Dynarex Corporation Expands Recall to Include Additional Products Due to Possible Health Risk

Summary

Company Announcement

Montvale, NJ, October 28, 2024 — Dynarex Corporation is expanding the recall initiated on September 19, 2024, to include an additional 373 cases of item number 4875, Dynacare Baby Powder, 14 oz., as well as 647 cases of item number 4874, Dynacare Baby Powder, 4 oz., because they have the potential to be contaminated with asbestos. Asbestos is a naturally occurring mineral that is often found near talc, an ingredient in many cosmetic products. Asbestos, however, is a known carcinogen and its health risks are well-documented. If talc mining sites are not carefully chosen or if proper steps are not taken to adequately purify the talc ore, it may contain asbestos.

The product was sent to distributors on or after January 18, 2024, by direct delivery in the following states: AL, AR, AZ, CA, CO, DE, FL, GA, IA, IL, IN, KY, LA, MA, MD, MN, MO, MS, MT, NC, NE, NJ, NM, NY, OH, OK, OR, PA, TN, TX, UT, VA, VT, WA, WI and sold online on Amazon (Amazon.com).

Both the 4875 and 4874 Baby Powder products are packaged in plastic bottles, 24 bottles to a case for the 14 oz. and 48 to a case for the 4 oz., with lot/batch numbers located on the bottom of the bottle and on each case (see images below).

There have been no illnesses or adverse events reported to date.

The recall was the result of a routine sampling program by the FDA, which revealed that the finished products contained asbestos. Upon further investigation, we have identified additional lots of products that may contain asbestos due to using the same bulk talc material. The company has ceased the distribution of the product as an investigation is proceeding to determine what caused the contamination of the talc.

Consumers who have purchased Dynacare Baby Powder (see products/lots below) should discontinue use immediately and return it for a full refund.

Please contact Dynarex Corporation at 888-396-2739 or 845-365-8200 during business hours of 8:30 AM to 5:00 PM Eastern Standard Time, or via email at [email protected] if you have any questions or need information on how to return the product or receive a full refund.

Health care professionals and consumers are encouraged to report any adverse events to FDA’s MedWatch Adverse Event Reporting program by:

• Completing and submitting the report online at MedWatch Online Voluntary Reporting Form
• Downloading and completing the form, then submitting it via fax at 1-800-FDA-0178

Link to Original Press Release