Product record

Phenytoin Sodium: batches declared Not of Standard Quality

Last checked 3 November 2026. Source: CDSCO monthly NSQ alerts, Jan 2019 to Sep 2026

8 batches of products named "Phenytoin Sodium" (as printed by the testing lab) failed a CDSCO or state drug-testing laboratory test between February 2020 and September 2026. This is a record of specific batches, it does not mean the molecule or every brand is unsafe.

Records by type

8 records linked to Phenytoin Sodium in the datasets we hold. A zero means nothing is on record in those datasets, not that nothing ever happened. What the labels mean.

0Banned or prohibited
0Recalled or suspended
8Failed a lab test
0Regulatory notice
Primary government sourceTier 1: government primary source

CDSCO drug alerts: Not of Standard Quality and spurious drugs

CDSCO · CDSCO monthly NSQ alerts, Feb 2020 to Sep 2026

View original document

Scope. A failed batch is not a verdict on every pack of this product. Regulatory actions can apply to one batch, one formulation, one period or one state. Always check the linked government document for the current position, and tell us if something is out of date. How we label records.

8
NSQ batches
6
Manufacturers
Assay
Most common reason
Sep 2026
Latest alert

Flagged batches

Batch Manufacturer Reason declared NSQ Tested by Alert
Batch T01260980Mfg Jan 2026 · Exp Dec 2027 Sidhbali FormulationsUttarakhand DescriptionDescription RDTL, Hubli, KarnatakaState lab Sep 2026
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
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
Batch PTS-225AMfg May 2024 · Exp Apr 2026 Pushkar Pharma Alcohol Content and Propylene Glycol contentOther CDL KolkataCDSCO lab Feb 2025
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
Batch T-23953Mfg Feb 2021 · Exp Jan 2023 Jackson Laboratories Pvt. LtdPunjab DescriptionDescription RDTL GuwahatiState lab Jan 2023
Batch PTS-155AMfg Oct 2021 · Exp Sep 2023 Pushkar PharmaHimachal Pradesh pHpH RDTL ChandigarhCDSCO lab Feb 2022
Batch T?18909Mfg Feb 2019 · Exp Jan 2021 Jackson Laboratories Pvt. LtdPunjab Assay and DescriptionAssay CDL KolkataCDSCO lab Feb 2020

How to use this. Match the batch number on your strip or bottle against the list. If your batch is listed, return it to the pharmacy and ask for a replacement; if not, the product is not on any alert as of September 2026. Check any batch number.