Product record

Amlodipine Besylate: 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 "Amlodipine Besylate" (as printed by the testing lab) failed a CDSCO or state drug-testing laboratory test between October 2023 and May 2026. 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 Amlodipine Besylate 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, Oct 2023 to May 2026

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 Always check the linked government document for the current position, and tell us if something is out of date.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

6
NSQ batches
6
Manufacturers
Assay
Most common reason
May 2026
Latest alert

Flagged batches

Batch Manufacturer Reason declared NSQ Tested by Alert
Batch AML-2506Mfg Dec 2025 · Exp Nov 2027 Apple Formulations Pvt. LtdUttarakhand The sample received does not conform to I.P. 2022 with respect to the test for Related substances. other test could not be done due to technical reason.Related substances CDTL, MumbaiCDSCO lab May 2026
Batch TA25-30Mfg Jan 2025 · Exp Dec 2026 Om Biomedic Pvt. LtdUttarakhand The sample does not conform to I.P. w.r.t. the tests for AssayAssay SDTL, AssamState lab Mar 2026
Batch 24230171Mfg Aug 2024 · Exp Jul 2026 Alkem Laboratories LtdHimachal Pradesh Incorrect labellingLabelling DTL, PuducherryState lab Oct 2025
Batch SPT240321Mfg Feb 2024 · Exp Jan 2026 Salus PharmaceuticalsHimachal Pradesh The Sample does not conform to standard in respect of the test for Assay & Uniformity of ContentAssay State Drugs Testing Laboratory, Agartala, TripuraState lab May 2025
Batch 1125Mfg Nov 2023 · Exp Oct 2026 Brilliant Lifesciences Pvt LtdGujarat DissolutionDissolution CDTL IndoreCDSCO lab Apr 2024
Batch PT-31011Mfg Apr 2023 · Exp Mar 2025 Pharmaroots HealthcareHimachal Pradesh Assay of AmlodipineAssay RDTL GuwahatiState lab Oct 2023

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.