Ingredient record · Acid reducer (proton pump inhibitor)
Esomeprazole: 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
1 entry containing Esomeprazole is on India's banned-drugs list, and 0 are banned today. 14 batches of medicines containing Esomeprazole failed a government lab test between February 2019 and June 2026, from 11 manufacturers. A failed batch concerns that batch only, not the medicine or every brand.
0
Banned combinations in force
1
Other listed orders (stayed, restricted, quashed)
14
Batches failed a lab test
Jun 2026
Latest lab alert
On the banned-drugs list
Esomeprazole 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 375mg + Esomeprazole Magnesium Trihydrate IP 20mg Hard Gelatin Capsules or TabletsFixed-dose combination · gi | Restricted | S.O. 3266(E) | 12 August 2024 | Other orders | Restricted (regulated with conditions), not prohibited, CDSCO 'List of 02 Restricted FDC drugs dated 12.08.2024'. |
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 |
|---|---|---|---|
| Esomeprazole | 6 | 5 | Jun 2026 |
| Esomeprazole Magnesium | 1 | 1 | Jun 2026 |
| Esomeprazole Itopride Hydrochloride | 1 | 1 | Dec 2025 |
| Esomeprazole Magnesisumtri Hydrate Levosulpiride | 1 | 1 | Nov 2024 |
| Esomeprazole Gastro Resistant | 1 | 1 | Jun 2024 |
| Esolip Esomeprazole Gastro Resistant | 1 | 1 | Oct 2022 |
| Esomeprazole Domperidone | 1 | 1 | Mar 2022 |
| Ewit Dsr Domperidone | 1 | 1 | Jul 2019 |
| Esopen | 1 | 1 | Feb 2019 |
Most recent failed batches
| Product | Batch | Manufacturer | Reason declared NSQ | Tested by | Alert |
|---|---|---|---|---|---|
| Esomeprazole Tablets IP | ZRST-3430Mfg 2026-02 · Exp 2028-01 | ZRS Pharmaceuticals India Pvt. LtdHimachal Pradesh | Sample does not conform to IP Standards. If fails the tests Assay and Dissolution as per IPAssay | DTL, TVMState lab | Jun 2026 |
| Esomeprazole Magnesium Tablets IP 40mg | VGT250168Mfg 2025-09 · Exp 2028-08 | Vapi Care Pharma Pvt. LtdGujarat | The sample does not conform to claim as per IP 2022 and Addendum 2024 in respect to the test of Dissolution (Buffer Stage).Dissolution | RDTL, ChandigarhCDSCO lab | Jun 2026 |
| Esomeprazole | VGT230127Mfg 2023-06 · Exp 2026-05 | Vapi Care Pharma Pvt. LtdGujarat | Dissolution test under buffer stageDissolution | SDT&RL, BhubaneswarState lab | May 2026 |
| Esomeprazole Tablets IP | ZTF-037AMfg 2025-06 · Exp 2027-05 | Zoic Biotech Pvt .LtdPunjab | The sample fails the test 'Dissolution' as per IPDissolution | DTL KonniState lab | Apr 2026 |
| Esomeprazole Tablets IP | AYT070385Mfg 2025-07 · Exp 2027-06 | Adwin PharmaHimachal Pradesh | The sample does not conform to IP 2022 requirements w.r.t Dissolution TestDissolution | DTL,Dalgate Srinagar kashmirState lab | Apr 2026 |
| Esomeprazole (EC) & Itopride Hydrochloride Capsule | PGC25-08Mfg 2025-03 · Exp 2027-02 | Plena Remedies | The sample does not conforms to the claim with respect to Assay of EsomeprazoleAssay | DTL, UdaipurState lab | Dec 2025 |
| Esomeprazole MagnesisumTri hydrate (EC) &Levosulpiride (SR) Capsules (ESODENSE-L Capsules) | CPC-0072Mfg 2023-08 · Exp 2025-07 | CycusPharmaHimachal Pradesh | Dissolution and Assay of LevosulpirideAssay | RDTL GuwahatiCDSCO lab | Nov 2024 |
| Esomeprazole Tablets IP 40 mg (Essokynt-40) | TT23-505Mfg 2023-07 · Exp 2025-06 | Tanishka Pharmaceuticals Pvt. LtdHimachal Pradesh | Dissolution (Buffer Stage)Dissolution | RDTL GuwahatiCDSCO lab | Oct 2024 |
| Esomeprazole Gastro- Resistant Tablets IP 40 mg (Esomedge- 40) | GD23083Mfg 2023-07 · Exp 2025-06 | GlenSmith Labs Private LimitedUttarakhand | DissolutionDissolution | CDL KolkataCDSCO lab | Jun 2024 |
| Esolip 40 (Esomeprazole Gastro-Resistant Tablets IP 40 mg) | TGD210190Mfg 2021-03 · Exp 2023-02 | Dm Pharma Private LimitedHimachal Pradesh | AssayAssay | RDTL GuwahatiState lab | Oct 2022 |
| Esomeprazole with Domperidone Tablets (ESSOF-D TABLETS) | APT-10-1524Mfg 2021-10 · Exp 2023-09 | Adwin PharmaHimachal Pradesh | AssayAssay | RDTL ChandigarhState lab | Mar 2022 |
| Esomeprazole Tablets IP (ESSOF- 20 TABLETS) | APT-07-0596Mfg 2021-07 · Exp 2023-06 | Adwin PharmaHimachal Pradesh | DissolutionDissolution | RDTL ChandigarhState lab | Feb 2022 |
| Ewit-DSR Capsules (Esomeprazole- 40mg (E.C) & Domperidone 30 mg (SR) Capsules) | C-6601Mfg 2018-08 · Exp 2020-07 | A.S. LifesciencesHaryana | Dissolution for EsomeprazoleDissolution | CDTL MumbaiCDSCO lab | Jul 2019 |
| Esopen ? 20 (Esomeprazole Tablets I.P.) | NT-171147Mfg 2017-11 · Exp 2019-10 | Gracure Pharmaceuticals LtdHimachal Pradesh | DissolutionDissolution | CDSCO, South Zone, ChennaiState lab | Feb 2019 |
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.