Case file
Maiden Pharmaceuticals (Sonipat, Haryana)
Last checked 1 October 2026
Maiden Pharmaceuticals of Sonipat, Haryana, made four paediatric syrups. Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup and Magrip N Cold Syrup, that the WHO linked in Medical Product Alert N°6/2022 on 5 October 2022 to acute kidney injury deaths of children in the Gambia. WHO testing found unacceptable levels of diethylene glycol and ethylene glycol. Haryana's drug authority halted production at the plant in October 2022 after inspections found manufacturing violations. India's government later stated that samples tested by its own laboratory complied with specifications, and disputed the causal link, a position the WHO did not accept. No later action against the company has been published.
Status as of 1 October 2026
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 Always check the linked government document for the current position, and tell us if something is out of date.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.
Affected products and batches
| Product | Batch | Note |
|---|---|---|
| Promethazine Oral Solution | Not stated | DEG/EG contamination per WHO testing |
| Kofexmalin Baby Cough Syrup | Not stated | DEG/EG contamination per WHO testing |
| Makoff Baby Cough Syrup | Not stated | DEG/EG contamination per WHO testing |
| Magrip N Cold Syrup | Not stated | DEG/EG contamination per WHO testing |
Current status
Production halted by Haryana in October 2022; the Indian government subsequently said its own tests found the samples compliant. No later change to the plant's licence has been published as of 1 Oct 2026. None of the four syrups was marketed in India.
What to do if you have this product
Step 1
The four syrups were exported and not sold in India; no domestic stock is known.
Step 2
Travellers or importers holding these products should not use them.
Sources
- WHO Medical Product Alert N°6/2022: Substandard (contaminated) paediatric medicinesWHOWorld Health Organization · 5 October 2022
- WHO: Full list of medical product alertsWHOWorld Health Organization