Manufacturer record
Alkem Health Science: regulatory record
Last checked 20 September 2026. Source: CDSCO monthly NSQ alerts and state drug-testing laboratories
29 batches manufactured by Alkem Health Science (Sikkim) were declared Not of Standard Quality between January 2023 and July 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.
Records by type
29 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
29Failed 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 Always check the linked government document for the current position, and tell us if something is out of date.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.
29
NSQ batches since 2023
15
Products affected
Assay
Most common failure
Jul 2026
Latest alert
Flagged batches per year
2023 · 122024 · 52025 · 32026 · 9
All flagged batches
| Product | Batch | Reason declared NSQ | Tested by | Alert |
|---|---|---|---|---|
| Pantoprazole Gastro-resistant Tablets IP 40 mg | 25444650Mfg 2025-12 · Exp 2028-05 | Identification - Doesn't conforms to I.P.Identification | Lucknow LabState lab | Jul 2026 |
| Pantoprazole Gastro-resistant and Domperidone Prolonged- released Capsules IP | 25441645Mfg 2025-05 · Exp 2027-04 | TESTS FOR ASSAY (CONTENT) OF PANTOPRAZOLE & UNIFORMITY OF WEIGHTAssay | DTL, DelhiState lab | Jul 2026 |
| Amoxycillin & Potassium Clavulanate Tablets IP | 25442245Mfg 2025-06 · Exp 2026-11 | 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) | 25443747Mfg 2025-09 · Exp 2027-02 | 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 | 25443966Mfg 2025-10 · Exp 2027-03 | 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 | 25444364Mfg 2025-11 · Exp 2027-04 | 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 | 25460922Mfg 2025-05 · Exp 2027-04 | 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 | 24443315Mfg 2024-09 · Exp 2026-08 | 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 | 25442306Mfg 2025-06 · Exp 2026-11 | 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) | 25441325Mfg 2025-04 · Exp 2026-09 | 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) | 24441792Mfg 2024-05 · Exp 2025-10 | 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] | 2444145 1Mfg 2024-04 · Exp 2026-03 | 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) | 22442076Mfg 2022-07 · Exp 2024-12 | Assay and Dissolution in acid stageAssay | RDTL GuwahatiCDSCO lab | Sep 2024 |
| Amoxicillin And Potassium Clavulanate Tablets I.P. (CLAVAM 625) | 23443940Mfg 2023-11 · Exp 2025-04 | 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) | 23444296Mfg 2023-12 · Exp 2025-11 | Spurious Identification, Assay, Dissolution & Related SubstanccesAssay | CDL KolkataCDSCO lab | Aug 2024 |
| Amoxicillin And Potassium Clavulanate Tablets IP (Clavam 625) | 23443940Mfg 2023-11 · Exp 2025-04 | Spurious Identification & Assay of Amoxycillin Trihydrate & Potassium ClavulanateAssay | CDL KolkataCDSCO lab | Aug 2024 |
| Paracetamol Tablets IP 500 mg (Pyricool 500) | 23444042Mfg 2023-11 · Exp 2026-10 | DissolutionDissolution | CDL KolkataCDSCO lab | Feb 2024 |
| Pantoprazole Gastro-resistant Tablets IP (PAN-40) | 22442076Mfg 2022-07 · Exp 2024-12 | AssayAssay | RDTL GuwahatiState lab | Dec 2023 |
| Pantoprazole Gastro- resistant Tablets IP (PAN 40) | 23440087Mfg 2023-01 · Exp 2025-06 | DissolutionDissolution | CDL KolkataCDSCO lab | Jul 2023 |
| Pantoprazole Gastro- Resistant and Domperidone Prolonged Release Capsules IP (PAN-D) | 23440762Mfg 2023-03 · Exp 2025-02 | 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) | 23440774Mfg 2023-03 · Exp 2024-08 | 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) | 22440483Mfg 2022-02 · Exp 2024-07 | Assay of PantoprazoleAssay | RDTL GuwahatiState lab | Jun 2023 |
| PAN 40 (Pantoprazole Gastro- Resistant Tablets I.P.) | 22441073Mfg 2022-04 · Exp 2024-09 | Assay of PantoprazoleAssay | RDTL GuwahatiState lab | Jun 2023 |
| PANTOPRAZOLE GESTRO- RESISTANT AND DOMPERIDONE PROLONGED- RELEASE CAPSULES IP PAN-D | 21442024Mfg 2021-07 · Exp 2023-06 | Assay of Pantoprazole and DomperidoneAssay | RDTL GuwahatiState lab | Apr 2023 |
| Taxim - O 200 (Cefixime Tablets I.P.) | 22181259Mfg 2022-08 · Exp 2024-07 | Identification & AssayAssay | CDL KolkataCDSCO lab | Feb 2023 |
| Pantoprazole Gastro- resistant Tablets IP PAN 40 | 21443328Mfg 2021-11 · Exp 2024-04 | Identification & Assay of PantoprazoleAssay | RDTL GuwahatiState lab | Feb 2023 |
| Pan 40 (Pantoprazole Gastro-resistant Tables IP) | 22442631Mfg 2022-09 · Exp 2025-02 | DissolutionDissolution | CDL KolkataCDSCO lab | Feb 2023 |
| CLAVAM 625 (Amoxycillin and Potassium Clavulanate Tablets IP) | 22442326Mfg 2022-08 · Exp 2024-01 | Identification and AssayAssay | CDL KolkataCDSCO lab | Feb 2023 |
| Montellion-10 (Montelukast Tablets IP 10 mg) | T3092Mfg 2022-10 · Exp 2024-09 | AssayAssay | CDL KolkataCDSCO lab | Jan 2023 |
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