Brand check
Is Azithral 500 banned in India?
Last checked 1 October 2026
Azithral 500 is not banned in India as of 1 Oct 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
- Evidence
- Government document
- Latest action
- 23 July 2026
- Last checked
- 1 October 2026
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 Always check the linked government document for the current position, and tell us if something is out of date.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 & 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 |
| Azithromycin Oral Suspension | Batch SFV25120Mfg May 2025 · Exp Apr 2027 | Sanasan Formulation | AssayAssay | SDTL, VijayawadaState lab | Feb 2026 |
| Cefixime, Azithromycin & Lactic Acid Bacillus Tablets | Batch CHO-50003Mfg Jan 2025 · Exp Dec 2026 | 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) | Batch 2827Mfg May 2025 · Exp Apr 2027 | 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) | Batch GB-2440Mfg Nov 2024 · Exp Oct 2026 | MG - Biotech Pvt. LtdHimachal Pradesh | AssayAssay | SDTL Raipur ChhattisgarhState lab | Dec 2025 |
| Azithromycin Tablets IP 500 mg. | Batch AYC-2407Mfg Jan 2024 · Exp Dec 2025 | 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 |
Ingredient records: Azithromycin
Sources
Government documents
- CDSCO: List of prohibited FDC drugs, 156 FDCs dated 02.08.2024RegulatorCDSCO · 2 August 2024
News reports
- 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