How to check if your eye drops were recalled

Write down the product name, lot number and expiration date from your bottle or carton, then search the FDA’s Recalls, Market Withdrawals, & Safety Alerts page for the product, filtering by drugs. Because not every recall gets a notice there, also search the FDA’s weekly Enforcement Report. A recall usually covers specific lots, so it only applies to you if your lot number matches.

Step by step: checking a bottle you own

• Get the box and the bottle. Note the exact product name, the size, the lot number and the expiration date.
• Go to fda.gov and open the page called Recalls, Market Withdrawals, & Safety Alerts.
• Type the brand or product name in the search box, and use the Product Type filter to show drugs.
• Open any notice that matches and read which lot numbers and dates it lists.
• If nothing shows up, search the FDA’s Enforcement Report for the same name.
• Check the manufacturer’s own website or call its listed phone number to confirm.

Why the FDA recalls page may not list everything

The FDA describes that page as information gathered from press releases and other public notices about certain recalls. It says plainly that not all recalls have press releases or appear there. The complete list is the weekly Enforcement Report, which the FDA says includes every recall once it has been classified. The recalls page also archives notices after about three years, so an older recall may only be in the archive or the Enforcement Report.

What the recall classes mean

When you read a notice or a report entry, you’ll often see a class number. The FDA defines them this way:

• Class I: there’s a reasonable chance that using the product could cause serious health problems or death.
• Class II: the product may cause temporary or medically reversible problems, or the chance of serious harm is remote.
• Class III: using the product is not likely to cause adverse health effects.
• Market withdrawal: a minor issue the FDA wouldn’t take legal action over, which the company corrects or removes on its own.

A recall can start with the company itself, at the FDA’s request, or by FDA order. The class tells you how serious the agency considers the problem, which helps you decide how quickly to act.

Matching the lot number exactly

Recalls are usually tied to particular lots, not to every bottle with that name. Read your lot code character by character against the notice, including letters, dashes and leading zeros. If the notice also lists expiration dates or package sizes, those should match too. If you’ve already thrown away the carton and the bottle label is worn, the company may be able to help if you give them the order date and where you bought it. Our guide to what the lot number on eye drops means shows where to look.

Drug safety communications are different

The FDA also publishes Drug Safety Communications, which share new information about risks of medicines with patients and health care professionals. They aren’t recalls and don’t pull lots off shelves, but they can tell you about a concern with an ingredient or a type of product. If you take several medicines, it’s worth knowing the page exists.

If your lot is on a recall

• Stop using the bottle and keep it, with the carton, until you know what the notice asks you to do.
• Follow the instructions in the notice for refunds or returns; they come from the company running the recall.
• If you’ve been using it and your eyes hurt, your vision changed, or you feel unwell, contact your doctor.
• Report a problem you think the product caused through the FDA’s MedWatch program, which takes reports from the public about over-the-counter medicines.

Checking Quell

The same steps apply to Quell. Search the FDA’s recalls page and the Enforcement Report for it by name and compare your lot number with anything you find. If you have a question about a specific bottle, call Aurora Pharmaceuticals, LLC at 615.465.6041 (M–F 9AM–5PM CST) with the lot number in hand. The rest of the label, including its warnings, is on our Drug Facts page.

Separately from any recall, the label lists checks that apply every time you use a bottle. Its Do not use line reads: If this product changes color. Its stop-use line: Stop use and ask a doctor if you feel eye pain or changes in your vision, if irritation or redness continues, or if the condition worsens or persists for 72 hours. Those apply to any bottle, recalled or not, and they’re worth keeping in mind alongside the date. Eye symptoms that need a doctor covers when a drop isn’t the answer.