Manufacturer record
Alkem Health Science: regulatory record
Last checked 3 November 2026. Source: CDSCO monthly NSQ alerts and state drug-testing laboratories
33 batches manufactured by Alkem Health Science (Sikkim) were declared Not of Standard Quality between January 2023 and August 2026. Records are batch-specific findings by government laboratories as published in CDSCO's monthly alerts; where a company has stated that a flagged batch was counterfeit, that statement is noted when reported.
Most recent flagged batch: 25460922, Cefixime Tablets IP (exp Apr 2027). SDTL, Guwhati, Assam (state lab) found it not of standard quality: The sample does not conform to I.P. w.r.to the tests for Dissolution and Assay. Listed in the August 2026 alert.
Records by type
33 records linked to Alkem Health Science 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
33Failed a lab test
0Regulatory notice
Primary government sourceTier 1: government primary source
CDSCO drug alerts: Not of Standard Quality and spurious drugs
Scope. A company appearing here is not a finding that its products are unsafe. 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 Always check the linked government document for the current position, and tell us if something is out of date.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.
33
NSQ batches since 2023
16
Products affected
Assay
Most common failure
Aug 2026
Latest alert
Flagged batches per year
2023 · 132024 · 52025 · 32026 · 12
All flagged batches
| Product | Batch | Reason declared NSQ | Tested by | Alert |
|---|---|---|---|---|
| Cefixime Tablets IP | Batch 25460922Mfg May 2025 · Exp Apr 2027 | The sample does not conform to I.P. w.r.to the tests for Dissolution and AssayAssay | SDTL, Guwhati, AssamState lab | Aug 2026 |
| Amoxicillin and Potassium Clavulanate Tablets IP | Batch 26441735Mfg May 2026 · Exp Oct 2027 | The sample does not conform to IP in respect of Assay of Clavulanic AcidAssay | LUCKNOW LABState lab | Aug 2026 |
| Pantoprazole Gastro-resistant Tablets IP 40 mg | Batch 25444650Mfg Dec 2025 · Exp May 2028 | Identification - Doesn't conforms to I.P.Identification | Lucknow LabState lab | Jul 2026 |
| Pantoprazole Gastro-resistant and Domperidone Prolonged- released Capsules IP | Batch 25441645Mfg May 2025 · Exp Apr 2027 | TESTS FOR ASSAY (CONTENT) OF PANTOPRAZOLE & UNIFORMITY OF WEIGHTAssay | DTL, DelhiState lab | Jul 2026 |
| Telmisartan & Amlodipine Tablets IP | Batch 25440443Mfg Jan 2025 · Exp Dec 2026 | The sample does not conform to I.P. w.r.to the tests for DissolutionDissolution | SDTL, GuwahatiState lab | Jun 2026 |
| Amoxycillin & Potassium Clavulanate Tablets IP | Batch 25442245Mfg Jun 2025 · Exp Nov 2026 | The sample does not conform to I.P. w.r.to the tests for Identification and AssayAssay | SDTL, GuwahatiState lab | Jun 2026 |
| Amoxycillin and Potassium Clavulanate Tablets IP) | Batch 25443747Mfg Sep 2025 · Exp Feb 2027 | The sample does not conform to standard in respect of the test for Assay & Dissolution of Amoxycillin.Assay | SDTL,Govt. of Tripura, AgartalaState lab | May 2026 |
| Amoxycillin and Potassium Clavulanate Tablets IP | Batch 25443966Mfg Oct 2025 · Exp Mar 2027 | The sample does not conform to standard quality in respect of the test for Dissolution of Amoxycillin and Assay for Clavulanic Acid performed.Assay | SDTL,Govt. of Tripura, AgartalaState lab | May 2026 |
| Amoxycillin and Potassium Clavulanate Tablets IP | Batch 25444364Mfg Nov 2025 · Exp Apr 2027 | The sample does not conform to standard quality in respect of the test for Dissolution of Amoxycillin and Assay for Clavulanic Acid performed.Assay | SDTL,Govt. of Tripura, AgartalaState lab | May 2026 |
| Cefixime Tablets IP 200 mg | Batch 25460922Mfg May 2025 · Exp Apr 2027 | The sample does not conform to I.P. w.r.to the tests for Identification and Assay SpuriousAssay | SDTL, AssamState lab | Apr 2026 |
| Calcium & Vitamin D3 Tablets | Batch 24443315Mfg Sep 2024 · Exp Aug 2026 | The sample does not conform to I.P. w.r.to the tests for Dissolution & AssayAssay | SDTL, AssamState lab | Apr 2026 |
| Amoxycillin and Potassium Clavulanate Tablets IP | Batch 25442306Mfg Jun 2025 · Exp Nov 2026 | The sample does not conform to standard quality in respect of the test for ?Dissolution of Amoxycillin and Assay for Clavulanic Acid performed.Assay | SDTL, TripuraState lab | Apr 2026 |
| Amoxycillin & Potassium Clavulanate Tablets IP(CLAVAM 625) | Batch 25441325Mfg Apr 2025 · Exp Sep 2026 | The sample does not conform to standard quality in respect of the test for Dissolution of Amoxycillin performed.Dissolution | SDTL, Govt. of Tripura, Agartala. State- TripuraState lab | Dec 2025 |
| Amoxicillin and Potassium Clavulanate Tablet I.P. (Clavam-625) | Batch 24441792Mfg May 2024 · Exp Oct 2025 | The sample does not conform to I.P. with respect to Identification and content of Amoxicillin and Clavulanic Acid.Identification | BDCL, PATNAState lab | Oct 2025 |
| Ondem-4 [Ondansetro n Tablets IP] | Batch 2444145, 1Mfg Apr 2024 · Exp Mar 2026 | It fails the test dissolution specified in the Laboratory Protocol as per IPDissolution | DTL ThiruvananthapuramState lab | Jan 2025 |
| Pantoprazole Gastro-resistant Tablets IP.. (PAN 40) | Batch 22442076Mfg Jul 2022 · Exp Dec 2024 | Assay and Dissolution in acid stageAssay | RDTL GuwahatiCDSCO lab | Sep 2024 |
| Amoxicillin And Potassium Clavulanate Tablets I.P. (CLAVAM 625) | Batch 23443940Mfg Nov 2023 · Exp Apr 2025 | Identification, Dissolution and Assay of Amoxicillin and Clavulanic AcidAssay | RDTL GuwahatiCDSCO lab | Sep 2024 |
| Pantoprazole Gastro-Resistant and Domperidone Prolonged-Release Capsules IP (Pan - D) | Batch 23444296Mfg Dec 2023 · Exp Nov 2025 | Spurious Identification, Assay, Dissolution & Related SubstanccesAssay | CDL KolkataCDSCO lab | Aug 2024 |
| Amoxicillin And Potassium Clavulanate Tablets IP (Clavam 625) | Batch 23443940Mfg Nov 2023 · Exp Apr 2025 | Spurious Identification & Assay of Amoxycillin Trihydrate & Potassium ClavulanateAssay | CDL KolkataCDSCO lab | Aug 2024 |
| Paracetamol Tablets IP 500 mg (Pyricool 500) | Batch 23444042Mfg Nov 2023 · Exp Oct 2026 | DissolutionDissolution | CDL KolkataCDSCO lab | Feb 2024 |
| Pantoprazole Gastro-resistant Tablets IP (PAN-40) | Batch 22442076Mfg Jul 2022 · Exp Dec 2024 | AssayAssay | RDTL GuwahatiState lab | Dec 2023 |
| Pantoprazole Gastro- resistant Tablets IP (PAN 40) | Batch 23440087Mfg Jan 2023 · Exp Jun 2025 | DissolutionDissolution | CDL KolkataCDSCO lab | Jul 2023 |
| Pantoprazole Gastro- Resistant and Domperidone Prolonged Release Capsules IP (PAN-D) | Batch 23440762Mfg Mar 2023 · Exp Feb 2025 | Identification & Assay of Pantoprazole & Domperidone (Sample is deemed to be Spurious)Assay | CDL KolkataCDSCO lab | Jul 2023 |
| Amoxycillin and Potassium Clavulanate Tablets IP (CLAVAM 625) | Batch 23440774Mfg Mar 2023 · Exp Aug 2024 | Identification & Assay of Amoxycillin and Clavulanic Acid (Sample is deemed to be Spurious)Assay | CDL KolkataCDSCO lab | Jul 2023 |
| Pantoprazole Gastro- Resistant Tablets IP (PAN*40) | Batch 22440483Mfg Feb 2022 · Exp Jul 2024 | Assay of PantoprazoleAssay | RDTL GuwahatiState lab | Jun 2023 |
| PAN 40 (Pantoprazole Gastro- Resistant Tablets I.P.) | Batch 22441073Mfg Apr 2022 · Exp Sep 2024 | Assay of PantoprazoleAssay | RDTL GuwahatiState lab | Jun 2023 |
| CLAVAM 625 (Amoxicillin And Potassium Clavulanate Tablets I.P.) | Batch 22442372Mfg Aug 2022 · Exp Jan 2024 | Identification of Clavulanic Acid and Assay of Amoxicillin and Clavulanic AcidAssay | RDTL GuwahatiState lab | May 2023 |
| PANTOPRAZOLE GESTRO- RESISTANT AND DOMPERIDONE PROLONGED- RELEASE CAPSULES IP PAN-D | Batch 21442024Mfg Jul 2021 · Exp Jun 2023 | Assay of Pantoprazole and DomperidoneAssay | RDTL GuwahatiState lab | Apr 2023 |
| Taxim - O 200 (Cefixime Tablets I.P.) | Batch 22181259Mfg Aug 2022 · Exp Jul 2024 | Identification & AssayAssay | CDL KolkataCDSCO lab | Feb 2023 |
| Pantoprazole Gastro- resistant Tablets IP PAN 40 | Batch 21443328Mfg Nov 2021 · Exp Apr 2024 | Identification & Assay of PantoprazoleAssay | RDTL GuwahatiState lab | Feb 2023 |
| Pan 40 (Pantoprazole Gastro-resistant Tables IP) | Batch 22442631Mfg Sep 2022 · Exp Feb 2025 | DissolutionDissolution | CDL KolkataCDSCO lab | Feb 2023 |
| CLAVAM 625 (Amoxycillin and Potassium Clavulanate Tablets IP) | Batch 22442326Mfg Aug 2022 · Exp Jan 2024 | Identification and AssayAssay | CDL KolkataCDSCO lab | Feb 2023 |
| Montellion-10 (Montelukast Tablets IP 10 mg) | Batch T3092Mfg Oct 2022 · Exp Sep 2024 | AssayAssay | CDL KolkataCDSCO lab | Jan 2023 |
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