Generic Prozac (Fluoxetine) Recalled Due to Abnormal Testing Results

In 2018, the manufacturer Teva Pharmaceuticals issued a voluntary nationwide recall of fluoxetine (Prozac), because of irregular testing results. Fluoxetine is an antidepressant medication used to treat conditions like depression, obsessive-compulsive disorder, and panic attacks. 

Here, we’ll talk more about why fluoxetine was recalled. We’ll also go over why drug recalls are important and what to do if you think your medication has been affected by one.  

Why was fluoxetine recalled?

According to the FDA, one of the ingredients used to create the fluoxetine 10 mg tablet was not up to the agency’s standards. The tablets in these batches, or “lots,” contained an impurity called lactoside, which was not supposed to be in the medication. This was identified during routine testing of the product. 

While the presence of lactoside is not likely to have significant health consequences, Teva pulled certain lots of fluoxetine.

Why are drug recalls important?

Drug recalls help ensure that medications are safe to use. They can give you confidence that the FDA continues to watch manufacturing practices over time. They are done to help make sure that medications distributed and used throughout the U.S. are safe.

Medications are recalled for many different reasons, and recalls are usually unpredictable. But, at any given time, most medications do not have a drug recall in place. So you can be reasonably confident that any medication you take does not have impurities. 

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If a problem is found with a medication, it will likely be recalled. If you were dispensed or given a medication that’s subject to a recall, you should be notified by your pharmacy or healthcare provider’s office. You can also contact your pharmacy or search the FDA website for more information about medication recalls.

Who makes Prozac?

Since Prozac was approved by the FDA in 1987, Eli Lilly and Company has been the manufacturer of the brand-name product. The manufacturer’s brand-name medication is still available today, but most pharmacies dispense the generic, fluoxetine. 

With all medications, after the patent on the brand-name product expires, other manufacturers can make a generic version of it. Generic medications tend to cost less than brand-name versions.

Generic medications must be thoroughly tested to ensure they are equivalent to the brand-name medication in safety and effectiveness. In 2001, Teva became one of several companies authorized to make fluoxetine.

Which fluoxetine products were recalled?

According to Teva, the affected products were shipped from March 24, 2016 to January 4, 2018. The recall affected the following:

• Medication: Fluoxetine 10 mg tablets

• Manufacturer: Teva Pharmaceuticals

• National Drug Code (NDC): 00093-7188-56

Only certain lots of the medication were affected. All of the affected lots were distributed within the U.S. Brand-name Prozac wasn’t affected by this recall, and neither were other versions of fluoxetine made by different generic manufacturers. 

What was done to alert those who may have been affected?

Teva Pharmaceuticals notified distributors, wholesalers, and pharmacies by letter and arranged for the return of all recalled products.

What should I do if I think I may have a medication affected by a drug recall?

You should contact your healthcare provider if you have experienced any problems that you think may be related to taking a medication that has been recalled. You should not stop taking any prescribed medications without talking to your healthcare provider first. 

Your pharmacy receives notifications of any drug recalls that affect lots of medications that they stock. If you have a medication from a lot that has been affected by a drug recall, you should be notified by your pharmacy or healthcare provider’s office.

Always inspect your medications, including all parts of the packaging and devices. Although it’s difficult to detect a difference in a medication’s quality, if you notice it doesn’t look or smell right, contact the manufacturer or ask your pharmacist for more information. You can also notify the FDA’s MedWatch reporting program, as they can conduct necessary investigations.

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Written by:

Austin Ulrich, PharmD, BCACP

Austin Ulrich, PharmD, BCACP, is a board-certified ambulatory care clinical pharmacist. In his early career, he provided direct patient care in a variety of settings, including hospital and community pharmacies, and in a primary care clinic as a clinical pharmacist.

Edited by:

Samvida Patel, MNSP, INHC

Samvida Patel, MNSP, INHC, is a health editor at GoodRx. She is a nutritionist and integrative nutrition health coach with over 8 years of experience in health communications.

Reviewed by:

Joshua Murdock, PharmD, BCBBS

Joshua Murdock, PharmD, BCBBS, is a licensed pharmacist in Arizona, Colorado, and Rhode Island. He has worked in the pharmacy industry for more than 10 years and currently serves as a pharmacy editor for GoodRx.

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U.S. Food & Drug Administration. (2022). MedWatch: The FDA safety information and adverse event reporting program.