Product record

Bromhexine Hcl: batches declared Not of Standard Quality

Last checked 20 September 2026. Source: CDSCO monthly NSQ alerts, Jan 2019, Jul 2026

1 batch of products named "Bromhexine Hcl" (as printed by the testing lab) failed a CDSCO or state drug-testing laboratory test between May 2025 and May 2025. This is a record of specific batches, it does not mean the molecule or every brand is unsafe.

Records by type

1 record linked to Bromhexine Hcl 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
1Failed 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

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 Always check the linked government document for the current position, and tell us if something is out of date.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.

1
NSQ batches
1
Manufacturers
Labelling
Most common reason
May 2025
Latest alert

Flagged batches

Batch Manufacturer Reason declared NSQ Tested by Alert
BRO-2401Mfg 2024-06 · Exp 2027-05 Medibest Pharma Pvt. Ltd. N-31 (1) The label of the received sample Bromhexine Hcl Tabs. IP 8mg (BRONCO), mentions the proper name of the drug whose font size is smaller than the brand name whereas the proper name of the drug should be at least two font size larger than the brand name as prescribed under Rule 96 (1), i (A) of the Drugs and Cosmetics Rules. (2) The name of the received sample mentions as Bromhexine HCL Tabs. IP 8mg, however Bromhexine HCL Tabs IP is an official monograph hence should be labelled as Bromhexine HCL Tabs IPLabelling State lab , PuducherryState lab May 2025

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 July 2026. Check any batch number.