Brand check
Is Clavam 625 banned in India?
Last checked 19 September 2026. A few details are still being checked against the original document.
Clavam 625 is not banned in India as of 19 Sep 2026; the batch 23443940 flagged by CDSCO in its August 2024 alert was described by Alkem as spurious and not manufactured by the company.
- Classification
- No ban or recall found in official records
- Decided by
- CDSCO / Ministry of Health and Family Welfare
- Reference
- No Section 26A notification; CDSCO monthly drug alert, Aug 2024 (published 27 Sep 2024)
- Latest action
- 1 May 2026
- Last checked
- 19 September 2026details being verified
Amoxicillin 500 mg capsules. Photo: Amoxicillin 500mg capsules on a plate (Sandoz).jpg by Henrysz (CC BY 4.0). Brand names and logos belong to their owners and are used here to identify the product this entry is about. All photo credits.
Medical Dialogues: Drugs in CDSCO samples counterfeit, not ours, say leading pharma companies
We have not yet found this action in a published government document. Treat it as reported, not confirmed. If you have the order, send it to us.
Scope. A record here does not by itself mean a product or company is unsafe or banned today. 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 Always check the linked government document for the current position, and tell us if something is out of date.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.
Below: Blacklisted's explanationWe explain what has been reported. The report above is the best source we hold.
Key facts
- Governing authority
- CDSCO, Ministry of Health and Family Welfare
- Ban notification
- None; amoxicillin + clavulanate is an essential medicine
- Flagged batch
- 23443940: CDSCO Aug 2024 alert (NSQ); Alkem: 'spurious, not manufactured by Alkem'
- Later amoxyclav findings
- Spurious amoxyclav batch 25440617 (Feb 2026); spurious batch from Apex Formulation and NSQ batches from Sun, Medreich, Alkem (May 2026)
- Manufacturer
- Alkem Laboratories
Where the claim comes from
In September 2024 the CDSCO's alert for August samples listed a Clavam 625 batch as not of standard quality alongside Pan-D, Shelcal 500 and other well-known brands. Alkem, Sun Pharma and Torrent all said the flagged packs were counterfeit and not made by them. Headlines said 'Clavam 625 fails quality test' and the story circulated as a ban. Later amoxyclav findings in 2026 kept it alive.
Clavam 625 is Alkem's brand of amoxicillin with clavulanic acid, one of the most prescribed antibiotics in India. It is not banned. Amoxicillin + clavulanate is on the National List of Essential Medicines and has never been the subject of a Section 26A notification.
The brand became news through the CDSCO's monthly quality alerts. The alert for August 2024, published on 27 September 2024, listed Clavam 625 batch 23443940 among 48 "not of standard quality" and 4 spurious samples. Alkem responded that the batch was spurious and not manufactured by the company, in other words, a counterfeit carrying its name. The same alert produced identical statements from Sun Pharma, Torrent and Glenmark about their brands, and the Indian Pharmaceutical Alliance complained that publishing counterfeit findings under legitimate brand names damages the companies.
Amoxicillin + clavulanate keeps appearing in the alerts because it is so widely made and so widely faked. The February 2026 alert declared an amoxyclav batch, 25440617, spurious. The May 2026 alert listed NSQ batches from Sun Pharma, Medreich and Alkem and a spurious batch from a firm named Apex Formulation.
None of this changes the drug's status. A batch-level finding means the sample tested did not meet the pharmacopoeial standard or was not what its label claimed. The practical response is to buy from a licensed pharmacy, keep the bill and check the batch number against the alerts.
What this means for you
The antibiotic is not withdrawn
Clavam 625 and other amoxicillin + clavulanate products are licensed and widely used.
Read the two statements side by side
CDSCO's finding is batch-specific. The company says the batch was not made by it, i.e. counterfeit. Both can be true: someone else made a fake pack with the brand's name.
Buy from a licensed pharmacy and keep the strip
Fakes reach the market through informal channels; a bill and a batch number let you check against CDSCO alerts.
This is a record of official orders, not medical advice. Do not stop a prescribed medicine without asking your doctor or pharmacist.
Batches flagged in CDSCO alerts
Products whose name matches this brand or molecule in CDSCO monthly NSQ alerts. A flagged batch is a single batch; the company's response, where reported, is noted on the page above.
| Product | Batch | Manufacturer | Reason declared NSQ | Tested by | Alert |
|---|---|---|---|---|---|
| Amoxycillin & Potassium Clavulanate Tablets IP(CLAVAM 625) | 25441325Mfg 2025-04 · Exp 2026-09 | Alkem Health ScienceSikkim | 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 | Alkem Health ScienceSikkim | 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 |
| Amoxycillin & Potassium Clavulanate Tablets I.P. (Amoxyclav 625) | MFK0076Mfg 2024-02 · Exp 2026-01 | Medicef Pharma. Plot No. 28Himachal Pradesh | Identification and Assay of Amoxycillin and Clavulanic Acid.Assay | CDL, KolkataCDSCO lab | Jul 2025 |
| Amoxicillin And Potassium Clavulanate Tablets I.P. (CLAVAM 625) | 23443940Mfg 2023-11 · Exp 2025-04 | Alkem Health ScienceSikkim | Identification, Dissolution and Assay of Amoxicillin and Clavulanic AcidAssay | RDTL GuwahatiCDSCO lab | Sep 2024 |
| Amoxicillin And Potassium Clavulanate Tablets IP (Clavam 625) | 23443940Mfg 2023-11 · Exp 2025-04 | Alkem Health ScienceSikkim | Spurious Identification & Assay of Amoxycillin Trihydrate & Potassium ClavulanateAssay | CDL KolkataCDSCO lab | Aug 2024 |
| Amoxycillin and Potassium Clavulanate Tablets IP (CLAVAM 625) | 23440774Mfg 2023-03 · Exp 2024-08 | Alkem Health ScienceSikkim | Identification & Assay of Amoxycillin and Clavulanic Acid (Sample is deemed to be Spurious)Assay | CDL KolkataCDSCO lab | Jul 2023 |
| CLAVAM 625 (Amoxicillin And Potassium Clavulanate Tablets I.P.) | 22442372Mfg 2022-08 · Exp 2024-01 | Alkem Health Science (Unit of Alkem Laboratories Ltd.)Sikkim | Identification of Clavulanic Acid and Assay of Amoxicillin and Clavulanic AcidAssay | RDTL GuwahatiState lab | May 2023 |
| CLAVAM 625 (Amoxycillin and Potassium Clavulanate Tablets IP) | 22442326Mfg 2022-08 · Exp 2024-01 | Alkem Health ScienceSikkim | Identification and AssayAssay | CDL KolkataCDSCO lab | Feb 2023 |
Official sources and primary records
- Medical Dialogues: Drugs in CDSCO samples counterfeit, not ours, say leading pharma companiesNewsMedical Dialogues
- Outlook Business: Did not manufacture drugs flagged in CDSCO report, say leading pharma companiesNewsOutlook Business
- Medical Dialogues: CDSCO flags 4 drug batches as suspected spurious in February 2026 alertNewsMedical Dialogues · 23 March 2026
- PharmaTutor: CDSCO flags 157 drug samples as not of standard quality, 2 declared spurious in May 2026NewsPharmaTutor
- Outlook Business: Linking spurious drugs with legitimate manufacturers has severe reputational, financial impact. IPANewsOutlook Business