Brand check
Is Phenergan banned in India?
Last checked 19 September 2026. A few details are still being checked against the original document.
Phenergan and other single-ingredient promethazine products are not banned in India as of 19 Sep 2026; the only promethazine combination subject to a ban order is pholcodine + promethazine, a different product.
- Classification
- No ban or recall found in official records
- Decided by
- CDSCO / Ministry of Health and Family Welfare
- Reference
- No Section 26A notification for promethazine; pholcodine + promethazine: S.O. 789(E) 10 Mar 2016 (quashed), reported in the 2 Jun 2023 list (being verified)
- Latest action
- 2 June 2023
- Last checked
- 19 September 2026details being verified
Promethazine syrup bottles. Photo: Promethazine bottles.jpg by Uslinctusstore11 (CC0). Brand names and logos belong to their owners and are used here to identify the product this entry is about. All photo credits.
WHO Medical Product Alert N°6/2022: Substandard (contaminated) paediatric medicines
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 Always check the linked government document for the current position, and tell us if something is out of date.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 for promethazine
- Related FDC
- Pholcodine + promethazine (Tixylix-type), 2016 entry quashed; reported in the Jun 2023 14-FDC list (being verified)
- Manufacturer
- Sanofi (Phenergan)
- Children
- Promethazine is contraindicated under 2 years on the label; DGHS Oct 2025 advisory on cough syrups also applies
Where the claim comes from
Promethazine appears in a combination, pholcodine + promethazine, that was banned in 2016, quashed, and reported banned again in June 2023. It is also the base of Promethazine Oral Solution, one of the four Maiden Pharmaceuticals syrups named in WHO Alert N°6/2022 after the Gambia deaths. Both stories attached themselves to Phenergan, the best-known promethazine brand.
Phenergan is Sanofi's brand of promethazine, a first-generation antihistamine used for allergy, nausea, motion sickness and sedation. It is not banned in India, and no Section 26A notification names promethazine on its own.
Two events explain the searches. The first is a combination. Pholcodine + promethazine, sold for cough under brands such as Tixylix, was banned on 10 March 2016 under S.O. 789(E), quashed with the rest of the 344-FDC wave, and then, as a pre-1988 combination, sent for expert review. Reports of the June 2023 order banning 14 older FDCs include pholcodine + promethazine; that entry is flagged for verification. Pholcodine itself has been withdrawn in several countries over an allergy risk with anaesthetics. None of this affects single-ingredient Phenergan.
The second is contamination. In October 2022 the WHO's Alert N°6/2022 named four Maiden Pharmaceuticals syrups linked to child deaths in the Gambia, one of which was a Promethazine Oral Solution. The problem was diethylene glycol in the manufacturer's product, not promethazine as a drug.
Phenergan carries a label contraindication for children under two because of respiratory depression, and the October 2025 DGHS advisory against cough syrups for under-2s reinforces that. Adults can use it as prescribed; it causes drowsiness.
What this means for you
Phenergan tablets, syrup and injection remain available
They are prescription medicines and are not subject to any ban.
Not for children under two
This is a long-standing label contraindication because of breathing suppression, separate from any ban.
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 |
|---|---|---|---|---|---|
| Promethazine Injection I.P. 2ml | HLI992MMfg 2026-12 · Exp 2027-11 | Himalaya Meditek Pvt. Ltd.Plot No. 35&36Uttarakhand | The sample does not conform to I.P with respect to test for 'Particulate matter' and is also not of standard quality for the reason stated under Description.Description | CDL, KolkataCDSCO lab | Jul 2026 |
| Promethazine Hydrochloride Syrup IP | MDL-C819Mfg 2025-12 · Exp 2027-11 | Marvellon Pharmaceuticals Pvt.LtdHimachal Pradesh | ContentOther | DTL, Chennai-06State lab | Jun 2026 |
| Promethazine Injection IP | HLI511GMfg 2025-07 · Exp 2027-06 | Himalaya Meditek Pvt. Ltd.Plot No. 35&36Uttarakhand | The sample does not conform to I.P. with respect to test for pH, Particulate matter, Extractable volume, Assay of Promethazine Hydrochloride and Description.Assay | CDL, KolkataCDSCO lab | Feb 2026 |
| Promethazine Hydrochloride Injection IP 25mg/ml | AHL0107Mfg 2025-08 · Exp 2027-07 | Abaris Healthcare Pvt.Ltd. Survey No. 2458/001Gujarat | The sample does not conform to IP with respect to the Test of Particulate matter and Description.Description | CDL, KolkataCDSCO lab | Feb 2026 |
| Promethazine Injection IP-2ML | 24FNC80Mfg 2024-03 · Exp 2026-02 | SVP Life SciencesUttarakhand | Sample does not conform to requirement for assay.Assay | DTL ChennaiState lab | Nov 2024 |
| Promethazine Injection IP 25 mg / ml | 4A04070Mfg 2024-08 · Exp 2026-07 | Ciron Drugs & Pharmaceuticals Pvt. LtdMaharashtra | AssayAssay | CDL KolkataCDSCO lab | Nov 2024 |
| Promethazine Hydrochloride Injection I.P. (PHENERGAN) 2ml | AHH0230Mfg 2022-08 · Exp 2025-07 | NitinLifesciences LtdHimachal Pradesh | pH and Assay/ Content of Promethazine HydrochlorideAssay | RDTL GuwahatiCDSCO lab | Nov 2024 |
| Promethazine Hydrochloride Injection I.P. (PHENERGAN) | AHH0367Mfg 2022-12 · Exp 2025-11 | Nitin Lifesciences LtdHimachal Pradesh | Assay of Promethazine HydrochlorideAssay | RDTL GuwahatiCDSCO lab | Sep 2024 |
| Promethazine Hydrochloride Syrup IP (Phena Kid Syrup) | DEML- 304269Mfg 2023-02 · Exp 2025-01 | Dr. Edwin Medilabs Pvt. Ltd | AssayAssay | CDL KolkataCDSCO lab | Apr 2024 |
| Promethazine Hydrochloride Injection I.P. 25mg ? 2 ml | I-15314Mfg 2017-10 · Exp 2019-09 | Jackson Laboratories Pvt. LtdPunjab | Description and Particulate MatterDescription | CDL KolkataCDSCO lab | Jan 2019 |
Official sources and primary records
- News
- Deccan Herald: Govt bans 14 fixed-dose combination drugs used to treat cough, feverNewsDeccan Herald · 3 June 2023
- WHO Medical Product Alert N°6/2022: Substandard (contaminated) paediatric medicinesWHOWorld Health Organization · 5 October 2022
- AIR: Health ministry advises cough syrups should not be prescribed or dispensed to children below two yearsNewsAll India Radio · 4 October 2025