Brand check

Is Levocet banned in India?

Last checked 1 October 2026

Levocet. Status: Not banned · some combos banned (2024).

Levocet and other single-ingredient levocetirizine products are not banned in India as of 1 Oct 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
Evidence
Government document
Latest action
11 April 2025
Last checked
1 October 2026

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.

Primary government sourceTier 1: government primary source

CDSCO: List of prohibited FDC drugs, 156 FDCs dated 02.08.2024

CDSCO / Ministry of Health and Family Welfare · No Section 26A notification for levocetirizine; banned FDCs in S.O. 3285(E), 3440(E) of 2 Aug 2024 · 2 August 2024

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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 Always check the linked government document for the current position, and tell us if something is out of date.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
Montelukast Sodium and Levocetirizine Hydrochloride Tablets IP Batch FMT26015SLMfg Apr 2026 · Exp Mar 2028 Shiva Biogenetic Laboratories Pvt. LtdHimachal Pradesh The sample does not conform to IP in respect of DissolutionDissolution LUCKNOW, Uttar PradeshState lab Sep 2026
Montelukast Sodium and Levocetirizine Hydrochloride Tablets Batch ZDTY030Mfg Dec 2025 · Exp Nov 2027 Pro-pharma Care Pvt. LtdUttarakhand The sample dose not conform to I.P., in respect of Uniformity of content and DissolutionDissolution LUCKNOW, Uttar PradeshState lab Sep 2026
Montelukast Sodium & Levocetirizine Hydrochloride Tablets IP Batch T260356KMfg Mar 2026 · Exp Feb 2028 Unispeed Pharmaceuticals Pvt. LtdHimachal Pradesh The sample does not conform to IP in respect of DissolutionDissolution LUCKNOW, Uttar PradeshState lab Sep 2026
Levocetirizine Tablets IP 5mg Batch 0726A021Mfg Jan 2026 · Exp Dec 2027 FDC LimitedGoa The sample does not conform to IP in respect of DissolutionDissolution LUCKNOW, Uttar PradeshState lab Sep 2026
Levocetirizine Hydrochloride, Ambroxol Hydrochlolride Batch 26LK024Mfg Jan 2026 · Exp Jan 2028 Kantil Pharmaceuticals Pvt. LtdHimachal Pradesh The sample does not comply with the prescribed requirement for 'Description'Description DTL, Dalgate Srinagar KashmirState lab Sep 2026
Levocetirizine Hydrochloride & Montelukast Sodium tablets IP Batch UGT-25627LMfg May 2025 · Exp Apr 2027 Ultra Drugs Pvt. LtdHimachal Pradesh DescriptionDescription DTL, Bengaluru, KarnatakaState lab Sep 2026
Levocetirizine Dihydrochloride 5mg Tablets IP Batch MPR-251105Mfg Nov 2025 · Exp Oct 2027 Preet Remedies LtdHimachal Pradesh The sample is not of standard quality for the reason stated under "Description" of the tablets.Description RDTL, GuwahatiCDSCO lab Sep 2026
Levocetirizine Dihydrochloride & Montelukast Tablets IP Batch LGP12/303/37Mfg Dec 2025 · Exp Nov 2027 Logos PharmaHimachal Pradesh The sample does not conform to IP with respect to the DissolutionDissolution SDTL, GuwahatiState lab Sep 2026
Montelukast sodium & Levocetirizine hydrochloride Tablets IP Batch VRNT-933Mfg Mar 2025 · Exp Feb 2027 Vrihaan Pharmaceuticals LLP DissolutionDissolution FDL, VadodaraState lab Aug 2026
Montelukast Sodium & Levocetirizine Hydrochloride Suspension Batch DL508027Mfg Aug 2025 · Exp Jul 2027 Renowed Life SciencesUttarakhand Assay of Levocetirizine Hydrochloride.Assay SFDTL, UttarakhandState lab Aug 2026
Montelukast & Levocetirizine Hydrochloride Syrup Batch PTKLA004Mfg Nov 2025 · Exp Oct 2027 Laborate Pharmaceuticals India Ltd (Unit-ii) 31Himachal Pradesh Assay of Levocetirizine HydrochlorideAssay SFDTL, UttarakhandState lab Aug 2026
Levocetirizine Hydrochloride and Montelukast Tablets Batch 41046Mfg Nov 2025 · Exp Oct 2027 Ronak Life Care Pvt. Ltd The sample does not comply as per I.P. 2022 with respect to the test for Dissolution of Montelukast.Dissolution RDTL, GuwahatiCDSCO lab Aug 2026
Levocetirizine Dihydrochloride,Montelukast Soidum & Ambroxol (SR) Batch ITH002Mfg Aug 2025 · Exp Jul 2027 Cis Life Care Pvt.Ltd.44-45 The sample does not confom to IP 2022 requirements with respect to Uniformity of weightUniformity of weight/content DTL,Dalgated Srinagar KashmirState lab Aug 2026
Levocetirizine Dihydrochloride Tablets I.P. Batch B13225006Mfg Nov 2025 · Exp Oct 2027 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 Batch ABC04ABAMfg Dec 2025 · Exp Nov 2027 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 Batch ALL1169Mfg Aug 2024 · Exp Jul 2026 Arcon LabsHimachal Pradesh Content of MontelukastOther SDT&RL, BhubaneswarState lab Jun 2026
Levocetirizine HCl & Montelukast Sodium Syrup. Batch SL-151Mfg Jun 2025 · Exp May 2027 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 Batch PRT2501-149Mfg Jan 2025 · Exp Dec 2026 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 Batch CRL2407068BMfg Jul 2024 · Exp Jun 2026 Casca Remedies Pvt. LtdHaryana Content of Levocetrizine Hydrochlroride & MontelukastOther SDT&RL, BhubaneswarState lab May 2026
Levocetrizine Dihydrochloride Tablets IP) Batch LEE-2501Mfg Jun 2025 · Exp May 2027 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
Showing 20 of 40 records

Ingredient records: Levocetirizine, Phenylephrine, Paracetamol, Menthol, Ambroxol, Montelukast

Sources

Government documents

News reports