Brand check

Is Allegra banned in India?

Last checked 1 October 2026

Allegra. Status: Not banned.

Allegra is not banned in India as of 1 Oct 2026; fexofenadine has never been named in a Section 26A notification, and no fexofenadine combination appears in the 2016 to 2026 FDC ban lists.

Classification
No ban or recall found in official records
Decided by
CDSCO / Ministry of Health and Family Welfare
Reference
No Section 26A notification for fexofenadine
Evidence
Government document
Latest action
2 August 2024
Last checked
1 October 2026

Photo: Cocillana.JPG by unknown (CC0). All photo credits.

Primary government sourceTier 1: government primary source

CDSCO: Drugs banned in India (consumer section)

CDSCO / Ministry of Health and Family Welfare · No Section 26A notification for fexofenadine

View original document

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 Always check the linked government document for the current position, and tell us if something is out of date.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
Marketer
Sanofi / Opella (Allegra)
Variants
Allegra 120, Allegra 180, Allegra-M (with montelukast), none banned
Historical note
Fexofenadine replaced terfenadine, which was banned for heart-rhythm risk

Where the claim comes from

Fexofenadine is the active metabolite of terfenadine, an antihistamine banned in India and elsewhere in the late 1990s for causing dangerous heart rhythms, and the two names are sometimes confused. More recently, the 2024 cold-tablet bans and the 2025 to 2026 chlorpheniramine + phenylephrine restriction put 'antihistamine' and 'ban' in the same headlines.

Allegra is the fexofenadine brand from Sanofi's consumer business, sold in 120 mg and 180 mg tablets and, as Allegra-M, in combination with montelukast. It is not banned in India.

Fexofenadine has never been the subject of a Section 26A notification. It does not appear in the CDSCO's list of banned single-ingredient drugs, and no fexofenadine combination is in the FDC ban waves of 2016, 2018, 2023, 2024 or 2026. Fexofenadine + montelukast, the Allegra-M combination, was likewise not in the April 2025 list of 35 unapproved combinations.

The question probably has two roots. Fexofenadine is the active metabolite of terfenadine, a 1990s antihistamine that was banned in India and withdrawn worldwide because it could cause a dangerous heart rhythm, particularly with certain antibiotics and antifungals. Fexofenadine was developed precisely because it does not carry that risk, but the family connection means the two names sometimes travel together in old lists. More recently, headlines about cetirizine and levocetirizine cold combinations being banned in 2024 and about chlorpheniramine + phenylephrine restrictions in 2025 to 2026 have made "antihistamine ban" a recurring phrase.

Allegra is non-sedating for most people and available over the counter. If a CDSCO monthly alert ever names a fexofenadine batch, that finding is batch-specific; compare the number on the strip.

What this means for you

Nothing has changed

Allegra and generic fexofenadine remain available as before.

Terfenadine is the banned one

Allegra's predecessor was withdrawn; the successor molecule was designed to avoid that problem.

This is a record of official orders, not medical advice. Do not stop a prescribed medicine without asking your doctor or pharmacist.

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
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 & Montelukast Sodium Tablets) Batch GB25051Mfg Aug 2025 · Exp Jan 2028 Devbhoomi PharmaceuticalsUttarakhand Assay for Montelukast onlyAssay RDTL, Bellary, KarnatakaState lab Mar 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
Acebrophylline (SR), Fexofenadine Hydrochloride and Montelukast Sodium Tablets (LEVOICE-3D TABLETS) Batch T21G522DMfg Jul 2021 · Exp Jun 2023 Bajaj FormulationsUttarakhand Assay of Montelukast Sodium calculated as MontelukastAssay RDTL ChandigarhState lab Dec 2021
Fexofenadine Tablets I.P. 120 mg Batch CT-8321220Mfg Dec 2020 · Exp Nov 2022 Clevus LifesciencesHimachal Pradesh DissolutionDissolution CDL KolkataCDSCO lab Jul 2021
FEN PIL-120 (Fexofenadine Hydrochloride Tablets I.P. 120 mg) Batch AWX29002Mfg Oct 2019 · Exp Sep 2021 Psychotropics India LtdUttarakhand DissolutionDissolution CDL KolkataCDSCO lab Jun 2021
FEXOFENADINE HYDROCHLORIDE TABLETS IP Batch FXNT-1009Mfg Nov 2020 · Exp Oct 2022 Wings Biotech LLPHimachal Pradesh DissolutionDissolution RDTL ChandigarhCDSCO lab May 2021
Showing 20 of 24 records

Ingredient records: Fexofenadine

Sources

Government documents

News reports