';
CLOSE
Tags Posts tagged with "Product Recall"

Product Recall

0 2087

The Office of Developmental Programs (ODP) is sharing this important announcement from the PA Department of Health.

As of November 11, 2025, 15 infants with suspected or confirmed infant botulism were reported from 12 states: Arizona, California (2), Illinois (2), Kentucky, Minnesota, New Jersey, North Carolina, Oregon, Pennsylvania, Rhode Island, Texas (2), and Washington. Laboratory confirmation for some cases is ongoing. Illnesses started on dates ranging from mid-August to November 2025. All 15 infants were hospitalized and treated with BabyBIG®. No deaths were reported. Infants ranged in age from 16 to 157 days. State and local public health officials are interviewing caregivers about the foods infants were fed in the month before they got sick. All 15 (100%) reported feeding ByHeart Whole Nutrition infant formula. This investigation is ongoing, and additional cases may be identified.

All ByHeart Whole Nutrition Infant Formula products were recalled. This includes all unexpired lots of formula cans and single-serve “anywhere” sticks. The link to the recall can be found here.

According to the FDA, ByHeart Whole Nutrition Infant Formula makes up less than 1 percent of all infant formula sales in the United States. Given this small market share, recall of these products is unlikely to create shortage concerns of infant formula for parents and caregivers.

Summary:

  • On November 11, 2025, ByHeart, Inc. recalled all lots of ByHeart Whole Nutrition Infant Formula in response to the U.S. Food and Drug Administration’s (FDA’s) ongoing investigation into a recent outbreak of infant botulism.
  • According to the company’s website, ByHeart Whole Nutrition Infant Formula was sold through its website ByHeart.com and through retail stores nationwide, including Amazon, Kroger, Walmart, Whole Foods, Target, SamsClub, and others.
  • Infant botulism is a rare but potentially fatal paralytic illness that impacts babies less than one year old. Symptoms can include constipation, poor feeding, drooping eyelids, weak cry, and progressive muscle weakness.
  • Health care providers (HCP) should call the California Infant Botulism Treatment and Prevention Program (IBTPP) immediately at 510-231-7600 for consultation of suspected case. Consultation is available 24/7. Treatment with botulism immune globulin, BabyBIG®, obtained from California Department of Health, is recommended for all suspected cases of infant botulism.
  • Infant botulism is a reportable disease in PA; all suspected cases must be reported to the Pennsylvania Department of Health (DOH) at 1-877-PA-HEALTH or their local health department.

For More Information

0 4206

The Office of Developmental Programs (ODP) has shared this important announcement from the U. S. Food and Drug Administration (FDA).

FDA MedWatch — DermaKleen, Dermasarra, Kleenfoam, and Perigiene Products by DermaRite Industries

DermaRite Industries is recalling the below products due to microbial contamination identified as Burkholderia cepacia.

Risk Statement:

Burkholderia cepacia complex (BCC) in these products may result in serious and life-threatening infections. The contaminated products may be used by immunosuppressed individuals or by people attending to immunosuppressed individuals. In healthy individuals with minor skin lesions, the use of the product will more likely result in local infections, whereas in immunocompromised individuals the infection is more likely to spread into blood stream leading to life-threatening sepsis.

The recalled products were distributed nationwide in the United States and in Puerto Rico.

To date, DermaRite has not received any reports of adverse events related to this recall.

Background:

  • DermaKleen is an OTC Healthcare antiseptic lotion soap with Vitamin E indicated for handwashing to decrease bacteria on the skin.
  • DermaSarra is an OTC External analgesic indicated for temporary relief of itching associated with minor skin irritations due to dry skin, insect bites, detergents, sunburn.
  • KleenFoam is an OTC Antimicrobial foam soap with aloe vera indicated for handwashing to decrease bacteria on the skin after changing diapers, after assisting ill people, or before contact with a person under medical care or treatment.
  • PeriGiene is an OTC Antiseptic cleanser indicated for use in the perineal area.

Recommendations:

  • Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this product.
  • Consumers with questions regarding this recall can contact Mary Goldberg at 973-569-9000 x104 or via email.
  • DermaRite has notified its distributors and customers by email to immediately examine available inventory and destroy all affected products in accordance with each facility’s process.

For more information about this recall and specific product number, visit the FDA’s website.

0 2183

The Office of Developmental Programs (ODP) has shared an important announcement from the US Food and Drug Administration (FDA).

Manual Resuscitator Recall: SunMed Holdings, LLC Removes Adult Manual Resuscitator Devices Due to Incorrect Assembly of B/V Filter

SunMed Holdings, LLC is recalling this product due to a manufacturing issue where the B/V filter was assembled onto the patient port instead of the exhalation port. This incorrect configuration may result in a delay in therapy during emergency use.

The use of the affected product may cause serious adverse health consequences, including lack of oxygen to the body (hypoxia), build-up of carbon dioxide in the blood (hypercapnia), organ failure, and death.

There have been no reported injuries. There have been no reports of death.

Device Use

The manual resuscitator is used to provide emergency respiratory support to adult patients. It includes a face mask, bag reservoir, filter, manometer, and oxygen tubing, and is used during situations such as cardiac arrest or respiratory failure to manually deliver breaths.

Affected Product

  • Product Names: Adult Manual Resuscitator with Medium Adult Mask, Bag Reservoir, Filter, Manometer and 7 ft. Oxygen Tubing
  • Unique Device Identifier (UDI)/Model: Each: 10884389164822, Case: 40884389164823
  • Lot/Serial Numbers: 526782, 526790, 526796, 526797, 526798, 526800, 526802, 526804, 526805, 526806, 26807, 526808, 526809, 526810, 526814, 526815, 526816, 526811, 526817, 526818

What to Do  

  • Stop using and quarantine all affected product immediately.
  • Document quantity on hand and arrange to return or destroy affected units.

On May 1, 2025, SunMed Holdings, LLC sent all affected customers an Urgent Medical Device Recall notice recommending the following actions:

  • Check your inventory for the affected product.
  • Stop using the product immediately and quarantine it.
  • Document the amount of product on hand and return or destroy affected units.
  • Distribute the recall notice to any customers who received the product from you.
  • Complete and return the response form via email as soon as possible.
  • If you need urgent assistance or replacement, contact SunMed directly.
  • Notify all affected personnel in your organization of recall.

Refer to the FDA Original Press Release for instructions on requesting a replacement and additional information.

© 2021 - Rehabilitation & Community Providers Association