FDA Announces Nationwide Recall of Vitruvias Therapeutics Thyroid Tablets

 

August 25, 2026 | Pharmaceutical Regulatory & Drug Safety News

The U.S. Food and Drug Administration (FDA) has published a nationwide recall announcement concerning one lot of Vitruvias Therapeutics, Inc.’s Thyroid Tablets, USP 30 mg, after testing confirmed the potential for the product to be superpotent.

Vitruvias Therapeutics initiated the voluntary recall of Lot No. 504950 to the consumer level. The FDA published the company’s recall announcement on August 24, 2026.

Product Details

• Product: Thyroid Tablets, USP 30 mg
• NDC: 69680-166-00
• Lot Number: 504950
• Expiration Date: September 30, 2026
• Units Released: 3,655
• Units Sold: 1,955
• Distribution: Nationwide in the United States
• Distribution Period: January 31, 2025 – September 30, 2025

Reason for Recall

The recall was initiated because testing confirmed the potential for the product to be superpotent, meaning that the tablets may contain excessive levels of thyroid hormones.

Thyroid Tablets, USP are a natural thyroid preparation derived from porcine thyroid glands and contain levothyroxine (T4) and liothyronine (T3). They are used for the treatment of hypothyroidism.

Exposure to excessive thyroid hormone levels may result in hyperthyroidism, with potential symptoms including weight loss, heat intolerance, fatigue, nervousness, muscle weakness, hypertension, chest pain, rapid heartbeat and heart-rhythm disturbances.

The FDA identifies elderly patients, pregnant women and infants, particularly with prolonged exposure, as populations that may face greater risks from excessive thyroid hormone levels.

Important Advice for Patients

Patients currently taking Thyroid Tablets, USP from Lot 504950 should not discontinue the medication without first consulting their healthcare provider. Patients should contact their healthcare provider for further guidance and/or a replacement prescription.

Vitruvias Therapeutics stated that, to date, it has not received reports of adverse events known to be related to this recall. The company is notifying wholesalers and arranging for destruction of the recalled product.

Regulatory Significance

The recall highlights the importance of potency control, finished-product testing and ongoing quality surveillance for drug products containing thyroid hormones, where relatively small variations in active pharmaceutical ingredient content can have clinically significant consequences.

For pharmaceutical manufacturers and quality professionals, the case reinforces the importance of robust assay testing, content uniformity, stability monitoring, batch-release controls and pharmacovigilance systems.

Source: U.S. Food and Drug Administration (FDA), Vitruvias Therapeutics, Inc. recall announcement, August 2026.

Pfizer Blames Birth Control Recall On Packaging Error

Pfizer recalled 1 million packages of birth control pills last Wednesday, as a result of mechanical and vision inspection problems on its packaging line in December 2011. The error caused inexact tablet counts or out-of-sequence tablets in the blister packs. In an investigation, the company discovered 14 lots of Lo-Ovral-28 and 14 lots of the generic norgestrel/ethinyl estradio pills contained incorrect dosing.

A Pfizer spokesperson said an automatic packaging process placed the pills in the wrong order in the packs, meaning that placebo pills were placed where active ingredient pills should have been, and vice versa.

The company believes that only 30 packets of the birth control pills were affected by the mix-up, and that the problem has been identified and fixed.In a statement, Pfizer said this packaging issue shouldn't cause any health risks, but added, "as a result of this packaging error, the daily regimen for these oral contraceptives may be incorrect and could leave women without adequate contraception, and at risk for unintended pregnancy."The pills were manufactured by Pfizer last year, but marketed by Akrimax Pharmaceuticals.

Slimming capsules containing sibutramine banned in Taiwan

Pharmaceutical firms have been ordered to recall slimming capsules, including Meridia, which contain the substance sibutramine, within a month, after reports showed the weight-loss drug increases risks of cardiovascular disease, the Department of Health announced in a statement issued Saturday.

The health department's announcement came after the U.S. Food and Drug Administration this week demanded Abbotte Laboratories to stop selling its sibutramine-based diet pill Meridia in North America, following the reports.

Sales of the drug have been suspended in the European Union.

Meridia is used in combination with a reduced calorie diet and exercise to help people lose weight and maintain their weight loss. It is in a class of medications called appetite suppressants which act on appetite control centers in the brain to decrease appetite.

In addition to the product recall, the authorities in Taiwan have also decided to annul the approval for 15 kinds of medications containing sibutramine, starting Oct. 11.

Besides Meridia, other sibutramine-based medications that have received regulatory approval include: Reductil, Sytramee, Losfat, Moi-Allison, Sibutil, Shapedesign and Controkilo.

According to statistics from Taiwan's health authorities, 302 people experienced discomfort after taking medications containing sibutramine. Of the cases, 115 were proven related to cardiovascular disease, but no death was reported.

Products Seized from Caraco Pharmaceutical Labs

After continued failure to adhere to the U.S. Food and Drug Administrations (FDA) Good Manufacturing Practice requirements, the U.S.Marshalls seized all of the drug products and materials that were found in the Caraco Pharmaceutical Labs Ltd. Caraco has three locations in Michigan – Detroit, Farmington Hills and Wixom. The Center for Drug Evaluation and Research is committed to protecting the public from companies who do not adhere to the safe and hygienic guidelines that are set by the FDA.

The company has enacted its own voluntary recalls of products since January 2009 as it became aware of inconsistencies in the production of some of its drugs. These inconsistencies were evident in some tablets that were oversized which in turn affected the correct dosage for effective treatment.

A warning letter was sent to Caraco on October 31, 2008 that discusses in detail all of the violations that this company is accused of and has ignored to date. Failure of quality control is elaborated on as serious inconsistencies in the production of drugs were discovered from the above mentioned facilities. Cross contamination of products was found, incorrect levels of certain medications that should be included in some of the medications were noted and failure to put certain products on hold because of manufacturing problems was also addressed.

The Caraco plants manufacture over 33 different drugs in a variety of strengths. The FDA seized all of the drugs as well as the ingredients that are used to produce the drugs. Of all of the products seized, the FDA is concerned that there could be a shortage of one of the products, choline magnesium trisalicylate which is used as a general pain reliever. The other medications are listed on the FDA site and are not expected to cause a shortage because of the confiscation as other pharmaceutical companies produce the same products.

Some of the more commonly used products manufactured by Caraco that have come under fire include Metformin, which is used by patients with type 2 diabetes to control blood sugar levels, Clozapine, which is administered as an anti-psychotic treatment for patients who suffer from schizophrenia, and Oxaprozin, which is used to treat inflammatory joint pain caused by osteoarthritis and rheumatoid arthritis.

Just the three examples listed above open up the possibility of complications as a result of the violations that have been confirmed at the Caraco manufacturing plants. Inconsistent doses that relate to any of the above conditions could result in serious side affects.

A diabetic who is not receiving a high enough dose or a too low dose of metformin can be affected directly through the effects it has on his or her blood sugar levels. An incorrect dose of medication that is administered to someone who is being treated for physcotic episodes could quickly become life threatening. And uncontrolled joint pain could be experienced by patients who suffer from both types of arthritis.

If you currently take or have taken in the past any medications manufactured by the Caraco companies, and have experienced any complications as a result, contact our law firm, Napoli, Bern Ripka, at 1-888-LAW-IN-NY. Our attorneys have experience in helping victims receive compensation for becoming victim to the negligence of major pharmaceutical manufacturers.

NACo endorses pharmaceutical take-backs

Requiring pharmaceutical companies to take back unwanted medicines has received the official endorsement of the Washington-based National Association of Counties (NACo). Like similar initiatives for other types of waste, pharmaceutical take-back programs seek to shift the expense of disposing of unwanted medicines from state and local governments to the products' producers.

NACo passed a resolution during its annual meeting in Nashville, Tenn., to adopt a policy supporting producer responsibility for unwanted medicines, saying that storing the medicines causes numerous and complex problems. Leftover medicine may contribute to drug abuse and accidental poisonings, and disposing of the medicines contributes to ground and surface water contamination, according to the resolution. "There are examples of successful take back programs in the U.S and Canada that benefit the health both of the environment and the population," said Ramsey County, Minn., Commissioner Victoria Reinhardt, who introduced the proposal along with three commissioners from Washington.

The Athens, Ga.-based Product Policy Institute helped develop the resolution. View more information on the resolution, and more information about NACo's recent conference.

Generic Drug Co Recalls Acetaminophen To Avoid Dose Confusion

WASHINGTON -A generic pharmaceutical company based in Georgia is recalling concentrated drops of acetaminophen, a key ingredient in Tylenol, to help patients avoid accidentally overdosing on the product, the U.S. Food and Drug Administration said Wednesday.

Acetaminophen, a drug in Tylenol and a host of cough medicines and painkillers, is under intense scrutiny by the FDA because high-doses of the medicine are the leading cause of liver damage.

The FDA said Brookstone Pharmaceuticals LLC has voluntarily begun recalling its Concentrated Acetaminophen Drops, which are available in 16-ounce bulk containers. "The firm is recalling its product to the consumer level as a cautionary measure to minimize any confusion and potential risk to patients from dosing errors," the company said in a press release, which was posted on the FDA's Web site Wednesday.

A Brookstone representative wasn't immediately available to comment.

The FDA has been looking at liver-injury concerns associated with acetaminophen for more than 30 years. At a widely publicized FDA meeting in June, more than 30 doctors and researchers recommended new limits on dosing for acetaminophen and asked that the painkillers Percocet and Vicodin be pulled from the market. Percocet, made by Endo Pharmaceuticals Holdings Inc. (ENDP), and Abbott Laboratories' (ABT) Vicodin combine acetaminophen with other pain-killing ingredients.

About 100 people die annually from accidentally overdosing on acetaminophen, though the FDA says it is safe if taken at recommended levels. Part of the problem with dealing with liver injuries associated with acetaminophen is the drug's prevalence. Often patients don't realize they are taking an over-the-counter product and a prescription product at the same time that contain that same ingredient.

The company's recall is tied directly to confusion about dosing and the FDA's advisory panel meeting in June. "Brookstone has not received any adverse events associated with this product but due to recent advisory panel concerns, Brookstone has taken voluntary action," the company's press release said.

Brookstone Pharmaceuticals Issues a Voluntary Recall of All Lots of BrookstonePharmaceuticals' Concentrated Acetaminophen Drops

FOR IMMEDIATE RELEASE – July 13, 2009 – Brookstone Pharmaceuticals, LLC, Alpharetta, GA has initiated anationwide voluntary recall of all lots of Concentrated Acetaminophen Drops (NDC#42192-504-16) in 16 ounce (473 ml) bulk containers. This 16oz container is comparableto the size generally used to package regular strength acetaminophen liquid preparations.This aspect of the product coupled with the absence of an integrated dosage deliverydevice is a contributing factor to possible dosing errors, especially inadvertentoverdosing. Brookstone has distributed 344 bottles nationally and has donated 5301bottles to charity for international distribution.

Over dosage of acetaminophen may result in liver toxicity, kidney damage, and blooddisorders. FDA is aware of several medication error reports that document lifethreateningor fatal adverse events in children less than three years of age, due toconfusion associated with the concentrated versus regular strength acetaminophen liquid.Also, in a recent FDA advisory panel, it was recommended that one of the two strengthsof acetaminophen should be removed from the market due to possible confusion whichcould result in overdosing.

Brookstone’s concentrated acetaminophen contains acetaminophen 80 mg/0.8 mL.Regular strength acetaminophen elixir contains 160 mg/5 ml. The firm is recalling itsproduct to the consumer level as a cautionary measure to minimize any confusion andpotential risk to patients from dosing errors.

Brookstone Pharmaceuticals has notified customers that it has voluntarily stoppedmanufacturing and shipping Concentrated Acetaminophen Drops in bulk containers andhas also advised customers (wholesalers and hospitals) to quarantine and hold the productfor return to Brookstone Pharmaceuticals for a full refund. Customers with questionsabout the recall may contact Brookstone Pharmaceuticals, LLC at 1-800-541-4802,option 2. Brookstone has not received any adverse events associated with this product butdue to recent advisory panel concerns, Brookstone has taken voluntary action.

The recalled drops were manufactured by Pharmaceutical Associates, Inc. This recall isbeing conducted with the knowledge of the Food and Drug Administration.

Customers who have this product in their possession should stop using it immediately.Any adverse events that may be related to the use of this product should be reported tothe FDA's MedWatch Program by phone at 1-800-FDA-1088 or by fax at 1-800-FDA-0178 or by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787.

FDA Stops Shipments of 33 Generic Drugs from Caraco Plants

WASHINGTON,- Federal marshals dispatched by the FDA have stopped all shipments from three generic drug manufacturing plants in Michigan operated by Caraco Pharmaceutical Laboratories.

The action affects 33 different drugs. It was taken after the company repeatedly failed to correct defects in its manufacturing processes, FDA officials said, despite a warning letter last October and several recalls this year.

Deborah Autor, director of the compliance office at FDA's Center for Drug Evaluation and Research, said the agency's most recent inspection, in May, revealed "serious deficiencies" in the quality control at the plants.

Earlier this year, Caraco had initiated recalls for oversize tablets and formulation errors.

The affected drugs include generic versions of many widely prescribed medications, including the antidiabetic agents glipizide and metformin; high blood pressure meds atenolol, carvedilol, and hydrochlorothiazide; and the psychotropic medications clozapine, clonazepam, and paroxetine.

The company is prohibited from shipping products until the FDA certifies that it is meeting its so-called cGMP quality control standards.

Autor emphasized that patients currently taking drugs produced by Caraco should not stop them. No problems with drugs shipped recently from the plants have come to light, she said.

"All the products we knew to be defective have been recalled [previously]," she said.

She added that the agency would act quickly if it learns of other defects.

In the meantime, the FDA will work with Caraco management to resolve the manufacturing problems.

"Our goal is to get Caraco up and running safely," Autor said. She was unable to say how long that may take.

For one product -- choline magnesium trisalicylate, an oral painkiller -- the action will create a shortage because Caraco has been the sole supplier.

Autor said physicians should look for alternative medications for their patients now on this drug.

Here is the full list of Caraco drugs affected by the seizure:

Allopurinol tablets

Amlodipine tablets

Atenolol tablets

Baclofen tablets

Carvedilol tablets

Cetirizine tablets

Cetirizine IR tablets

Choline magnesium trisalicylate tablets

Citalopram HBR tablets

Clonazepam tablets

Clozapine tablets

Digoxin tablets

Flurbiprofen tablets

Fluvoxamine maleate tablets

Glipizide tablets

Glipizide/metformin tablets

Hydrochlorothiazide tablets

Meloxicam tablets

Meperidine HCl C-II tablets

Metformin tablets

Methimazole tablets

Metoprolol tartrate tablets

Midrin capsules

Mirtazapine tablets

Oxaprozin tablets

Paromomycin sulfate, USP capsules

Paroxetine tablets

Phentermine HCl tablets

Ticlopidine HCl tablets

Tizanidine HCl tablets

Tramadol HCl tablets

Tramadol HCl/acetaminophen tablets

Zolpidem tartrate tablets

Central Florida Pharmaceutical Litigation Attorneys Discuss Recall of Digitek

In April of 2008, the pharmaceutical company Actavis Totowa issued a nationwide recall of all lots of Digitek distributed by Mylan Pharmaceuticals due to the risk that these pills may contain a hazardous double-dose of the active ingredient digoxin. The Digitek recall was Class I in nature, meaning that the drug in question has the potential to cause death or serious health complications. The specific defect in the recalled lots of Digitek was that the tablets were manufactured at twice their intended size. Accordingly, these tablets contained double the approved level of digoxin which has led to dangerous overdoses in many consumers.

Digitek is designed to treat congestive heart failure and abnormal heart rhythms. However, when patients consume more than the prescribed amount of this drug, a condition known as digitalis toxicity can occur. This form of toxicity can be caused by consuming the recalled double-strength Digitek tablets. Symptoms of digitalis toxicity include:

Nausea

Vomiting

Abnormally low blood pressure

Cardiac instability & heart palpitations

Cold sweats

Dizziness

Irregular pulse/slow heart rate (bradycardia)

Trouble breathing, particularly when lying down

Loss of appetite

Loss of consciousness

Decreased urination

Visual changes in color perception, particularly yellow & green-like distortions

Death

Many Digitek consumers were notified of the recall by their pharmacies subsequent to the April 2008 news. If a family member has died due to heart/cardiac complications, find out if they were taking Digitek during the time period leading up to their death. If you or a loved one was prescribed a recalled lot of Digitek and suffered harm, contact the product liability and medical malpractice attorneys at Rue & Ziffra, P.A. Our law offices can be reached at 1-888-246-8613. Alternatively, visit Florida Product Liability Lawyers / Pharmaceutical Litigation Attorneys Rue & Ziffra website at www.RueZiffra.com for more information on the nationwide Digitek recall and the ways in which our legal team can help you achieve the compensation you deserve.