Product record
Amlodipine Besylate: 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 "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.
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 Always check the linked government document for the current position, and tell us if something is out of date.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 |
|---|---|---|---|---|
| AML-2506Mfg 2025-12 · Exp 2027-11 | 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 |
| TA25-30Mfg 2025-01 · Exp 2026-12 | Om Biomedic Pvt. LtdUttarakhand | The sample does not conform to I.P. w.r.t. the tests for AssayAssay | SDTL, AssamState lab | Mar 2026 |
| 24230171Mfg 2024-08 · Exp 2026-07 | Alkem Laboratories LtdHimachal Pradesh | Incorrect labellingLabelling | DTL, PuducherryState lab | Oct 2025 |
| SPT240321Mfg 2024-02 · Exp 2026-01 | 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 |
| 1125Mfg 2023-11 · Exp 2026-10 | Brilliant Lifesciences Pvt LtdGujarat | DissolutionDissolution | CDTL IndoreCDSCO lab | Apr 2024 |
| PT-31011Mfg 2023-04 · Exp 2025-03 | 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 July 2026. Check any batch number.