09/01/2026	08/24/2026	Peak Performance Peptides	Center for Drug Evaluation and Research (CDER)	Unapproved New Drugs/Misbranded
09/01/2026	08/18/2026	Reliance Life Sciences Private Limited	Center for Drug Evaluation and Research (CDER)	CGMP/Finished Pharmaceuticals/Adulterated
09/01/2026	08/27/2026	Jabil Inc.	Center for Drug Evaluation and Research (CDER)	CGMP/Finished Pharmaceuticals/Adulterated
09/01/2026	08/18/2026	Shoolin Pharma Chem LLP	Center for Drug Evaluation and Research (CDER)	CGMP/Active Pharmaceutical Ingredient (API)/Adulterated
09/01/2026	08/24/2026	Royal Peptides LLC	Center for Drug Evaluation and Research (CDER)	Unapproved New Drugs/Misbranded
09/01/2026	08/24/2026	NuScience Peptides LLC	Center for Drug Evaluation and Research (CDER)	Unapproved New Drugs/Misbranded
09/01/2026	08/24/2026	Peptide Partners LLC	Center for Drug Evaluation and Research (CDER)	Unapproved New Drugs/Misbranded
09/01/2026	08/24/2026	TXP Innovations LLC dba Tex Peptides	Center for Drug Evaluation and Research (CDER)	Unapproved New Drugs/Misbranded
09/01/2026	08/04/2026	Mesquite Gourmet LLC	Office of Inspections and Investigations	Foreign Supplier Verification Program (FSVP)
09/01/2026	08/18/2026	B&P Mutual Corp	Office of Inspections and Investigations	Foreign Supplier Verification Program (FSVP)

 

• B. MAGI may be harmful due to hidden ingredients
• DMagic Plus may be harmful due to hidden ingredients
• Premium OrgaZEN 10000 may be harmful due to hidden ingredient
• Anaconda Premium 500K may be harmful due to hidden ingredient

FDA reminds compounders not to use dietary supplement grade glutathione for injectables

 [8/27/2026] FDA is aware of reports of at least 30 patients who experienced adverse events following the administration of intravenous (IV) glutathione alone or in combination with other ingredients.

The glutathione was compounded by different compounding pharmacies, all of which obtained their glutathione (Lot #229536) from Medisca Inc., U.S. headquarters in Plattsburgh, N.Y. The glutathione was labeled as dietary supplement grade, which is not an appropriate ingredient to make injectable drugs.

FDA is aware of two pharmacies located in Texas that have conducted recalls related to elevated endotoxin levels in their glutathione injectable drugs.

Reported adverse events included fever, chills, pain, dizziness, signs of shock and sepsis-like symptoms, with some resulting in hospitalizations. These symptoms are consistent with exposure to excessive endotoxin levels. Endotoxin exposure also can cause myalgia (muscle pain), headache, nausea, vomiting, hypotension (low blood pressure) and death. However, not all these symptoms have been reported in association with these glutathione adverse events.

Medisca informed the agency on August 20, 2026, that it sent its U.S. customers a warning not to use its dietary supplement grade glutathione in the compounding of injectable drugs. The agency urges compounders that received dietary supplement grade glutathione from Medisca to contact their customers and instruct them to discontinue use of the IV glutathione product.

FDA continues to receive reports of adverse events consistent with endotoxin exposure and is actively investigating. The agency will provide updates as additional information becomes available.

What compounders should know

• Compounders are responsible for ensuring all components used in injectable drugs are appropriate for their intended use and should not use dietary supplement grade ingredients when making injectable drugs.
• Ingredients labeled for dietary supplement use may contain impurities and contaminants, including endotoxins, that may be harmful when administered as an injectable drug.
• FDA urges compounders to know their bulk drug substance, or active pharmaceutical ingredient (API) and excipient suppliers and ensure all ingredients they use to produce injectable drugs are manufactured under conditions and specifications appropriate for the intended route of administration.
• Compounders should not rely on testing alone to ensure the quality of the drug. Quality should be built into every step of the compounding process, including ingredient sourcing, stock solution preparation and finished drug release.

FDA previously communicated in 2019 about the use of dietary ingredient glutathione for compounding injectable drugs and the agency remains concerned about continued risks to patients.

FDA recommendations

• Health care professionals should check with their compounders regarding the source of the glutathione used to make injectable drugs for their patients.
• API suppliers, relabelers and repackagers should clearly identify the upstream manufacturer of all APIs on labels and certificate of analyses (COAs) and include explicit statements regarding the appropriate and inappropriate uses of each ingredient.
• Consumers who have concerns should talk to their health care professionals.

Reporting adverse events

FDA encourages consumers, health care professionals and compounders to report adverse events or quality problems experienced with the use of compounded drugs to FDA’s MedWatch Adverse Event Reporting program:

• Complete and submit the report online at MedWatch: The FDA Safety Information and Adverse Event Reporting Program or
• Download and complete the form, then submit it via fax at 1-800-FDA-0178.

 Qu Feng Huo Lou Dan may be harmful due to hidden ingredient

FDA Issues Emergency Use Authorization for Generic Drug to Prevent New World Screwworm in Cattle FDA’s 14th EUA against NWS

For Immediate Release:

September 03, 2026

The U.S. Food and Drug Administration today issued an Emergency Use Authorization (EUA) for Capstar (nitenpyram) tablets and revised the EUA for Nitenpyram Tablets, the generic version of Capstar, to authorize both products for the prevention and treatment of New World screwworm (NWS) infestations (myiasis) in dogs, puppies, cats, and kittens that weigh at least two pounds and are at least four weeks old. Nitenpyram Tablets were initially authorized in June 2026 for treatment only.

“Although the FDA has authorized or conditionally approved multiple products for the treatment of New World screwworm in dogs and cats, none were for prevention – until today,” said Timothy Schell, Ph.D., director of the FDA’s Center for Veterinary Medicine. “The FDA is addressing a previously unmet need and giving pet owners and veterinarians important tools to protect dogs and cats from NWS infestations.”

Currently, most dogs and cats in the U.S. are at low risk of NWS exposure because confirmed cases of NWS are in a limited geographic region. However, dogs and cats that live in, travel to, or return from areas where NWS infestations have been identified by state or federal animal health officials, as well as certain countries south of the U.S. border, should be closely monitored for signs of infestation, such as visible maggots or foul odors in wounds or body openings (e.g., eyes, ears, nose, mouth). Seek immediate veterinary care for infested dogs and cats. For up-to-date U.S. case information, see the U.S. Department of Agriculture’s dashboard of Confirmed Detections of New World Screwworm.

Based on the totality of the scientific evidence available, the FDA has concluded it is reasonable to believe that Capstar and Nitenpyram Tablets may be effective in the prevention and treatment of NWS myiasis in certain dogs, puppies, cats, and kittens when used as authorized, and the known and potential benefits of the products outweigh their known and potential risks.

Capstar and Nitenpyram Tablets are available over the counter and come in two tablet sizes: 11.4 and 57 mg. Dosage is based on a dog’s or cat’s weight. Do not administer to pets less than two pounds or younger than four weeks old.

For detailed information about how to use these products, pet owners should carefully review the relevant product’s fact sheet. All EUA product Fact Sheets, FOI Summaries, and Letters of Authorization are available on Emergency Use Authorization of Animal Drugs for NWS.

These EUAs will be in effect until they are revoked or the HHS Secretary terminates the declaration that the potential public health emergency presented by NWS justifies the emergency use authorization of animal drugs for NWS.

Capstar is sponsored by Sergeant’s Pet Care Products LLC of Omaha, Nebraska, and Nitenpyram Tablets are sponsored by Felix Pharmaceuticals Pvt. Ltd. based in Ireland.

Related Information

• Animal Drugs for New World Screwworm
• Emergency Use Authorization of Animal Drugs for NWS
• Screwworm.gov – Unified Government Response to Protect the United States

FDA Issues Emergency Use Authorization for Drugs to Prevent and Treat New World Screwworm in Dogs and Cats

 The U.S. Food and Drug Administration today issued an Emergency Use Authorization (EUA) for Capstar (nitenpyram) tablets and revised the EUA for Nitenpyram Tablets, the generic version of Capstar, to authorize both products for the prevention and treatment of New World screwworm (NWS) infestations (myiasis) in dogs, puppies, cats, and kittens that weigh at least two pounds and are at least four weeks old. Nitenpyram Tablets were initially authorized in June 2026 for treatment only.

“Although the FDA has authorized or conditionally approved multiple products for the treatment of New World screwworm in dogs and cats, none were for prevention – until today,” said Timothy Schell, Ph.D., director of the FDA’s Center for Veterinary Medicine. “The FDA is addressing a previously unmet need and giving pet owners and veterinarians important tools to protect dogs and cats from NWS infestations.”

Currently, most dogs and cats in the U.S. are at low risk of NWS exposure because confirmed cases of NWS are in a limited geographic region. However, dogs and cats that live in, travel to, or return from areas where NWS infestations have been identified by state or federal animal health officials, as well as certain countries south of the U.S. border, should be closely monitored for signs of infestation, such as visible maggots or foul odors in wounds or body openings (e.g., eyes, ears, nose, mouth). Seek immediate veterinary care for infested dogs and cats. For up-to-date U.S. case information, see the U.S. Department of Agriculture’s dashboard of Confirmed Detections of New World Screwworm.

Based on the totality of the scientific evidence available, the FDA has concluded it is reasonable to believe that Capstar and Nitenpyram Tablets may be effective in the prevention and treatment of NWS myiasis in certain dogs, puppies, cats, and kittens when used as authorized, and the known and potential benefits of the products outweigh their known and potential risks.

Capstar and Nitenpyram Tablets are available over the counter and come in two tablet sizes: 11.4 and 57 mg. Dosage is based on a dog’s or cat’s weight. Do not administer to pets less than two pounds or younger than four weeks old.

For detailed information about how to use these products, pet owners should carefully review the relevant product’s fact sheet. All EUA product Fact Sheets, FOI Summaries, and Letters of Authorization are available on Emergency Use Authorization of Animal Drugs for NWS.

These EUAs will be in effect until they are revoked or the HHS Secretary terminates the declaration that the potential public health emergency presented by NWS justifies the emergency use authorization of animal drugs for NWS.

Capstar is sponsored by Sergeant’s Pet Care Products LLC of Omaha, Nebraska, and Nitenpyram Tablets are sponsored by Felix Pharmaceuticals Pvt. Ltd. based in Ireland.

  MAXMAN Coffee may be harmful due to hidden drug ingredients

 

• Esbelta Chupapanza Flat Belly may be harmful due to hidden ingredient
• Esbelta Intense Loss may be harmful due to hidden ingredients

FDA Issues Emergency Use Authorization for Drug to Treat New World Screwworm in Dogs and Puppies U.S. Food and Drug Administration sent this bulletin at 08/13/2026 02:01 PM EDT

 The U.S. Food and Drug Administration today issued an Emergency Use Authorization (EUA) for Simparica TRIO (sarolaner, moxidectin, and pyrantel chewable tablets) for the treatment of New World screwworm (NWS) infestations (myiasis) in dogs and puppies.

Currently, most dogs in the U.S. are at low risk of NWS exposure due to their geographic location. However, dogs that live in, travel to, or return from areas where NWS infestations have been identified by state or federal animal health officials, as well as certain countries south of the U.S. border, should be closely monitored for signs of infestation, such as visible maggots or foul odors in wounds or body openings (eyes, ears, nose, mouth). Seek immediate veterinary care for infested dogs.

For up-to-date U.S. case information, see the U.S. Department of Agriculture’s dashboard of Confirmed Detections of New World Screwworm. At present, NWS has only been detected in specific areas of Texas and New Mexico.

“The FDA continues to authorize products to give veterinarians and pet owners multiple treatment options, in the unlikely event animals under their care become infested with New World screwworm,” said Acting FDA Commissioner Kyle Diamantas, J.D. “To date, the U.S. has been successful in containing the spread of NWS. We are hopeful it will remain that way, and by authorizing products like this, the U.S. will be ready if the need arises.”

Based on the totality of the scientific evidence available, the FDA has concluded it is reasonable to believe that Simparica TRIO may be effective in the treatment of NWS myiasis in dogs and puppies when used as authorized, and the known and potential benefits of the product outweigh its known and potential risks. Simparica TRIO is not authorized for the prevention of NWS.

“We want dog owners to be informed, not alarmed,” said Timothy Schell, Ph.D., director of the FDA's Center for Veterinary Medicine. “The best thing dog owners can do right now is stay aware of the situation, know the signs of infestation, and have a conversation with their veterinarian if they have concerns.”

Simparica TRIO was approved by the FDA in 2020 for heartworm, flea, and tick-related indications in dogs and puppies. Sarolaner, one of the active ingredients in Simparica TRIO, belongs to a class of antiparasitic drugs called isoxazolines. Although isoxazoline products are commonly used and safe for most dogs, the products have been associated with neurologic adverse reactions, including muscle tremors, loss of coordination, and seizures. Because professional expertise is required to monitor for and respond to these reactions, Simparica TRIO is available only by prescription from a licensed veterinarian. Dog owners should consult with a veterinarian to determine if Simparica TRIO is appropriate for their dog.

Detailed product information can be found in the Fact Sheet for Veterinarians: Emergency Use Authorization of Simparica TRIO (sarolaner, moxidectin, and pyrantel chewable tablets) for New World Screwworm (NWS).

This EUA will be effective until it is revoked or the HHS Secretary terminates the declaration that the potential public health emergency presented by NWS justifies the emergency use authorization of animal drugs for NWS.

Simparica TRIO is sponsored by Zoetis Inc., based in Kalamazoo, Michigan.

found at and quoted from FDA Issues Emergency Use Authorization for Drug to Treat New World Screwworm in Dogs and Puppies - stuckrichmond@gmail.com - Gmail

Preemption and the Federal Food, Drug, and Cosmetic Act (FD&C Act)

 Preemption and the Federal Food, Drug, and Cosmetic Act (FD&C Act) | Congress.gov | Library of Congress