Ingredient record · Antihistamine and anti-nausea medicine
Promethazine: bans, restrictions and failed batches in India
Last checked 20 September 2026. Sources: CDSCO banned-drugs notifications and monthly NSQ alerts, Jan 2019 to Jul 2026
8 entries containing Promethazine are on India's banned-drugs list, and 4 are banned today. 10 batches of medicines containing Promethazine failed a government lab test between January 2019 and July 2026, from 9 manufacturers. A failed batch concerns that batch only, not the medicine or every brand.
4
Banned combinations in force
4
Other listed orders (stayed, restricted, quashed)
10
Batches failed a lab test
Jul 2026
Latest lab alert
Is it banned? Our answer pages
Not banned
On the banned-drugs list
Promethazine on its own is not on CDSCO's banned list. The entries below are specific combinations that contain it. Status follows CDSCO's own notes on each entry.
| Drug / combination | Action | Notification | Date | Order | Status note |
|---|---|---|---|---|---|
| Pholcodine + PromethazineFixed-dose combination · cough-cold | Banned | S.O. 2396(E) | 2 June 2023 | 14 FDCs · Jun 2023 | Prohibited under s.26A on DTAB/Expert Committee advice; these are 14 of the 15 'pre-1988' FDCs excluded from the 2018 re-ban (Imipramine + Diazepam not included). |
| Paracetamol + PromethazineFixed-dose combination · cough-cold | Banned | S.O. 4457(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Dextromethorphen + PromethazineFixed-dose combination · cough-cold | Banned | S.O. 4553(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Pholcodine + Phenylephrine + PromethazineFixed-dose combination · cough-cold | Banned | S.O. 4562(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Pholcodine + PromethazineFixed-dose combination · cough-cold | Under examination | S.O. 789(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; SC order 15.12.2017 treated it as a pre-1988 FDC, under examination with Expert Committee per CDSCO list as on 22.11.2021 (note 3#). 14 of these 15 were re-prohibited on 02.06.2023 (wave 2023-14). |
| Paracetamol + PromethazineFixed-dose combination · cough-cold | Quashed | S.O. 790(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Dextromethorphen + PromethazineFixed-dose combination · cough-cold | Quashed | S.O. 891(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Pholcodine + Phenylephrine + PromethazineFixed-dose combination · cough-cold | Quashed | S.O. 900(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
Products that failed lab tests
Product names as printed by the testing labs, grouped. Open a product to see every batch number.
| Product | Batches | Makers | Latest |
|---|---|---|---|
| Promethazine Hydrochloride | 5 | 5 | Jun 2026 |
| Promethazine | 3 | 2 | Jul 2026 |
| Promethazine Hydrochloride /ml | 1 | 1 | Feb 2026 |
| Promethazine / Ml | 1 | 1 | Nov 2024 |
Most recent failed batches
| Product | Batch | Manufacturer | Reason declared NSQ | Tested by | Alert |
|---|---|---|---|---|---|
| Promethazine Injection I.P. 2ml | HLI992MMfg 2026-12 · Exp 2027-11 | 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 | 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. 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 | AHL0107Mfg 2025-08 · Exp 2027-07 | 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 | 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 |
Holding a strip or bottle? The batch number is printed after "B. No." Check it against every alert. If it matches, return it to the pharmacy. What the labels mean: status guide.