NAFDAC raises alarm over fake Otrivin, orders nationwide recall

The National Agency for Food and Drug Administration and Control (NAFDAC) has issued an urgent warning regarding the widespread circulation of counterfeit Otrivin Nasal Drops across Nigeria, and ordered a nationwide clearance of the product due to potential health hazards.

In a public warning (No. 019/2026) on its website, the agency revealed that the children’s (0.05%) and adult versions of the nasal drops currently on the market are unregistered and unsafe to use.

“The Marketing Authorization Holder has confirmed that they are not currently importing any Otrivin products into Nigeria. As a result, all products in circulation are counterfeit,” NAFDAC said.

The discovery follows a complaint filed with the agency’s Post-Marketing Surveillance Directorate, which led to the identification of unapproved products in circulation.

Otrivin nose drops are widely used to treat nasal congestion, allergies and inflammation, but NAFDAC warns that counterfeit variants may contain dangerous or substandard substances.

“Unregistered products pose a significant risk to public health. They may cause treatment failure, adverse reactions, or worsening of medical conditions,” the agency warned.

According to NAFDAC, genuine Otrivin products have registration numbers 04-5350 (children) and 04-0026 (adults), while counterfeit versions are associated with suspicious batch numbers such as 7U8T and SU8X, often marked with current production and expiration dates.

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In response, the agency has activated a national law enforcement network, instructing zonal directors and state coordinators to intensify monitoring and remove the products from circulation.

NAFDAC also asked distributors, retailers, health professionals and nurses to remain vigilant.

“All medical products must be sourced from official and licensed suppliers. The authenticity and physical condition of the product must always be verified before use,” he stressed.

Consumers and healthcare providers have been advised to report suspected counterfeit products to the nearest NAFDAC office or through official reporting channels.

The warning comes amid a series of recent alerts the agency issued regarding counterfeit and unregistered medicines, including products falsely marketed as HIV cures, fake baby food and fake cancer treatments.

NAFDAC further revealed that the alert will be escalated to the World Health Organization’s global monitoring system to help curb the distribution of counterfeit products internationally.

For now, the agency has urged Nigerians to avoid purchasing or using Otrivin nasal drops on the market until further notice.

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