Recall of YAZ PLUS Tablets in South Africa

Bayer (Pty) Ltd, in close consultation with the South African Health Products Regulatory Authority (SAHPRA), is issuing a medicine recall, classified as Class II, Type A, for a specific batch (WEW96J) of YAZ PLUS Tablets. 

Reason for Recall:

The recall has been initiated due to the discovery of a limited number of YAZ PLUS packs from Batch WEW96J in retail pharmacies with a mix-up in the sequence of hormone-containing and hormone-free tablets. The affected packs contain:

  • 24 light orange hormone-free tablets, and
  • 4 pink film-coated hormone tablets,

instead of the correct arrangement of:

  • 24 pink film-coated hormone tablets, and
  • 4 light orange hormone-free tablets.

Mix-up of arrangement:

Incorrect blisterCorrect blister

 

This mix-up has resulted in some packs containing only 4 hormone tablets instead of the required 24, compromising the product's contraceptive efficacy.

 

Batch Information:

The recall only affects Batch WEW96J of YAZ PLUS Tablets, with an expiry date of March 2026.

 

Action Required:

Healthcare professionals, wholesalers, hospitals, retail pharmacy outlets, doctors, nurses, pharmacists, authorized prescribers, dispensers, and individual customers or patients in possession of the affected Batch must return product to their Healthcare facility from which it was dispensed, for credit.

 

If you are in possession of YAZ PLUS tablets from the affected batch, you are urged to:

  1. Stop Use Immediately: If you have been taking the tablets from a batch that is affected with the mix-up, stop taking them immediately and contact your healthcare professional. While only a limited number of packs from the respective batch is affected, as a precautionary measure, no tablets from these packs shall be used until you have consulted your Healthcare Practitioner, as they may potentially not provide the contraceptive protection you expect. 
  2. Return the Product: Please return any affected packs to the pharmacy or retailer where you purchased them for a replacement or refund.
  3. Check Your Packs: If you have multiple packs of YAZ PLUS, please check each one of them, to ensure they are not from the affected batch.
  4. Consult Healthcare Provider: If you have consumed tablets from the affected batch, or if you have concerns about your contraceptive coverage, please consult your healthcare provider as soon as possible for advice.

Bayer (Pty) Ltd takes the safety and efficacy of its products seriously and is committed to ensuring that all YAZ PLUS tablets in the market meet the highest quality standards. The root cause for the mix-up of tablets in the packaging has been identified and corrective measures have been implemented. This incident is limited to only this one batch and no other batches are impacted. The company is working diligently with SAHPRA and healthcare providers to facilitate the recall process and minimize any inconvenience to our customers.

We are dedicated to addressing this issue promptly and ensuring the continued health and safety of all our customers.

 

Further Information and Support:

For more information about this recall, or if you have any questions or concerns, please contact Bayer +27 (0) 11 921 5000. Our team is available to provide the support and information you need.


Contact for media inquiries:

Contact person: Monalisa Mncube
Phone: +27 82 797 3852
Email: monalisa.mncube@bayer.com

 

Report a side effect:
Patient Safety Reporting - Introduction

Report a product quality complaint for Pharmaceutical Products:
afptc@bayer.com