Product record
Azithromycin: batches declared Not of Standard Quality
Not bannedIs Azithromycin banned in India?Not banned · several combinations prohibited. Read the answer
Not bannedIs Azithromycin (Azithral 500) banned in India?Not banned · spurious batch reported. Read the answer
Last checked 3 November 2026. Source: CDSCO monthly NSQ alerts, Jan 2019 to Sep 2026
33 batches of products named "Azithromycin" (as printed by the testing lab) failed a CDSCO or state drug-testing laboratory test between February 2019 and August 2026. This is a record of specific batches, it does not mean the molecule or every brand is unsafe.
Records by type
33 records linked to Azithromycin in the datasets we hold. A zero means nothing is on record in those datasets, not that nothing ever happened. What the labels mean.
0Banned or prohibited
0Recalled or suspended
33Failed a lab test
0Regulatory notice
Primary government sourceTier 1: government primary source
CDSCO drug alerts: Not of Standard Quality and spurious drugs
Scope. A failed batch is not a verdict on every pack of this product. 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 Always check the linked government document for the current position, and tell us if something is out of date.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.
33
NSQ batches
28
Manufacturers
Assay
Most common reason
Aug 2026
Latest alert
Flagged batches
| Batch | Manufacturer | Reason declared NSQ | Tested by | Alert |
|---|---|---|---|---|
| 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 |
| 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 |
| 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 |
| Batch 26150Mfg Mar 2026 · Exp Feb 2028 | Zeta Formulation Private Limited | pH and ContentpH | DTL, Chennai-06State lab | Jun 2026 |
| 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 |
| Batch 1501/25Mfg Aug 2024 · Exp Jul 2026 | Livin FormulationsTelangana | Content of AzithromycinOther | SDT&RL, BhubaneswarState lab | Jun 2026 |
| 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 |
| Batch HAZT-2501Mfg Aug 2025 · Exp Jul 2027 | Heal (India) Laboratories Pvt. Ltd | DissolutionDissolution | DTL,ChennaiState lab | Mar 2026 |
| Batch SFV25120Mfg May 2025 · Exp Apr 2027 | Sanasan Formulation | AssayAssay | SDTL, VijayawadaState lab | Feb 2026 |
| 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 |
| Batch JL-2469Mfg Feb 2025 · Exp Jan 2027 | Jainsons HealthcareUttarakhand | The sample received does not conform to I.P. 2022 with respect to the test for AssayAssay | CDTL, MumbaiCDSCO lab | Nov 2025 |
| Batch T-220124Mfg Jan 2024 · Exp Dec 2026 | 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 |
| Batch JL-2538Mfg Sep 2025 · Exp Aug 2027 | Jainsons HealthcareUttarakhand | The sample does not conform to I.P.2022 with respect to test for "Assay of Azithromycin"Assay | CDTL, MumbaiCDSCO lab | Oct 2025 |
| Batch TG23074AMfg Mar 2024 · Exp Feb 2026 | Cure Health Pharmaceuticals Pvt LtdHimachal Pradesh | DescriptionDescription | FDAL, MaharashtraState lab | Sep 2025 |
| Batch GT400149Mfg Apr 2024 · Exp Mar 2026 | Gnosis Pharmaceuticals Pvt. LtdHimachal Pradesh | Test for dissolution.Dissolution | CDL, KolkataCDSCO lab | Jul 2025 |
| Batch AYC-2407Mfg Jan 2024 · Exp Dec 2025 | Apple Formulations Pvt. LtdUttarakhand | Dissolution of AzithromycinDissolution | RDTL GuwahatiCDSCO lab | Jun 2025 |
| Batch BGL24257Mfg Oct 2024 · Exp Sep 2026 | Bestcare Formulations Pvt LtdPuducherry | pH and the content of Azithromycin.pH | DTL MaduraiState lab | Jun 2025 |
| Batch PPTC082Mfg Nov 2023 · Exp Oct 2026 | Pratima PharmaceuticalsMaharashtra | 1. The sample does gives identification for the presence of Azithromycin 2. Additional identification:-The sample gives identification for the presence of Paracetamol.3. Found Content of Paracetamol in the sample is 147.24mg/TabIdentification | S.K, Jadhav, Pune-Zone 3 , FDA Lab, M.S. Chhatrapati Sambhajinagar . Maharashtra StateState lab | May 2025 |
| Batch DL-52Mfg Oct 2024 · Exp Sep 2026 | DUTCH FormulationsHimachal Pradesh | Dissolution, Uniformity of weight and Assay of Azithromycin Dihydrate calculated as AzithromycinAssay | RDTL, ChandigarhCDSCO lab | May 2025 |
| Batch Not mentionedMfg ? · Exp ? | Paradox PharmaceuticalsHimachal Pradesh | Identification, Dissolution and Assay of Azithromycin Dihydrate Calculated as Anhydrous AzithromycinAssay | RDTL, ChandigarhCDSCO lab | May 2025 |
| Batch AZR2411010Mfg Jan 2025 · Exp Dec 2026 | Paradox PharmaceuticalsHimachal Pradesh | Identification, Dissolution and the Assay of AzithromycinAssay | RDTL, ChandigarhCDSCO lab | May 2025 |
| Batch A004Mfg Dec 2023 · Exp Nov 2025 | Smith & Kenner Pharmaceuticals Pvt.LtdTelangana | The label of the drug should be mentioned as Azithromycin Oral suspension IP. But the letters IP is not mentioned on the labelLabelling | State Lab, Drugs Control Laboratory, TelanganaState lab | May 2025 |
| Batch AZ1-206Mfg Oct 2023 · Exp Mar 2025 | Overseas Health Care Pvt. Ltd | Uniformity of VolumeUniformity of weight/content | CDL KolkataCDSCO lab | Feb 2025 |
| Batch NZKT-013Mfg Aug 2023 · Exp Jul 2025 | M Sea Pharmaceuticals (P) LtdHimachal Pradesh | DissolutionDissolution | CDL KolkataCDSCO lab | Jul 2024 |
| Batch NZYMT-223Mfg Sep 2023 · Exp Aug 2025 | M Sea Pharmaceuticals (P) LtdHimachal Pradesh | DissolutionDissolution | CDL KolkataCDSCO lab | Jul 2024 |
| Batch 45865Mfg Mar 2023 · Exp Feb 2025 | Reon PharmaGujarat | Identification and Assay of Azithromycin Dihydrate equivalent to anhydrous AzithromycinAssay | RDTL ChandigarhState lab | Dec 2023 |
| Batch BL-12913Mfg Dec 2021 · Exp Nov 2023 | Park PharmaceuticalsHaryana | Assay & DissolutionAssay | RDTL GuwahatiState lab | Feb 2023 |
| Batch AYA-2101Mfg Jan 2021 · Exp Dec 2022 | Apple Formulations Pvt. LtdUttarakhand | Assay/content of Anhydrous AzithromycinAssay | RDTL GuwahatiState lab | Sep 2022 |
| Batch NT-18899Mfg Feb 2019 · Exp Jan 2021 | H.L. Healthcare Pvt. Ltd | AssayAssay | RDTL ChandigarhCDSCO lab | Dec 2019 |
| Batch RAL-048Mfg Jun 2018 · Exp May 2020 | Ronak Life Care Pvt. LtdGujarat | DissolutionDissolution | RDTL GuwahatiState lab | Dec 2019 |
| Batch L-1724703Mfg Nov 2017 · Exp Oct 2019 | Hanuchem LaboratoriesHimachal Pradesh | Assay & pHAssay | RDTL GuwahatiState lab | Oct 2019 |
| Batch AS7001Mfg Sep 2017 · Exp Aug 2019 | Halewood Laboratories Pvt. LtdGujarat | DissolutionDissolution | RDTL GuwahatiState lab | Mar 2019 |
| Batch 17SGDL002Mfg Apr 2017 · Exp Mar 2019 | Synokem Pharmaceuticals LtdUttarakhand | Related substances and the Assay of Azithromycin calculated as Anhydrous AzithromycinAssay | RDTL ChandigarhState lab | Feb 2019 |
How to use this. Match the batch number on your strip or bottle against the list. If your batch is listed, return it to the pharmacy and ask for a replacement; if not, the product is not on any alert as of September 2026. Check any batch number.