The National Agency for Food and Drug Administration and Control (NAFDAC) is alerting the public about the recall of one batch of Juhel Folic acid 5mg x1000 tablet, describing the product as substandard.
According to a statement published on the agency’s official website, the affected batch was identified during the Risk-Based Post Marketing Surveillance (PMS) conducted in February 2025.
Laboratory analysis revealed that the product did not meet the required quality standards.
“The product was found to be substandard following laboratory tests, which showed low active pharmaceutical ingredient (API) content,” NAFDAC stated.
The agency noted that a root cause analysis carried out by the manufacturer Juhel Pharma Ltd. attributed the problem to a malfunction in the weight adjuster device of the tableting machine, which led to inadequate API content. Consequently, the manufacturer initiated a recall of the affected batch.
“The product is Juhel Folic Acid 5mg x1000 tablets, with Lot Number 0531, manufactured by Juhel Pharma Ltd., 35 Nkwubor Road, Emene – Enugu,” the statement reads.
Health risks of substandard medicines
NAFDAC warned that administering substandard medicines poses significant risks to patient health and public health.
“These risks include poisoning, treatment failure, drug resistance, and even death.
“Substandard medicines may contain toxic substances, incorrect ingredients, or incorrect dosages, leading to severe adverse effects,” the agency said.
Folic acid is commonly used to treat or prevent folate deficiency anaemia and is especially critical during pregnancy, as it supports the proper development of the baby’s brain, skull, and spinal cord, helping to prevent neural tube defects such as spina bifida.
Agency moves to mop up affected products
In response to the issue, NAFDAC said all zonal directors and state coordinators have been directed to conduct surveillance and remove the substandard product from circulation in their respective regions.
The agency urged distributors, retailers, healthcare professionals, and caregivers to be vigilant.
“All medical products must be obtained from authorized or licensed suppliers. The authenticity and physical condition of products should be carefully checked,” NAFDAC stated.
Healthcare professionals and consumers are encouraged to report any suspicion of substandard or falsified medicines to the nearest NAFDAC office.
More insights
However, NAFDAC expressed concern following a recent alert from India’s Central Drugs Standard Control Organization (CDSCO), which flagged several pharmaceutical products as Not of Standard Quality (NSQ).
The declaration came after CDSCO conducted laboratory analysis on drug samples obtained from various sales and distribution points across India. The affected drugs failed to meet required quality standards and were formally designated as NSQ, signaling potential safety and efficacy risks.
NAFDAC noted that some of the pharmaceutical companies whose products were implicated in the CDSCO’s findings have subsidiaries, partners, or distributed products in Nigeria.
Among the companies involved are those with significant presence or partnerships in Nigeria, including firms like Abaris Healthcare Pvt Ltd, Alencure Biotech Pvt Ltd, Eurolife Healthcare Pvt Ltd, Health Biotech Ltd, HIGGS Healthcare, Kamataka Antibiotics & Pharmaceuticals Ltd (KAPL), Laborate Pharmaceuticals India Ltd, Legend Industries, Martins & Brown Biosciences Pvt Ltd., Mascot Health Series Pvt Ltd, Micron Pharmaceutical, Orison Pharma International, Rivpra Formulation Pvt Ltd, Sai Parenterals Ltd, Symbiosis Pharmaceuticals Pvt Ltd, Syncom Formulations (India) Ltd, and Zee Laboratories Ltd.
