Product record
Azithromycin: batches declared Not of Standard Quality
Last checked 20 September 2026. Source: CDSCO monthly NSQ alerts, Jan 2019, Jul 2026
31 batches of products named "Azithromycin" (as printed by the testing lab) failed a CDSCO or state drug-testing laboratory test between February 2019 and July 2026. This is a record of specific batches, it does not mean the molecule or every brand is unsafe.
Records by type
31 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
31Failed 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 Always check the linked government document for the current position, and tell us if something is out of date.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.
31
NSQ batches
27
Manufacturers
Assay
Most common reason
Jul 2026
Latest alert
Flagged batches
| Batch | Manufacturer | Reason declared NSQ | Tested by | Alert |
|---|---|---|---|---|
| 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 |
| 26150Mfg 2026-03 · Exp 2028-02 | Zeta Formulation Private Limited | pH and ContentpH | DTL, Chennai-06State lab | Jun 2026 |
| 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 |
| 1501/25Mfg 2024-08 · Exp 2026-07 | Livin Formulations Survey no. 807Telangana | Content of AzithromycinOther | SDT&RL, BhubaneswarState lab | Jun 2026 |
| 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 |
| HAZT-2501Mfg 2025-08 · Exp 2027-07 | Heal (India) Laboratories Pvt. Ltd | DissolutionDissolution | DTL,ChennaiState lab | Mar 2026 |
| SFV25120Mfg 2025-05 · Exp 2027-04 | Sanasan Formulation | AssayAssay | SDTL, VijayawadaState lab | Feb 2026 |
| 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 |
| 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 |
| 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 |
| 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 |
| TG23074AMfg 2024-03 · Exp 2026-02 | Cure Health Pharmaceuticals Pvt Ltd. Village Raipur P.O DeothiHimachal Pradesh | DescriptionDescription | FDAL, MaharashtraState lab | Sep 2025 |
| GT400149Mfg 2024-04 · Exp 2026-03 | Gnosis Pharmaceuticals Pvt. LtdHimachal Pradesh | Test for dissolution.Dissolution | CDL, KolkataCDSCO lab | Jul 2025 |
| AYC-2407Mfg 2024-01 · Exp 2025-12 | Apple Formulations Pvt. LtdUttarakhand | Dissolution of AzithromycinDissolution | RDTL GuwahatiCDSCO lab | Jun 2025 |
| BGL24257Mfg 2024-10 · Exp 2026-09 | Bestcare Formulations Pvt LtdPuducherry | pH and the content of Azithromycin.pH | DTL MaduraiState lab | Jun 2025 |
| PPTC082Mfg 2023-11 · Exp 2026-10 | 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 |
| DL-52Mfg 2024-10 · Exp 2026-09 | DUTCH FormulationsHimachal Pradesh | Dissolution, Uniformity of weight and Assay of Azithromycin Dihydrate calculated as AzithromycinAssay | RDTL, ChandigarhCDSCO lab | May 2025 |
| Not mentionedMfg ? · Exp ? | Paradox PharmaceuticalsHimachal Pradesh | Identification, Dissolution and Assay of Azithromycin Dihydrate Calculated as Anhydrous AzithromycinAssay | RDTL, ChandigarhCDSCO lab | May 2025 |
| AZR2411010Mfg 2025-01 · Exp 2026-12 | Paradox PharmaceuticalsHimachal Pradesh | Identification, Dissolution and the Assay of AzithromycinAssay | RDTL, ChandigarhCDSCO lab | May 2025 |
| A004Mfg 2023-12 · Exp 2025-11 | 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 |
| AZ1-206Mfg 2023-10 · Exp 2025-03 | Overseas Healthcare Pvt. Ltd | Uniformity of VolumeUniformity of weight/content | CDL KolkataCDSCO lab | Feb 2025 |
| NZKT-013Mfg 2023-08 · Exp 2025-07 | M Sea Pharmaceuticals (P) LtdHimachal Pradesh | DissolutionDissolution | CDL KolkataCDSCO lab | Jul 2024 |
| NZYMT-223Mfg 2023-09 · Exp 2025-08 | M Sea Pharmaceuticals (P) LtdHimachal Pradesh | DissolutionDissolution | CDL KolkataCDSCO lab | Jul 2024 |
| 45865Mfg 2023-03 · Exp 2025-02 | Reon PharmaGujarat | Identification and Assay of Azithromycin Dihydrate equivalent to anhydrous AzithromycinAssay | RDTL ChandigarhState lab | Dec 2023 |
| BL-12913Mfg 2021-12 · Exp 2023-11 | Park PharmaceuticalsHaryana | Assay & DissolutionAssay | RDTL GuwahatiState lab | Feb 2023 |
| AYA-2101Mfg 2021-01 · Exp 2022-12 | Apple Formulations Pvt. LtdUttarakhand | Assay/content of Anhydrous AzithromycinAssay | RDTL GuwahatiState lab | Sep 2022 |
| NT-18899Mfg 2019-02 · Exp 2021-01 | H.L. Healthcare Pvt. Ltd | AssayAssay | RDTL ChandigarhCDSCO lab | Dec 2019 |
| RAL-048Mfg 2018-06 · Exp 2020-05 | Ronak Life Care Pvt. LtdGujarat | DissolutionDissolution | RDTL GuwahatiState lab | Dec 2019 |
| L-1724703Mfg 2017-11 · Exp 2019-10 | Hanuchem LaboratoriesHimachal Pradesh | Assay & pHAssay | RDTL GuwahatiState lab | Oct 2019 |
| AS7001Mfg 2017-09 · Exp 2019-08 | Halewood Laboratories Pvt. LtdGujarat | DissolutionDissolution | RDTL GuwahatiState lab | Mar 2019 |
| 17SGDL002Mfg 2017-04 · Exp 2019-03 | 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 July 2026. Check any batch number.