Product record
Ambroxol Hydrochloride: batches declared Not of Standard Quality
Last checked 3 November 2026. Source: CDSCO monthly NSQ alerts, Jan 2019 to Sep 2026
6 batches of products named "Ambroxol Hydrochloride" (as printed by the testing lab) failed a CDSCO or state drug-testing laboratory test between February 2020 and April 2025. This is a record of specific batches, it does not mean the molecule or every brand is unsafe.
Records by type
6 records linked to Ambroxol 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 Always check the linked government document for the current position, and tell us if something is out of date.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 724559Mfg Dec 2024 · Exp Nov 2026 | Syndicate Pharma 185/BMadhya Pradesh | Misbranded The drug failed to indicate the common name of the colour, used in the drug, on the product label, as required under Rule 127(2) of the Drugs Rules, 1945. The label merely states Approved Colour Used. Hence, the drug is deemed to be Misbranded under Section 17 of the Drugs and Cosmetics Act, 1940, as it is not labeled in the prescribed manner.Misbranded | State Lab Drugs Control Laboratory, TelanganaState lab | Apr 2025 |
| Batch 724543Mfg Nov 2024 · Exp Oct 2026 | By: Syndicate Pharma 185/BMadhya Pradesh | Misbranded The drug failed to indicate the common name of the colour, used in the drug, on the product label, as required under Rule 127(2) of the Drugs Rules, 1945. The label merely states Approved Colour Used. Hence, the drug is deemed to be Misbranded under Section 17 of the Drugs and Cosmetics Act, 1940, as it is not labeled in the prescribed manner.Misbranded | State Lab Drugs Control Laboratory, TelanganaState lab | Apr 2025 |
| Batch 724373Mfg Sep 2024 · Exp Aug 2026 | Syndicate Pharma 185/B/185/B-1Madhya Pradesh | MISBRANDED The drug sample is deemed to be MISBRANDED as it is only indicated as approved colour used on the label of the product but failed to indicate the comon name of the colour on the label as required as per Rule 127(2) of Drugs Rules, 1945. Hence the drug is deemed to be Misbranded as per Section 17 of Drugs and Cosmetics Act, 1940, as the drug is not labeled in the prescribed manner.Misbranded | State Lab Drugs Control Laboratory, TelanganaState lab | Nov 2024 |
| Batch GF296Mfg Dec 2023 · Exp Nov 2025 | Global FormulationsTelangana | Weight per mlWeight | CDTL HyderabadCDSCO lab | Jan 2024 |
| Batch AML3035Mfg Jul 2023 · Exp Jun 2025 | Caplet India Pvt. LtdWest Bengal | DescriptionDescription | CDL KolkataCDSCO lab | Oct 2023 |
| Batch AMB E18001 1219Mfg Dec 2019 · Exp Nov 2022 | Anuh Pharma LtdMaharashtra | Assay & Related SubstancesAssay | CDTL MumbaiState 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.