Q.01

How do I check which drugs the FDA has recalled?

The official source is the FDA's weekly Enforcement Report, which covers every recall the FDA monitors. You can search it on the FDA website, or I can query its drug recall records for you by product, firm, reason, class, status or date.

Approach: I searched the FDA openFDA drug enforcement recall records (the data behind the Enforcement Report) and opened the FDA's own recall pages.

Three ways to check

  1. Ask me. I can search the FDA drug recall records by drug or ingredient name, recalling firm, recall number, reason (for example NDMA, particulate matter or non-sterility), class, status (Ongoing, Completed or Terminated) and report date. Each record lists:

    • the product description, including NDC codes
    • the reason for recall
    • the class
    • whether the recall was voluntary or FDA-mandated
    • the date the recall started and the date it appeared in the report

    For example:

    • 225 Class I drug recalls are currently marked Ongoing.
    • The most recent Class I recalls in my search are from the 2 September 2026 report. They are Fresenius Kabi's Tyenne (tocilizumab-aazg) 400 mg/20 mL vials, which contained glass particles [1], and B. Braun's Lactated Ringer's Injection 1000 mL, which contained particulate matter [2].
    • Searching by impurity finds, for example, the 2018 valsartan combination recalls for NDMA, which were Class II and are now terminated [3].

  2. The FDA Enforcement Report. The FDA publishes it weekly and covers recalls in Class I, II, III and "not yet classified". You can browse each week's report or search it on AccessData, with quick or advanced search filtered to drugs and keyword search on product, brand or reason. There is also an API and email alerts. The FDA notes that a class is usually set only once the firm has given all the information needed. A recall marked "pending" meets the definition of a recall, but the FDA hasn't finished assessing the hazard yet. (FDA Enforcement Reports)

  3. The FDA's Recalls, Market Withdrawals & Safety Alerts page. This lists press releases and public notices. You can filter by product type (Drugs), whether the recall has ended, and date, and you can subscribe to email updates. It is not complete: the FDA says not all recalls get a press release or appear on this page. It also keeps only three years of content and moves older items to a yearly archive. For a full record, use the Enforcement Report. (FDA Recalls page)

If you give me a drug, ingredient, NDC, firm or time period, I can pull every matching recall with its class and status.

Q.02

What's the difference between a recall and a market withdrawal?

The difference is how serious the violation is. A recall removes or corrects a marketed product that FDA considers to violate the law, to the point where FDA would take legal action against it (for example, seizure). A market withdrawal is the same physical action for a product with only a minor violation that FDA would not take legal action over, or with no violation at all. Under FDA's definitions a recall does not include a market withdrawal.

Approach: The FDA's recall regulations (21 CFR Part 7) aren't in the datasets I can search, so I read the official GovInfo print of 21 CFR 7.3 (April 2024 edition) and FDA's "Recalls Background and Definitions" page.

How 21 CFR 7.3 defines the terms

TermDefinitionWhat it means in practice
Recall (§7.3(g))"A firm's removal or correction of a marketed product that the Food and Drug Administration considers to be in violation of the laws it administers and against which the agency would initiate legal action, e.g., seizure."FDA gives it Class I, II or III and it appears in the Enforcement Report.
Market withdrawal (§7.3(j))"A firm's removal or correction of a distributed product which involves a minor violation that would not be subject to legal action by the FDA or which involves no violation, e.g., normal stock rotation practices, routine equipment adjustments and repairs, etc."It is not a recall and gets no recall class.
Stock recovery (§7.3(k))Removal or correction of a product that "has not been marketed or that has not left the direct control of the firm", and "no portion of the lot has been released for sale or use".This is also excluded from the recall definition.
Correction (§7.3(h))"Repair, modification, adjustment, relabeling, destruction, or inspection (including patient monitoring) of a product without its physical removal to some other location."A recall or withdrawal can be done this way, without physically removing the product.

Source: 21 CFR 7.3, GovInfo (4-1-24 edition)

What this means for you

  • Classification only applies to recalls. FDA's Class I, II or III shows "the relative degree of health hazard presented by the product being recalled" (§7.3(m)). Class I means a "reasonable probability" of serious adverse health consequences or death. Class II means temporary or medically reversible effects, or a remote chance of serious ones. Class III means adverse health consequences are not likely. A market withdrawal has no class because FDA would not take legal action over it.
  • FDA decides which one it is, not the firm. A recall depends on whether FDA "considers" the product violative and would act against it. So a firm's own label of "withdrawal" can be reclassified as a recall once FDA evaluates the health hazard.
  • Both remove or correct product that has already been distributed. The physical action can look the same. The legal difference is how serious the violation is. If the product never left the firm's control, it is a stock recovery.
  • FDA's plain-language summary says the same thing: recalls are "actions taken by a firm to remove a product from the market", while a market withdrawal "occurs when a product has a minor violation that would not be subject to FDA legal action". (FDA, Recalls Background and Definitions)

For devices, the same FDA page also describes a medical device safety alert. FDA issues these where a device "may present an unreasonable risk of substantial harm."

Q.03

What do Class I, II and III mean?

The class shows how serious the health hazard is, with Class I the most serious. FDA gives each recall a number (I, II or III) "to indicate the relative degree of health hazard presented by the product being recalled" (21 CFR 7.3(m)). Market withdrawals and stock recoveries get no class.

Approach: The recall regulation is not in the datasets I can search, so I took the definitions from the official GovInfo print of 21 CFR 7.3 (4-1-24 edition). The examples come from the FDA drug recall records behind the weekly Enforcement Report.

ClassDefinition in 21 CFR 7.3(m)Examples from FDA drug recall records
Class I"a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death"• DermaRite antiseptic soaps contaminated with Burkholderia cepacia (Sept 2025, ongoing) [4][5]
• Lidocaine pain gel made with ethanol that contained methanol (May 2024) [6]
Class IIuse or exposure "may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote"• KIMMTRAK (tebentafusp-tebn) injection was subpotent (Sept 2025) [7]
• Compounded testosterone/triamcinolone pellets, recalled for CGMP deviations with possible metal particulate (Nov 2025) [8]
• Phenylephrine injectable bags, recalled for cGMP deviations (May 2026) [9]
Class IIIuse or exposure "is not likely to cause adverse health consequences"• Epinephrine 1 mg/mL vials failed impurity specifications (June 2026) [10]
• Bisoprolol/HCTZ tablets had traces of ezetimibe (Dec 2025) [11]
• Ciclopirox gel tubes broke at the seal (Oct 2024) [12]
• Glimepiride tablets had a misprint (Feb 2024) [13]

Source for the definitions: 21 CFR 7.3, GovInfo

Points worth knowing

  • The class is about the hazard, not the defect type. The same kind of problem can land in different classes. Contamination of a non-sterile product was Class I for the B. cepacia soaps but Class II for a salicylic acid spray that tested positive for Staphylococcus aureus [14]. FDA decides case by case through its health hazard evaluation (21 CFR 7.41).
  • FDA assigns the class, not the firm. A recall can appear in the Enforcement Report as "Not Yet Classified" until FDA finishes its assessment.
  • The class is separate from the status. All three classes can be Ongoing, Completed or Terminated. Most of the examples above are still ongoing.

I can pull every current Class I drug recall, or break recalls down by class and reason over a period you choose.

Q.04