Pharmaceutical giant recalls compromised batch of contraceptive pills in SA after packaging ‘mix-up’

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

By Ray Mahlaka

21 Nov 2024

Bayer, the pharmaceutical company behind the birth control pill Yas Plus, said a packaging ‘mix-up’ has necessitated a recall. South Africa joins the US, which has also had incidents of contraceptive pills being recalled.

Pharmaceutical giant Bayer has recalled a batch of contraceptive pills it manufactures over what it calls a packaging “mix-up”, which could compromise the efficacy of the birth control medication.

The batch of contraceptive pills in question are called Yaz Plus, which might not be effective in preventing pregnancy.

In a media statement released on Thursday, 21 November, Bayer said it has initiated the recall “in close consultation” with the South African Health Products Regulatory Authority (Sahpra), a medicine regulator in South Africa.

Sahpra confirmed the recall, adding that it is working with Bayer to speedily manage the process as the compromised contraceptive pills have already been distributed to retail pharmacies. Sahpra said the affected contraceptive pills were distributed between 3 and 24 November 2023.

Sahpra CEO Boitumelo Semete-Makokotlela said the recall was necessary “to protect the public from the possible inefficacy of the affected batch”.

Bayer has initiated a “Class II, Type A” recall for the batch of Yaz Plus tablets identified as WEW96J, which expires in March 2026.

According to Sahpra standards listed on its website, a Class II recall is for “medicines that possibly could cause temporary or medically reversible adverse health problem or mistreatment”, which is usually applied for medicines that are mislabelled, carry incorrect information, or where there is a mix-up of products in containers.

Meanwhile, Type A recall is “designed to reach all suppliers of medicines [such as] wholesalers, hospitals, retail pharmacy outlets, doctors, nurses, pharmacists, authorised prescribers and dispensers, as well as individual customers or patients”. This type requires pharmaceutical giants such as Bayer to inform the public about the recall and release a media statement.

Bayer has detailed the circumstances that have led to the recall, saying:

“This recall is initiated due to a limited number of packs found in retail pharmacies with a mix-up of the sequence of hormone-containing and hormone-free tablets, wherein some packs had 24 light orange hormone-free, and four pink film-coated hormone tablets instead of 24 pink film-coated hormone tablets and four light orange hormone-free tablets.”

(Source: Bayer)

In other words, some Yaz Plus packs had 24 hormone-free pills instead of the 24 actual hormone tablets used for contraception. The 24 hormone-free pills that are contained in the compromised batch, also known as “sugar” pills or “reminder” pills, are meant to help people remember to take a pill every day and start the next pack on time.

Bayer said the compromised batch of contraceptive pills would not “provide the expected contraceptive efficacy”, thus necessitating a recall.

Bayer urged patients who had pills from the compromised batch to stop using them immediately.

“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.

“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 said all healthcare professionals, wholesalers, hospitals, retail pharmacy outlets, doctors, nurses, pharmacists, authorised prescribers, dispensers and individual customers or patients with pills from the affected batch could return them in exchange for credit.

Consumers have been urged to return any affected packs to the pharmacy or retailer where they purchased them for a replacement or refund.

South Africa joins the ranks of other countries that have recalled contraceptive pills.

There have been several recall incidents in the US, most recently in August 2023. At the time, US-based pharmaceutical company Lupin recalled two batches of its birth control pill called Tydemy because they may have reduced effectiveness. Pharmaceutical giant Pfizer also found itself on the wrong side in 2012, as around 1 million packets of its birth control tablets were recalled in the US for not being effective in preventing pregnancy. DM

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