The Union Health Ministry implemented a ban on 156 "irrational" FDC medicines, effective immediately. These medicines, including widely used antibiotics, painkillers, and multivitamins, were commonly used to treat fever, cough, and infections. The ban was imposed due to the associated health risks and lack of therapeutic justification for the ingredients in these FDCs.

What are FDC medicines?

FDCs or fixed-dosed combinations, also known as "cocktail drugs," are medications that combine multiple drugs in a single pill. They are designed to treat multiple symptoms or conditions simultaneously. While they offer convenience, they can pose significant risks. These risks include the possibility of overdose, adverse interactions between the drugs, and the development of antibiotic resistance. Additionally, many FDC medicines lack sufficient scientific evidence to support their safety and efficacy.

Expert opinions on FDC medicines

Experts have raised concerns about the use of FDC medicines. They believe that many of these combinations lack sufficient scientific evidence to support their safety and effectiveness. Additionally, the combination of multiple drugs in a single pill can increase the risk of adverse side effects and interactions with other medications.

Experts have also found that FDC medicines may not be as effective as individual drugs in treating certain conditions. It is important to note that safer and more effective alternatives are available for most of the medical conditions that FDC medicines were used to treat. One particular concern is the inclusion of antibiotics in some FDCs. Overuse of antibiotics can contribute to the development of antibiotic resistance, a major public health threat.

The risks of FDC medicines

The use of FDC medicines can lead to adverse effects, including serious ones. Additionally, safer alternatives, tested in clinical trials, are available to treat the same medical conditions. Experts recommend prescribing drugs individually based on a patient's clinical symptoms rather than combining them in FDCs.

The ban on irrational FDC medicines by the Union Health Ministry can be seen as a positive step towards promoting rational drug use and protecting public health. The goal is to eliminate unnecessary and potentially harmful drug combinations. This is a step forward in reducing the risks associated with medication and ensure safer and more effective treatment options for patients.

More than 20 vials of compounded tirzepatide, a GLP-1 medication containing the same active ingredient as Eli Lilly’s Mounjaro and Zepbound, have been recalled in the US over sterility concerns, according to the Food and Drug Administration (FDA).

The recall, issued by Apothecary Pharma, also includes a vial of NAD+ injection.

The FDA classified the recall as Class II, meaning the affected products could cause temporary or medically reversible adverse health consequences, while the likelihood of serious harm is considered low.

The recall follows a December 2025 FDA warning letter to Apothecary Pharma, which cited serious deficiencies in the North Carolina company’s sterile drug production practices.

The recalled injections are compounded versions of tirzepatide. Unlike FDA-approved, brand-name medications, compounded drugs are custom-prepared by pharmacies to meet specific patient needs.

Which Compounded GLP-1 Injections Were Recalled?

Also read: US FDA May Allow Pharmacies To Make Unapproved Peptide Injections: What Are the Safety Concerns?

The affected tirzepatide product is a prescription injection with a concentration of 18 mg/mL, supplied in a 4 mL multidose vial. Its National Drug Code (NDC) number is 85091-001-18.

The recalled lot numbers are AP-202622 through AP-202625 and AP-202627 through AP-202644. The products have beyond-use dates ranging from October 7 to November 26, 2026.

The recall also includes one vial of NAD+ injection.

What Should You Do If You Have a Recalled Vial?

The FDA and Apothecary Pharma have not issued a public statement clarifying what patients should do with the affected vials. Some customers have reported receiving requests through their prescribers to return or dispose of the products or contact the manufacturer directly.

NewLife Rx, a pharmaceutical fulfillment service that distributed some of the recalled vials, reportedly told certain customers that Apothecary had described the recall as a documentation issue.

According to a notice reviewed by USA TODAY, the recall was conducted at the retail level and did not extend to patients or require them to stop using or return their medications.

However, neither the FDA nor Apothecary Pharma has publicly clarified the reason for the recall or the safety of the affected products.

Although a Class II classification indicates a relatively low likelihood of serious harm, it does not mean a product is entirely risk-free.

If you have an affected lot, consult your prescriber or healthcare provider before using it again and follow their instructions.

Read More: Retatrutide Driving Peptide-Linked Emergency Hospital Admissions In Australia: What Are The Risks?

What Are the Risks of Compounded GLP-1 Drugs?

A compounded drug is a medication prepared by a compounding pharmacy to meet an individual patient's specific medical needs. This may include removing an allergen, adjusting a dosage, or preparing a formulation that is not commercially available.

While these medications can serve specific medical needs, they are not FDA-approved in the same way as branded drugs. The FDA does not review compounded formulations for safety, effectiveness, and quality before they are marketed.

Demand for GLP-1 medications for weight loss skyrocketed worldwide between 2022 and 2025, leading to shortages of semaglutide and tirzepatide.

During these shortages, compounding pharmacies were legally allowed under specific circumstances to prepare several versions of these medications.

Many patients turned to compounded GLP-1s because they were often affordable, available, and easier to buy online.

Potential risks of compounded GLP-1 drugs include:

• Inaccurate Dosing
• Sterility Concerns
• Different Ingredients
• Limited Safety Data
• Counterfeit or Unregulated Products

The US Food and Drug Administration (FDA) has approved Hibsago (bepirovirsen), a first-of-its kind treatment for certain adults with chronic hepatitis B. The drug controlled virus activity in some patients after stopping all treatment.

Announced on October 20, 2026, the approval makes Hibsago the first FDA-approved antisense oligonucleotide for chronic hepatitis B.

It is approved for certain adults without cirrhosis who have already been taking antiviral medication for at least six months, have suppressed levels of hepatitis B virus (HBV) and meet specific criteria for hepatitis B surface antigen (HBsAg).

In clinical trials, 19% of patients receiving Hibsago maintained viral control 24 weeks after stopping all hepatitis B treatment. No amount of HBsAg was detected in their blood. The treatment is meant to offer an alternative for some patients who otherwise need long-term antiviral medication.

“For many people living with chronic hepatitis B, treatment can mean taking antiviral medication for years to keep the virus suppressed,” said Wendy Carter, DO, acting director of the Office of Infectious Diseases in the FDA’s Center for Drug Evaluation and Research.

“Hibsago provides a new treatment approach that gives some patients the possibility of maintaining control of the virus after all chronic HBV treatment has ended. This approval represents an important advance for people living with this serious disease.”

How Does Hibsago Work?

Hibsago targets the genetic aspects the hepatitis B virus targets. By reducing viral RNA and hepatitis B surface antigen, the drug helps the immune system control the infection even after after treatment ends.

The drug is administered as an injection under the skin for up to 24 weeks, alongside a patient's existing hepatitis B medication. Patients continue their treatment for at least 24 weeks after the final Hibsago injection. They can then stop all treatment if they meet specified clinical and laboratory criteria.

The FDA also authorised a diagnostic test to help identify eligible patients and monitor them during treatment.

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What Did The Clinical Trials Find?

The approval was supported by two Phase 3 trials, B-Well 1 and B-Well 2, which compared Hibsago with a placebo in adults receiving established antiviral treatment.

Across the trials, 24% of patients receiving Hibsago met the criteria to stop their existing antiviral medication, compared to none in the placebo groups.

At 24 weeks after stopping all treatment, 19% of patients receiving Hibsago maintained viral control. Hepatitis B surface antigen was also no longer detectable in their blood.

The outcome means the virus remains controlled without ongoing treatment according to specified laboratory criteria.

Also read: H. pylori, HPV Among Five Infections Behind 1 In 8 Cancers Worldwide: Lancet

What Are The Risks?

Hibsago carries a warning for serious liver reactions and thrombocytopenia, or low platelet counts, which can increase the risk of life-threatening bleeding.

Other warnings include poor kidney function and inflammatory reactions like vasculitis. Patients require regular blood tests and medical monitoring before and during treatment.

The FDA granted Hibsago Fast Track and Breakthrough Therapy designations, along with Priority Review. The drug was approved for GSK plc.

The treatment is not suitable for everyone with chronic hepatitis B. Eligibility depends on liver health, existing treatment, viral suppression and laboratory results.

Chronic hepatitis B infections among children and young adults in the United States could rise by 83% if the country moves away from routinely recommending vaccination at birth for all newborns, according to a new study titled Projected Effect of 2026 Federal Changes to the Childhood Immunization Schedule on Chronic Hepatitis B Virus Infections in the United States, published in Annals of Internal Medicine recently.

Researchers from Massachusetts General Hospital and Harvard Medical School analysed outcomes for a birth cohort of 3.6 million infants over their first 20 years.

The study examined the impact of changes to US hepatitis B vaccine recommendations for babies born to mothers who test negative for the virus.

Under the revised approach, parents and healthcare providers decide together whether and when to begin vaccination. The findings suggest that this could leave more children vulnerable to infection, increasing the cases of chronic hepatitis B.

What Did The Study Find?

The model compared universal vaccination at birth with two alternatives. The first is delaying the first dose until at least two months of age, and the second is leaving the decision to parents and healthcare providers.

Researchers estimated that delaying vaccination could increase chronic hepatitis B infections acquired by age 20 by 19%. Under the second option, the estimated increase was 83%.

The model estimated 255 chronic infections under universal birth-dose vaccination, compared to 303 if vaccination was delayed and 467 under shared decision-making.

The number of people who remained at high risk to hepatitis B at age 20 was also projected to increase. Under universal vaccination at birth, around 232,000 people in the cohort would remain at risk. This rose to 474,000 with delayed vaccination and approximately 1.8 million under shared decision-making.

Study's corresponding author Amir Mohareb said, “These findings show why policy makers should re-implement recommendations for universal hepatitis B vaccination at birth.”

Also read: Hepatitis C: Could 8-Week Treatment Help India Reach More Patients?

Importance Of Hepatitis B Birth Dose

Hepatitis B is a viral infection that affects the liver and spreads through infected blood and certain bodily fluids, including during childbirth. Infection acquired during infancy is likely to become chronic, leading to cirrhosis, liver failure or liver cancer in the future.

The universal hepatitis B birth-dose recommendation was introduced in the US in 1991. The first dose provides early protection, including when maternal infection is missed or a child's exposure risk is not recognised.

In December 2025, the US Advisory Committee on Immunization Practices recommended replacing universal vaccination at birth with shared decision-making for infants whose mothers test negative.

The Centers for Disease Control and Prevention adopted this approach in January 2026. Babies born to mothers who test positive or whose infection status is unknown continue to be recommended to receive the birth dose promptly, along with hepatitis B immune globulin when indicated.

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Increase In Infections, Deaths And Costs

The changes in vaccine policy is also likely to lead to hundreds more infections, deaths, and millions of dollars in higher costs, according to another research published in JAMA Pediatrics.

Pediatricians, public health experts, and dozens of medical groups warned that it could harm children and their families. So the JAMA studies modelled the potential impact of the policy.

The first study estimated that delaying the first hepatitis B vaccine dose by two months for babies born in a single year to mothers who tested negative — about 80 percent of the 3.6 million US births annually — would increase lifetime health-care costs by at least $16 million, The Washington Post reported. If vaccination were delayed by seven months, it would cost an additional $19.8 million.

The second study modeled what would happen if only 10 per cent of babies born to unscreened mothers received a birth dose; an additional 628 babies would get infected.

“One of the most concerning implications is how many more infected Hep B babies will we see,” said co-author Rachel Epstein, a pediatric and adult infectious diseases clinician at Boston Medical Center.

“A universal birth dose helps prevent a substantial number of infections in babies of a lifelong condition that we do not have a cure for,” she added.