PRESENCE OF US-RECALLED EYE DROPS IN SINGAPORE'S MARKET AND REGULATORY ASSURANCE OF EYE PRODUCT HYGIENE STANDARDS

NOTICE PAPER NO. 829

NOTICE OF QUESTION FOR WRITTEN ANSWER

FOR THE SITTING OF PARLIAMENT ON 05 MAY 2026

Name and Constituency of Member of Parliament

Dr Choo Pei Ling

MP for Chua Chu Kang GRC

Question No. 1498

To ask the Coordinating Minister for Social Policies and Minister for Health with reference to the nationwide voluntary recall of eye drops in the United States initiated on 3 March 2026 (a) whether any of these eye products are sold in Singapore; and (b) how does the Ministry ensure that the eye products sold in Singapore meet stringent hygiene standards.

Answer

1        The lubricating eyedrops manufactured by K.C. Pharmaceuticals and recalled by United States Food and Drug Administration in March 2026 are not registered for sale in Singapore.

2        All eyedrops need to be registered with the Health Sciences Authority (HSA) prior to any import or supply in Singapore. As part of the registration process, HSA reviews the product's quality, safety, and performance, including the sterilisation process and shelf life in accordance with relevant international standards. Manufacturers must also hold a valid ISO 13485 certification, which is a validation that robust quality controls are in place throughout the design and production to ensure that stringent hygiene standards are met. In addition, HSA conducts post-market surveillance of any eye drops marketed if there are any adverse events reported, both locally and globally, to review if product recalls should be initiated.