Ingredient record · Added to amoxicillin so bacteria cannot break it down
Clavulanic acid: bans, restrictions and failed batches in India
Last checked 20 September 2026. Sources: CDSCO banned-drugs notifications and monthly NSQ alerts, Jan 2019 to Jul 2026
3 entries containing Clavulanic acid are on India's banned-drugs list, and 2 are banned today. 164 batches of medicines containing Clavulanic acid failed a government lab test between January 2019 and July 2026, from 102 manufacturers. A failed batch concerns that batch only, not the medicine or every brand.
2
Banned combinations in force
1
Other listed orders (stayed, restricted, quashed)
164
Batches failed a lab test
Jul 2026
Latest lab alert
Is it banned? Our answer pages
Not banned
Not banned · spurious batch reported
On the banned-drugs list
Clavulanic acid on its own is not on CDSCO's banned list. The entries below are specific combinations that contain it. Status follows CDSCO's own notes on each entry.
| Drug / combination | Action | Notification | Date | Order | Status note |
|---|---|---|---|---|---|
| Cefixime + Lactobacillus + Clavulanic AcidFixed-dose combination · antibiotics | Banned | S.O. 214(E) | 11 January 2019 | Other orders | One of 80 FDCs prohibited vide S.O. 180(E)-259(E) dated 11.01.2019 (CDSCO letter 22.01.2019). In force per CDSCO list as on 22.11.2021. |
| Amoxicillin + Cefixime + Potassium Clavulanic AcidFixed-dose combination · antibiotics | Banned | S.O. 4426(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Amoxicillin + Cefixime + Potassium Clavulanic AcidFixed-dose combination · antibiotics | Quashed | S.O. 757(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
Products that failed lab tests
Product names as printed by the testing labs, grouped. Open a product to see every batch number.
Top 30 of 58 products by number of batches.
Most recent failed batches
| Product | Batch | Manufacturer | Reason declared NSQ | Tested by | Alert |
|---|---|---|---|---|---|
| Cefuroxime Axetil & Potassium Clavulanate Tablets I.P. | CXCA25014EMfg 2025-08 · Exp 2027-01 | J.M. LaboratoriesHimachal Pradesh | The sample does not conform to I.P. with respect to the tests of Dissolution and Assay of Cefuroxime and Clavulanic Acid.Assay | CDL, KolkataCDSCO lab | Jul 2026 |
| Cefpodoxime Proxetil & Clavulanic Acid Tablets | BT-0564Mfg 2025-09 · Exp 2027-02 | Addll Biotech Pvt. LtdHimachal Pradesh | Identity test negative for Cefpodoxime Proxetil & Clavulanic AcidOther | Lucknow LabState lab | Jul 2026 |
| Amoxycillin, Potassium Clavulanate & Lactic Acid Bacillus Tablets | BR-1227Mfg 2026-03 · Exp 2027-08 | Velnex Medicare India Pvt. Ltd | Identification - Doesn't conforms to I.P.Identification | Lucknow LabState lab | Jul 2026 |
| Amoxycillin and Potassium Clavulanate Tablets IP (500 mg+125mg | CVTC-815Mfg 2025-09 · Exp 2027-08 | Nestor Pharmaceuticals Limited 11Haryana | Content of Clavulanic AcidOther | GORAKHPUR LAB, UPState lab | Jul 2026 |
| Amoxycillin and Potassium Clavulanate Tablets IP | CBZ19ADAMfg 2025-12 · Exp 2027-11 | Malik Lifesciences Pvt. LtdUttarakhand | Dissolution of AmoxycillinDissolution | Lucknow LabState lab | Jul 2026 |
| Amoxycillin &Potassium Clavulanate Tablets | Not MentionedMfg ? · Exp ? | Astam Healthcare Pvt. LtdHimachal Pradesh | MISBRANDED DRUGS.Misbranded | SFDTL UttarakhandState lab | Jul 2026 |
| Amoxycillin & Potassium Clavulanate, Lactic Acid Bacillus Tablets | MWDC-5421GMfg 2026-01 · Exp 2027-12 | Sabi Pharmaceuticals Pvt. Ltd - . Shivnath Gogoi PathAssam | Identity test negative for Amoxycillin & Clavulanic AcidOther | Lucknow LabState lab | Jul 2026 |
| Amoxycillin & Potassium Clavulanate Tablets IP | KT25030Mfg 2025-02 · Exp 2027-01 | Orbit Lifescience Pvt. Ltd | The sample does not conform to I.P. w.r.to the tests for Dissolution and Assay of Clavulanic AcidAssay | CDL,KolkataState lab | Jul 2026 |
| Amoxycillin & Potassium Clavulanate Tablets IP | VT251527Mfg 2025-09 · Exp 2027-02 | VADSP PharmaceuticalsHimachal Pradesh | The sample does not conform to I.P. w.r.to the tests for Dissolution and Assay of Clavulanic AcidAssay | CDL,KolkataState lab | Jul 2026 |
| Amoxycillin & Potassium Clavulanate Tablets IP | 826D074Mfg 2026-03 · Exp 2027-08 | Medreich LimitedKarnataka | Identification - Doesn't conforms to I.P.Identification | Lucknow LabState lab | Jul 2026 |
| Amoxycillin & Potassium Clavulanate Tablets IP | MFL0122Mfg 2025-03 · Exp 2027-02 | Medicef PharmaHimachal Pradesh | Identification - Doesn't conforms to I.P.Identification | Lucknow LabState lab | Jul 2026 |
| Amoxycillin & Potassium Clavulanate Tablets IP | TB250343CMfg 2025-06 · Exp 2027-02 | Polestar Power Industries (Pharma Division)Himachal Pradesh | Identification - Doesn't conforms to I.P.Identification | Lucknow LabState lab | Jul 2026 |
| Amoxycillin & Potassium Clavulanate Tablets I.P. | HPT25002Mfg 2025-06 · Exp 2026-11 | Hariom PharmaceuticalsHimachal Pradesh | The sample does not conform to claim as per I.P. 2022 with respect to the test for Assay and Dissolution of Amoxycillin and Clavulanic Acid.Assay | RDTL, GuwahatiCDSCO lab | Jul 2026 |
| Amoxicillin and Potassium Clavulanate Tablets IP | 26440256Mfg 2026-01 · Exp 2027-06 | Alkem Health Sciences A Unit of Alkem Laboratories Ltd. Unit-2Sikkim | Identification - Doesn't conforms to I.P.Identification | Lucknow LabState lab | Jul 2026 |
| Amoxycillin& Potassium Clavulanate Tablets IP | MFK0983Mfg 2024-12 · Exp 2026-11 | Medicef PharmaHimachal Pradesh | The sample does not conform to I.P. w.r.to the tests for Identification and AssayAssay | SDTL, GuwahatiState lab | Jun 2026 |
Showing 15 of 164 records
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