Manufacturer record

Samkem 15-B & 10-B: regulatory record

Last checked 20 September 2026. Source: CDSCO monthly NSQ alerts and state drug-testing laboratories

6 batches manufactured by Samkem 15-B & 10-B (Madhya Pradesh) were declared Not of Standard Quality between April 2025 and November 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.

Records by type

6 records linked to Samkem 15-B & 10-B 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
6Failed 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, Apr 2025 to Nov 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 Always check the linked government document for the current position, and tell us if something is out of date.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.

6
NSQ batches since 2025
3
Products affected
Dissolution
Most common failure
Nov 2025
Latest alert

Flagged batches per year

2025 · 6

All flagged batches

Product Batch Reason declared NSQ Tested by Alert
Levosalbutamol Sulphate Syrup 1mg/5ml L24/0639AMfg 2025-03 · Exp 2027-02 The sample received does not conform to manufactures specification with respect to the test for assay only.Assay CDTL,HyderabadCDSCO lab Nov 2025
Bromhexine Hydrochloride Syrup 4mg/5mL L25/0111AMfg 2025-05 · Exp 2027-04 The sample received does not conform to manufactures specification with respect to the test for assay only.Assay CDTL,HyderabadCDSCO lab Nov 2025
Albendazole Tablets IP 400 mg T24/011AMfg 2024-12 · Exp 2026-11 Sample Does not comply in respect of Dissolution Test as per IP.Dissolution State Lab Drugs Control Laboratory, TelanganaState lab Apr 2025
Albendazole Tablet IP 400 mg, T24/007AMfg 2024-12 · Exp 2026-11 Dissolution does not comply as per IP.Dissolution State Lab Drugs Control Laboratory, TelanganaState lab Apr 2025
Albendazole Tablet IP 400 mg, T24/020AMfg 2024-12 · Exp 2026-11 Dissolution does not comply as per IP.Dissolution State Lab Drugs Control Laboratory, TelanganaState lab Apr 2025
Albendazole Tablet IP 400 mg, T24/016AMfg 2024-12 · Exp 2026-11 Dissolution does not comply as per IP.Dissolution State Lab Drugs Control Laboratory, TelanganaState lab Apr 2025

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