Brand check
Is Allegra banned in India?
Last checked 19 September 2026
Allegra is not banned in India as of 19 Sep 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
- Latest action
- 2 August 2024
- Last checked
- 19 September 2026
Photo: Cocillana.JPG by Xanor (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 Always check the linked government document for the current position, and tell us if something is out of date.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 Fexofenadine is the active metabolite of terfenadine, a 1990s antihistamine that was banned in India and withdrawn worldwide because it could cause a dangerous heart rhythm, particularly with certain antibiotics and antifungals.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) | GB25051Mfg 2025-08 · Exp 2028-01 | Devbhoomi PharmaceuticalsUttarakhand | Assay for Montelukast onlyAssay | RDTL, Bellary, KarnatakaState lab | Mar 2026 |
| Fexofenadine Hydrochloride tablets 120mg (Fexomon-120.) | MT2503039Mfg 2025-03 · Exp 2027-02 | MONIQUE PHARMACEUTICALS PVT. LTD.PLOT NO. 676Haryana | Test of Dissolution (at 10 min), Dissolution (at 30 min)Dissolution | RDTL, ChandigarhCDSCO lab | Jul 2025 |
| Fexofenadine Tablets IP (Fexodil 180 mg) | T-4029Mfg 2025-01 · Exp 2026-12 | Jackson Laboratories Pvt. LtdPunjab | Dissolution test after 10 min and after 30 minDissolution | CDL, KolkataCDSCO lab | May 2025 |
| Fexofenadine Tab IP [Fexodil-180] | T ? 3105Mfg 2024-10 · Exp 2026-09 | 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. | UGT231163Mfg 2023-08 · Exp 2025-07 | Unimarck Healthcare LtdUttarakhand | DissolutionDissolution | RDTL GuwahatiCDSCO lab | Jan 2025 |
| Fexofenadine Hydrochloride Tablets IP (MANOFEX-180 ) | CT24250327 AMfg 2024-05 · Exp 2026-04 | CMG BIOTECH PVT.LTD | DissolutionDissolution | CDL KolkataCDSCO lab | Dec 2024 |
| Fexofenadine Hydrochloride Tablets I.P. | T-2403971Mfg 2023-03 · Exp 2026-02 | Oscar Remedies Pvt. Ltd | Dissolution of Fexofenadine Hydrochloride.Dissolution | RDTL GuwahatiCDSCO lab | Oct 2024 |
| Fexofenadine Hydrochloride Tablets IP | T-2403971Mfg 2024-03 · Exp 2026-02 | Oscar Remedies Pvt. Ltd | Uniformity of Weight and DissolutionDissolution | RDTL GuwahatiCDSCO lab | Sep 2024 |
| Fexofenadine Hydrochloride Tablets I.P. | 658-021Mfg 2023-11 · Exp 2025-10 | Signature Phytochemical IndustriesUttarakhand | DissolutionDissolution | RDTL GuwahatiCDSCO lab | Sep 2024 |
| Fexofenadine Hydrochloride Tablets IP 120 mg | MP9AA2303Mfg 2023-07 · Exp 2026-06 | Maxtar Bio-GenicsHimachal Pradesh | DissolutionDissolution | CDL KolkataCDSCO lab | Aug 2024 |
| Fexofenadine Hydrochloride Tablets IP 120 mg | MP9AA2303 (Two different samples received with same batch number)Mfg 2023-07 · Exp 2026-06 | Maxtar Bio-GenicsHimachal Pradesh | DissolutionDissolution | CDL KolkataCDSCO lab | Aug 2024 |
| Fexofenadine Hydrochloride Tablets IP (MANOFEX-180 TABLETS) | CT232407 15AMfg 2023-08 · Exp 2025-07 | CMG BIOTECH PVT. LTD | Dissolution (In 10 minutes) and (in 30 minutes)Dissolution | RDTL ChandigarhCDSCO lab | Jun 2024 |
| Fexofenadine Hydrochloride Tablets IP | 658-009Mfg 2022-09 · Exp 2024-08 | Signature Phytochemical IndustriesUttarakhand | DissolutionDissolution | CDL KolkataCDSCO lab | Dec 2023 |
| FEXOFENADINE HCL TABLETS IP 120 mg (REFEXO TABLETS 120 mg) | OT-220196Mfg 2022-05 · Exp 2024-04 | Orchid Bio?Tech LtdUttarakhand | DissolutionDissolution | CDTL HyderabadCDSCO lab | Sep 2022 |
| FEXOFENADINE HYDROCHLORIDE TABLETS I.P. | GT211107Mfg 2021-06 · Exp 2023-05 | Theon Pharmaceuticals LtdHimachal Pradesh | DissolutionDissolution | CDTL HyderabadCDSCO lab | Jul 2022 |
| Acebrophylline (SR), Fexofenadine Hydrochloride and Montelukast Sodium Tablets (LEVOICE-3D TABLETS) | T21G522DMfg 2021-07 · Exp 2023-06 | Bajaj FormulationsUttarakhand | Assay of Montelukast Sodium calculated as MontelukastAssay | RDTL ChandigarhState lab | Dec 2021 |
| Fexofenadine Tablets I.P. 120 mg | CT-8321220Mfg 2020-12 · Exp 2022-11 | Clevus LifesciencesHimachal Pradesh | DissolutionDissolution | CDL KolkataCDSCO lab | Jul 2021 |
| FEN PIL-120 (Fexofenadine Hydrochloride Tablets I.P. 120 mg) | AWX29002Mfg 2019-10 · Exp 2021-09 | Psychotropics India LimitedUttarakhand | DissolutionDissolution | CDL KolkataCDSCO lab | Jun 2021 |
| FEXOFENADINE HYDROCHLORIDE TABLETS IP | FXNT-1009Mfg 2020-11 · Exp 2022-10 | WINGS BIOTECHHimachal Pradesh | DissolutionDissolution | RDTL ChandigarhCDSCO lab | May 2021 |
| Fexcor-120 (Fexofenadine Hydrochloride Tablets I.P. 120 mg) | OBRP01Mfg 2019-08 · Exp 2021-07 | Akums Drugs & Pharmaceuticals LtdUttarakhand | DescriptionDescription | CDL KolkataCDSCO lab | Jun 2020 |
Official sources and primary records
- Regulator
- CDSCO: List of prohibited FDC drugs, 156 FDCs dated 02.08.2024RegulatorCDSCO · 2 August 2024
- Business Today: India halts 35 drug combinations over health risks, full listNewsBusiness Today · 17 April 2025