FDA August 2026 Medical Recalls: Glutathione, Infant Breathing Circuits, and Morphine Label Mix-Up

Status: Active company recalls posted by FDA. FDA republishes company announcements as a public service and does not endorse the companies. Source dates: August 4-6, 2026. Last reviewed: August 7, 2026. This is a safety summary, not medical advice.

FDA August 2026 Medical Recalls: Glutathione, Infant Breathing Circuits, and Morphine Label Mix-Up

Three medical-product recalls posted by the Food and Drug Administration require immediate checks by patients, prescribers, hospitals, pharmacies, and respiratory-care teams. The products involve compounded glutathione with elevated bacterial endotoxin, neonatal and infant heated-wire breathing circuits with electrical connector damage, and a morphine package that may contain a Dilaudid syringe.

The risk and instructions differ. Patients with the recalled glutathione are told to stop and quarantine it. Facilities using the affected breathing circuits are told to stop and discard them. Health-care facilities must stop using and return the recalled morphine lot. Do not substitute one product’s remedy for another.

A fast label check

Do not act on the product name alone. Read the lot, item number, date, and pack label. A close match is not enough. The notice must match the product in hand.

• Glutathione: Look for lot 1980571, 1981940, or 1984345. Each listed lot has an August 27, 2026 expiration date.
• Infant circuit: Use the FDA item table and find the date made. The stated scope is on or before July 8, 2026.
• Morphine: Check the outer pack for lot 6402820 and product code 764411. The pack may hold the wrong drug.

If an item matches, move it out of use at once. Keep it apart from safe stock. Then follow the exact return, waste, or pick-up steps in that notice. Do not throw out a product when the firm asks for a return. Do not return a circuit when the firm says to discard it.

If the label is hard to read, call the maker or the care team. Do not guess. Keep a note of who checked the item, when it was checked, and what was done next.

Victory Medical Center Pharmacy compounded glutathione

Victory Medical Center Pharmacy recalled three lots of VMC Compounded Glutathione 200 mg/mL multi-dose vials after pharmacy testing found elevated bacterial endotoxin levels. The recall reaches the patient level and covers lot numbers 1980571, 1981940, and 1984345, all with an August 27, 2026 expiration date.

The product was distributed to consumers in Texas, Florida, and New York. The company statement says injectable products with elevated endotoxin have a reasonable probability of causing serious medical events, including fever, low blood pressure, inflammatory reactions, anaphylactic shock, and death.

Victory reported adverse events including fever, chills, severe headache, nausea, vomiting, rapid heart rate, blood-pressure changes, body aches, and injection-site reactions. The FDA page does not give a case count or establish that every reported event was caused by the product. It does establish that the company received such reports and recalled the listed lots after its testing result.

Patients should stop using the recalled product immediately, quarantine it, contact the pharmacy for retrieval and disposition, and contact the prescribing clinician if they experienced a problem. The official consumer number is 512-279-0985. The company says patients and prescribers will receive a full refund for recalled product if they have not already been reimbursed.

Medline Hudson RCI neonatal and infant breathing circuits

Medline initiated a nationwide recall of Hudson RCI Neonatal/Infant Heated Wire Breathing Circuits after receiving reports of sporadic electrical-connector failures. In affected circuits, the heated-wire connector at the Neptune humidifier can discolor, melt, smoke, smell burned, or show other localized heat damage.

Medline reported an observed event rate of 0.011 percent across the distributed population and said it was not aware of serious health consequences from use. That low reported rate does not cancel the recall. These devices are used for infants, and continued loss of heating can expose a patient to inadequately conditioned gas and increased circuit condensation.

The company statement says cold or dry gas can damage the airway, contribute to bronchospasm, thick secretions, obstruction, cold stress, and respiratory distress. Condensation can contribute to unintended positive end-expiratory pressure, circuit obstruction, or pooled fluid entering an infant’s airway.

The recall covers listed Medline and Teleflex item numbers manufactured on or before July 8, 2026 and distributed from June 28, 2021, through July 31, 2026. Products manufactured on or after July 9 are outside the stated scope. Because labels changed from Teleflex to Medline beginning in 2024, facilities should compare both the item number and manufacturing date using FDA’s table.

Consumers and facilities with affected circuits should stop using and discard them rather than return them. Medline is arranging credit and can be reached at 866-359-1704 or recalls@medline.com. Clinical teams should manage any patient transition through their established respiratory-care procedures.

Fresenius Kabi morphine package may contain Dilaudid

Fresenius Kabi recalled one nationwide lot of Morphine Sulfate Injection USP, Simplist 2 mg/1 mL because a MicroVault labeled as morphine may contain a prefilled syringe of Dilaudid, or hydromorphone HCl, 0.5 mg/0.5 mL.

The affected outer-product lot is 6402820, product code 764411, expiration 12/2028. It shipped from January 29 through June 9, 2026. The FDA photos show that the incorrect Dilaudid syringe can bear a different lot number, but facilities should quarantine the recalled morphine lot based on the official product table and return instructions.

The company says using mislabeled product has a reasonable probability of causing serious harm, including life-threatening respiratory depression and death. The highest-risk patients include people who do not regularly use opioids, patients with respiratory disease, children, and patients also taking central-nervous-system depressants. No adverse events had been reported for the recalled lot when the announcement was posted.

Health-care facilities should immediately stop distributing, dispensing, or using the affected lot and return all units to Fresenius Kabi. The quality-assurance number is 866-716-2459. Patients who believe they may have received the product should contact a clinician rather than trying to identify or interpret an administered syringe on their own.

What the three notices prove and do not prove

• Confirmed: Victory recalled three compounded-glutathione lots after testing identified elevated bacterial endotoxin.
• Confirmed company report: Victory received the adverse-event types listed above; the public notice does not provide a final causation finding or total case count.
• Confirmed: Medline recalled specified neonatal and infant heated-wire circuits manufactured on or before July 8, 2026.
• Confirmed company report: Medline calculated a 0.011 percent observed event rate and reported no known serious health consequence at posting time.
• Confirmed: Fresenius Kabi recalled morphine lot 6402820 because an outer package may contain a Dilaudid syringe.
• Confirmed company report: No adverse event had been reported for that morphine lot when the notice was issued.
• Pending: FDA classification or enforcement updates, final retrieval totals, additional event reports, and recall termination.
• Not established: The public notices do not prove every distributed unit was defective or that each reported symptom was caused by a recalled product.

How patients and facilities should document action

Record the product name, lot or item number, expiration or manufacturing date, quantity, location, quarantine date, and final return or disposal. Facilities should preserve distribution records and document each downstream notice. Patients should photograph labels if it is safe to do so, keep recall correspondence, and avoid posting records that expose health or contact information.

Adverse events and quality problems may be reported through FDA MedWatch. A MedWatch report is a safety report, not proof of legal liability or medical causation. Patients experiencing urgent symptoms should seek medical care first.

FDA and the companies should publish retrieval percentages, corrected product availability, and any scope change with dated update notes. Hospitals should not have to compare screenshots to determine whether a device or drug remains covered.

August 10 update: three additional FDA medical-product notices

BadPD’s review of the FDA recall feed identified three official notices that were not in the original August 7 roundup.

• BD intraosseous needle sets: BD recalled specified lots after reports of difficulty removing the obturator. The FDA-posted announcement lists 75 complaints, 45 serious-injury reports, and four death reports in which the problem occurred during out-of-hospital cardiac-arrest resuscitation. The notice does not establish the device as the sole cause of death. See BadPD’s dedicated BD recall ledger.
• OPTIRAY Imaging Bulk Package 350: Liebel-Flarsheim recalled lot 25ZF3670, NDC 0019-1333-65, expiration May 31, 2027, because particulate matter included plastic materials, stainless steel, and glass. The July 31 company announcement was posted by FDA on August 4. The company reported no related adverse events at posting time and directed facilities to stop use, quarantine the lot, and arrange return and replacement.
• Adequan veterinary injections: American Regent Animal Health recalled two Adequan Canine lots and two Adequan i.m. horse-injection lots after visible glass-fiber material was found. The July 31 company announcement was posted by FDA on August 3. Owners and veterinary professionals should match the official lot table and use the company’s return process.

The update does not merge the outcome records. The BD complaint, injury, and death-report figures apply to the recalled intraosseous needle sets, not to OPTIRAY or Adequan.

Sources

• FDA: Victory Medical Center Pharmacy compounded glutathione recall (company announcement and FDA posting August 5, 2026).
• FDA: Medline Hudson RCI neonatal and infant heated-wire breathing-circuit recall (company announcement August 5; FDA posting August 6, 2026).
• FDA: Fresenius Kabi Morphine Sulfate Injection Simplist recall (company announcement August 4; FDA posting August 5, 2026).
• FDA MedWatch reporting program (checked August 7, 2026).