Ingredient record · Anti-vomiting medicine
Ondansetron: 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
2 entries containing Ondansetron are on India's banned-drugs list, and 2 are banned today. 54 batches of medicines containing Ondansetron failed a government lab test between March 2019 and September 2026, from 47 manufacturers. A failed batch concerns that batch only, not the medicine or every brand.
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 | 22 | 19 | Aug 2026 |
| Ondansetron Hydrochloride | 5 | 4 | Sep 2026 |
| Ondansetron Orally Disintegrating | 5 | 5 | Mar 2026 |
| Ondansetron /ml | 4 | 4 | May 2026 |
| Ondansetron Orally Disintegration | 2 | 2 | Sep 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 Orally Disintegration Tablets IP | Batch SBT-456Mfg Sep 2025 · Exp Aug 2027 | Sarthak Biotech Pvt. Ltd | The sample does not conform to IP standards. It fails the test Dissolution as per IPDissolution | RDTL , ErnakulamState lab | Sep 2026 |
| Ondansetron Hydrochloride Injection IP | Batch NON 09Mfg Jul 2026 · Exp Jun 2028 | PAR Pharmaceuticals Pvt. LtdUttarakhand | The sample does not conform to I.P. in respect of Particulate Matter & Extractable Volume.Particulate matter | LUCKNOW, Uttar PradeshState lab | Sep 2026 |
| Ondansetron Injection IP | Batch 26ERB36Mfg Feb 2026 · Exp Jan 2028 | Svp Life SciencesHaryana | The sample does not conforms to the IP with respect to Sterility.Sterility | DTL, JaipurState lab | Aug 2026 |
| Ondansetron Tablets IP 4 mg | Batch TB251158Mfg Jan 2026 · Exp Dec 2027 | 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 | Batch TG252335Mfg Nov 2025 · Exp Oct 2027 | Symbiosis Pharmaceuticals Pvt. Ltd. - (Plant-I) Symbiosis HouseHimachal Pradesh | Assay & DissolutionAssay | Lucknow LabState lab | Jul 2026 |
| Ondansetron Orally Disntagrating Tablets IP | Batch SPT252281Mfg Oct 2025 · Exp Sep 2027 | 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 | Batch ST-34645Mfg Oct 2024 · Exp Sep 2026 | Samay Pharma India Pvt. LtdHimachal Pradesh | Disintegration TestDisintegration | Lucknow LabState lab | Jul 2026 |
| Ondansetron Tablets IP | Batch ONST-1006Mfg Jul 2026 · Exp Jun 2027 | 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 | Batch A25BI018CMfg Nov 2025 · Exp Oct 2027 | Nixi Laboratories Pvt. LtdHimachal Pradesh | AssayAssay | King Institute of Preventive Medicine & Research, Guindy, Chennai-32State lab | May 2026 |
| Ondansetron Injection IP-2mg/ml | Batch TON-102Mfg Nov 2025 · Exp Oct 2027 | 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 | Batch TG24-0742Mfg Apr 2024 · Exp Mar 2026 | Athens Life SciencesHimachal Pradesh | Assay, Disintegration & Dissolution.Assay | DTL, JaipurState lab | Mar 2026 |
| Ondansetron Orally Disintegrating Tablets IP 4 mg | Batch OSD-2501Mfg Nov 2025 · Exp Oct 2027 | 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 | Batch ODS3602Mfg Jan 2026 · Exp Dec 2027 | Modern LaboratoriesMadhya Pradesh | pH and AssayAssay | SDTL, TripuraState lab | Mar 2026 |
| Ondansetron Hydrochloride Oral Solution IP | Batch INT-01Mfg Apr 2025 · Exp Mar 2027 | Sresan Pharmaceutical ManufacturerKarnataka | Test for pHpH | DTL, Bengaluru, KarnatakaState lab | Feb 2026 |
| Ondansetron Injection IP | Batch LA24174BMfg Feb 2025 · Exp Jan 2027 | 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 |
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.