Guide

Understanding drug recalls

How the FDA recall system works, what the three recall classes mean, and what to do if a medication you take is recalled.

FDA Recalls database → MedWatch alerts →

What is a drug recall?

A drug recall is the removal or correction of a marketed product that violates FDA regulations. Recalls protect the public from products that are defective, unsafe, contaminated, mislabelled, or otherwise potentially harmful.

Recent examples from our news feed include the 0.9% sodium chloride bags recalled due to a potential KCl mix-up and compounded glutathione recalled over elevated endotoxin levels. The full FDA recall database is searchable at FDA.gov/safety/recalls.

The three recall classes

Class I

Most serious

A reasonable probability that the product will cause serious adverse health consequences or death. Immediate consumer action is required.

Example: IV bag containing KCl instead of saline — risk of fatal cardiac arrhythmia.

Class II

Moderate

May cause temporary or medically reversible adverse health consequences. Remote probability of serious harm.

Example: Drug labelled with incorrect potency that may cause under/overdosing with reversible effects.

Class III

Minor

Use is unlikely to cause adverse health consequences but the product violates FDA manufacturing or labelling regulations.

Example: Container does not meet child-resistant packaging requirements.

How the recall process works

Firm or FDA identifies problem

A manufacturer quality check, consumer complaint, FDA inspection, or post-market surveillance identifies a potential violation or safety risk.

Firm initiates recall or FDA requests it

Most firms initiate voluntarily. FDA classifies the recall (I, II, or III) and assigns a recall classification within 10 business days.

Strategy is approved

The firm submits a recall strategy: scope (consumer/retail/wholesale), communication plan, and disposition method (destruction, re-labelling, reconditioning).

Recall notice issued

Press announcements are published on FDA.gov and MedWatch. Healthcare providers and patients are notified depending on recall depth and class.

Effectiveness checks

FDA monitors progress and may conduct effectiveness checks to verify the recalled product has been removed from the market.

Recall terminated

FDA terminates the recall when it determines that all reasonable efforts have been made to remove the product from the market.

Source: FDA Drug Recall FAQ and 21 CFR Part 7 (Recalls).

What patients and caregivers should do

Check the recall notice

Each recall notice lists the affected lot numbers, NDC codes, and expiry dates. Search your label or bottle for these numbers. The notice is available at FDA Recalls.

Contact your pharmacy

Pharmacies that dispensed recalled product are required to contact patients. They can facilitate return and replacement. For serious medications, ask your pharmacist about alternative supply before stopping.

Do not abruptly stop critical medications

For antiseizure drugs, antihypertensives, or diabetes medications, stopping abruptly can be dangerous. Consult your prescriber or pharmacist to arrange an alternative supply first. Check ASHP Drug Shortages for alternatives.

Report adverse events

If you experienced a problem with a recalled medication, report it to FDA MedWatch (1-800-FDA-1088). Reports help FDA track safety signals and act faster.

Frequently asked questions

What are the three FDA recall classes?

Class I: A reasonable probability that use will cause serious adverse health consequences or death (e.g., potassium chloride mix-up in IV bags). Class II: May cause temporary or medically reversible effects (e.g., mislabelled potency). Class III: Unlikely to cause adverse effects but violates regulations (e.g., label formatting). See the FDA recalls page for current listings.

Are drug recalls mandatory or voluntary?

Most drug recalls are voluntary, initiated by the manufacturer. FDA has authority to mandate recalls under the FDA Safety and Innovation Act (FDASIA 2012), but typically voluntary actions suffice. FDA classifies and monitors all recalls. See FDA Drug Recall FAQ and Federal Register mandatory recall rule.

How do I find out if a drug I take has been recalled?

FDA maintains a searchable recalls and safety alerts database. You can also sign up for MedWatch safety alerts via email. Pharmacies that dispensed recalled drugs are typically required to contact patients; the NABP pharmacy verification database can help verify legitimate pharmacies.

What should patients do with recalled medication?

Follow the recall notice instructions — usually return the product to your pharmacy or dispose of it per local medication disposal guidelines (see FDA medication disposal guidance). Do not abruptly stop a critical medication without a replacement; consult your prescriber first. Current drug shortage alternatives may be found on ASHP Drug Shortages.

What is a market withdrawal vs. a recall?

A market withdrawal is when a firm removes a product due to a minor violation that would not warrant FDA enforcement. It is not a formal recall. A recall involves a regulatory violation — typically safety, purity, potency, or labelling. A stock recovery covers products that have not yet reached consumers. See the FDA Recall FAQ for all definitions.