Brand check
Is Allegra banned in India?
Last checked 1 October 2026
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.
CDSCO: Drugs banned in India (consumer section)
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 Always check the linked government document for the current position, and tell us if something is out of date.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 Fexofenadine is the active metabolite of terfenadine, a 1990s antihistamine that was banned in India and withdrawn worldwide because it could cause a dangerous heart rhythm, particularly with certain antibiotics and antifungals.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 |
Ingredient records: Fexofenadine
Sources
Government documents
- Regulator
- CDSCO: List of prohibited FDC drugs, 156 FDCs dated 02.08.2024RegulatorCDSCO · 2 August 2024
News reports
- Business Today: India halts 35 drug combinations over health risks, full listNewsBusiness Today · 17 April 2025