FDA Recalls 32 Children’s Medications After Discovery Of Microbial Contamination

The pharmaceutical company King Bio has recalled 32 of their children’s and infant medications due to positive tests for microbial contamination. The company issued a press release on August 22, 2018 saying that they were issuing the recall at the consumer level “out of an abundance of caution.”

According to the company, a small percentage of their products manufactured between August 2017 and April 2018 have tested positive for microbial contamination, and use of the products could result in increased infections that may require medical attention and be life-threatening. King Bio has not currently received any reports of injury or illness from consumers.

The medications were distributed nationwide to both distributors and stores between August 2017 and July 2018. Customers and retailers are advised to discontinue use and sales of the products immediately.

Photo: Adobe Stock/ Rido
Photo: Adobe Stock/ Rido

The medicines are used to treat a variety of common ailments in children and infants such as stomach aches, fever, and cough as well less-common conditions both physical and emotional. The recall includes 19 over-the-counter medications and 13 medications for professional-use only.

Below is a complete list of the recalled medications. All come in two-ounce bottles unless otherwise noted:

DK Attention & Learning Enh.

UDF_UPC: 357955501527
Lot numbers: 050216G, 070816C, 092617F

Chicken Pox Symptom Relief

UDF_UPC: 357955602521
Lot numbers: 021216K, 062716D

Children’s Appetite & Weight

UDF_UPC: 357955551720
Lot numbers: 080916M, 091316D, 050516E, 072516E

Children’s Appetite Enhance

UDF_UPC: 357955531821
Lot numbers:020117F, 060216E, 080916B, 092415F

Children’s Cough Relief

UDF_UPC: 357955514527
Lot numbers: 021216J, 030916T, 092815E

Children’s Fever Reliever

UDF_UPC: 357955515920
Lot numbers: 050516E, 072516E

Children’s Growth & Development

UDF_UPC: 357955514220
Lot numbers: 050516E, 072516E

DK Newborn Tonic

UDF_UPC: 357955511427
Lot numbers: 063016K, 112315F

DK Nosebleed Relief

UDF_UPC: 357955514022
Lot numbers: 050516H, 080916J


UDF_UPC: 357955501725
Lot numbers: 041416K, 061616D

Children’s Ear Relief Formula

UDF_UPC: 357955531524
Lot numbers: 072516G, 112315B, 050216P

DK Teething

UDF_UPC: 357955501824
Lot numbers: 020717B, 110716C, 080317D, 111617E, 020118F

DK Colic Relief

UDF_UPC: 357955515821
Lot numbers: 092017A, 020118H

Tummy Aches

UDF_UPC: 357955514626
Lot numbers: 050516D, 072216Q, 021918B

Kids Multi- Strain Flu Relief

UDF_UPC: 357955042228
Lot numbers: 071316A, 071316A, 111015B, 112015A

Kids Stress & Anxiety

UDF_UPC: 357955042327
Lot numbers: 070516E, 081016G

Kids Sleep Aid

UDF_UPC: 357955042426
Lot numbers: 063016D, 081016F

Kids Bed Wetting (NP)

UDF_UPC: 357955501220
Lot numbers: 111717C, 101615B

Kids Candida (4-ounce bottle)

UDF_UPC: 357955332244
Lot numbers: 011416G, 011917R, 081016E, 092815AA, 041518H

Below Medications Are SafeCare Prescriptions And Are For Professional Use Only:

Kids Attention & Learning (SCRX)

UDF_UPC: 357955001522
Lot numbers: 121617A, 032316C, 091216A

Bed Wetting Prevention (SCRX)

UDF_UPC: 357955001225
Lot numbers: 102216B

Chicken Pox Symptom Relief (SCRX)

UDF_UPC: 357955782520
Lot numbers: 042616D

Children’s Cough (SCRX)

UDF_UPC: 357955014522
Lot numbers: 091015B, 120616B

Children’s Ear Formula (SCRX)

UDF_UPC: 357955075721
Lot numbers: 032316B

Children’s Fever Reliever (SCRX)

UDF_UPC: 357955015925
Lot numbers: 082516A, 102015F

Children’s Growth & Development (SCRX)

UDF_UPC: 357955014225
Lot numbers: 020917A, 062716E

Colic Relief (SCRX)

UDF_UPC: 357955015826
Lot numbers: 111717E

Newborn Tonic (SCRX)

UDF_UPC: 357955011422
Lot numbers: 110915H

Teething (SCRX)

UDF_UPC: 357955501824
Lot numbers: 032216C

Tummy Aches (SCRX)

UDF_UPC: 357955014621
Lot numbers: 022316F

Children’s Appetite & Weight (SCRX)

UDF_UPC: 357955251729
Lot numbers: 102016J

Children’s Appetite Enhancer (SCRX)

UDF_UPC: 357955031826
Lot numbers: 022316G

If you have one of the above products, you can contact King Bio at 866-298-2740 or via email at recall@kingbio.com to arrange for a return.

Any problems or adverse reactions should be reported to your doctor, and can also be reported to the FDA’s MedWatch Event Reporting system.

Find full details and updates about the recall on the FDA’s website.

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