Drug Recalls: 5 Steps To Take If You Have a Recalled Medication

Why are drugs recalled?

Drug recalls occur when the quality or safety of a drug has been compromised. It can be due to the drug itself or its packaging and labeling. Quality and safety standards are defined in laws regulated by the FDA.

Most drug recalls are initiated voluntarily by the manufacturer, but on occasion, drug recalls can be requested or mandated by the FDA. After the initial announcement, the FDA categorizes the recall under one of three classes based on how serious the problem is.

Class I recalls. Class I recalls are the most serious type. The FDA defines a Class I recall as one that involves “a dangerous or defective product that could cause serious health problems or death.”  

Example: In 2016, two lots of hyoscyamine tablets were recalled because they were found to contain tablets of non-uniform strength. Some tablets were superpotent, while others were subpotent.

Class II recalls. Class II recalls are the most common type of recall, and they’re not as serious as Class I recalls. According to the FDA, Class II recalls involve “products that might cause a temporary health problem, or pose only a slight threat of a serious nature.”

Example: Earlier this month, one lot of Children’s Advil was recalled due to overdosing concerns related to a labelling error. The dosage cup was marked in teaspoons and the instructions on the label were described in milliliters.

Class III recalls. Class III recalls are the least serious. The FDA defines Class III recalls as those involving “products that are unlikely to cause any adverse health reaction, but that violate FDA labeling or manufacturing laws.”

Example: In 2017, one lot of glipizide extended-release tablets was recalled because it failed limits for water content during stability testing.

How are patients notified of recalls?

These days, it’s common to learn about recalls from news outlets and online articles, but there are many other ways in which recall announcements reach the public. Here are some examples:

• The FDA, manufacturer or dispensing pharmacy may notify patients by telephone, mail, fax or email if a medication has been recalled.
• The manufacturer usually posts recall information on their website.
• The FDA may publically announce a recall via news and other media.
• The FDA publishes a weekly Enforcement Report of recalls on their website. You can also subscribe to a newsletter to get this report in your email every week.
• The FDA has a Twitter profile, @FDArecalls, where they announce recalls.

What should I do if I think I have a recalled drug?

1) Get informed.

Manufacturers typically publish drug recall announcements on their own websites. The FDA also re-publishes them here. For more information, you can contact the manufacturer or FDA directly.

• Contact the manufacturer. Manufacturer contact information is usually listed in the recall announcement or on the manufacturer’s website.
• Contact the FDA. You can contact the FDA’s Center for Drug Evaluation and Research (CDER) with any questions or concerns at [email protected] or through the following toll-free numbers: 1-855-543-3784 or 1-310-796-3400.

These sites list recall announcements on related medicine products:

• Recalls and withdrawals of animal and veterinary products
• Recalls on biologic products
• Recalls on medical devices

2) Find out if you should stop taking your medication.

If you’ve already started taking your drug, your first instinct when it’s recalled might be to stop taking it right away—but that’s not always the safest decision. Remember, recalls are usually for minor issues. While many over-the-counter drugs can be discontinued at will, some prescription drugs are critical for your health, and you’ll want to continue taking them until your doctor finds a replacement for you.

3) Find out if your medication belongs to a recalled lot.

Drug recalls pertain to certain lots of the medicine that were made during a given time period. To find out which lot numbers were affected by a recall, read the official recall announcement either on the manufacturer’s website or on the FDA’s website here.

Next, you’ll want see if your drug belongs to any of the recalled lots. Lot numbers are fairly easy to identify on box packaging; the lot number will be printed on one of the box’s side panels. We’ve included some tips for other common packaging below.  

Bottles and vials

Drug bottles will often have the lot number printed next to the expiration date, either by the barcode (1) or underneath the dosing instructions (2).  

Blister packs

Many blister packs now come with lot numbers and expiration dates printed on their foil backings.

Tubes for creams and gels

Lot numbers on tubes for creams and gels are often printed on or right above the crimp at the end of the tube (3). They can also be on the back of the tube, sometimes hidden in the storage information text (4).

Pharmacy stock containers

Now, if you have a prescription that came in a pharmacy stock container (like a transparent orange pill bottle) without a manufacturer label on it, you’ll need to call your pharmacy to find out your drug’s lot number. Pharmacies keep records of which lots they’ve used and when, so they’ll be able to tell you if you have a recalled medication based on when your prescription was filled.

4) Safely dispose of your medication.

Safely disposing of your recalled medication will reduce the chances of you or others accidentally taking it, and prevent the drug from contaminating the environment. If your medication came with specific disposal instructions, follow those instructions. Some medicines, including controlled substances, need to be taken to an authorized take-back site or flushed down the toilet.

If your medication didn’t come with specific disposal instructions and there are no authorized take-back sites near you, check the FDA’s website on how to dispose of it here. In most cases, you can safely dispose of medicines in your household trash. Just remember to mix the medicine in with something you wouldn’t want to eat (like dirt, cat litter or used coffee grounds) and put that mixture into a sealed plastic bag before tossing it into the trash.

5) Contact your doctor.

Contact your doctor immediately if you experience any unusual symptoms that you think might be related to taking a recalled medication. It’s also a good idea to have your medication packaging and prescription information handy just in case your doctor needs them.

When you bring home any new medication, always inspect it, including all parts of the packaging. If you notice that it doesn’t look or smell right, or if the packaging has been opened or tampered with, contact the manufacturer or your pharmacist for next steps. Any adverse reactions or quality problems can also be reported to the FDA’s MedWatch Reporting Program.

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