At least 12 countries including the US, Canada, Dominican Republic, Guam, Guatemala, Jamaica, Puerto Rico, Panama, Trinidad & Tobago, the UAE, Kuwait and Fiji will be affected by the recall.
McNeil Consumer Healthcare said in a statement that it was initiating the "voluntary recall" in consultation with Health Canada "because these products may not fully meet the required manufacturing specifications".
The company, a subsidiary of the Canadian firm Johnson and Johnson, advised consumers who had purchased these recalled products to discontinue their use.
The statement said the company is "conducting a comprehensive quality assessment across its manufacturing operations".
It said that the company had identified corrective actions that would be implemented before new manufacturing is initiated at the US plant where the recalled products were made.
The recall came as UN bodies called for more research and clinical trials to close gaps in the market for children's medicines that cost millions lives in developing countries each year.
Francisco Blanco, the head of medicines and nutrition division of the UN children's fund (Unicef), said that there was a need for more clinical trials and research into paediatric medicines.
Unicef and the World Health Organisation published a list of medicines designed for children and said it exposed dangerous shortfalls.
The Geneva-based WHO said the children's medicine guide, which will be available online, would help doctors and health workers get better access to some of the 240 basic medicines.