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PITTSBURGH– The Food and Drug Administration announced a nationwide recall of itsViagra, a generic version of the erectile dysfunction drug used in treating erectile dysfunction (ED).

In a letter published inThe New York Timeson Thursday, FDA commissioner Michael Leach said the agency had “severely” impacted the quality of the product, which has been linked to an increased risk of heart attacks and strokes in some people.

The agency said it was “continually reviewing the safety, effectiveness, and regulatory review” of Viagra. But, “we continue to follow up with our own review of the safety profile and regulatory review process, and we will keep our own review of Viagra and any potential risks and opportunities to minimize these risks to the greatest degree possible.”

Leach said the agency was “reviewing the safety, effectiveness, and regulatory review of Viagra” in order to ensure that it is not linked to heart problems.

“We have done extensive review and analysis of all the information presented and concluded that the product is not safe, effective, or safe for the general public to use. As a result, we are committed to working with the FDA to ensure that we remain committed to protecting the public’s health and safety,” Leach said.

The FDA has asked the agency to immediately stop its action on Viagra, a prescription drug used to treat ED.

Pfizer, the maker of Viagra, said it is working with regulatory authorities “to provide more information about the product.

“It is important that we continue to follow up with the FDA to ensure the safety and efficacy of our products,” said Pfizer spokesman Dan Hofer. “We do not anticipate that any of our products will be recalled.”

Pfizer also said it is reviewing the safety of its own drug, which is made by Eli Lilly.

Lilly has recalled the generic version of the drug, which has been linked to a potentially fatal heart condition called a type 2 diabetes.

Lilly said it is also reviewing other drugs used to treat ED, including the generic version of the drug.

Lilly said it is working with the FDA and other regulatory authorities to ensure the safety of its own drug and other products.

“We are pleased to announce that the FDA has recalled Viagra and all of its products to ensure they are no longer being used in the way they once were,” said FDA spokeswoman Emily Johnson. “Our FDA’s continued review of the safety of these products and all of our other drugs, and the FDA’s review of these products, is part of the FDA’s ongoing efforts to ensure the safety and effectiveness of these products.”

The FDA has asked the company to voluntarily stop selling Viagra on the company’s website, which is part of a broader recall of all its drugs, as well as all of Lilly’s products, including Viagra.

https://www.fda.gov/drugs/drugs.htm

Copyright © 2025 FiercePharma. All rights reserved.

Disclosure:

The above is the “Patent” section of the FDA website. We are aware of no other relationship between the FDA and pharmaceutical companies. The FDA encourages consumers to report adverse events related to the use of their drugs to the FDA’s MedWatch program:

https://www.fda.gov/medwatch/medwatch-products/epogen.

About Pfizer

Pfizer Inc. () has spent the last 13 years dedicated to helping men achieve their sexual, mental, emotional, and physical goals. As a leader in men’s health products, Pfizer is committed to helping men achieve their sexual, mental, emotional, and physical goals. The company’s commitment to helping men achieve their sexual, mental, emotional, and physical goals is reflected in its annual “Pfizer Annual Report,” which was released in February 2025.

Related:

As the largest manufacturer of prescription medications across all therapeutic categories, Pfizer is committed to helping men achieve their sexual, mental, emotional, and physical goals.

Viagra Connect is available in Ireland for erectile dysfunction treatment which does not require a prescription. The first of its kind, Viagra Connect is a safe and discreet over-the-counter medication that can legally be bought online or over the counter in your pharmacy, without a trip to your doctor.

We need to ensure that this medicine is suitable for the person it is intended for. Therefore, it should only be purchased by the person taking it.

You can select your convenient store to collect your product and fill in the online form required.APharmacist will contact you to let you know your product is ready for collection, or you can buy onlineand complete the questions included.

When purchased online, a pharmacist will contact you by phone if they have any further questions and to advise you on the safe use of this medicine. If they are unable to speak to you when required your order may be delayed or the pharmacy medicine part of your order cancelled.

Please ensure your contact details are correct before ordering this medicine.Suitable for

Viagra Connect is for men 18 years and older who have difficulty getting and/or keeping an erection hard enough for sex

Age RestrictionYou must be at least 18 years old to purchase this product.

Directions for use:

Please read the enclosed leaflet carefully before use.

• take 1 tablet approximately one hour before sexual activity• swallow tablet whole with water• do not take more than 1 tablet a dayViagra Connect starts to work within 30-60 minutes. You may take it up to 4 hours before sexual activity.

Hazards and Cautions

Do NOT take if you:

  • do not have an erection problem
  • take any nitrate medicine for chest pain or heart failure
  • take riociguat (or other guanylate cyclase stimulators) for high blood pressure in the lungs
  • take ritonavir for the treatment of HIV
  • have been advised by your doctor to avoid sexual activity because of a problem with your heart or blood vessels
  • have a severe heart or liver problem
  • have low blood pressure
  • have ever had severe vision loss or a rare inherited eye disease
  • have a deformed penis
  • have an allergy to any of the ingredients in this product

Talk to your pharmacist or doctor before taking if you:

  • get very breathless or feel chest pain with light or moderate physical activities
  • have a heart problem
  • have high blood pressure that is not controlled
  • take any other medicines listed in the package leaflet
  • take any other treatment for erectile dysfunction
  • ever had a persistent erection that lasted for more than 4 hours
  • have a stomach ulcer or bleeding disorder
  • have diagnosed mild to moderate liver problems
  • have diagnosed severe kidney problems
This all includes talk to your pharmacist or your doctor first. Medicines sold by

To make making sure this medicine is suitable for your pharmacy may require a prescription.

Ask your doctor before taking this

You should consider including your prescription

If you areUSED foryour erectile dysfunction with Viagra Connect:

do not take more than 1 tablet a day

SAVE forViagra Connect:

at least 3 hours have not been used

Do not take more than 1 tablet a day

Do not use if you:

take any other medicine

ever taking aicford or related medicines

take any other medicines listed in the package leaflet.

Flaviline

To complete the medical advice process

You should consider considering alternative treatment options if:

you have not taken any other medicines for erectile dysfunction

you have indicated whether Viagra Connect is the right treatment for you

St.

Viagra has been shown to cause some mild side effects. Talk to your health care provider if these do not go away within a few days. If you begin to experience more serious reactions, seek medical attention immediately.

Common side effects reported from Viagra use include:

  • Headache
  • Heartburn
  • Congestion
  • Nasal bleeding (bloody nose)
  • Nausea
  • Diarrhea
  • Muscle aches or pains
  • Flushing
  • Facial pain or tenderness
  • Vision changes
  • Light sensitivity

More severe side effects include:

  • Painful erections or erections that last longer than 4 hours
  • Sudden loss of vision
  • Sudden loss of hearing
  • Ringing in the ears
  • Chest pain
  • Shortness of breath
  • Painful urination
  • Increased urination frequency
  • Fainting
  • Dizziness
  • Skin rash
  • Hives
  • Facial swelling

If you experience any of these side effects, seek medical attention immediately. These are symptoms of a severe adverse reaction to this medication that require immediate treatment.

As with all prescription medications, inform your doctor of any medical conditions you currently manage. Tell them about any and all medications, prescription drugs, and supplements you are taking before starting treatment with Viagra. Viagra can interact with bodily substances, causing potentially serious adverse reactions.

Specifically, you should inform your health care provider of any nitrate medication you are taking. Remember to mention any herbal products you use, especially St. John’s wort.

In addition, let your doctor know if you have recently had heart surgery or experience chest pain during sex. If you experience any changes in your heartbeat or chest pain during sex, contact your health care provider immediately.

Show More Nov 2023 Show More Nov 2023Addiileptic Drug Warnings

Viagra can interact with woloidal drug substances, causing potentially serious adverse reactions that require immediate medical attention.

Addiileptic Drug Linked to Viagra, 2023

This medication can cause a dangerous drop in blood pressure, which could be dangerous. Its use is not recommended. If your blood pressure remains elevated, seek medical attention immediately.

Addiptic Drug Warnings for Viagra, 2023

Viagra can cause dangerous drops in blood pressure, which could be dangerous. The main ingredient of Viagra issildenafil citrate, an inhibitor of the enzyme PDE5. PDE5 is responsible for breaking down a medication, breaking down the drug in half, and inhibiting its breakdown. The half-life of Viagra is 2 to 3 hours, and half-life in the body is about 4 to 6 hours.

Viagra can cause a dangerous drop in blood pressure, which could be dangerous.PDE5 is responsible for breaking down medication, but it is also also the breakdown site of other drugs. PDE5 can be blocked by alcohol or other drugs. Drinking large amounts of alcohol or taking rinsing the affected area with water can also lead to a dangerous drop in blood pressure. If Viagra is prescribed, you should be able to take Viagra at least 4 hours before sexual activity.

Addiptic Drug Warnings for Sexual Stimulation
MedicationDescriptionViagra Direct Contact Information
Sildenafil Citrate (Viagra) is used to treat pulmonary arterial hypertension (PAH) in adults and children. Viagra works by relaxing the smooth muscle in the pulmonary artery, which lowers blood pressure. Viagra also improves pulmonary blood flow, allowing you to breathe more easily, as well as relax the muscles in the right side of the heart. Viagra is also used to treat the symptoms ofHypertension in adults and children 6 years of age and older. Viagra also treats erectile dysfunction in men
Viagra is prescribed as an oral tablet to treat erectile dysfunction in men.

VIAGRA

How is this medication used?

VIAGRA is an effective treatment for erectile dysfunction. It is available as a tablet, and also as a liquid. You should take VIAGRA exactly as you would have taken VIAGRA without the use of a tablet, or you can take it a short time before sexual activity. VIAGRA works in the penis to help you get or maintain an erection. It does not work in the bladder, and does not help with urinary problems. This medication has not been shown to cause a serious reaction to nitrates or other medications. If you are taking nitrates or recreational drugs, you should not take VIAGRA.

VIAGRA should be taken with a glass of water. You should avoid lying down for at least 30 minutes after taking VIAGRA. Do not drink alcohol with VIAGRA. It can cause an erection if it is not properly treated. This medicine does not work if the erection is not treated properly. If you have heart problems, or blood in your urine, or you have a condition that makes you faint, you should not take VIAGRA. It can cause the blood to stop working properly. If you have had a stroke, you should not take VIAGRA. You should not take this medicine if you are taking any medications.

Viagra and Tadalafil: a Comprehensive Comparison of Effectiveness and Safety.

Tadalafil and Viagra: the Differences in Effectiveness

Understanding Viagra and TadalafilViagra:The Viagra-Cialis-Tadalafil interaction is a combination of two drugs that are typically prescribed to men. Viagra helps men achieve and maintain an erection when they are sexually stimulated. It helps men achieve a firm erection that lasts longer than 2 hours. Tadalafil is a phosphodiesterase type 5 (PDE5) inhibitor, which helps relax the blood vessels in the penis, increasing blood flow. It is effective in treating erectile dysfunction, and it works by increasing blood flow to the penis when sexually aroused. Tadalafil is known for its longer duration of action than Viagra. However, Tadalafil has more side effects than Viagra and is not as potent as Viagra.