Regulatory status record
Is Cefixime banned in India?
Last checked 3 November 2026
Cefixime is not banned in India; several cefixime combinations are prohibited, including azithromycin + cefixime (S.O. 4422(E), 2018) and cefixime + acetylcysteine (S.O. 3413(E), 2024), and two lactic acid bacillus versions were halted on 11 Apr 2025.
- Classification
- No ban or recall found in official records
- Decided by
- CDSCO / Ministry of Health and Family Welfare
- Reference
- No Section 26A notification for cefixime alone; S.O. 4422(E), 4425(E), 4426(E), 4435(E) (7 Sep 2018); S.O. 214(E), 215(E) (11 Jan 2019); S.O. 3413(E) (2 Aug 2024); CDSCO letter of 11 Apr 2025
- Evidence
- Government document
- Latest action
- 11 April 2025
- Last checked
- 3 November 2026
Photo: Tablets Pills by khunkorn laowisit (CC0). All photo credits.
CDSCO: Updated banned drugs list with present status (as on 22.11.2021)
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 Always check the linked government document for the current position, and tell us if something is out of date.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
- Cefixime alone
- Not banned; essential medicine
- Banned FDCs
- Azithromycin + cefixime, S.O. 4422(E); cefixime + linezolid, S.O. 4425(E); amoxicillin + cefixime + clavulanic acid, S.O. 4426(E); cefixime + levofloxacin, S.O. 4435(E) (all 7 Sep 2018); cefixime + ornidazole, S.O. 215(E), and cefixime + lactobacillus + clavulanic acid, S.O. 214(E) (11 Jan 2019); cefixime + acetylcysteine, S.O. 3413(E) (2 Aug 2024)
- Halted FDCs
- Cefixime 200 mg + ofloxacin 200 mg + lactic acid bacillus; cefixime 200 mg + azithromycin 250 mg + lactic acid bacillus: CDSCO direction, 11 Apr 2025
- Common brands
- Zifi (FDC), Taxim-O (Alkem), Zifi-O (cefixime + ofloxacin), Cefix
Where the claim comes from
Cefixime combinations have been banned in 2018, 2019 and 2024, and two were halted in April 2025. Each was reported as 'cefixime combination banned', and since Zifi is the most recognised cefixime brand, 'is Zifi 200 banned' and 'is Taxim-O banned' followed.
Cefixime is a third-generation oral cephalosporin used for typhoid, urinary and respiratory infections, and sold under brands such as Zifi, Taxim-O and Cefix. It is not banned in India.
Single-ingredient cefixime is an essential medicine and has never been named in a Section 26A notification. Several cefixime combinations have been. On 7 September 2018 the Health Ministry prohibited azithromycin + cefixime (S.O. 4422(E)), cefixime + linezolid, amoxicillin + cefixime + clavulanic acid, and cefixime + levofloxacin. On 11 January 2019 it added cefixime + ornidazole and cefixime + lactobacillus + clavulanic acid. On 2 August 2024 the 156-FDC notification prohibited cefixime + acetylcysteine (S.O. 3413(E)). On 11 April 2025 the CDSCO directed state licensing authorities to halt two cefixime products with lactic acid bacillus, one with ofloxacin and one with azithromycin; that direction is not a Section 26A ban.
The two-drug cefixime + ofloxacin combination, sold as Zifi-O and others, is not in these lists. Cefixime + azithromycin, sometimes searched as "Zifi AZ", is: CDSCO's list shows azithromycin + cefixime as prohibited under S.O. 4422(E) of 7 Sep 2018.
Cefixime is also a frequent subject of monthly quality alerts, because so many manufacturers make it; those findings are batch-specific and do not affect the drug's status.
If a doctor has prescribed cefixime, the course should be completed. If a pack lists azithromycin, acetylcysteine or another antibiotic with cefixime, compare it with the lists above and ask the pharmacist for the plain product instead.
What this means for you
Zifi and Taxim-O are unaffected
Single-ingredient cefixime tablets, dispersible tablets and suspensions remain licensed.
Zifi-O is also unaffected
The two-drug cefixime + ofloxacin combination was not halted; only the version with lactobacillus was.
Finish the course
An antibiotic course should be completed as prescribed; check with your doctor rather than stopping over a headline.
This is a record of official orders, not medical advice. Do not stop a prescribed medicine without asking your doctor or pharmacist.
Entries on the banned drugs list
| Drug / combination | Action | Notification | Date | Status note |
|---|---|---|---|---|
| Cefixime 200mg + Ofloxacin 200mg + Lactic Acid Bacillus 60 Million Spores Tablets | Halted | CDSCO F.No. 4-01/2023-DC (Misc. 3) dated 11.04.2025, Annexure Sr. 8 | 11 April 2025 | CDSCO direction to state licensing authorities, 11 Apr 2025, not a Section 26A gazette ban |
| Cefixime 200mg + Azithromycin 250mg + Lactic Acid Bacillus 60 Million Spores Film Coated Tablets | Halted | CDSCO F.No. 4-01/2023-DC (Misc. 3) dated 11.04.2025, Annexure Sr. 25 | 11 April 2025 | CDSCO direction to state licensing authorities, 11 Apr 2025, not a Section 26A gazette ban |
| Cefixime + Acetyl Cysteine | Banned | S.O. 3413(E) | 2 August 2024 | Prohibited under s.26A; notifications dated 02.08.2024, gazetted 21-22 Aug 2024. |
| Cefixime + Lactobacillus + Clavulanic Acid | Banned | S.O. 214(E) | 11 January 2019 | 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. |
| Cefixime + Ornidazole | Banned | S.O. 215(E) | 11 January 2019 | 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. |
| Azithromycin + Cefixime | Banned | S.O. 4422(E) | 7 September 2018 | In force per CDSCO list as on 22.11.2021 |
| Cefixime + Linezolid | Banned | S.O. 4425(E) | 7 September 2018 | In force per CDSCO list as on 22.11.2021 |
| Amoxicillin + Cefixime + Potassium Clavulanic Acid | Banned | S.O. 4426(E) | 7 September 2018 | In force per CDSCO list as on 22.11.2021 |
| Cefixime + Levofloxacin | Banned | S.O. 4435(E) | 7 September 2018 | In force per CDSCO list as on 22.11.2021 |
| Azithromycin + Cefixime | Quashed | S.O. 752(E) | 10 March 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Cefixime + Linezolid | Quashed | S.O. 756(E) | 10 March 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Amoxicillin + Cefixime + Potassium Clavulanic Acid | Quashed | S.O. 757(E) | 10 March 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
Ingredient records
Every banned combination and failed batch containing each ingredient.
Batches declared Not of Standard Quality
Batches of products containing Cefixime flagged in CDSCO monthly alerts. An NSQ result concerns one batch, not the molecule or the brand.
| Product | Batch | Manufacturer | Reason declared NSQ | Tested by | Alert |
|---|---|---|---|---|---|
| Cefixime, Ornidazole and Lactic Acid Bacillus Tablets | Batch EBL-421Mfg Apr 2026 · Exp Mar 2028 | Ticoma PharmaciaPunjab | The sample does not conform to declared formula in respect of Content of anhydrous CefiximeOther | Gorakhpur, Uttar PradeshState lab | Sep 2026 |
| 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 |
| Cefixime and Lactic Acid Bacillus Tablets | Batch MHPL-733Mfg Dec 2025 · Exp Nov 2027 | Medinok Healthcare Pvt. LtdPuducherry | tests for Uniformity of Dispersion and Disintegration onlyDisintegration | DTL, Bengaluru, KarnatakaState lab | Sep 2026 |
| Cefixime Tablets I.P. 200 mg | Batch T6229Mfg Jul 2026 · Exp Jun 2028 | Zest PharmaMadhya Pradesh | DescriptionDescription | SDTL, PunjabState lab | Sep 2026 |
| Cefixime Tablets I.P. 200 mg | Batch T6228Mfg Jul 2026 · Exp Jun 2028 | Zest PharmaMadhya Pradesh | DescriptionDescription | SDTL, PunjabState lab | Sep 2026 |
| Cefixime Tablets I.P. 200 mg | Batch T6227Mfg Jul 2026 · Exp Jun 2028 | Zest PharmaMadhya Pradesh | DescriptionDescription | SDTL, PunjabState lab | Sep 2026 |
| Cefixime Oral Suspension IP Dry Syrup 100mg/5ml | Batch CADC-02Mfg Feb 2025 · Exp Jan 2027 | Nestor Pharmaceuticals Limited IIHaryana | The Sample does not conform to IP Standards. It fails the tests Water and Assay as per IP as specified in the Laboratory ProtocolAssay | DTL, TVPMState lab | Sep 2026 |
| Cefixime Dispersible Tablets I.P. | Batch PYITL003Mfg May 2025 · Exp Apr 2027 | Laborate Pharmaceuticals India LtdHimachal Pradesh | DESCRIPTION ? TABLETS HAVING BROWN COLOR SPOTS ON SURFACE.Description | SDTL, UttarakhandState lab | Sep 2026 |
| Cefixime Tablets IP | Batch 25460922Mfg May 2025 · Exp Apr 2027 | Alkem Health ScienceSikkim | The sample does not conform to I.P. w.r.to the tests for Dissolution and AssayAssay | SDTL, Guwhati, AssamState lab | Aug 2026 |
| Cefixime Oral Suspension I.P. | Batch CEXD-1074Mfg Jun 2025 · Exp Nov 2026 | Wings Biotech LLPHimachal Pradesh | Content for Anhydrous CefiximeOther | SDT&RL, BhubaneswarState lab | Aug 2026 |
| Cefixime, Ofloxacine & Lactic Acid Bacillus Tablets | Batch ST-25190Mfg Jan 2026 · Exp Dec 2027 | Candimed Life SciencesUttarakhand | Identity test negative for Cefixime & OfloxacinOther | Lucknow LabState lab | Jul 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 with Lactic Acid Bacillus Dispersible Tablets | Batch CT/25/792Mfg Jan 2026 · Exp Dec 2027 | Ciphem PharmaGujarat | The sample does not conform to the claim with respect to Assay of Cefixime Trihydrate Eq. to Anhydrous Cefixime.Assay | DTL JaipurState lab | Jul 2026 |
Sources
Government documents
- CDSCO: List of prohibited FDC drugs, 156 FDCs dated 02.08.2024RegulatorCDSCO · 2 August 2024
- CDSCO: Updated banned drugs list with present status (as on 22.11.2021)RegulatorCDSCO · 22 November 2021
- CDSCO letter F.No. 4-01/2023-DC (Misc. 3), 11 Apr 2025: 35 FDCs to be haltedRegulatorCDSCO · 11 April 2025
- Regulator
News reports
- Business Today: India halts 35 drug combinations over health risks, full listNewsBusiness Today · 17 April 2025