Ingredient record · Epilepsy medicine
Sodium valproate: 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 Sodium valproate are on India's banned-drugs list, and 2 are banned today. 28 batches of medicines containing Sodium valproate failed a government lab test between March 2019 and September 2026, from 20 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)
28
Batches failed a lab test
Sep 2026
Latest lab alert
On the banned-drugs list
Sodium valproate 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 |
|---|---|---|---|---|---|
| Divalproex Sodium + OxcarbazepineFixed-dose combination · other | Banned | S.O. 3345(E) | 2 August 2024 | 156 FDCs · Aug 2024 | Prohibited under s.26A; notifications dated 02.08.2024, gazetted 21-22 Aug 2024. |
| Divalproex Sodium + LevetiracitamFixed-dose combination · other | Banned | S.O. 3346(E) | 2 August 2024 | 156 FDCs · Aug 2024 | Prohibited under s.26A; notifications dated 02.08.2024, gazetted 21-22 Aug 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 |
|---|---|---|---|
| Divalproex Sodium | 9 | 5 | Apr 2026 |
| Sodium Valproate Gastro Resistant | 5 | 4 | Sep 2026 |
| Sodium Valproate | 5 | 3 | Nov 2025 |
| Sodium Valproate Valproic Acid Controlled Release | 4 | 4 | Nov 2025 |
| Divalproex | 2 | 1 | Dec 2024 |
| Prolonged Release Sodium Valproate | 1 | 1 | Sep 2022 |
| Valate | 1 | 1 | May 2019 |
| Sodium Valproate Enteric Coated | 1 | 1 | Mar 2019 |
Most recent failed batches
| Product | Batch | Manufacturer | Reason declared NSQ | Tested by | Alert |
|---|---|---|---|---|---|
| Sodium Valproate Gastro-Resistant Tablets IP 200mg | Batch GT501554AMfg Dec 2025 · Exp Nov 2027 | Gnosis Pharmaceuticals Pvt. Ltd. Nahan RoadHimachal Pradesh | DissolutionDissolution | Drug Testing Laboratory, Chennai-6State lab | Sep 2026 |
| Divalproex Sodium Extended-release Tablets IP | Batch N2407172Mfg Jul 2024 · Exp Jun 2026 | Talent HealthcareUttarakhand | The sample does not conform to I.P. for the reason stated under Description.Description | CDL, KolkataCDSCO lab | Apr 2026 |
| Divalproex Sodium Extended-release Tablets IP | Batch N2407173Mfg Jul 2024 · Exp Jun 2026 | Talent HealthcareUttarakhand | The sample does not conform to IP and Manufacturer's specification for the reason stated under Description.Description | CDL, KolkataCDSCO lab | Mar 2026 |
| Sodium Valproate and Valproic Acid Controlled Release Tablets | Batch ST-240134Mfg Jan 2024 · Exp Dec 2025 | Supermax Drugs & Drugs Pharmaceuticals Pvt. Ltd. (Unit-II)Uttarakhand | DescriptionDescription | SDT&RL, BhubaneswarState lab | Nov 2025 |
| Sodium Valproate Tablets IP 300 mg | Batch RG24129TMfg Mar 2024 · Exp Feb 2026 | Rescures LIfe Sciences Ltd. 131-132 EPIP Phase-1Himachal Pradesh | The sample is not of standard quality for the reason stated under "Description" of the tablets.Description | RDTL, GuwahatiCDSCO lab | Nov 2025 |
| Sodium Valproate Gastro-resistant Tablets I.P. 200 mg. | Batch 425-263Mfg Jan 2025 · Exp Dec 2026 | Zee Laboratories Ltd. Behind 47Himachal Pradesh | The sample is not of standard quality for the reason stated under "Description" of the tablets.Description | RDTL, GuwahatiCDSCO lab | Nov 2025 |
| Sodium Valproate Gastro resistant Tablets IP 200 mg. | Batch 03637Mfg Mar 2024 · Exp Feb 2026 | Healthy Life Pharma Pvt. Ltd. Factory : N ? 31/1Maharashtra | The sample is not of standard quality for the reason stated under "Description" of the tablets.Description | RDTL, GuwahatiCDSCO lab | Nov 2025 |
| Sodium Valproate & Valproic Acid Controlled Release Tablets | Batch ADT25196BMfg Jan 2025 · Exp Dec 2026 | Astonea Labs Pvt. LtdHaryana | The sample does not conform to claim as per Patent and Proprietary in respect to the Assay of Sodium ValproateAssay | RDTL,ChandigarhCDSCO lab | Nov 2025 |
| Divalproex Sodium Extended-release Tablets IP | Batch N2309085Mfg Sep 2023 · Exp Aug 2025 | Talent Healthcare 66-67Uttarakhand | DescriptionDescription | CDL, KolkataCDSCO lab | Aug 2025 |
| Divalproex Sodium Extended-release Tablets IP | Batch N2309086Mfg Sep 2023 · Exp Aug 2025 | Talent Healthcare 66-67Uttarakhand | DescriptionDescription | CDL, KolkataCDSCO lab | Aug 2025 |
| Divalproex Extended Release Tablets IP (JKMSCL Hospital Supply not for sale) | Batch 2406031Mfg Jun 2024 · Exp May 2026 | Biodeal Pharmaceuticals Pvt. LtdHimachal Pradesh | Uniformity of WeightsUniformity of weight/content | DTL Srinagar (J&K) & MDTL Kathua (J&K)State lab | Dec 2024 |
| Divalproex Extended Release Tablets IP (JKMSCL Hospital Supply not for sale) | Batch 2407185Mfg Jul 2024 · Exp Jun 2026 | Biodeal Pharmaceuticals Pvt. LtdHimachal Pradesh | Uniformity of WeightsUniformity of weight/content | DTL Srinagar (J&K)State lab | Dec 2024 |
| Divalproex Sodium Tablets IP 500 mg | Batch D2306Mfg Dec 2023 · Exp Nov 2026 | Smith & Kenner Pharmaceuticals Pvt.Ltd | NOT OF STANDARD QUALITY 1. The coating is not uniform and rough surface is observed on the whole tablet, hence description does not complies as per IP. 2. The dissolution test parameter doees not complies as per manufacturing method of analysis, hence the drug Divalproex sodium is of Not of Standard Quality with respect to Description and Dissolution test parameter.Dissolution | State Lab Drugs Control Laboratory, TelanganaState lab | Nov 2024 |
| Tablets, Divalproex Sodium SR Tablets 500 mg | Batch TMT-0211Mfg Jun 2024 · Exp May 2026 | Tas Med (India) Pvt.ltdHimachal Pradesh | MISBRANDED The drug product Divalproex Sodium SR Tablets is official in the currect edition of IP 2022. and as required as per second schedule of the Drugs and cosmetics Act, 1940, the said drug product shall comply with the standards set out in the Indian Pharmacopoeia. But the designation IP in conjunctin with the official title Divalproex Sodium SR Tablets on the label of the drug product was not mentioned as an indication that the drug product purports to comply with IP standrds. Hence the drug product shall be deemed to be MISBRANDED DRUG as per Section 17 of the drug and Cosmetics Act 1940 as it not labeled in the prescribed mannerMisbranded | State Lab Drugs Control Laboratory, TelanganaState lab | Oct 2024 |
| Divalproex Sodium SR Tablets 500 mg | Batch TMT-0164Mfg Jun 2024 · Exp May 2024 | Tas Med (India) Pvt.ltdHimachal Pradesh | MISBRANDED The drug product Divalproex Sodium SR Tablets is official in the currect edition of IP 2022. and as required as per second schedule of the Drugs and cosmetics Act, 1940, the said drug product shall comply with the standards set out in the Indian Pharmacopoeia. But the designation IP in conjunctin with the official title Divalproex Sodium SR Tablets on the label of the drug product was not mentioned as an indication that the drug product purports to comply with IP standrds. Hence the drug product shall be deemed to be MISBRANDED DRUG as per Section 17 of the drug and Cosmetics Act 1940 as it not labeled in the prescribed mannerMisbranded | State Lab Drugs Control Laboratory, TelanganaState lab | Oct 2024 |
Showing 15 of 28 records
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