Neptune’s Fix Recalled: FDA Warns That Tianeptine-Containing Products Are Associated with Seizures, Loss of Consciousness and Death

When 32-year-old graphic designer Matthew Cornier decided to work late at his Point Pleasant, New Jersey, office, he went to a convenience store and purchased several shot-size bottles of Neptune’s Fix, a purported dietary supplement sold with a claim that it will improve mental focus.

Several hours later Matthew was found dead in his office by his fiancée. The bottles of Neptune’s Fix were close to his body. Only one bottle had been consumed.

Unbeknown to Matthew, and many other users of Neptune’s Fix, this innocent-appearing product — sold at convenience stores, gas stations and smoke shops — and marketed as “Happiness in a Bottle” — contains a dangerous ingredient called tianeptine, which is unregulated in the U.S., and goes by the street name of “gas station heroin.”

Matthew’s story is not uncommon. Neptune’s Fix, and other tianeptine-containing products — including Za Za Red, Tianaa and Pegasus — are “illegally sold with claims to improve brain function and treat anxiety, depression, pain, opioid use disorder and other conditions,” according to a warning issued by the U.S. Food and Drug Administration (FDA). The FDA has warned that Neptune’s Fix, specifically, and tianeptine, in general, have been associated with seizures, loss of consciousness and death. Moreover, as tianeptine is highly addictive, abuse and withdrawal from it can closely resemble opioid toxicity and withdrawal, according to the U.S. Centers for Disease Control and Prevention (CDC).

In the midst of the current opioid crisis, tianeptine abuse is of extreme public health concern. In 2013, only four cases of tianeptine exposure were reported nationwide, according to America’s Poison Control Centers, which represents and collects data from the 55 poison control centers that span the U.S. In 2023, that number skyrocketed to 391 cases. The problem is probably worse than what the data reflects, as reports to poison control centers are voluntary. In additional to Matthew, several other people have died after taking tianeptine products.

At least twelve states have banned the sale of tianeptine, according to the FDA. Similar legislation is pending in New Jersey and Pennsylvania. In early 2024, legislation was introduced in Congress to classify tianeptine as a Schedule III drug under the Controlled Substance Act, which would make it illegal to sell tianeptine without a prescription.

On January 28, 2024, less than two months after Matthew’s death, Neptune Resources, the dietary supplement company behind Neptune’s Fix, announced that it was voluntarily recalling all Neptune’s Fix products, which are: Neptune’s Fix Elixir, Neptune’s Fix Extra Strength Elixir, and Neptune’s Fix Tablets. On February 15, 2024, Super Chill Products, another distributor of Neptune’s Fix, announced that it also was recalling its Neptune’s Fix products. According to the FDA, products distributed by Super Chill also are labeled as “Neptune’s Fix,” but the label and packaging might be slightly different than the products distributed by Neptune Resources. Super Chill has not issued a public notification to inform consumers of its recall.

While the two recalls are a step in the right direction, there undoubtedly will be Neptune’s Fix products that are not returned or destroyed, but instead will be unaccounted for, putting unsuspecting consumers at risk. Nor do the recalls solve the wider problem of similar tianeptine-containing products that are still available for purchase.

While not meant to be exhaustive, below we answer some of the most frequently asked questions that consumers have about Neptune’s Fix and tianeptine.

What Is Tianeptine?

Tianeptine is an antidepressant that is approved for use in low dosages in some European, Asian and Latin American countries. It is not approved for medical use in the United States. Although tianeptine-containing products are often labeled as dietary supplements in the U.S., tianeptine does not meet the statutory definition of a dietary supplement, and the FDA considers these products to be adulterated under the federal Food, Drug and Cosmetic Act.

Is Tianeptine Safer Than Street Drugs?

Tianeptine is not safer than street drugs. While many people in the U.S. take tianeptine products under the mistaken belief that they are a safer alternative to opioids like fentanyl or heroin or attempt to use tianeptine to wean off opioids, the FDA warns against such uses.

According to the FDA, consumers may inadvertently become addicted to tianeptine and should avoid all products containing it, especially those claiming to treat opioid use disorder. Relying on tianeptine products with unsubstantiated claims may delay those who suffer from opioid use disorder from entering recovery and may put them at greater risk of overdose and death.

News reports have told the stories of innocent consumers who developed expensive and addictive tianeptine habits. As one tianeptine user said, “You have to dose every 4 hours to prevent withdrawal once you’re hooked. … That’s 5 or 6 bottles a day … it’s easily a $150-a-day habit.” Another said, “I’ve taken 75 Pegasus pills some days … this went on for 4 years.” A third user said, “I used to have a 6-9 bottle a day habit.” One man described spending $2,000 per month to buy increasingly large quantities of Za Za Red, sacrificing food for his family, before finally quitting cold turkey.

What Are the Specific Health Risks Associated with Neptune’s Fix?

According to the recall announcement, the FDA advises that there is a “reasonable probability of life-threatening events including suicidal ideation or behavior for children, adolescents and young adults 25 and younger.” The FDA also says that individuals can unintentionally overdose and experience serious and potentially life-threatening risks including, confusion, seizures, drowsiness, dry mouth and shortness of breath. These symptoms may be exacerbated by alcohol. Further, there’s an increased risk of adverse and potentially lethal effects when tianeptine is mixed with some antidepressants known as monoamine oxidase inhibitors (MAOls).

The CDC also warned in February 2024 that Neptune’s Fix may be contaminated with different types of synthetic cannabinoids, which are linked to life-threatening effects such as seizures, hallucinations, brain swelling, heart palpitations and chest pains. This alarming finding was based on a 2023 investigation of 17 adults in New Jersey who had severe reactions after consuming Neptune’s Fix or other products that contain tianeptine. Of them, 13 were hospitalized in intensive care.

How Do I Know If I Have a Neptune’s Fix Product?

As set forth in the recall announcement, Neptune’s Fix Elixir and Extra Strength Elixir are packaged in amber glass bottles with a “shrink sleeve” label that covers the entire cap/bottle and is perforated at the cap to facilitate opening. Neptune’s Fix tablets are packaged in 20-count blister packs held in small boxes or 4-count foil packets. The products can be identified by the name Neptune’s Fix and its logo which is an illustration of the Roman God Neptune with a green beard and a trident.

What Should I Do If I Have a Neptune’s Fix Product?

The recall announcement instructs consumers to immediately stop using all Neptune’s Fix products. Consumers should either destroy them or return them to their place of purchase.

What Should I Do If I Believe I Am Having an Adverse Reaction to Neptune’s Fix?

The FDA advises that anyone who experiences a bad reaction to a tianeptine product should seek medical help immediately.

What Should I Do If I Or a Loved One Has Been Injured or Killed by Neptune’s Fix?

Feldman Shepherd attorneys John M. Dodig and Jason A. Daria said product liability law requires that all products be safe for their intended as well as expected use, and that includes products that are marketed and sold as dietary supplements. Tianeptine does not meet the statutory definition of a dietary supplement, nor is it approved for any medical use in the United States. Any claims to the contrary are false and illegal. Dodig and Daria recommend contacting a product liability attorney as soon as possible if you or a loved one has been seriously injured or killed by Neptune’s Fix or another product that contains tianeptine.

“People with health concerns turned to Neptune’s Fix thinking it was safe, and that it would help them. They purchased it in a store, not some back alley. Neptune Resources and other companies that make dietary supplements, or purport to make them, must be held responsible for ensuring that their products are safe and that their label claims are truthful and substantiated,” Dodig said.

“No one should die in their office because they took a small energy drink to help them improve focus. Nor should anyone rapidly become an addict because they were misled by a product label. It is imperative that all parties responsible for putting tianeptine products in the marketplace be held legally accountable before more innocent people get hurt,” Daria said.

The attorneys at Feldman Shepherd, which include a physician/attorney and two nurse/attorneys, have extensive experience handling cases involving unsafe drugs and medical devices. They were heavily involved in the nationwide Vioxx litigation, representing numerous clients who suffered heart attacks and strokes after being prescribed the popular pain management drug. Dodig and Daria presently represent Matthew’s family in wrongful death product liability litigation against Neptune Resources.

If you believe you or a loved one was seriously injured or killed by Neptune’s Fix or another tianeptine-containing product, please fill out our online form or contact us by phone at (215) 567-8300 or via e-mail at jdodig@feldmanshepherd.com or jdaria@feldmanshepherd.com for a free, confidential consultation.