Ingredient record · Antibiotic (macrolide)
Azithromycin: 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
19 entries containing Azithromycin are on India's banned-drugs list, and 9 are banned today. 52 batches of medicines containing Azithromycin failed a government lab test between February 2019 and July 2026, from 44 manufacturers. A failed batch concerns that batch only, not the medicine or every brand.
9
Banned combinations in force
10
Other listed orders (stayed, restricted, quashed)
52
Batches failed a lab test
Jul 2026
Latest lab alert
Is it banned? Our answer pages
Not banned · spurious batch reported
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 | 31 | 26 | Jul 2026 |
| Cefixime Azithromycin Lactic Acid Bacillus | 8 | 8 | Jul 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 and Lactic Acid Bacillus Tablets | TB25115Mfg 2025-03 · Exp 2027-02 | Forgo Pharmaceuticals (P) LtdHaryana | Content of anhydrous AzithromycinOther | GORAKHPUR LAB, UPState lab | Jul 2026 |
| Cefixime, Azithromycin & Lactic Acid Bacillus Tablets | ST-25193Mfg 2025-01 · Exp 2027-12 | Candimed Life SciencesUttarakhand | Identity test negative for Cefixime & AzithromycinOther | Lucknow LabState lab | Jul 2026 |
| Cefixime, Azithromycin & Lactic Acid Bacillus Tablets | PL-26089Mfg 2025-09 · Exp 2027-08 | Velnex Medicare India Pvt. Ltd | Identity test negative for Cefixime & AzithromycinOther | Lucknow LabState lab | Jul 2026 |
| Cefixime & Azithromycin Tablets | MWDC-5421GMfg 2026-01 · Exp 2027-12 | Geenac PharmaUttarakhand | Identity test negative for Cefixime & AzithromycinOther | Lucknow LabState lab | Jul 2026 |
| AZITHROMYCIN ORAL SUSPENSION IP 200 MG/5ML | 41410Mfg 2024-10 · Exp 2026-09 | 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 | 25I-T1749Mfg 2025-12 · Exp 2027-11 | Orison Pharma International Khari | Test for Uniformity of Weight of TabletsUniformity of weight/content | RDTL, Bellary, KarnatakaState lab | Jun 2026 |
| Azithromycin Oral Suspension IP | 26150Mfg 2026-03 · Exp 2028-02 | Zeta Formulation Private Limited | pH and ContentpH | DTL, Chennai-06State lab | Jun 2026 |
| Azithromycin Oral Suspension | AZ/L/01/5005Mfg 2025-10 · Exp 2027-09 | Vital Therapeutics & Formulations Pvt.LtdTelangana | Assay for Azithromycin AnhydrousAssay | RDTL, Bellary, KarnatakaState lab | Jun 2026 |
| Azithromycin Oral Suspension IP 100 mg/5ml | 1501/25Mfg 2024-08 · Exp 2026-07 | Livin FormulationsTelangana | Content of AzithromycinOther | SDT&RL, BhubaneswarState lab | Jun 2026 |
| Azithromycin Oral Suspension 100 ml | 25243Mfg 2025-07 · Exp 2027-06 | 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 | HAZT-2501Mfg 2025-08 · Exp 2027-07 | Heal (India) Laboratories Pvt. Ltd | DissolutionDissolution | DTL,ChennaiState lab | Mar 2026 |
| Azithromycin Oral Suspension | SFV25120Mfg 2025-05 · Exp 2027-04 | Sanasan Formulation | AssayAssay | SDTL, VijayawadaState lab | Feb 2026 |
| Cefixime, Azithromycin & Lactic Acid Bacillus Tablets | CHO-50003Mfg 2025-01 · Exp 2026-12 | Park PharmaceuticalsHaryana | Assay for Cefixime (as Anhydrous) & Azithromycin (as Anhydrous) onlyAssay | RDTL, Hubli, KarnatakaState lab | Jan 2026 |
| Cefixime & Azithromycin, Lactic Acid Bacillus Tablets(ARRCEF- AZ ) | 2827Mfg 2025-05 · Exp 2027-04 | MLARRX Pharmaceuticals No 18 Gopalakrishanan Raod T Nagar Chennai 600017Tamil Nadu | AssayAssay | SDTL Raipur ChhattisgarhState lab | Dec 2025 |
| Cefixime & Azithromycin with Lactic Acid Bacillus Tablets (G-CEF- AZ ) | GB-2440Mfg 2024-11 · Exp 2026-10 | MG - Biotech Pvt. LtdHimachal Pradesh | AssayAssay | SDTL Raipur ChhattisgarhState lab | Dec 2025 |
Showing 15 of 52 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.