A recall in the news can reach you before your pharmacist has said anything about it, and it may cover only batches that never reached your home. Call the pharmacy that filled your prescription with any question about the recall, with the box in your hand. You can also match your box to the recall yourself, and tell whether it asks you to stop tonight or to check with your pharmacy first.
Is the recall about your box, or a batch that never reached you?
The recall is about your box only if a code on the box or its container label appears among the codes the recall lists; if it lists only other codes, it is about a batch other than yours. Every recall FDA monitors goes into its Enforcement Report, whatever its grade, from Class I, the most serious, to Class III, or not yet graded, and you can search the report by product description, code information or recalling firm.
Within each recall's entry in that report, the codes sit in a field called Code Information, which holds the lot or serial numbers, product numbers, expiration dates, sell-by or use-by dates and similar codes that appear on the product or its labeling. Find the lot number and the expiration date on your box or container label, and check each one against the entry.
The entry also names the firm that started the recall and the distribution pattern, meaning the general area, such as states, countries or territories, where the product first went. Later distribution by the businesses that received it may not be included, so a recall that does not name your state has not cleared your box.
Company press releases, mostly for Class I recalls, are posted on FDA's Drug Recalls page. Not every recall has a press release or is posted there, so a medicine missing from that page has not been cleared. A recall you saw announced may not be in the Enforcement Report yet either: firms often start voluntary recalls and announce them, and the announcement may come well before FDA finishes classifying the recall and posts it.
If you cannot match your box to an entry, ask your pharmacy, or put your question about that recall to the recalling company named in the entry, or to FDA. You can email a drug question to FDA's Division of Drug Information at [email protected]. A box whose label does not match your prescription at all is a separate problem, with checks of its own (see Check a vial or pen that doesn't match your prescription).
What Class I, Class II and Class III mean
Class I, Class II and Class III grade a recall by how likely the recalled product is to harm someone who uses it or is exposed to it, and how serious that harm would be, and Class I is the most serious and Class III the least:
| Class | What it means |
|---|---|
| Class I | There is a reasonable probability that using the product, or being exposed to it, will cause serious adverse health consequences or death. |
| Class II | Using or being exposed to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse health consequences is remote. |
| Class III | Using or being exposed to the product is not likely to cause adverse health consequences. |
Most drug recalls are Class II. A Class I recall is urgent and in most circumstances involves removing the drug from the market, while a Class III recall could involve problems such as minor labeling errors, defective packaging or incorrect expiration dates.
An entry marked Not Yet Classified is an early entry, and its seriousness has not been graded yet. Listing a recall that way alerts the public sooner when a company starts one, and the class is filled in once FDA has reviewed the company's information and finished a health hazard evaluation.
The company usually starts a drug recall, and FDA grades it. A recall may be conducted on a firm's own initiative, by FDA request, or by FDA order under statutory authority, but for most drugs a recall is a voluntary action by the company, which is why most drug recall notices carry the line "This recall is being conducted with the knowledge of the U.S. Food and Drug Administration." A market withdrawal is a different event: the product has a minor violation that would not be subject to FDA legal action, and the firm removes it from the market or corrects the violation.
Do you stop taking it tonight?
Whether to stop tonight turns on how far down the supply chain the recall was aimed. That reach is the recall's depth, the extent of product removal through the distribution chain, and the recall notice states whether it is at the consumer or user level, the retail level or the wholesale level.
Depth is set separately from the class, though the two loosely line up. Class I recalls may extend to the consumer level, the urgent situations in which everyone using the drug should immediately stop using it. Class II recalls may extend to the retail level, where the company removes the product from store and pharmacy shelves, and Class III recalls may extend to the wholesale level, to keep more of the product from reaching those shelves.
For a consumer-level recall that includes your box, follow the recall notice, and take any question about it to your pharmacy. For a recall aimed at the retail or wholesale level, or one you cannot place, call your pharmacy before you stop anything. Asking first matters most for those recalls, since stopping a drug unnecessarily would do more harm than keeping on with it.
Your health plan or insurer may also send you a recall letter, sometimes about a recall that was never aimed at consumers. Most recalls in letters like these were at the retail or wholesale level, and such a letter says no action is needed on your part. If yours does not say that, or you are unsure, ask your pharmacy.
If your box is in a consumer-level recall, or your pharmacy tells you to stop, call the office of the clinician who prescribed it and ask whether they can prescribe an alternative medicine or write a new prescription to replace the returned box. A question about going without the medicine until a replacement arrives is for that office too.
Through NicoCares, the pharmacy to call is the one you chose: it fills a prescription a physician writes for you, for delivery to the address you gave. Questions for the prescriber's office go instead to your care team: message them in Spruce, the app NicoCares invites you to by email, and include the lot number. A Spruce reply has no deadline, so ask your pharmacy by phone whether to stop tonight, and if a replacement cannot wait for a reply, call your pharmacy or your own doctor's office about it.
What happens to the box, and what if something has already gone wrong?
Return or dispose of the box as the recall notice directs, since a drug recall notice includes the product defect, the associated health risks and specific instructions for how to dispose of the recalled drug. If the return or disposal instructions are unclear, talk with the pharmacist at your pharmacy, read them the lot number, and ask whether they want the box back.
Go to an emergency room or call 911 for problems such as these, whether or not the recall turns out to include your box:
- trouble breathing
- passing out or fainting
- sudden confusion
- seizures
- vomiting or loose stools that do not stop
- a possible poisoning or overdose of medicine
- a severe allergic reaction with trouble breathing, swelling or hives
If you feel unwell after taking some from a box you think is recalled, and it is not one of the emergencies above, call your own doctor's office today, even if someone else prescribed the medicine, with the lot number and the recall you saw. When the office is not open, the line may pass you to an on-call nurse or provider.
You can also report a problem with a medicine to FDA through MedWatch, its safety reporting program for health professionals, patients and consumers (see Reporting a side effect that has not gone away). To have FDA's announcements of recalls, market withdrawals and safety alerts emailed to you, sign up on its recalls page, keeping in mind that not every recall is posted there.
