Ingredient record · Epilepsy medicine
Phenytoin: 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 Phenytoin are on India's banned-drugs list, and 1 is banned today. 14 batches of medicines containing Phenytoin failed a government lab test between July 2019 and September 2026, from 11 manufacturers. A failed batch concerns that batch only, not the medicine or every brand.
1
Banned combinations in force
1
Other listed orders (stayed, restricted, quashed)
14
Batches failed a lab test
Sep 2026
Latest lab alert
On the banned-drugs list
Phenytoin 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 |
|---|---|---|---|---|---|
| Phenytoin + Phenobarbitone SodiumFixed-dose combination · other | Banned | S.O. 2405(E) | 2 June 2023 | 14 FDCs · Jun 2023 | Prohibited under s.26A on DTAB/Expert Committee advice; these are 14 of the 15 'pre-1988' FDCs excluded from the 2018 re-ban (Imipramine + Diazepam not included). |
| Phenytoin + Phenobarbitone SodiumFixed-dose combination · other | Under examination | S.O. 1028(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; SC order 15.12.2017 treated it as a pre-1988 FDC, under examination with Expert Committee per CDSCO list as on 22.11.2021 (note 3#). 14 of these 15 were re-prohibited on 02.06.2023 (wave 2023-14). |
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 |
|---|---|---|---|
| Phenytoin Sodium | 8 | 6 | Sep 2026 |
| Phenytoin | 3 | 3 | Jan 2026 |
| Phenytoin Sodium / Ml | 1 | 1 | Aug 2021 |
| Eptoin | 1 | 1 | Nov 2019 |
| Medtoin | 1 | 1 | Nov 2019 |
Most recent failed batches
| Product | Batch | Manufacturer | Reason declared NSQ | Tested by | Alert |
|---|---|---|---|---|---|
| Phenytoin Sodium Tablets I.P 100 mg | Batch T01260980Mfg Jan 2026 · Exp Dec 2027 | Sidhbali FormulationsUttarakhand | DescriptionDescription | RDTL, Hubli, KarnatakaState lab | Sep 2026 |
| Phenytoin Sodium Injection USP 2ml | Batch 33P25002Mfg Sep 2025 · Exp Aug 2027 | Radiant Parenterals LtdGujarat | The sample does not conform to U.S.P. 48 with respect to the Test for Alcohol and Propylene Glycol content (Alcohol content)Other | CDTL, MumbaiCDSCO lab | Jun 2026 |
| Phenytoin Tablets IP 100 mg | Batch T-5616Mfg Apr 2025 · Exp Mar 2027 | Jackson Laboratories Pvt. LtdPunjab | The sample fails in the Test for Description of Tablets.Description | MDTL Kathua, Jammu and KashmirState lab | Jan 2026 |
| Phenytoin Sodium Injection USP-2ml | Batch 45PSA138Mfg May 2024 · Exp Apr 2026 | SPM Drugs (P) Ltd | Sample does not conform to the requirement for assayAssay | King Institute of Preventive Medicine & Research, Guindy, Chennai-32State lab | May 2025 |
| Phenytoin Tablets IP 100 mg | Batch T-1150Mfg Apr 2024 · Exp Mar 2026 | Jackson Laboratories Pvt.Ltd 22-24Punjab | The sample does not conforms w.r.t the test for descriptionDescription | DTL Srinagar (J&K) & MDTL Kathua (J&K)State lab | Feb 2025 |
| Phenytoin Sodium Injection USP | Batch PTS-225AMfg May 2024 · Exp Apr 2026 | Pushkar Pharma | Alcohol Content and Propylene Glycol contentOther | CDL KolkataCDSCO lab | Feb 2025 |
| Phenytoin Sodium Injection USP | Batch HIPY23012CMfg Oct 2023 · Exp Sep 2025 | M/.s Health Biotech LtdHimachal Pradesh | Alcohol, Propylene Glycol and Particulate MatterParticulate matter | RDTL ChandigarhCDSCO lab | Aug 2024 |
| Phenytoin Sodium Tablets IP 100 mg | Batch T-23953Mfg Feb 2021 · Exp Jan 2023 | Jackson Laboratories Pvt. LtdPunjab | DescriptionDescription | RDTL GuwahatiState lab | Jan 2023 |
| PHENYTOIN SODIUM INJECTION USP | Batch PTS-155AMfg Oct 2021 · Exp Sep 2023 | Pushkar PharmaHimachal Pradesh | pHpH | RDTL ChandigarhCDSCO lab | Feb 2022 |
| Phenytoin Sodium Injection 50mg / ml | Batch P0492Mfg Sep 2020 · Exp Aug 2022 | Bharat Parenterals LtdGujarat | pH & VolumepH | CDL KolkataCDSCO lab | Aug 2021 |
| Phenytoin Sodium Tablets I.P. 100 mg | Batch T?18909Mfg Feb 2019 · Exp Jan 2021 | Jackson Laboratories Pvt. LtdPunjab | Assay and DescriptionAssay | CDL KolkataCDSCO lab | Feb 2020 |
| Medtoin (Phenytoin Sodium Tablets I.P.) | Batch SPT190048AMfg Jan 2019 · Exp Dec 2020 | Salus PharmaceuticalsHimachal Pradesh | Description and DisintegrationDescription | CDL KolkataCDSCO lab | Nov 2019 |
| Eptoin 300 ER (Phenytoin Sodium Extended Release Tablets 300 mg) | Batch SDE0020Mfg Mar 2019 · Exp Feb 2021 | Sidmak Laboratories (India) Pvt. LtdUttarakhand | DissolutionDissolution | CDTL MumbaiCDSCO lab | Nov 2019 |
| Phenytoin Oral Suspension I.P. | Batch 8L03129Mfg Apr 2018 · Exp Mar 2020 | Ciron Drugs & Pharmaceuticals Pvt. LtdMaharashtra | AssayAssay | CDL KolkataCDSCO lab | Jul 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.