Product record
Bromhexine Hydrochloride /: batches declared Not of Standard Quality
Last checked 3 November 2026. Source: CDSCO monthly NSQ alerts, Jan 2019 to Sep 2026
5 batches of products named "Bromhexine Hydrochloride /" (as printed by the testing lab) failed a CDSCO or state drug-testing laboratory test between February 2024 and January 2026. This is a record of specific batches, it does not mean the molecule or every brand is unsafe.
Records by type
5 records linked to Bromhexine Hydrochloride / in the datasets we hold. A zero means nothing is on record in those datasets, not that nothing ever happened. What the labels mean.
CDSCO drug alerts: Not of Standard Quality and spurious drugs
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 Always check the linked government document for the current position, and tell us if something is out of date.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.
Flagged batches
| Batch | Manufacturer | Reason declared NSQ | Tested by | Alert |
|---|---|---|---|---|
| Batch BHS24002Mfg Mar 2024 · Exp Feb 2027 | Galpha Laboratories LimitedHimachal Pradesh | ContentOther | Drugs Testing Laboratory, Madurai-19State lab | Jan 2026 |
| Batch L25/0111AMfg May 2025 · Exp Apr 2027 | Samkem 15-B & 10-BMadhya Pradesh | The sample received does not conform to manufactures specification with respect to the test for assay only.Assay | CDTL,HyderabadCDSCO lab | Nov 2025 |
| Batch TBH4-015Mfg Mar 2025 · Exp Feb 2028 | J.P. Industries BhudHimachal Pradesh | sample does not conform to I.P. with respect to the "Assay of Bromhexine Hydrochloride".Assay | CDL, KolkataCDSCO lab | Sep 2025 |
| Batch BRO-2401Mfg Jun 2024 · Exp May 2027 | 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 |
| Batch 31413Mfg Aug 2023 · Exp Jul 2025 | Zenith Drugs Pvt. LtdMadhya Pradesh | pH and AssayAssay | CDTL HyderabadCDSCO lab | Feb 2024 |
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.