Recalls, Corrections and Removals
Most recalls are voluntary in name and unavoidable in fact. The classification is a judgment about health hazard, and it drives how deep the action goes, whether the public is warned and how hard the firm must check that it worked.
The rule in short
Under 21 CFR Part 7 a recall is a firm's removal or correction of a marketed product that the agency considers in violation of the law. Recalls are classified by health hazard: class I for a reasonable probability of serious consequences or death, class II for temporary or reversible consequences, class III where harm is unlikely. A recall strategy sets depth, public warning and effectiveness checks.
A recall is a firm's removal or correction of a marketed product that the agency considers in violation of the law and against which it would initiate legal action. That definition contains the point most people miss: a recall is the firm's action, taken because the alternative is enforcement. It is voluntary in form and rarely voluntary in substance.
The vocabulary and why it matters
Three related terms are distinguished by regulation. A correction is the repair, modification, adjustment, relabeling, destruction or inspection of a product without its physical removal to another location; patient monitoring can qualify. A market withdrawal is the removal or correction of a distributed product involving a minor violation that would not be subject to legal action, or involving no violation at all, such as normal stock rotation. A stock recovery reaches product that has not been marketed or has not left the firm's direct control.
Only the first category is a recall. Firms are attracted to the other labels because they carry less reporting and less visibility, and misclassification is a recurring enforcement theme. The test is not what the firm calls the action but whether the product in distribution violates the law in a way the agency would act on.
Classification by health hazard
Classification is made by the agency after a health hazard evaluation conducted by scientific personnel. The evaluation considers whether any disease or injuries have already occurred, whether existing conditions could contribute to a hazard, the hazard to particular populations such as children or the immunocompromised, the degree of seriousness of the hazard, the likelihood of occurrence, and the immediate and long-range consequences.
Classification is the agency's determination, not the firm's, and it usually follows rather than precedes the start of the action. A firm that begins recovering product does so on its own assessment of the hazard, and the classification arrives afterward. Firms sometimes wait for the classification before acting, which inverts the sequence and leaves violative product in distribution while a file is reviewed.
Class I applies where there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II applies where use may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. Class III applies where use is not likely to cause adverse health consequences. Volume, cost and embarrassment play no part in the classification.
Recovering product is the visible half of a recall. Demonstrating that everyone who needed to be reached was reached is the half that determines when the action can end. The strategy specifies a level of checking, ranging from contacting every consignee to contacting none, and the firm must document the contacts, the responses and the disposition of product at each level. Firms that recall diligently and document loosely find the recall staying open long after the product came back.
The recall strategy
Every recall runs on a strategy that the firm develops and the agency reviews. Depth of recall is the first element: whether the action reaches the wholesale level, the retail level, or the consumer or user level. Depth follows the hazard and the pattern of distribution, so a class I problem in a product dispensed to patients ordinarily reaches the user.
The second element is the public warning, used where a product presents a serious hazard and other means of reaching those at risk are inadequate. The third is effectiveness checking, expressed as a level that fixes what proportion of consignees must be contacted and verified. The firm's recall communication must be clear, identify the product precisely, state the reason and the hazard, and tell the recipient what to do, and it should not contain promotional material or reassurance that undermines the message.
| Action | Trigger | Typical measures | Reporting |
|---|---|---|---|
| Class I recall | Reasonable probability of serious harm or death | User-level depth, public warning, high effectiveness checking | Reported and classified; published in the enforcement report |
| Class II recall | Temporary or reversible consequences, or remote serious risk | Retail or user depth, checking at a defined level | Reported and classified; published |
| Class III recall | Adverse consequences unlikely | Usually wholesale depth, limited checking | Reported and classified; published |
| Market withdrawal | Minor violation not subject to legal action, or none | Removal or correction without a recall strategy | Not classified as a recall; records retained |
| Stock recovery | Product never left the firm's direct control | Internal retrieval and disposition | Not a recall; internal records |
| Device correction or removal to reduce a risk to health | Action taken to reduce risk or remedy a violation posing risk | Field correction, retrieval, or both | Written report to the agency within the stated period |
Beginning a recall and ending one
A firm that decides to recall on its own initiative notifies the agency promptly and provides the information the regulation lists: identification of the product, the reason, an evaluation of the risk, the total quantity produced and the period, the quantity distributed and the distribution pattern, copies of the communications used, and the strategy proposed. Where the agency requests a recall instead, the request states the basis and the firm's response is expected quickly.
Device manufacturers and importers carry an additional duty. Where a correction or removal is initiated to reduce a risk to health posed by the device, or to remedy a violation caused by the device that may present a risk to health, a written report must be submitted within the period the regulation states. Actions not required to be reported must still be recorded and the records kept available.
Recalls continue through periodic status reports until they are terminated, and termination requires an agency determination that all reasonable efforts have been made to remove or correct the product in accordance with the strategy, and that it is reasonable to believe the product has been removed and proper disposition made. Notice of termination is given in writing. Behind almost every recall lies a signal that arrived through the channels in adverse event and malfunction reporting or a system failure of the kind found during quality system inspections. Locating affected product depends on the transaction records described in supply chain tracing and the duty to verify, and where the fix is words rather than goods, the route is the one in labeling content and how it is changed.
Points to carry away
- A recall is a firm action; a market withdrawal involves a minor violation or none.
- A correction addresses a product in place without physically removing it.
- Classification is based on a health hazard evaluation, not on the volume affected.
- The recall strategy sets depth of recall, public warning and effectiveness checks.
- Device corrections and removals to reduce a risk to health must be reported promptly.
- A recall ends only when the agency determines reasonable efforts have been made.
Questions readers ask
Can the agency compel a recall?
It depends on the product. For devices the statute provides authority to order a recall where there is a reasonable probability that a device intended for human use would cause serious adverse health consequences or death, after an opportunity for an informal hearing. Similar authority exists for certain other product categories. For most drugs there is no general mandatory recall authority, which is why the agency's usual tool is a request that a firm recall voluntarily, backed by the seizure and injunction remedies it does have. Firms that refuse a request are choosing litigation, not avoiding action.
What is a stock recovery?
It is the retrieval of product that has not been marketed or has not left the direct control of the firm, meaning product still on the firm's premises or in its own warehouse. Because nothing has been released into distribution, it is not a recall and it is not reported as one. The distinction is narrow and firms sometimes stretch it: product shipped to a contracted third-party warehouse or consigned to a distributor is generally no longer under direct control. Getting this classification wrong turns an internal matter into an unreported recall.
Does a recall have to be publicly announced?
Not always. A public warning is one element of a recall strategy and is used where the product presents a serious hazard and other means of reaching the people at risk are inadequate. A recall reaching only hospitals through direct notification may need no press release. Separately, the agency publishes classified recalls in its periodic enforcement report, so an action that was not announced by the firm still becomes public through that route. Firms should plan communications on the assumption that the action will be visible.
Sources
- eCFR — 21 CFR 7.3, DefinitionsRecall, correction, market withdrawal, stock recovery and the three recall classifications.
- eCFR — 21 CFR 7.41, Health Hazard Evaluation and Recall ClassificationThe factors considered in evaluating the hazard and assigning a class.
- eCFR — 21 CFR 7.42, Recall StrategyDepth of recall, public warning and the levels of effectiveness checking.
- eCFR — 21 CFR 7.46, Firm-Initiated RecallWhat a firm must tell the agency when it begins a recall on its own initiative.
- eCFR — 21 CFR 7.55, Termination of a RecallThe standard for ending a recall and the written notice of termination.
- eCFR — 21 CFR 806.10, Reports of Corrections and RemovalsThe device report required when action is taken to reduce a risk to health.
- Cornell Legal Information Institute — 21 U.S.C. 360h, Notification and Other RemediesNotification, repair, replacement, refund and the authority to order a device recall.
Liberty Law Library is a publication, not a law firm. This article states general rules and cites its sources; it is not advice about any particular case, and the law differs by state and changes over time.
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