Manufacturer record

DUTCH Formulations: regulatory record

Last checked 3 November 2026. Source: CDSCO monthly NSQ alerts and state drug-testing laboratories

3 batches manufactured by DUTCH Formulations (Himachal Pradesh) were declared Not of Standard Quality in May 2025. Records are batch-specific findings by government laboratories as published in CDSCO's monthly alerts; where a company has stated that a flagged batch was counterfeit, that statement is noted when reported.

Most recent flagged batch: DL-136, Ofloxacin and Ornidazole Tablets IP 200 mg+500mg (exp Nov 2026). RDTL, Chandigarh (CDSCO lab) found it not of standard quality: Uniformity of weight, Dissolution of Ornidazole, Dissolution of Ofloxacin and Assay of Ofloxacin and Ornidazole. Listed in the May 2025 alert.

Records by type

3 records linked to DUTCH Formulations 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
3Failed 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, May 2025 to May 2025

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Scope. A company appearing here is not a finding that its products are unsafe. 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 Always check the linked government document for the current position, and tell us if something is out of date.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.

3
NSQ batches since 2025
3
Products affected
Assay
Most common failure
May 2025
Latest alert

Flagged batches per year

2025 · 3

All flagged batches

Product Batch Reason declared NSQ Tested by Alert
Ofloxacin and Ornidazole Tablets IP 200 mg+500mg Batch DL-136Mfg Dec 2024 · Exp Nov 2026 Uniformity of weight, Dissolution of Ornidazole, Dissolution of Ofloxacin and Assay of Ofloxacin and OrnidazoleAssay RDTL, ChandigarhCDSCO lab May 2025
Ofloxacin Tablets IP 200 mg Batch DL-55Mfg Oct 2024 · Exp Sep 2026 Dissolution and Assay of OfloxacinAssay RDTL, ChandigarhCDSCO lab May 2025
Azithromycin Tablets IP 500 mg Batch DL-52Mfg Oct 2024 · Exp Sep 2026 Dissolution, Uniformity of weight and Assay of Azithromycin Dihydrate calculated as AzithromycinAssay RDTL, ChandigarhCDSCO lab May 2025

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