Zimbabwe Recalls Two Batches of Nifedipine 10mg

By Staff Reporter | Harare

The Ministry of Health and Child Care has confirmed the recall of two batches of Nifedipine 10mg tablets after quality testing found that the medicines no longer met required specifications.

The recall affects batches 112033 and 117367, manufactured by Remedica Ltd, a pharmaceutical company based in Cyprus. In a statement issued on September 12, 2026, the Ministry said the recall was ordered by the Medicines Control Authority of Zimbabwe (MCAZ) following its routine post-market surveillance programme. “The Ministry further confirms that the MCAZ notice currently circulating concerning the recall of specific batches of Nifedipine 10mg tablets is genuine and forms part of the Authority’s routine regulatory and post-market surveillance activities,” the Ministry said.

Nifedipine is a commonly prescribed medicine used to manage high blood pressure and certain cardiovascular conditions. According to the Ministry, the affected batches were identified after quality testing produced out-of-specification results during stability testing. The recall has been classified as a Class II recall and extends to the retail and consumer levels.

MCAZ guidance explains that Class II recalls cover defects that could potentially cause illness or mistreatment but do not meet the threshold for a Class I recall. Examples include products that fail specifications relating to assay, stability, fill or weight, and dissolution. This means affected stock is expected to be withdrawn from the pharmaceutical supply chain, including pharmacies and health facilities, while patients who may already have the affected batches are also covered by the recall.

Patients urged to check medicine batches

The recall is particularly important for patients who regularly take Nifedipine for hypertension or other cardiovascular conditions. Patients should check the batch number on their medicine packaging to determine whether it is among the affected batches. However, patients taking Nifedipine should not simply stop treatment because of the recall without speaking to a doctor, pharmacist or other qualified healthcare professional.

Nifedipine is used to lower blood pressure, and abruptly changing or stopping prescribed treatment without appropriate medical advice can create health risks. Anyone who discovers that they have one of the recalled batches should seek guidance from a pharmacist or healthcare provider on the appropriate replacement.

The Ministry's confirmation is part of Zimbabwe's medicines safety system, in which MCAZ monitors medicines already on the market for quality, safety and effectiveness. MCAZ's online services include regulatory systems and an approved human medicines register, although the Authority notes that its online information should not replace professional medical advice.

Levodopa/Carbidopa also affected

The Ministry also confirmed that the same round of testing identified quality concerns involving Levodopa/Carbidopa tablets, another medicine manufactured by Remedica. Levodopa/Carbidopa is used in the management of Parkinson's disease and Parkinsonism. The development means the latest regulatory action is not confined to Nifedipine and highlights the importance of post-market surveillance in identifying medicines that may fall outside approved quality specifications after reaching the market.

MCAZ's recall procedures allow the regulator to remove medicines from the distribution chain when defects are identified, whether the recall is initiated by the manufacturer, supplier or the Authority itself. The Authority classifies recalls according to the potential health risk and can require withdrawal at wholesale, retail or consumer level.

What consumers should do

Patients who use Nifedipine are advised to check the batch number on their packaging rather than assuming that all Nifedipine 10mg tablets have been affected. Only the specified batches are subject to the recall described by the Ministry. Anyone who is unsure whether their medicine is affected should take the packaging to a registered pharmacy or consult a healthcare professional.

The Ministry of Health and Child Care provides pharmaceutical and public-health services as part of its national health system, while MCAZ is responsible for medicines regulation in Zimbabwe. The recall demonstrates why patients should retain medicine packaging where possible, as batch numbers and expiry dates are important when regulators issue safety or quality alerts.

For now, the affected Nifedipine batches are being withdrawn while the regulatory process continues. Patients who depend on Nifedipine should therefore check their batch number and seek professional advice if they have one of the recalled batches, rather than discontinuing treatment on their own.

Nifedipine recall Zimbabwe