10 Children’s Drugs NAFDAC Has Recalled, Flagged or Warned Nigerians About

NAFDAC Alerts Nigerians Over 10 Children’s Medicines and Syrups Flagged for Safety Concerns

The National Agency for Food and Drug Administration and Control (NAFDAC) has, at different times, issued recalls and safety alerts concerning a number of paediatric medicines, antibiotics and cough syrups following concerns ranging from contamination and low active pharmaceutical ingredients to falsification and illegal distribution.

Parents and caregivers have been advised to purchase medicines only from licensed pharmacies and authorised suppliers and to carefully check product details before administering medicines to children.

Here are 10 products that have featured in NAFDAC safety alerts or regulatory actions:

1. Benylin Paediatric Syrup

   NAFDAC announced a recall involving a batch of Benylin Paediatric Syrup in April 2024. The action followed concerns over the affected batch. Importantly, the recall did not amount to a permanent ban on every Benylin product. NAFDAC’s current Greenbook still lists Benylin Paediatric Syrup as an active registered product.

2. Asian Ampicillin/Cloxacillin Oral Suspension

   NAFDAC warned against the illegal manufacture, distribution and sale of substandard and falsified Asian Ampicillin/Cloxacillin Oral Suspension. The Agency said about 2,460 bottles were discovered in six shops in Kano State during surveillance operations.

3. Annmox Amoxicillin Suspension 125mg/5ml

   NAFDAC issued Public Alert No. 35/2025 concerning substandard batches of Annmox Amoxicillin Suspension manufactured by Jawa International Limited. Laboratory findings showed inadequate levels of the required active pharmaceutical ingredient.

4. Jawamox Amoxicillin Suspension 125mg/5ml

   Jawamox was included in the same NAFDAC 2025 safety alert after batches were found to contain insufficient active pharmaceutical ingredient. Such quality failures can potentially lead to ineffective treatment and contribute to antimicrobial resistance.

5. Astamocil Amoxicillin Suspension 125mg/5ml

   NAFDAC Public Alert No. 34/2025 identified a substandard batch of Astamocil Amoxicillin Suspension manufactured by Sam-Ace Limited. The affected batch was specifically identified by NAFDAC for regulatory action.

6. Astamentin Amoxicillin/Clavulanic Acid Suspension

   NAFDAC also flagged batches of Astamentin Amoxicillin/Clavulanic Acid Suspension in the same 2025 alert. The Agency classified the affected products as substandard.

7. Ambronol Syrup

   NAFDAC issued a safety communication concerning contaminated Ambronol Syrup following an international medical-product alert. The product was among syrups found to have quality concerns requiring public-health attention.

8. DOK-1 Max Syrup

   DOK-1 Max was also named alongside Ambronol in a NAFDAC alert concerning contaminated medicinal syrups. NAFDAC advised healthcare providers and members of the public to remain vigilant about substandard products entering the medicine supply chain.

9. Unregistered Nurofen for Children Products

   NAFDAC records show that foreign unregistered Nurofen syrup for children was discovered on sale during an investigation in Nigeria. The products found were mopped up from the outlet because they were not registered for the Nigerian market.

10. Contaminated Paediatric Cough Syrups Manufactured by Maiden Pharmaceuticals

    In October 2022, NAFDAC issued an alert concerning contaminated paediatric cough syrups manufactured by Maiden Pharmaceuticals Limited following an international safety warning. The alert followed serious concerns over toxic contaminants in paediatric liquid medicines.

NAFDAC Warns Parents

NAFDAC has repeatedly advised Nigerians against buying medicines from unauthorised dealers, open markets or questionable online sources.

Consumers should check the NAFDAC registration details, batch number, manufacturing and expiry dates and ensure that packaging has not been tampered with.

Suspected falsified, contaminated or substandard medicines should be reported to NAFDAC rather than administered to children.

Important clarification

The products above should not all be described as permanently banned medicines. Some alerts apply only to particular batches, manufacturers or unregistered versions of a product.

For example, although an affected batch of Benylin Paediatric Syrup was recalled in 2024, NAFDAC’s official Greenbook currently shows the product as registered with an active status.

A more accurate description is that the medicines have been recalled, flagged as substandard or falsified, found unregistered, or subjected to NAFDAC safety alerts.