Regulatory status record
Is Cetirizine banned in India?
Last checked 19 September 2026. A few details are still being checked against the original document.
Cetirizine is not banned in India as of 19 Sep 2026; the 2 Aug 2024 notification prohibited cetirizine + paracetamol + phenylephrine and cetirizine + terbutaline + ambroxol + guaiphenesin, 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 cetirizine; banned FDCs in S.O. 3285(E), 3440(E) of 2 Aug 2024 (exact numbers:, being verified
- Latest action
- 2 August 2024
- 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.
Goa DFDA circular: 156 FDCs banned (copy of Gazette list)
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 Always check the linked government document for the current position, and tell us if something is out of date.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
- Cetirizine tablets/syrup
- Not banned; on the National List of Essential Medicines
- Banned FDCs
- Cetirizine + paracetamol + phenylephrine (Cheston Cold-type); cetirizine + terbutaline + ambroxol + guaiphenesin, 2 Aug 2024
- Common brands
- Cetzine, Okacet, Zyrtec, Alerid, Incid-L
- Levocetirizine
- The single-isomer version; also not banned
Where the claim comes from
The August 2024 ban list included cetirizine + paracetamol + phenylephrine, the formula behind Cheston Cold and many generic cold tablets, and a four-drug cetirizine cough syrup. News lists showed 'cetirizine' in bold, and the single-ingredient antihistamine was assumed to be included.
Cetirizine is the most widely used antihistamine in India, sold under brands such as Cetzine, Okacet and Zyrtec and by every generic manufacturer. It is on the National List of Essential Medicines and it is not banned.
What was banned on 2 August 2024, in the 156-FDC notification, were two combinations. The first is cetirizine + paracetamol + phenylephrine, the cold tablet formula used by Cheston Cold and dozens of generic "cold" brands. The second is cetirizine + terbutaline + ambroxol + guaiphenesin, a four-drug cough syrup. In both cases the expert committee found no therapeutic justification for the fixed combination and some risk, which is the standard test under Section 26A. The exact S.O. numbers for these entries should be read from the CDSCO's official PDF.
Cetirizine on its own was not in that list, nor in the 2016, 2018, 2023 or 2026 waves, nor in the April 2025 list of 35 unapproved combinations. Levocetirizine, the refined version of the same molecule, is in the same position: the molecule is legal, and only specific cold combinations containing it were banned.
For allergy sufferers nothing has changed. For anyone using a "cold and flu" tablet, the ingredient list is what matters: cetirizine with paracetamol and phenylephrine in one tablet is a prohibited product, and a pharmacist can suggest taking the components separately if a doctor agrees.
What this means for you
Plain cetirizine is unaffected
Tablets and syrup for allergy remain licensed and over the counter in the usual strengths.
Cold tablets with cetirizine are different
If the pack also lists paracetamol and phenylephrine, it is the banned Cheston Cold-type combination.
This is a record of official orders, not medical advice. Do not stop a prescribed medicine without asking your doctor or pharmacist.
Entries on the banned drugs list
| Drug / combination | Action | Notification | Date | Status note |
|---|---|---|---|---|
| Cetirizine HCl + Paracetamol + Phenylephrine HCl | Banned | S.O. 3385(E) | 2 August 2024 | Prohibited under s.26A; notifications dated 02.08.2024, gazetted 21-22 Aug 2024. |
| Cetirizine HCl + Phenylephrine HCl | Banned | S.O. 3386(E) | 2 August 2024 | Prohibited under s.26A; notifications dated 02.08.2024, gazetted 21-22 Aug 2024. |
| Levo Cetirizine + Phenylephrine HCl | Banned | S.O. 3387(E) | 2 August 2024 | Prohibited under s.26A; notifications dated 02.08.2024, gazetted 21-22 Aug 2024. |
| Levo Cetirizine + Phenylephrine HCl + Paracetamol | Banned | S.O. 3388(E) | 2 August 2024 | Prohibited under s.26A; notifications dated 02.08.2024, gazetted 21-22 Aug 2024. |
| Phenylephrine HCl + Paracetamol + Levocetirizine HCl + Menthol | Banned | S.O. 3389(E) | 2 August 2024 | Prohibited under s.26A; notifications dated 02.08.2024, gazetted 21-22 Aug 2024. |
| Levo Cetirizine HCl + Ambroxol HCl + Paracetamol | Banned | S.O. 3390(E) | 2 August 2024 | Prohibited under s.26A; notifications dated 02.08.2024, gazetted 21-22 Aug 2024. |
| Levo Cetirizine HCl + Ambroxol HCl + Phenylephrine HCl | Banned | S.O. 3391(E) | 2 August 2024 | Prohibited under s.26A; notifications dated 02.08.2024, gazetted 21-22 Aug 2024. |
| Diethylcarbamazine Citrate + Levocetirizine HCl | Banned | S.O. 3393(E) | 2 August 2024 | Prohibited under s.26A; notifications dated 02.08.2024, gazetted 21-22 Aug 2024. |
| Cetirizine HCl + Terbutaline Sulphate + Ambroxol HCl + Guaifenesin | Banned | S.O. 3400(E) | 2 August 2024 | Prohibited under s.26A; notifications dated 02.08.2024, gazetted 21-22 Aug 2024. |
| Nimesulide + Pseudoephedrine + Cetirizine | Banned | S.O. 256(E) | 11 January 2019 | One of 80 FDCs prohibited vide S.O. 180(E)-259(E) dated 11.01.2019 (CDSCO letter 22.01.2019). In force per CDSCO list as on 22.11.2021. |
| Nimesulide + Cetirizine + Caffeine | Banned | S.O. 4381(E) | 7 September 2018 | In force per CDSCO list as on 22.11.2021 |
| Paracetamol + Cetirizine + Caffeine | Banned | S.O. 4383(E) | 7 September 2018 | In force per CDSCO list as on 22.11.2021 |
Batches declared Not of Standard Quality
Batches of products containing Cetirizine flagged in CDSCO monthly alerts. An NSQ result concerns one batch, not the molecule or the brand.
| Product | Batch | Manufacturer | Reason declared NSQ | Tested by | Alert |
|---|---|---|---|---|---|
| Paracetamol, Phenylephrine HCL, Guaiphenesin, Cetirizine Hydrochloride & Ambroxol HCL Tablets | SBT-3351Mfg 2025-07 · Exp 2027-06 | Supercure Biotech Pvt. LtdHaryana | The sample is found to be Not of Standard Quality for the reason stated under Description.Description | CDL, KolkataCDSCO lab | Jul 2026 |
| 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 |
| 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 |
| Cetirizine Syrup IP | CIZ-2604Mfg 2026-03 · Exp 2028-02 | Apple Formulations Pvt. LtdUttarakhand | pHpH | SDTL, PunjabState lab | Jun 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 |
| Dextromethorphan Hydrobromide, Cetirizine Dihydrochloride, Ambroxol Hydrochloride & Methol Syrup | DLS5271Mfg 2025-08 · Exp 2027-07 | Dhwanilife care Pvt. LtdGujarat | Ambroxol Hydrochloride contentOther | FDL, VadodaraState lab | May 2026 |
| Aceclofenac, Paracetamol, Phenylephrine Hcl Cetirizine Hcl & Caffeine | GT-25294AMfg 2025-08 · Exp 2028-07 | Not Applicable | MisbrandadMisbranded | SDTL, ChhattisgarhState 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 |
| Cetirizine Hydrochloride Tablets I.P. 10mg | LPT2425300Mfg 2025-02 · Exp 2027-01 | Lannett Pharmaceuticals Pvt. Ltd | 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 |
Official sources and primary records
- CDSCO: List of prohibited FDC drugs, 156 FDCs dated 02.08.2024RegulatorCDSCO · 2 August 2024
- Goa DFDA circular: 156 FDCs banned (copy of Gazette list)RegulatorDirectorate of Food and Drugs Administration, Goa · 22 August 2024
- News