Brand check

Is Phenergan banned in India?

Last checked 1 October 2026

Phenergan. Status: Not banned.

Phenergan and other single-ingredient promethazine products are not banned in India as of 1 Oct 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
Evidence
Government document
Latest action
2 June 2023
Last checked
1 October 2026

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.

Primary government sourceTier 1: government primary source

WHO Medical Product Alert N°6/2022: Substandard (contaminated) paediatric medicines

CDSCO / Ministry of Health and Family Welfare · No Section 26A notification for promethazine; pholcodine + promethazine: S.O. 789(E) 10 Mar 2016 (quashed), reported in the 2 Jun 2023 list · 5 October 2022

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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 Always check the linked government document for the current position, and tell us if something is out of date.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
Ban notification
None for promethazine
Related FDC
Pholcodine + promethazine (Tixylix-type), 2016 entry quashed; reported in the Jun 2023 14-FDC list
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. 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. Batch HLI992MMfg Dec 2025 · Exp Nov 2027 Himalaya Meditek Pvt. LtdUttarakhand The sample does not conform to I.P. with respect to the Tests of pH and Assay.Assay CDL, KolkataCDSCO lab Sep 2026
Promethazine HCl Injection IP Batch 26FND32Mfg Apr 2026 · Exp Mar 2028 SVP Life SciencesUttarakhand The sample does not conform to I.P. in the respect of Assay and Particulate matter.Assay ALIGARH, Uttar PradeshState lab Sep 2026
Promethazine HCL Injection IP Batch 25FNL70Mfg Dec 2025 · Exp Nov 2027 SVP Life SciencesUttarakhand The sample does not conforms to I.P. in the respect of content of Promethazine HCI & pH.pH ALIGARH, Uttar PradeshState lab Sep 2026
Promethazine Injection I.P. 2ml Batch HLI992MMfg Dec 2026 · Exp Nov 2027 Himalaya Meditek Pvt. LtdUttarakhand 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 Batch MDL-C819Mfg Dec 2025 · Exp Nov 2027 Marvellon Pharmaceuticals Pvt. LtdHimachal Pradesh ContentOther DTL, Chennai-06State lab Jun 2026
Promethazine Injection IP Batch HLI511GMfg Jul 2025 · Exp Jun 2027 Himalaya Meditek Pvt. LtdUttarakhand 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 Batch AHL0107Mfg Aug 2025 · Exp Jul 2027 Abaris Healthcare Pvt. LtdGujarat 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 Batch 24FNC80Mfg Mar 2024 · Exp Feb 2026 SVP Life SciencesUttarakhand Sample does not conform to requirement for assay.Assay DTL ChennaiState lab Nov 2024
Promethazine Injection IP 25 mg / ml Batch 4A04070Mfg Aug 2024 · Exp Jul 2026 Ciron Drugs & Pharmaceuticals Pvt. LtdMaharashtra AssayAssay CDL KolkataCDSCO lab Nov 2024
Promethazine Hydrochloride Injection I.P. (PHENERGAN) 2ml Batch AHH0230Mfg Aug 2022 · Exp Jul 2025 NitinLifesciences LtdHimachal Pradesh pH and Assay/ Content of Promethazine HydrochlorideAssay RDTL GuwahatiCDSCO lab Nov 2024
Promethazine Hydrochloride Injection I.P. (PHENERGAN) Batch AHH0367Mfg Dec 2022 · Exp Nov 2025 Nitin Lifesciences LtdHimachal Pradesh Assay of Promethazine HydrochlorideAssay RDTL GuwahatiCDSCO lab Sep 2024
Promethazine Hydrochloride Syrup IP (Phena Kid Syrup) Batch DEML- 304269Mfg Feb 2023 · Exp Jan 2025 Dr. Edwin Medilabs Pvt.Ltd AssayAssay CDL KolkataCDSCO lab Apr 2024
Promethazine Hydrochloride Injection I.P. 25mg ? 2 ml Batch I-15314Mfg Oct 2017 · Exp Sep 2019 Jackson Laboratories Pvt. LtdPunjab Description and Particulate MatterDescription CDL KolkataCDSCO lab Jan 2019

Ingredient records: Promethazine

Sources

Government documents

News reports