Ingredient record · Antibiotic (penicillin group)
Amoxicillin: 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
16 entries containing Amoxicillin are on India's banned-drugs list, and 10 are banned today. 228 batches of medicines containing Amoxicillin failed a government lab test between January 2019 and September 2026, from 137 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)
228
Batches failed a lab test
Sep 2026
Latest lab alert
Is it banned? Our answer pages
Banned since 11 Jun 2026
Not banned
Not banned · several combos 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 68 products by number of batches.
Most recent failed batches
| Product | Batch | Manufacturer | Reason declared NSQ | Tested by | Alert |
|---|---|---|---|---|---|
| Amoxycillin, Cloxacillin & Lactic Acid Bacillus Capsules) | Batch SBC-25059Mfg Sep 2025 · Exp Aug 2027 | Spectrum Formulation Pvt. LtdUttarakhand | Description and Assay for CloxacillinAssay | DTL, Bengaluru, KarnatakaState 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 and potassium Clavunate Tablets Ip | Batch BMT-25079Mfg Aug 2025 · Exp Jul 2027 | Mancare Laboratories Pvt. LtdUttarakhand | DescriptionDescription | DTL BhopalState lab | Aug 2026 |
| Amoxycillin Dispersible Tablets IP 250mg | Batch SBT-25033Mfg Aug 2025 · Exp Jul 2027 | Spectrum Formulation Pvt. LtdUttarakhand | Test for Uniformity of WeightUniformity of weight/content | DTL, Bengaluru, KarnatakaState lab | Aug 2026 |
| Amoxycillin Capsuels IP 250 mg | Batch DVC250083Mfg Oct 2025 · Exp Sep 2027 | Daxin Pharmaceuticals Pvt. LtdHimachal Pradesh | The sample does not conform to IP in respect of Assay and Dissolution of AmoxycillinAssay | LUCKNOW LABState lab | Aug 2026 |
| Amoxycillin 500 Mg Capsules I.P. | Batch GH25HC-4AMfg Aug 2025 · Exp Jul 2027 | Glivert healthcare llpUttar Pradesh | In the compostion the label should be mentioned as Amoxycillin IP. But the label is mentioned as only Amoxycillin. Hence it is misbranded drug as per section 17 of Drugs and Cosmetics Act 1940.Misbranded | State Lab, DCL, TelanganaState lab | Aug 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 |
Showing 15 of 228 records
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