Ingredient record · Anti-vomiting medicine
Ondansetron: 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
2 entries containing Ondansetron are on India's banned-drugs list, and 2 are banned today. 51 batches of medicines containing Ondansetron failed a government lab test between March 2019 and July 2026, from 44 manufacturers. A failed batch concerns that batch only, not the medicine or every brand.
2
Banned combinations in force
0
Other listed orders (stayed, restricted, quashed)
51
Batches failed a lab test
Jul 2026
Latest lab alert
On the banned-drugs list
Ondansetron 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 |
|---|---|---|---|---|---|
| Ondansetron + ParacetamolFixed-dose combination · gi | Banned | S.O. 202(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. |
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 |
|---|---|---|---|
| Ondansetron | 21 | 18 | Jul 2026 |
| Ondansetron Orally Disintegrating | 5 | 5 | Mar 2026 |
| Ondansetron /ml | 4 | 4 | May 2026 |
| Ondansetron Hydrochloride | 4 | 3 | Mar 2026 |
| Ondansetron Orally Disintegration | 1 | 1 | Jul 2026 |
| Ondansetron Orally Disntagrating | 1 | 1 | Jul 2026 |
| Ondansetron M Set | 1 | 1 | May 2026 |
| Ondansetron Anset | 1 | 1 | Dec 2025 |
| Ondansetron Ranitidine Hci Vomibac R | 1 | 1 | Dec 2025 |
| Ondansetron Orally Disintegratin | 1 | 1 | Aug 2025 |
| Zyset Md | 1 | 1 | Jul 2025 |
| Onvin Md Ondansetron Orally Disintegrating | 1 | 1 | Jun 2025 |
| Emiral Od Ondansetron Orally Disintegrating | 1 | 1 | Apr 2025 |
| Onkam | 1 | 1 | Oct 2022 |
| Ondansetron Onet | 1 | 1 | May 2022 |
| Resent | 1 | 1 | Dec 2021 |
| Ontic | 1 | 1 | Jan 2021 |
| Auditon Md | 1 | 1 | Jun 2020 |
| Setnorm | 1 | 1 | Jun 2020 |
| Onstal | 1 | 1 | May 2020 |
| Vomiros Md | 1 | 1 | Apr 2019 |
Most recent failed batches
| Product | Batch | Manufacturer | Reason declared NSQ | Tested by | Alert |
|---|---|---|---|---|---|
| Ondansetron Tablets IP 4 mg | TB251158Mfg 2026-01 · Exp 2027-12 | Agron Remedies Pvt. Ltd | The sample received does not conform to i.p. 2022, ip addendum 2024 specification with respect to the test for related substances (total impurities) only.Related substances | CDTL, HyderabadCDSCO lab | Jul 2026 |
| Ondansetron Tablets IP 4 mg | TG252335Mfg 2025-11 · Exp 2027-10 | Symbiosis Pharmaceuticals Pvt. Ltd. - (Plant-I) Symbiosis HouseHimachal Pradesh | Assay & DissolutionAssay | Lucknow LabState lab | Jul 2026 |
| Ondansetron Orally Disntagrating Tablets IP | SPT252281Mfg 2025-10 · Exp 2027-09 | Salus PharmaceuticalsHimachal Pradesh | The sample has been declared as NSQ as it does not conform to IP standard with respect to Test for DisintegrationDisintegration | RDTL. Bellary KarnatakaState lab | Jul 2026 |
| Ondansetron Orally Disintegration Tablets IP | ST-34645Mfg 2024-10 · Exp 2026-09 | Samay Pharma India Pvt. LtdHimachal Pradesh | Disintegration TestDisintegration | Lucknow LabState lab | Jul 2026 |
| Ondansetron Tablets IP | ONST-1006Mfg 2026-07 · Exp 2027-06 | Wings Biotech LLPHimachal Pradesh | The sample does not conform to claim as per IP 2022 and Addendum 2024 in respect to the test of Dissolution.Dissolution | RDTL, ChandigarhCDSCO lab | May 2026 |
| Ondansetron Injection IP-2ml M-SET | A25BI018CMfg 2025-11 · Exp 2027-10 | Nixi Laboratories Pvt. LtdHimachal Pradesh | AssayAssay | King Institute of Preventive Medicine & Research, Guindy, Chennai-32State lab | May 2026 |
| Ondansetron Injection IP-2mg/ml | TON-102Mfg 2025-11 · Exp 2027-10 | Marc Laboratories Ltd. (Unit III)Himachal Pradesh | pHpH | King Institute of Preventive Medicine & Research, Guindy, Chennai-32State lab | May 2026 |
| Ondansetron Orally Disintegrating Tablets IP 8mg | TG24-0742Mfg 2024-04 · Exp 2026-03 | Athens Life SciencesHimachal Pradesh | Assay, Disintegration & Dissolution.Assay | DTL, JaipurState lab | Mar 2026 |
| Ondansetron Orally Disintegrating Tablets IP 4 mg | OSD-2501Mfg 2025-11 · Exp 2027-10 | Apple Formulations Pvt. LtdUttarakhand | The sample does not conform to I.P.w.r.t. the tests for AssayAssay | SDTL, AssamState lab | Mar 2026 |
| Ondansetron Hydrochloride Oral Solution IP | ODS3602Mfg 2026-01 · Exp 2027-12 | Modern LaboratoriesMadhya Pradesh | pH and AssayAssay | SDTL, TripuraState lab | Mar 2026 |
| Ondansetron Hydrochloride Oral Solution IP | INT-01Mfg 2025-04 · Exp 2027-03 | Sresan Pharmaceutical ManufacturerKarnataka | Test for pHpH | DTL, Bengaluru, KarnatakaState lab | Feb 2026 |
| Ondansetron Injection IP | LA24174BMfg 2025-02 · Exp 2027-01 | Symbiosis Pharmaceuticals Pvt. LtdHimachal Pradesh | The sample does not comply as per I.P. 2022 with respect to the test for Sterility and BETSterility | RDTL,GuwahatiCDSCO lab | Jan 2026 |
| Ondansetron and Ranitidine HCI Injection Vomibac R Injection | 110525Mfg 2025-05 · Exp 2027-04 | Pharma Chemico Laboratories DevghatHimachal Pradesh | The sample received does not conform to manufacturer specification with respect to The test for pH only.pH | CDTL-HyderabadCDSCO lab | Dec 2025 |
| Ondansetron Tablets IP Anset Tablets | RBMT-921Mfg 2025-09 · Exp 2028-08 | Ronald Pharmaceuticals (P) Ltd. B.No. 740-AGujarat | The sample does not conform to I.P. 2022 with respect to The test for Related substances.Related substances | CDTL, MumbaiCDSCO lab | Dec 2025 |
| Ondansetron Oral Solution IP | K3ADY003Mfg 2025-04 · Exp 2027-03 | Copmed Pharmaceuticals Pvt.LtdHimachal Pradesh | pHpH | DCL, TelanganaState lab | Sep 2025 |
Showing 15 of 51 records
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