The National Agency for Food and Drug Administration and Control (NAFDAC) has directed a recall of Embacef 125 Powder for Oral Suspension, following a confirmed case of product caking after reconstitution. The agency has warned that the product poses serious safety and treatment risks to patients.

What Triggered the Recall

The recall began after a complaint was filed at NAFDAC’s Ekiti State office, reporting that two bottles of Embacef suspension caked after the first day of reconstitution.

Upon investigation, NAFDAC verified the poor quality and concluded that the affected batch, and potentially other related batches—should be withdrawn from circulation.

Product Details

• Product Name: Embacef-125 Suspension (Cefuroxime Axetil USP Powder for Oral Suspension)

• Holder of Registration Certificate: Embassy Pharmaceutical and Chemicals Ltd, Lagos

• Manufacturer: Laborate Pharmaceutical India, Panipat, India

• Batch Number: PEDSE001

• NRN: A4-9040

• Manufacturing Date: 02/2025

• Expiry Date: 01/2027

Why Embacef Matters

Embacef contains Cefuroxime Axetil, a broad-spectrum antibiotic used to treat bacterial infections, including:

• Bronchitis

• Gonorrhea

• Lyme disease

• Infections of the throat, tonsils, ears, sinuses, urinary tract, and skin

Risk Statement

NAFDAC warns that using substandard or compromised antibiotics can have severe consequences, including:

• Treatment failure, worsening infections, and prolonged illness

• Severe complications or death if infections spread untreated

• Antibiotic resistance, a global health crisis that makes bacteria harder to treat

Pattern of Recent Recalls

The recall of Embacef adds to a troubling list of recent counterfeit and substandard product alerts in Nigeria, including:

• Amoxivue – falsified antibiotic in circulation

• Postinor-2 – fake emergency contraceptives threatening women’s health

• Cowbell Milk – counterfeit products with forged NAFDAC registration numbers

• Oxytocin injections – falsified maternal health drugs linked to life-threatening complications

This pattern reflects a growing challenge in Nigeria’s drug and consumer product supply chain, requiring increased vigilance by healthcare providers, pharmacists, and consumers.

What Healthcare Professionals and Patients Should Do

Protecting public health requires shared responsibility between healthcare providers and patients. With the growing wave of counterfeit and substandard medicines in Nigeria it has become more important than ever to remain vigilant.

For Healthcare Professionals

• Stop dispensing affected batches of Embacef immediately.

• Report adverse drug reactions or treatment failures linked to cefuroxime products.

• Educate patients about the risks of using substandard antibiotics.

• Source antibiotics only from licensed and verified distributors.

For Patients and Families

• Check packaging and batch numbers before use. Do not use Embacef with batch number PEDSE001.

• Report unusual drug reactions or treatment failure to NAFDAC.

• Avoid self-medication with antibiotics—always consult a qualified healthcare professional.

• Seek urgent care if infection symptoms worsen despite antibiotic use.

Reports can be made via:

• Toll-free line: 0800-162-3322

• Email: sf.alert@nafdac.gov.ng

• Med-Safety App (Android/iOS)

Me & You Pharma’s Commitment

At Me & You Pharma, we understand that counterfeit and substandard drugs undermine trust, worsen health outcomes, and put lives at risk. Nigerians face increasing threats from fake products.

We are committed to keeping you informed, empowered, and protected with pharmacist-led education and verified health updates.

Stay Informed, Stay Safe

Counterfeit and substandard medicines remain a public health emergency in Nigeria. Staying informed is your first defense.

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