Ingredient record · Added to amoxicillin so bacteria cannot break it down
Clavulanic acid: bans, restrictions and failed batches in India
Last checked 3 November 2026. Sources: CDSCO banned-drugs notifications and monthly NSQ alerts, Jan 2019 to Sep 2026
3 entries containing Clavulanic acid are on India's banned-drugs list, and 2 are banned today. 178 batches of medicines containing Clavulanic acid failed a government lab test between January 2019 and September 2026, from 109 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)
178
Batches failed a lab test
Sep 2026
Latest lab alert
Is it banned? Our answer pages
Not banned
Not banned · several combos 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 60 products by number of batches.
Most recent failed batches
| Product | Batch | Manufacturer | Reason declared NSQ | Tested by | Alert |
|---|---|---|---|---|---|
| Cefpodoxime & Potassium Clavulanate tablets | Batch VT260343Mfg May 2026 · Exp Oct 2027 | VADSP PharmaceuticalsHimachal Pradesh | Sample Does not complies for the Assay of Cefpodoxime and Clavulanic Acid, hence it is Not of Standard Quality.Assay | State Lab, DCL, TelanganaState lab | Sep 2026 |
| Amoxycillin and Potassium Clavulanate Tablets IP | Batch ABT25719Mfg Feb 2026 · Exp Jul 2027 | Alexa PhamaceuticalsHimachal Pradesh | The sample does not conform to IP with respect to content of Amoxycillin & Clavulanic acid on the basis of tests doneOther | LUCKNOW, Uttar PradeshState lab | Sep 2026 |
| Amoxycillin and Potassium Clavulanate Oral Suspension IP 228.5 mg | Batch GPF01ABBMfg Feb 2026 · Exp Jul 2027 | Malik Lifesciences Pvt. LtdUttarakhand | The sample for the reasons given be.ow:- does not conforms to I.P. in respect of content of Amoxycillin and Clavulanic Acid.Other | Meerut, Uttar PradeshState lab | Sep 2026 |
| Amoxycillin and Potassium Clavulanate Oral Suspension | Batch GPD26004Mfg Jan 2026 · Exp Jun 2027 | Affy ParentalsHimachal Pradesh | The sample does not conform to I.P. in respect of content of Clavulanic Acid & Water contentWater content | MEERUT, Uttar PradeshState lab | Sep 2026 |
| Amoxycillin Potassium Clavulanate & Lactic Acid Bacillus Tablets | Batch ABT25838Mfg Mar 2026 · Exp Aug 2027 | Alexa PharmaceuticalsHimachal Pradesh | Identification & Assay of Clavulanic Acid and Assay of AmoxycillinAssay | SDTL, Andhra Pradesh, VijayawadaState lab | Sep 2026 |
| Amoxycillin & Potassium Clavulanate Tablets I.P | Batch HPT25002Mfg Jun 2025 · Exp Nov 2026 | 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 | Sep 2026 |
| Amoxycillin & Potassium Clavulanate Tablets | Batch ABT26059Mfg Apr 2026 · Exp Sep 2027 | Alexa PhamaceuticalsHimachal Pradesh | The sample does not conform to IP in respect of Identification of Clavulanic Acid, hence spurious and the sampledoes not conform to I.P., in respect of Assay of Amoxycillin.Assay | LUCKNOW, Uttar PradeshState lab | Sep 2026 |
| Amoxycillin & Potassium Clavulanate Oral Suspension IP | Batch B7AEY043Mfg Oct 2025 · Exp Mar 2027 | Copmed Pharmaceuticals Pvt.LtdHimachal Pradesh | The sample does not conforms to I.P. in respect of Content of AmoxycillinOther | LUCKNOW, Uttar PradeshState lab | Sep 2026 |
| Amoxycillin & Potassium Clavulanate Injection IP 1200 mg | Batch D0092509AMfg Feb 2025 · Exp Jan 2027 | Protech TelelinksHimachal Pradesh | The sample does not conform to IP with respect to the Assay of Clavulanic Acid.Assay | CDL, KolkataCDSCO lab | Sep 2026 |
| Amoxycillin & Potassium Clavulanate Tablets IP (MOXIPILTM ? CV625 | Batch AEX35031Mfg Sep 2025 · Exp Feb 2027 | PIL Pharmaceuticals LimitedUttarakhand | The sample does not conforms to the IP with respect to Assay of Potassium Clavulanate Diluted eq. to Clavulanic Acid.Assay | DTL, JaipurState lab | Aug 2026 |
| Amoxicillin and Potassium Clavulanate Tablets IP | Batch 26441735Mfg May 2026 · Exp Oct 2027 | Alkem Health ScienceSikkim | The sample does not conform to IP in respect of Assay of Clavulanic AcidAssay | LUCKNOW LABState lab | Aug 2026 |
| Amoxicillin and Potassium Clavulanate Tablets IP | Batch 26440791Mfg Mar 2026 · Exp Aug 2027 | Alkem Health Science - Alkem Laboratories LimitedSikkim | The sample does not conform to IP in respect of Content of Clavulanic AcidOther | LUCKNOW LABState lab | Aug 2026 |
| Amoxicillin And Potassium Clavulanate Tablets IP | Batch GBR1240Mfg Jun 2026 · Exp May 2028 | Brooks Laboratories LtdHimachal Pradesh | The sample does not conform to claim as per IP 2022 in respect to the Test of Dissolution of Amoxycillin.Dissolution | RDTL, ChandigarhCDSCO lab | Aug 2026 |
| Amoxicillin & Potassium Clavulanate Tablets | Batch GNT-4081CMfg Jun 2025 · Exp May 2027 | Geenac PharmaUttarakhand | The sample does not conform to declared formula in respect of Identity test for Amoxicillin & Clavulanic Acid, Hence, SpuriousSpurious | VARANASI LABState lab | Aug 2026 |
| Cefuroxime Axetil & Potassium Clavulanate Tablets I.P. | Batch CXCA25014EMfg Aug 2025 · Exp Jan 2027 | 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 |
Showing 15 of 178 records
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