Brand check
Is Levocet banned in India?
Last checked 19 September 2026. A few details are still being checked against the original document.
Levocet and other single-ingredient levocetirizine products are not banned in India as of 19 Sep 2026; the 2 Aug 2024 notification prohibited levocetirizine combinations with phenylephrine, paracetamol, menthol or ambroxol, not the antihistamine alone.
- Classification
- No ban or recall found in official records
- Decided by
- CDSCO / Ministry of Health and Family Welfare
- Reference
- No Section 26A notification for levocetirizine; banned FDCs in S.O. 3285(E), 3440(E) of 2 Aug 2024 (exact numbers:, being verified
- Latest action
- 11 April 2025
- Last checked
- 19 September 2026details being verified
Cetirizine tablets in a blister pack. Photo: Cetirizine tablets under the brand name «Зодак».jpg by Issuial (CC0). Brand names and logos belong to their owners and are used here to identify the product this entry is about. All photo credits.
CDSCO: List of prohibited FDC drugs, 156 FDCs dated 02.08.2024
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 Always check the linked government document for the current position, and tell us if something is out of date.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
- Levocet (single ingredient)
- Not banned
- Levocet M (with montelukast)
- Not banned; the three-drug version with ambroxol was halted 11 Apr 2025
- Banned combinations
- Levocetirizine + phenylephrine (± paracetamol/menthol); levocetirizine + ambroxol + paracetamol or phenylephrine, 2 Aug 2024
- Manufacturer
- Hetero (Levocet)
Where the claim comes from
The August 2024 ban list contains at least five levocetirizine combinations, with phenylephrine, with phenylephrine and paracetamol, with menthol, and with ambroxol. Many carry 'Levo' in the brand name, and the news lists rendered them as 'levocetirizine banned'. Levocet, the best-selling single-ingredient brand, inherited the question.
Levocet is Hetero's brand of levocetirizine, a second-generation antihistamine used for allergic rhinitis and urticaria. Levocetirizine is not banned in India, and neither is Levocet.
The confusion comes from the August 2024 ban on 156 fixed-dose combinations, which removed a whole family of levocetirizine cold tablets: levocetirizine with phenylephrine, with phenylephrine and paracetamol, with menthol added, and with ambroxol plus paracetamol or phenylephrine. Those combinations were sold under dozens of brand names, many beginning with "Levo", and news summaries listed the ingredient rather than the brands. The regulator's stated reason was the same as for the rest of the list: no therapeutic justification for combining an antihistamine with a decongestant and an analgesic in one tablet.
Single-ingredient levocetirizine was not touched. Levocet M, which pairs levocetirizine with montelukast for allergic asthma and rhinitis, was not touched either; the three-drug version with ambroxol was among the 35 unapproved combinations halted by the CDSCO on 11 April 2025.
The exact S.O. numbers for the levocetirizine entries should be read from the CDSCO's official PDF rather than from news numbering. For patients, the check is the ingredient list: levocetirizine alone or with montelukast is fine, levocetirizine with phenylephrine or ambroxol is not.
What this means for you
Plain Levocet is unaffected
Levocetirizine tablets and syrup for allergy remain licensed.
Cold tablets with 'Levo' names need checking
If the pack lists phenylephrine or ambroxol with levocetirizine, it is a banned combination; ask your pharmacist for a replacement.
This is a record of official orders, not medical advice. Do not stop a prescribed medicine without asking your doctor or pharmacist.
Common questions
Is Levocet M banned?
No. Levocetirizine + montelukast is not banned; only the version with ambroxol added was halted in April 2025.
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 |
|---|---|---|---|---|---|
| Levocetirizine Dihydrochloride Tablets I.P. | B13225006Mfg 2025-11 · Exp 2027-10 | TORQUE PHARMACEUTICALS Pvt. LTD | The sample does not conform to the I.P. with respect to Dissolution of Levocetirizine Dihydrochloride.Dissolution | DTL JodhpurState lab | Jul 2026 |
| Levocetirizine & Montelukast Sodium Dispersible tablets | ABC04ABAMfg 2025-12 · Exp 2027-11 | Pure & Cure Healthcare Pvt. LtdUttarakhand | The sample does not conform to Label claim with respect to content of Montelukast in Montelukast sodium)Labelling | Drugs Testing Laboratory, Madurai-19State lab | Jul 2026 |
| Montelukast, Levocetrizine Dihydrochloride | ALL1169Mfg 2024-08 · Exp 2026-07 | Arcon LabsHimachal Pradesh | Content of MontelukastOther | SDT&RL, BhubaneswarState lab | Jun 2026 |
| Levocetirizine HCl & Montelukast Sodium Syrup. | SL-151Mfg 2025-06 · Exp 2027-05 | Shivam Enterprises (Pharma Division)Himachal Pradesh | Assay Of Montelukast Sodium I.P. ? Less than prescribed limit.Assay | SDFTL US Nagar,UKState lab | Jun 2026 |
| Levocetirizine Dihydrochloride Tablets IP 5mg | PRT2501-149Mfg 2025-01 · Exp 2026-12 | Regent Ajanta BiotechUttarakhand | The sample does not conform to standard quality in respect of the test for Description performed.Description | SDTL, Tripura, AgartalaState lab | Jun 2026 |
| Montelukast & Levocetrizine Hydrochloride Syrup | CRL2407068BMfg 2024-07 · Exp 2026-06 | Casca Remedies Pvt. LtdHaryana | Content of Levocetrizine Hydrochlroride & MontelukastOther | SDT&RL, BhubaneswarState lab | May 2026 |
| Levocetrizine Dihydrochloride Tablets IP) | LEE-2501Mfg 2025-06 · Exp 2027-05 | Apple Formulations Pvt. LtdUttarakhand | The sample does not conform to standard in respect of the test for Description performed.Description | SDTL,Govt. of Tripura, AgartalaState lab | May 2026 |
| Levocetirizine Tablets IP | PGT25-2392GMfg 2025-09 · Exp 2027-08 | Plena RemediesHimachal Pradesh | The sample does not conforms to the IP with respect to Assay of Levocetirizine Hydrochloride.Assay | DTL JaipurState lab | May 2026 |
| Levocetirizine Hydrochloride & Montelukast Syrup | JLH2523Mfg 2025-08 · Exp 2027-07 | Janveda Healthceuticals Pvt. LtdGujarat | Content of Levocetirizine Hydrochloride & MontelukastOther | FDL, VadodaraState lab | May 2026 |
| Levocetirizine Dihydrochloride Syrup | 1C0149Mfg 2026-03 · Exp 2028-02 | Deep PharmaGujarat | The sample does not conform to Manufacturers specification with respect to the test of Microbial contamination (Total aerobic viable count).Microbial limits | CDTL, MumbaiCDSCO lab | May 2026 |
| Montelukast Sodium and Levocetirizine Dihydrochloride Syrup | SP25990Mfg 2025-10 · Exp 2027-09 | Seejar Pharmaceuticalls | Assay for MontelukastAssay | DTL, Bengaluru, KarnatakaState lab | Apr 2026 |
| Levocetirizine Hydrochloride and Montelukast Sodium Tablets IP (5 mg/10 mg) | 310225017Mfg 2025-05 · Exp 2027-04 | Ravenbhel Healthcare Pvt. LtdJammu & Kashmir | DescriptionDescription | DTL, Bengaluru, KarnatakaState lab | Apr 2026 |
| Paracetamol, Levocetirizine Hydrochloride & Phenyleprine Hydrochloride Tablets | AMT-0309Mfg 2024-04 · Exp 2026-03 | Avalon Medicines Pvt. LtdHaryana | DescriptionDescription | DTL, Bengaluru, KarnatakaState lab | Mar 2026 |
| Levocetirizine Dihydrochloride and Montelukast Syrup | LR25J006Mfg 2025-10 · Exp 2027-09 | Rhombus Pharma Pvt. LtdGujarat | The sample received does not conform to I.P. 2022 with respect to the test for pHpH | CDTL, MumbaiCDSCO lab | Mar 2026 |
| Levocetirizine Dihydrochloride Tablets I.P | ATGI4259Mfg 2024-09 · Exp 2026-08 | Actinova Pvt. Ltd. At 147 Mauza SansiwalaHimachal Pradesh | Content of Levocetirizine DihydrochlorideOther | SDTL, PunjabState lab | Mar 2026 |
| Montelukast & Levocetirizine Dihydrochloride | E9AIY029Mfg 2025-08 · Exp 2027-07 | Pharma Force Lab (Unit II) Plot No. 83-86Himachal Pradesh | Assay of Montelukast Sodium IP & Levocetirizine Dihydrochloride IPAssay | FDTL,UttarakhandState lab | Feb 2026 |
| Levocetirizine Tablets IP 5 mg | R25021Mfg 2025-01 · Exp 2026-12 | Ripcord Pharmaceuticals Pvt. LtdMaharashtra | Failed DescriptionDescription | DTL, PuducherryState lab | Feb 2026 |
| Levocetirizine Hydrochloride and Montelukast Sodium Tablets IP | UGT-25293LMfg 2025-03 · Exp 2027-02 | Ultra Drugs Pvt. LtdHimachal Pradesh | The sample does not conform to I.P.w.r.t. the test for DissolutionDissolution | SDTL, AssamState lab | Feb 2026 |
| Levocetirizine HCl & Montelukast Sodium Suspension | GL250137Mfg 2025-10 · Exp 2027-09 | Grownbury Pharmaceuticals Pvt. LtdUttarakhand | The sample does not conforms to Manufacturers specification with respect to the Test for pH, Total yeasts and molds count, Microbial contamination, Total bacterial countpH | CDTL, MumbaiCDSCO lab | Feb 2026 |
| Levocetirizine Dihydrochloride and Montelukast Sodium Syrup | AL-24002Mfg 2025-01 · Exp 2026-12 | Tridus RemediesBihar | The sample does not conform to claim with respect to Assay of Montelukast Sodium and Description.Assay | CDL, KolkataCDSCO lab | Jan 2026 |
Official sources and primary records
- 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
- News