Brand check
Is Azithral 500 banned in India?
Last checked 19 September 2026. A few details are still being checked against the original document.
Azithral 500 is not banned in India as of 19 Sep 2026; CDSCO's October 2025 alert flagged batch 2408000201 as potentially spurious, and Alembic stated it had not manufactured that batch.
- Classification
- No ban or recall found in official records
- Decided by
- CDSCO / Ministry of Health and Family Welfare
- Reference
- No Section 26A notification; CDSCO monthly drug alert, Oct 2025
- Latest action
- 23 July 2026
- Last checked
- 19 September 2026details being verified
Azithromycin 250 mg capsules in a blister pack. Photo: Azithromycin 250mg.jpg by Kristoferb (CC BY-SA 3.0). Brand names and logos belong to their owners and are used here to identify the product this entry is about. All photo credits.
CDSCO: List of prohibited FDC drugs, 156 FDCs dated 02.08.2024
Scope. A record here does not by itself mean a product or company is unsafe or banned today. Regulatory actions can apply to one batch, one formulation, one period or one state. Always check the linked government document for the current position, and tell us if something is out of date. How we label records.
Below: Blacklisted's explanationWe organise and explain what the document says. The document above is the authority.
Key facts
- Governing authority
- CDSCO, Ministry of Health and Family Welfare
- Ban notification
- None; azithromycin is an essential medicine
- Flagged batch
- 2408000201: CDSCO Oct 2025 alert, potentially spurious; Alembic denied manufacture
- Manufacturer
- Alembic Pharmaceuticals
- Other azithromycin findings
- Azithromycin suspension NSQ in the Jun 2026 alert (other makers)
- Related banned FDC
- Azithromycin + adapalene (acne), 2 Aug 2024
Where the claim comes from
The CDSCO's October 2025 alert named five widely used brands as potentially spurious. Azithral 500, Telma-AM, Noophin and two Chymoral Forte batches, and the headline list travelled far. Each company denied making the batch, but 'Azithral flagged by CDSCO' became 'Azithral banned' in social posts. A separate search, 'why Zifi AZ banned', concerns a cefixime + azithromycin combination not found in any ban list.
Azithral 500 is Alembic's azithromycin, one of the most prescribed antibiotics in India and, as a result, one of the most counterfeited. It is not banned.
Azithromycin is an essential medicine and has never been the subject of a Section 26A notification. The only azithromycin combination on a ban list is azithromycin + adapalene, an acne product prohibited in the August 2024 list; it has nothing to do with the tablet.
The reason for the question is the CDSCO's monthly alert for October 2025, which listed five batches of well-known brands as potentially spurious. One was Azithral 500 batch 2408000201. Alembic stated that it had not manufactured that batch, which means the packs found were counterfeit. The same alert named Telma-AM, Chymoral Forte and a buprenorphine injection, with the same denials from their makers. This pattern, the regulator flags a batch, the brand owner says the batch is fake, is now routine, and the Indian Pharmaceutical Alliance has objected to the way such findings are reported under legitimate brand names.
An azithromycin suspension from another manufacturer appeared as not of standard quality in the June 2026 alert.
If you have Azithral 500, compare the batch number on the strip with 2408000201. If it differs, the alert does not concern your pack; if it matches, do not use it and show it to your pharmacist.
What this means for you
The antibiotic is not withdrawn
Azithral 500 and generic azithromycin remain licensed.
Read the two statements side by side
CDSCO's finding is batch-specific. The company says the batch was not made by it, i.e. counterfeit. Both can be true: someone else made a fake pack with the brand's name.
Finish a prescribed course
If your strip's batch number differs from 2408000201, the alert does not concern it.
This is a record of official orders, not medical advice. Do not stop a prescribed medicine without asking your doctor or pharmacist.
Common questions
Why is Zifi AZ banned?
We have not found cefixime + azithromycin in any ban notification. The claim appears to be a rumour; we will update if a source emerges.
Batches flagged in CDSCO alerts
Products whose name matches this brand or molecule in CDSCO monthly NSQ alerts. A flagged batch is a single batch; the company's response, where reported, is noted on the page above.
| 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) Ltd. Plot No. 92 Industrial AreaHaryana | 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. Ltd. Plot.No.47B/2Telangana | 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 Formulations Survey no. 807Telangana | 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 |
| Azithromycin Tablets IP 500 mg. | AYC-2407Mfg 2024-01 · Exp 2025-12 | Apple Formulations Pvt. LtdUttarakhand | The sample does not comply as per I.P. 2022 with respect to the test for "Dissolution" of Azithromycin.Dissolution | RDTL, GuwahatiCDSCO lab | Nov 2025 |
| Azithromycin Oral Suspension I.P. | JL-2469Mfg 2025-02 · Exp 2027-01 | Jainsons Healthcare Plot No.32Uttarakhand | The sample received does not conform to I.P. 2022 with respect to the test for AssayAssay | CDTL, MumbaiCDSCO lab | Nov 2025 |
| Cefixime, Azithromycin & Lactic Acid Bacillus Tablets (CEFICO- AZ TABLETS) | AP-241242Mfg 2025-01 · Exp 2026-12 | Park Pharmaceuticals 272 Ind. Area Phase IIHaryana | AssayAssay | SDTL Raipur ChhattisgarhState lab | Oct 2025 |
| Azithromycin Tablets I.P (Morzith-500 Tablets) | T-220124Mfg 2024-01 · Exp 2026-12 | Dr. Jee Pharma Pvt LtdUttarakhand | The Sample does not conform to I.P specification with respect to identification and content of AzithromicynIdentification | BDCL, PATNAState lab | Oct 2025 |
| Azithromycin Oral Suspension IP (AZAM-200) | JL-2538Mfg 2025-09 · Exp 2027-08 | Jainsons Healthcare (GMP Certified Company) Plot No. 32Uttarakhand | The sample does not conform to I.P.2022 with respect to test for "Assay of Azithromycin"Assay | CDTL, MumbaiCDSCO lab | Oct 2025 |
Official sources and primary records
- Medical Dialogues: CDSCO flags 5 batches of widely used drugs including Azithral 500, Telma-AM as potentially spuriousNewsMedical Dialogues
- ETV Bharat: CDSCO flags 159 substandard drugs in June; over 3,500 prosecution cases filed over five yearsNewsETV Bharat · 23 July 2026
- Outlook Business: Linking spurious drugs with legitimate manufacturers has severe reputational, financial impact. IPANewsOutlook Business
- CDSCO: List of prohibited FDC drugs, 156 FDCs dated 02.08.2024RegulatorCDSCO · 2 August 2024