Information status: July 8, 2026. This article is compiled from publicly available materials from the PMDA and Japan’s Ministry of Health, Labour and Welfare. It is provided solely as pharmaceutical-affairs information and for consumer safety education, and does not constitute medical, medication, or legal advice.
Japan has a relatively clear set of public channels for drug safety information. For Chinese-speaking users, the terms most easily confused are “recall,” “revision of the precautions for use,” “emergency safety information,” and “rapid safety communication.” These terms all look like risk alerts, but their meanings and the actions they call for are different.
1. Recall information: first check whether it involves a product you actually hold
The PMDA’s drug-recall pages let you search recall information for pharmaceuticals, in-vitro diagnostics, quasi-drugs, cosmetics, and similar products from fiscal year 2023 onward. Recalls are usually classified by degree of risk, and the pages also note that Class I and Class II recall information can be received through the PMDA Medinavi email service.
When an ordinary user sees the word “recall,” the first things to check are the product name, manufacturer, lot number, expiry date, and package size. Do not panic merely because a brand looks similar, and do not keep using a product just because “the medicine has not expired yet.” Recall information usually targets specific lots or specific problems.
2. Yellow Letters and Blue Letters: not ordinary news, but important safety communications
The PMDA calls emergency safety information the Yellow Letter, and rapid safety communications the Blue Letter. They are generally used for major risks that need to be conveyed relatively quickly to medical settings or to patients. According to the PMDA pages, on May 21, 2026 a rapid safety communication and patient/family materials were issued regarding serious hepatic function disorder associated with Tavneos Capsules 10 mg.
This kind of information usually does not mean that everyone must stop taking the medicine immediately. Patients on prescription drugs in particular must not stop the drug or change the dose on their own; they should contact the prescribing physician, pharmacist, or medical institution to confirm their individual risk and the next steps.
3. PMDA Medinavi: a safety radar for medical institutions and operators
PMDA Medinavi is the PMDA’s information email service, distributing emergency safety information, rapid safety communications, revisions of the precautions for use, recall information, approval information, RMPs, and other important content. For businesses that handle drug-related operations or that run a drug-information section on their website, continuously monitoring such sources is very important.
4. User action checklist
- Check the product name, dosage form, package size, lot number, and expiry date.
- Do not decide on your own that “any roughly similar medicine must be unusable,” and do not ignore a recall whose lot number is an exact match.
- If you take prescription drugs or are on long-term medication, contact your doctor or pharmacist first; do not stop the medication on your own.
- If an OTC or health product is affected by a recall, stop using it and contact the seller or the company’s consultation desk.
- Keep the packaging, purchase records, photographs, and a record of any discomfort or symptoms.
- If serious discomfort occurs, seek medical care first rather than waiting for a reply from platform customer service.
For Tsubaki, a pharmaceutical-affairs news section should not merely reprint that “a certain drug has been recalled”; it should instead help users learn to read the level, the source, and the personal action steps behind safety information.