The Recall Desk
Agency classClass IOur severity:SevereFDA (Drugs)·D-0219-2021·Announced 2021-01-06

Recall of Cord Care Powder Due to Cronobacter Sakazakii Contamination

A non-sterile Cord Care Powder product was recalled because testing found Cronobacter Sakazakii contamination, posing a potential health risk without confirmed illness reports.

The agency’s classification

FDA (Drugs): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "Microbial Contamination of a Non-Sterile Product: Product tested positive for Cronobacter Sakazakii."

Plain-English summary

The U.S. Food and Drug Administration (FDA) issued a recall for Cord Care Powder, a non-sterile product manufactured by Wishgarden Herbs, Inc. The product was found to be contaminated with Cronobacter Sakazakii, a microorganism that can cause serious illness. The recall affects 1,651 jars distributed nationwide in the USA, Egypt, and Canada across multiple production lots (P227 through P235). No deaths or injuries have been reported in connection with this product. Consumers are advised to stop using the product immediately and dispose of any remaining inventory. The manufacturer is Wishgarden Herbs, Incorporated, and the recall number is D-0219-2021.

Cronobacter Sakazakii is a bacterium that can cause severe infections, particularly in vulnerable populations such as pregnant women, neonates, and immunocompromised individuals. Because the product is non-sterile and was found to contain this pathogen, the FDA determined that there is a potential for harm even in the absence of confirmed illness reports. The agency's decision to issue a recall is based on the presence of a high-risk pathogen in a non-sterile product, which falls under the rubric for severity level 3 (High) when no illnesses or injuries have been reported but the hazard is a high-risk pathogen.

This recall is classified as a Consumer Product (specifically a non-sterile household care product) due to its intended use for cord maintenance. The hazard type is microbial contamination, specifically involving Cronobacter Sakazakii. No additional subcategories were specified beyond the general product description.

The recalled product

Product
Cord Care POWDER, 0.25 oz. (7 g) plastic jars, Wishgarden Herbs, Inc., Boulder, CO 80301. UPC 6-56490 24730 4
Manufacturer
Wishgarden Herbs, Incorporated
Category
Consumer Product — Non-sterile cord care powder
Hazard
Affected units
1,651

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (9)

  • Lot #: P227 - Exp. 11/2020
  • P228 - Exp. 12/2020
  • P229 - Exp. 02/2021
  • P230 - Exp. 04/2021
  • P231 - Exp. 06/2021
  • P232 - Exp. 09/2021
  • P233 - Exp. 01/2022
  • P234 - Exp. 05/2022
  • P235 - Exp. 08/2022

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 3 recalled by Wishgarden Herbs, Incorporated under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

Related recalls

Same manufacturer · Wishgarden Herbs, Incorporated

See all →

Same hazard · microbial contamination

See all →

Similar recalls