Wellements Iron Drops and Iron Drops Sample liquid Dietary Supplement - recalled due to Undeclared Milk

United States

Company name: Wellements LLC
Brand name: Wellements
Product recalled: Iron Drops liquid Dietary Supplement and Iron Drops Sample liquid Dietary Supplement
Reason of the recall: Undeclared Milk
FDA Recall date: July 25, 2020
Recall details: Wellements LLC of Scottsdale, Arizona, is issuing a voluntary recall of two lots of its 1oz/30ml bottle of Iron Drops (UPC 729609000098) liquid Dietary Supplement and the sample version being Iron Drops Sample liquid Dietary Supplement because they may contain an undeclared milk allergen. People who have an allergy or severe sensitivity to milk allergens run the risk of serious allergic reaction if they consume these products.

The recalled Iron Drops were distributed from 5.1.2019 to 7.22.2020 nationwide through select retail stores, Amazon.com and Wellements.com. The recalled Iron Drops Sample was distributed from 5.1.2019 to 7.22.2020 nationwide through promotional giveaways in select consumer purchases and select partners. Wellements Iron Drops are indicated for use in Infants 4 months to Children 3 years of age.

Wellements Iron Drops are sold in a 1oz glass amber bottle and packaged in an individual product carton that includes a 1ml oral syringe dispenser. The Wellements Iron Drops Sample is contained in a 1oz glass amber bottle filled to 2ml and packaged in an individual “SAMPLE- NOT FOR RESALE” product carton that includes a 1ml oral syringe dispenser. The recalled products lot coding is located on the bottom of the bottle in yellow ink and on the side, towards the bottom of the carton in black ink. The recalled product coding is as follows:

- Iron Drops Lot 18491 BB 1/2021
- Iron Drops Lot 10592 BB 10/2020
- Iron Drops Sample Lot 10592 BB 10/2020

There has been one allergic reaction reported to Wellements to date. The recall was initiated after it was discovered that product containing a milk allergen was distributed in packaging that did not reveal the presence of a milk allergen. Wellements LLC was informed that one of the raw material ingredients used in Wellements Iron Drops and Iron Drops Sample was mistakenly blended with lactose, a milk constituent that contained milk allergen, by its manufacturer before being supplied for the production of Wellements finished Iron Drops product(s).

Consumers who have purchased Wellements Iron Drops with lot number coding of 18491 BB 1/2021 or Lot 10592 BB 10/2020 are urged to return it to the place of purchase or contact Wellements directly for a full refund. Consumers who received the promotional Iron Drops Sample with lot number coding of 10592 BB 10/2020 are urged to contact Wellements and return it. Consumers with questions may contact the company between 8am-5pm PST at 800-255-2690.

Check the full recall details on www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/wellements-llc-issues-allergy-alert-undeclared-milk-allergen-two-lots-iron-drops-and-iron-drops

Source: FDA