Ingredient record · Antibiotic (penicillin group)
Amoxicillin: 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
16 entries containing Amoxicillin are on India's banned-drugs list, and 10 are banned today. 210 batches of medicines containing Amoxicillin failed a government lab test between January 2019 and July 2026, from 126 manufacturers. A failed batch concerns that batch only, not the medicine or every brand.
10
Banned combinations in force
6
Other listed orders (stayed, restricted, quashed)
210
Batches failed a lab test
Jul 2026
Latest lab alert
Is it banned? Our answer pages
Banned since 11 Jun 2026
Not banned
Not banned · spurious batch reported
Enzyme not banned · 4 combos banned
On the banned-drugs list
Amoxicillin 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 |
|---|---|---|---|---|---|
| Amoxicillin + Serratiopeptidase + Lactobacillus SporogenesFixed-dose combination · antibiotics | Banned | S.O. 3070(E) | 11 June 2026 | 16 FDCs · Jun 2026 | Prohibited under s.26A with immediate effect, 11.06.2026 (CDSCO list published 21.07.2026). |
| Amoxicillin + SerratiopeptidaseFixed-dose combination · antibiotics | Banned | S.O. 3072(E) | 11 June 2026 | 16 FDCs · Jun 2026 | Prohibited under s.26A with immediate effect, 11.06.2026 (CDSCO list published 21.07.2026). |
| Amoxicillin + Cloxacillin + Lactic Acid Bacillus + SerratiopeptidaseFixed-dose combination · antibiotics | Banned | S.O. 3081(E) | 11 June 2026 | 16 FDCs · Jun 2026 | Prohibited under s.26A with immediate effect, 11.06.2026 (CDSCO list published 21.07.2026). |
| Amoxicillin Trihydrate + Dicloxacillin Sodium + LactobacillusFixed-dose combination · antibiotics | Banned | S.O. 3411(E) | 2 August 2024 | 156 FDCs · Aug 2024 | Prohibited under s.26A; notifications dated 02.08.2024, gazetted 21-22 Aug 2024. |
| Amoxicillin + BromhexineFixed-dose combination · antibiotics | Banned | S.O. 2395(E) | 2 June 2023 | 14 FDCs · Jun 2023 | Prohibited under s.26A on DTAB/Expert Committee advice; these are 14 of the 15 'pre-1988' FDCs excluded from the 2018 re-ban (Imipramine + Diazepam not included). |
| Paracetamol + Diclofenac Sodium + Amoxicillin + Cloxacillin + Pantoprazole + Lactic Acid Bacillus + SerratiopeptidaseFixed-dose combination · antibiotics | Banned | S.O. 204(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 + DicloxacillinFixed-dose combination · antibiotics | Banned | S.O. 4423(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 | Banned | S.O. 4426(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Amoxicillin + TinidazoleFixed-dose combination · antibiotics | Banned | S.O. 4433(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Amoxicillin + Dicloxacillin + SerratiopeptidaseFixed-dose combination · antibiotics | Banned | S.O. 4440(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Amoxicillin + DicloxacillinFixed-dose combination · antibiotics | Quashed | S.O. 753(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Amoxicillin 250 mg + Potassiumclavulanate Diluted 62.5 mgFixed-dose combination · antibiotics | Quashed | S.O. 754(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| 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 |
| Amoxicillin + TinidazoleFixed-dose combination · antibiotics | Quashed | S.O. 764(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Amoxicillin + Dicloxacillin + SerratiopeptidaseFixed-dose combination · antibiotics | Quashed | S.O. 771(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Amoxicillin + BromhexineFixed-dose combination · antibiotics | Under examination | S.O. 777(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; SC order 15.12.2017 treated it as a pre-1988 FDC, under examination with Expert Committee per CDSCO list as on 22.11.2021 (note 3#). 14 of these 15 were re-prohibited on 02.06.2023 (wave 2023-14). |
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 66 products by number of batches.
Most recent failed batches
| Product | Batch | Manufacturer | Reason declared NSQ | Tested by | Alert |
|---|---|---|---|---|---|
| Deomax-LB (Amoxycillin. Cloxaeillin & Lactic Acid Closacillin & Lacne Acd Bacillus Capsules | JPC-3100Mfg 2024-10 · Exp 2026-09 | JMH PharmaUttarakhand | The sample does not pass the Assay of Anhy drous Amoxycillin & Cloxacillin per capsule is 10.86 mg & 67.73 mg against the claimed 250 mg.Assay | Gov Analyst Analyst. Haryana ChandigarhState 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 Oral Suspension IP | AMS2532Mfg 2025-06 · Exp 2026-11 | Modern LaboratoriesMadhya Pradesh | Content of Amoxycillin.Other | FDL, VadodaraState lab | Jul 2026 |
| Amoxycillin Dispersible Tablets IP | UOT25-522Mfg 2025-09 · Exp 2027-08 | Unisharp Organics Pvt. Ltd. Alamgir | AssayAssay | Lucknow LabState lab | Jul 2026 |
| Amoxycillin Capsules IP 500mg | BC12250010Mfg 2025-05 · Exp 2027-04 | Alencure Biotech Pvt LtdHimachal Pradesh | Content of Amoxycillin (82.7%)Other | Drugs Testing Laboratory, Chennai-06State 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 |
Showing 15 of 210 records
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