Free tool
FDA recall search
Search drug and device recalls by the reason FDA recorded, not just by company. Class I recalls, the ones with a reasonable probability of serious harm, are flagged on every result.
Search the reason, not the company
FDA's own recall database is built around finding a product you already know about. The useful question for a quality team is the other direction: what has FDA recalled for the failure mode we are worried about, and how often.
Searching "sterility" against Class I drug recalls returns 152 records. Searching "particulate" or "cross-contamination" returns a different corpus entirely. Those are your precedents, and the reason text is where they live.
A recall is one outcome of a quality failure. The others are a Form 483, a warning letter, and for the products that never reach market, a Complete Response Letter.
Frequently asked questions
- What do Class I, II and III mean?
- Class I means a reasonable probability that the product will cause serious adverse health consequences or death. Class II means temporary or medically reversible harm, with a remote probability of serious harm. Class III means the product is unlikely to cause harm but violates FDA regulations.
- What does the status mean?
- Ongoing means the recall is still in progress. Completed means the firm has finished its actions. Terminated means FDA has determined the recall is complete and there is no reasonable expectation of remaining product in commerce.
- Is a recall the same as a market withdrawal?
- No. A recall addresses a product that violates FDA law. A market withdrawal involves a minor violation FDA would not take action over, or no violation at all. Only recalls appear in the enforcement report this searches.
- Are all recalls FDA-mandated?
- Most are voluntary and firm-initiated. FDA has mandatory recall authority for devices, food and a few other categories, and it is rarely used. The voluntary or mandated status is shown on each result.
- Where does this data come from?
- openFDA's enforcement endpoints, queried live, so results are as current as FDA's own dataset. It covers 17,899 drug and 39,794 device recall records.
- Why can I only search drugs and devices?
- openFDA also serves food enforcement, which is the largest of the three and none of it concerns a regulatory or quality reader in life sciences. It is left out deliberately.
Check a failure mode against the precedent
Arca reads your deviation and CAPA records against FDA's enforcement history and shows where a failure you are investigating has already produced a recall elsewhere, cited to the record.