Ingredient record · Antibiotic (macrolide)
Azithromycin: 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
19 entries containing Azithromycin are on India's banned-drugs list, and 9 are banned today. 56 batches of medicines containing Azithromycin failed a government lab test between February 2019 and September 2026, from 48 manufacturers. A failed batch concerns that batch only, not the medicine or every brand.
Not banned Is Azithromycin banned in India? Not banned · several combinations prohibited. Read the full status record
9
Banned combinations in force
10
Other listed orders (stayed, restricted, quashed)
56
Batches failed a lab test
Sep 2026
Latest lab alert
Is it banned? Our answer pages
Not banned · spurious batch reported
Not banned · several combinations prohibited
Not banned · several combos banned
On the banned-drugs list
Azithromycin itself appears on the list as a single drug, see the entries marked "Single molecule" below. Status follows CDSCO's own notes on each entry.
| Drug / combination | Action | Notification | Date | Order | Status note |
|---|---|---|---|---|---|
| Cefixime 200mg + Azithromycin 250mg + Lactic Acid Bacillus 60 Million Spores Film Coated TabletsFixed-dose combination · antibiotics | Halted | CDSCO F.No. 4-01/2023-DC (Misc. 3) dated 11.04.2025, Annexure Sr. 25 | 11 April 2025 | 35 FDCs · Apr 2025 | CDSCO direction to state licensing authorities, 11 Apr 2025, not a Section 26A gazette ban |
| Azithromycin + AdapaleneFixed-dose combination · skin | Banned | S.O. 3310(E) | 2 August 2024 | 156 FDCs · Aug 2024 | Prohibited under s.26A; notifications dated 02.08.2024, gazetted 21-22 Aug 2024. |
| Ornidazole + Fluconazole + AzithromycinFixed-dose combination · antibiotics | Banned | S.O. 246(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. |
| Combikit of Azithromycin Dihydrate, Secnidazole and FluconazoleSingle molecule · antibiotics | Quashed | S.O. 4429(E) | 7 September 2018 | 328 FDCs · Sep 2018 | Quashed by Delhi HC order dated 18.02.2019; CDSCO appealed, sub judice (CDSCO list as on 22.11.2021, note 5#). |
| Azithromycin + CefiximeFixed-dose combination · antibiotics | Banned | S.O. 4422(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Azithromycin + LevofloxacinFixed-dose combination · antibiotics | Banned | S.O. 4424(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Azithromycin + OfloxacinFixed-dose combination · antibiotics | Banned | S.O. 4432(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Combikit of Fluconazole Tablet, Azithromycin Tablet and Ornidazole TabletsSingle molecule · antibiotics | Banned | S.O. 4438(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Azithromycin + CefpodoximeFixed-dose combination · antibiotics | Banned | S.O. 4441(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Azithromycin + AmbroxolFixed-dose combination · antibiotics | Banned | S.O. 4449(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Azithromycin + AcebrophylineFixed-dose combination · antibiotics | Banned | S.O. 4528(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Azithromycin + CefiximeFixed-dose combination · antibiotics | Quashed | S.O. 752(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Azithromycin + LevofloxacinFixed-dose combination · antibiotics | Quashed | S.O. 755(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Combikit of Azithromycin Dihydrate, Secnidazole and FluconazoleSingle molecule · antibiotics | Quashed | S.O. 760(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Azithromycin + OfloxacinFixed-dose combination · antibiotics | Quashed | S.O. 763(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Combikit of Fluconazole Tablet, Azithromycin Tablet and Ornidazole TabletsSingle molecule · antibiotics | Quashed | S.O. 769(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Azithromycin + CefpodoximeFixed-dose combination · antibiotics | Quashed | S.O. 772(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Azithromycin + AmbroxolFixed-dose combination · antibiotics | Quashed | S.O. 781(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Azithromycin + AcebrophylineFixed-dose combination · antibiotics | Quashed | S.O. 865(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.
| Product | Batches | Makers | Latest |
|---|---|---|---|
| Azithromycin | 33 | 28 | Aug 2026 |
| Cefixime Azithromycin Lactic Acid Bacillus | 9 | 9 | Sep 2026 |
| Azithromycin Lactic Acid Bacillus | 1 | 1 | Aug 2026 |
| Cefixime Azithromycin | 1 | 1 | Jul 2026 |
| Azithromycintablets | 1 | 1 | Jun 2026 |
| Azini | 1 | 1 | Oct 2025 |
| Cefidxime Azithromycin Lactic Acid Baciullus | 1 | 1 | Aug 2025 |
| Azithrojes Azithromycin | 1 | 1 | Jul 2025 |
| Azi Xl | 1 | 1 | Jun 2025 |
| Ronnin | 1 | 1 | Apr 2025 |
| Vithrocin Azithromycin | 1 | 1 | Dec 2024 |
| Elthrom | 1 | 1 | Jun 2024 |
| Cifazime Az | 1 | 1 | Dec 2022 |
| Azithromycin Azustan | 1 | 1 | Sep 2022 |
| Albithral | 1 | 1 | Apr 2022 |
| Azorid | 1 | 1 | Mar 2019 |
Most recent failed batches
| Product | Batch | Manufacturer | Reason declared NSQ | Tested by | Alert |
|---|---|---|---|---|---|
| Cefixime, Azithromycin & Lactic Acid Bacillus | Batch PP-242154Mfg Feb 2025 · Exp Sep 2027 | Park Pharmaceuticals 272Haryana | ASSAY OF CEFIXIME I.P. & AZITHROMYCIN- Less than prescribed limit.Assay | SDTL, UttarakhandState lab | Sep 2026 |
| Azithromycin Tablets IP 500 mg | Batch 2408001232Mfg Oct 2024 · Exp Sep 2026 | Alembic Pharmaceuticals LtdSikkim | The sample does not conform to I.P. w.r.to the tests for Identification and AssayAssay | SDTL, Guwhati, AssamState lab | Aug 2026 |
| Azithromycin Oral Suspension IP 100mg/5ml | Batch AZS1401Mfg May 2026 · Exp Apr 2028 | Unicure India LtdUttar Pradesh | The content of Azithromycin I.P. eq to Anhydrous Azithromycin found to be 80.34 mg per 5 ml (80.34%) against label claim of 100 mg per 5 mlLabelling | SDTL, PunjabState lab | Aug 2026 |
| Azithromycin & Lactic Acid Bacillus Tablets | Batch GT30389JMfg Dec 2025 · Exp Nov 2027 | J.M. LaboratoriesHimachal Pradesh | The sample does not conform to claim as per Schedule V of Drug and Cosmetics Act and Rules 1945 with respect to Assay of Lactic Acid Bacillus.Assay | CDL, KolkataCDSCO lab | Aug 2026 |
| Cefixime, Azithromycin and Lactic Acid Bacillus Tablets | Batch TB25115Mfg Mar 2025 · Exp Feb 2027 | Forgo Pharmaceuticals (P) LtdHaryana | Content of anhydrous AzithromycinOther | GORAKHPUR LAB, UPState lab | Jul 2026 |
| Cefixime, Azithromycin & Lactic Acid Bacillus Tablets | Batch ST-25193Mfg Jan 2025 · Exp Dec 2027 | Candimed Life SciencesUttarakhand | Identity test negative for Cefixime & AzithromycinOther | Lucknow LabState lab | Jul 2026 |
| Cefixime, Azithromycin & Lactic Acid Bacillus Tablets | Batch PL-26089Mfg Sep 2025 · Exp Aug 2027 | Velnex Medicare India Pvt. Ltd | Identity test negative for Cefixime & AzithromycinOther | Lucknow LabState lab | Jul 2026 |
| Cefixime & Azithromycin Tablets | Batch MWDC-5421GMfg Jan 2026 · Exp Dec 2027 | Geenac PharmaUttarakhand | Identity test negative for Cefixime & AzithromycinOther | Lucknow LabState lab | Jul 2026 |
| AZITHROMYCIN ORAL SUSPENSION IP 200 MG/5ML | Batch 41410Mfg Oct 2024 · Exp Sep 2026 | Zenith Drugs Ltd. 72/5 & 72/3Madhya Pradesh | 1. The content of azithromycin in the sample is less(i.e. 65.76% of the labelled amount than the i.p. Limits. 2.Tthe sample is infested with fungus growth. all the observations are done in normal daylight conditions with unaided eyes.4xl5 ml intact brown coloured plastic bottles received for analysis. When opens for analysis, it is observed that in all these 4X15 ML bottles particles are stick around the neck of the bottle. During analysis when the content from these 4x15 ml bottles after shaking transferred individually in clean dry sterilised glass beaker, contains yellow coloured suspension. Yellow coloured suspension which mixes uniformly after shaking.Labelling | FDAL, MumbaiState lab | Jul 2026 |
| AzithromycinTablets IP | Batch 25I-T1749Mfg Dec 2025 · Exp Nov 2027 | Orison Pharma International Khari | Test for Uniformity of Weight of TabletsUniformity of weight/content | RDTL, Bellary, KarnatakaState lab | Jun 2026 |
| Azithromycin Oral Suspension IP | Batch 26150Mfg Mar 2026 · Exp Feb 2028 | Zeta Formulation Private Limited | pH and ContentpH | DTL, Chennai-06State lab | Jun 2026 |
| Azithromycin Oral Suspension | Batch AZ/L/01/5005Mfg Oct 2025 · Exp Sep 2027 | Vital Therapeutics & Formulations Pvt.LtdTelangana | Assay for Azithromycin AnhydrousAssay | RDTL, Bellary, KarnatakaState lab | Jun 2026 |
| Azithromycin Oral Suspension IP 100 mg/5ml | Batch 1501/25Mfg Aug 2024 · Exp Jul 2026 | Livin FormulationsTelangana | Content of AzithromycinOther | SDT&RL, BhubaneswarState lab | Jun 2026 |
| Azithromycin Oral Suspension 100 ml | Batch 25243Mfg Jul 2025 · Exp Jun 2027 | HYT Formulations 1st 2nd & rd Floors RoomTelangana | The sample does not meets the Specification wrt. Assay of Azithromycin as per STP.Assay | State Lab, DCL, TelanganaState lab | Apr 2026 |
| Azithromycin Tablets IP 250 mg | Batch HAZT-2501Mfg Aug 2025 · Exp Jul 2027 | Heal (India) Laboratories Pvt. Ltd | DissolutionDissolution | DTL,ChennaiState lab | Mar 2026 |
Showing 15 of 56 records
Holding a strip or bottle? The batch number is printed after "B. No." Check it against every alert. If it matches, return it to the pharmacy. What the labels mean: status guide.