Product record
Ambroxol Hydrochloride /: batches declared Not of Standard Quality
Last checked 20 September 2026. Source: CDSCO monthly NSQ alerts, Jan 2019, Jul 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 Always check the linked government document for the current position, and tell us if something is out of date.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 |
|---|---|---|---|---|
| 724559Mfg 2024-12 · Exp 2026-11 | 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 |
| 724543Mfg 2024-11 · Exp 2026-10 | 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 |
| 724373Mfg 2024-09 · Exp 2026-08 | 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 |
| GF296Mfg 2023-12 · Exp 2025-11 | Global FormulationsTelangana | Weight per mlWeight | CDTL HyderabadCDSCO lab | Jan 2024 |
| AML3035Mfg 2023-07 · Exp 2025-06 | Caplet India Pvt. LtdWest Bengal | DescriptionDescription | CDL KolkataCDSCO lab | Oct 2023 |
| AMB E18001 1219Mfg 2019-12 · Exp 2022-11 | 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 July 2026. Check any batch number.