Ingredient record · Antihistamine for allergy
Fexofenadine: bans, restrictions and failed batches in India
Last checked 3 November 2026. Sources: CDSCO banned-drugs notifications and monthly NSQ alerts, Jan 2019 to Sep 2026
1 entry containing Fexofenadine is on India's banned-drugs list, and 0 are banned today. 23 batches of medicines containing Fexofenadine failed a government lab test between February 2019 and September 2026, from 17 manufacturers. A failed batch concerns that batch only, not the medicine or every brand.
0
Banned combinations in force
1
Other listed orders (stayed, restricted, quashed)
23
Batches failed a lab test
Sep 2026
Latest lab alert
Is it banned? Our answer pages
Not banned
On the banned-drugs list
Fexofenadine on its own is not on CDSCO's banned list. The entries below are specific combinations that contain it. Status follows CDSCO's own notes on each entry.
| Drug / combination | Action | Notification | Date | Order | Status note |
|---|---|---|---|---|---|
| Acebrophylline (SR) 200mg + Montelukast 10mg + Fexofenadine Hydrochloride 120mg TabletFixed-dose combination · cough-cold | Halted | CDSCO F.No. 4-01/2023-DC (Misc. 3) dated 11.04.2025, Annexure Sr. 13 | 11 April 2025 | 35 FDCs · Apr 2025 | CDSCO direction to state licensing authorities, 11 Apr 2025, not a Section 26A gazette ban |
Products that failed lab tests
Product names as printed by the testing labs, grouped. Open a product to see every batch number.
| Product | Batches | Makers | Latest |
|---|---|---|---|
| Fexofenadine Hydrochloride | 14 | 10 | Jul 2025 |
| Fexofenadine | 2 | 2 | May 2025 |
| Fexofenadine Hydrochloride Montelukast Sodium | 1 | 1 | Sep 2026 |
| Fexofenadine Fexodil | 1 | 1 | Mar 2025 |
| Fexofenadine Hcl Refexo | 1 | 1 | Sep 2022 |
| Acebrophylline Fexofenadine Hydrochloride Montelukast Sodium | 1 | 1 | Dec 2021 |
| Fen Pil | 1 | 1 | Jun 2021 |
| Fexcor | 1 | 1 | Jun 2020 |
| Fexodil | 1 | 1 | Feb 2020 |
Most recent failed batches
| Product | Batch | Manufacturer | Reason declared NSQ | Tested by | Alert |
|---|---|---|---|---|---|
| Fexofenadine Hydrochloride & Montelukast Sodium Tablets | Batch GB25051Mfg Aug 2025 · Exp Jan 2028 | Devbhoomi PharmaceuticalsUttarakhand | The Content of MontelukastOther | FDAL, M. S Chhatrapatri Sambhajinagar, F.D.A Mahrasthra StateState lab | Sep 2026 |
| Fexofenadine Hydrochloride tablets 120mg (Fexomon-120.) | Batch MT2503039Mfg Mar 2025 · Exp Feb 2027 | Monique Pharmaceuticals Pvt. LtdHaryana | Test of Dissolution (at 10 min), Dissolution (at 30 min)Dissolution | RDTL, ChandigarhCDSCO lab | Jul 2025 |
| Fexofenadine Tablets IP (Fexodil 180 mg) | Batch T-4029Mfg Jan 2025 · Exp Dec 2026 | Jackson Laboratories Pvt. LtdPunjab | Dissolution test after 10 min and after 30 minDissolution | CDL, KolkataCDSCO lab | May 2025 |
| Fexofenadine Tab IP [Fexodil-180] | Batch T ? 3105Mfg Oct 2024 · Exp Sep 2026 | Jackson Laboratories Pvt. LtdPunjab | It fails the test ?Dissolution? as per IPDissolution | Drugs Testing Laboratory ThiruvananthapuramState lab | Mar 2025 |
| Fexofenadine Hydrochloride Tablets I.P. 120 mg. | Batch UGT231163Mfg Aug 2023 · Exp Jul 2025 | Unimarck Healthcare LtdUttarakhand | DissolutionDissolution | RDTL GuwahatiCDSCO lab | Jan 2025 |
| Fexofenadine Hydrochloride Tablets IP (MANOFEX-180) | Batch CT24250327 AMfg May 2024 · Exp Apr 2026 | CMG Biotech Pvt. Ltd | DissolutionDissolution | CDL KolkataCDSCO lab | Dec 2024 |
| Fexofenadine Hydrochloride Tablets I.P. | Batch T-2403971Mfg Mar 2023 · Exp Feb 2026 | Oscar Remedies Pvt. Ltd | Dissolution of Fexofenadine Hydrochloride.Dissolution | RDTL GuwahatiCDSCO lab | Oct 2024 |
| Fexofenadine Hydrochloride Tablets IP | Batch T-2403971Mfg Mar 2024 · Exp Feb 2026 | Oscar Remedies Pvt. Ltd | Uniformity of Weight and DissolutionDissolution | RDTL GuwahatiCDSCO lab | Sep 2024 |
| Fexofenadine Hydrochloride Tablets I.P. | Batch 658-021Mfg Nov 2023 · Exp Oct 2025 | Signature Phytochemical IndustriesUttarakhand | DissolutionDissolution | RDTL GuwahatiCDSCO lab | Sep 2024 |
| Fexofenadine Hydrochloride Tablets IP 120 mg | Batch MP9AA2303Mfg Jul 2023 · Exp Jun 2026 | Maxtar Bio-GenicsHimachal Pradesh | DissolutionDissolution | CDL KolkataCDSCO lab | Aug 2024 |
| Fexofenadine Hydrochloride Tablets IP 120 mg | Batch MP9AA2303 (Two different samples received with same batch number)Mfg Jul 2023 · Exp Jun 2026 | Maxtar Bio-GenicsHimachal Pradesh | DissolutionDissolution | CDL KolkataCDSCO lab | Aug 2024 |
| Fexofenadine Hydrochloride Tablets IP (MANOFEX-180 TABLETS) | Batch CT232407 15AMfg Aug 2023 · Exp Jul 2025 | CMG Biotech Pvt. Ltd | Dissolution (In 10 minutes) and (in 30 minutes)Dissolution | RDTL ChandigarhCDSCO lab | Jun 2024 |
| Fexofenadine Hydrochloride Tablets IP | Batch 658-009Mfg Sep 2022 · Exp Aug 2024 | Signature Phytochemical IndustriesUttarakhand | DissolutionDissolution | CDL KolkataCDSCO lab | Dec 2023 |
| FEXOFENADINE HCL TABLETS IP 120 mg (REFEXO TABLETS 120 mg) | Batch OT-220196Mfg May 2022 · Exp Apr 2024 | Orchid Bio?Tech LtdUttarakhand | DissolutionDissolution | CDTL HyderabadCDSCO lab | Sep 2022 |
| FEXOFENADINE HYDROCHLORIDE TABLETS I.P. | Batch GT211107Mfg Jun 2021 · Exp May 2023 | Theon Pharmaceuticals LtdHimachal Pradesh | DissolutionDissolution | CDTL HyderabadCDSCO lab | Jul 2022 |
Showing 15 of 23 records
Holding a strip or bottle? The batch number is printed after "B. No." Check it against every alert. If it matches, return it to the pharmacy. What the labels mean: status guide.