch THE26003ALMfg Apr 2026 · Exp Mar 2028 | Hindustan Laboratories LimitedMaharashtra | Dissolution TestDissolution | SDTL, Andhra Pradesh, VijayawadaState lab | Sep 2026 |
| Pantoprazole Gastro Resistant Tablets IP 40 mg | Batch PGR018Mfg Nov 2025 · Exp Oct 2027 | RTN Pharma | Test for DissolutionDissolution | DTL, Bengaluru, KarnatakaState lab | Sep 2026 |
| Pantoprazole For Injection I.P. | Batch SPDD-001BMfg Apr 2026 · Exp Mar 2028 | Sai Pharma Pvt. LtdHaryana | The sample does not conform to I.P. in the respect of Assay.Assay | ALIGARH, Uttar PradeshState lab | Sep 2026 |
| Pantoprazole & Domperidone Tablets | Batch SRGT-25971Mfg Nov 2025 · Exp Oct 2027 | Spas RemediseHimachal Pradesh | Test for DisintegrationDisintegration | RDTL, Bellary, KarnatakaState lab | Sep 2026 |
| Pantoprazole Sodium & Domperidone Capsules | Batch SC-2085Mfg Mar 2026 · Exp Feb 2028 | Sidhdeep Biotech (P) Ltd | Assay of Pantoprazole Sodium I.P. and Domperidone I.P.Assay | SFDTL, UttarakhandState lab | Aug 2026 |
| Pantoprazole Gastro-Resistant Tablets IP 40mg | Batch APT-241290Mfg Jan 2025 · Exp Dec 2026 | ABOD PharmaceuticalsUttarakhand | The Sample does not Comply with IP requirements for the Dissolution-B Test.Dissolution | FDAL, MumbaiState lab | Aug 2026 |
| Pantoprazole For Injection I.P. 40 mg | Batch 1250095Mfg Jun 2025 · Exp May 2027 | Agron Remedies Pvt. Ltd. SarverkheraUttarakhand | The sample does not conform to IP in the respect of content of pantoprazole and particulate matter.Particulate matter | ALIGARH LABState lab | Aug 2026 |
| Pantoprazole and Domperidone Tablets | Batch T-241215Mfg Dec 2024 · Exp Nov 2026 | 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 | Batch AN-06-25Mfg Oct 2025 · Exp Sep 2027 | Anchor Pharma Pvt. LtdDaman & Diu | TEST FOR DISINTEGRATION TIMEDisintegration | DTL, DelhiState lab | Jul 2026 |
| Pantoprazole Tablets IP | Batch PEP5001Mfg Feb 2025 · Exp Jan 2027 | Finecure Pharmaceuticals Ltd. PF-5 & 6Gujarat | Dissolution testDissolution | SDT&RL, BhubaneswarState lab | Jul 2026 |
| Pantoprazole Tablets IP | Batch AGW01AKAMfg Sep 2025 · Exp Aug 2027 | Pure & Cure Healthcare Pvt. LtdUttarakhand | The sample does not conform to IP standards. It fails the test Dissolution.Dissolution | DTL, KonniState lab | Jul 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.