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Medicine recalls

Prescription and over-the-counter medicine recalls in the FDA enforcement reports of the last 60 days. Do not stop a medicine because of a notice before talking to a pharmacist or doctor.

FDASource: U.S. Food and Drug Administration (opens in a new tab)

58 medicines notices, newest first

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Hazard and remedy text is quoted from the agency, unedited. The red tag names the kind of risk with a word from that text. Every notice links to its official page.

About medicine recalls

Most drug recalls are about a lot, not the medicine

A drug recall almost always concerns specific lots: a batch that failed a stability or dissolution test, a labeling mix-up, or a contamination risk at one plant. The same medicine from another lot, or from another manufacturer, is not part of it.

The lot number and the expiry date are printed on the bottle or carton, often embossed on the crimp of a tube or the flap of a box. On a pharmacy vial the lot may not be shown at all; the pharmacy that filled the prescription can tell which lot you received.

Why you should not simply stop

Stopping a medicine for blood pressure, seizures, mental health or blood thinning can be more dangerous than the defect that caused the recall. Many recalls are Class II or III, where the risk from the affected lot is low. Call the pharmacy: they can check the lot, replace the product and tell you whether to keep taking it meanwhile.

FDA requires this notice on data from openFDA, and it applies here: do not rely on it to make decisions regarding medical care.

Reading the reason

The reasons are written in regulatory shorthand. “Failed stability specifications” means a sample of the lot no longer met its quality limits before the expiry date. “Lack of assurance of sterility” means the process could not guarantee a sterile product, which matters most for injections and eye drops. “CGMP deviations” means the plant did not follow required manufacturing practice. This site shows the reason as FDA wrote it.

Questions and answers

How do I know if my prescription is from a recalled lot?

Compare the lot number on the manufacturer package with the lots on the notice. If your medicine came in a pharmacy vial, call the pharmacy: they keep the lot of what they dispensed.

What does NDC mean on the notice?

The National Drug Code, a number that identifies the manufacturer, the product and the package size. It appears on the label and helps confirm you are looking at the same product and strength.

Are recalls of medical devices listed here?

No. Device recalls are published by FDA in a separate report and are not collected by this site yet.

Who do I tell about a side effect or a defective medicine?

Your doctor or pharmacist first. Problems can also be reported to FDA through its MedWatch program.

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