King Bio, Inc. Recalls Numerous Pet Products – Microbial Contamination Risk

The Food and Drug Administration is warning consumers and pet owners not to use drug products, including homeopathic drug products, made by King Bio Inc., Asheville, N.C., and labeled as Dr. King’s, as these products may pose a safety risk to people (especially infants, children, pregnant women and those with compromised immune systems), as well as pets due to high levels of microbial contamination identified at the manufacturing site. King Bio has expanded its voluntary recall for a second time to include all water-based (aqueous) drug products marketed for human and animals. The FDA recommends that consumers stop using and dispose of these products immediately.

King Bio manufactures a range of products for adults, children and pets. A list of all recalled products can be found on the King Bio website. A list of the recalled pet products is below:

Product Number Brand Product Name Lot # UPC Code
30-6043 VET (D) Allergies 032116D & 082216C 357955604341
30-6045  VET (D) Urinary Incontinence 041416D & 102116B 357955604549
30-6046  VET NP Allergies 111017A 357955604341
30-6047  VET Urinary Incontinence(NP) 010118T 357955604549
30-6052  VET (D) Urinary Tract Irritations 081315E, 081015M, 041416C & 081016A 357955605249
30-6118  VET (D) Trauma & Wounds 081815P & 060716C 357955611844
30-6130  VET (D) Odor Freee 062615F & 081315G 357955613046
30-6156  VET Appetite Control 111516Q & 120616D 357955615644
30-6158  VET (D) Digestion Reliever 081015P & 111516F 357955615842
30-6162  VET (D) Muscle, Joint & Arthritis 081315J, 041416G & 090816E 357955616245
30-6168  VET (D) Skin Irritations & Itch Re 072516K & 011617A 357955616849
30-6169  VET (D) Better Breath/Teeth & Gums 030916X & 090116B 357955616948
30-6170  VET Skin Irritations & Itch Rel(NP 010818D 357955616849
30-6171  VET Better Breath/Teeth & Gums(NP) 121417G 357955616948
30-6602  VET (D) Doggie Drool 081015R 357955660248
30-6603  VET Foul Gas & Stool Relief 112116A 357955660347
30-6604  VET (D) Stop Bark 052516D 357955660446
30-6850  VET Multi Stress Control 081315P & 011217A 357955685043
4301C NATURAL PET (D) (Cat) Skin & Itch 030816G, 052516A, 062816J, 091416B & 123016C 357955430148
4302C NATURAL PET (D) (Cat) UTI 082015B, 102215J, 030816F, 072216E, 090816C, 101016C & 010517D 357955430247
4304C NATURAL PET Anxiety/Stress (Cat) 030816H, 072916B, 101816A & 011817C 357955430445
4306C NATURAL PET Skin & Itch (Cat) (NP) 121417H 357955430148
4307C NATURAL PET UTI (Cat) (NP) 090717B, 111617A & 010118BF 357955430247
4308C NATURAL PET Oral Health (Cat) (NP) 022318E 357955431046
4309C NATURAL PET Anxiety & Stress (Cat) (NP) 112317B 357955430445
4401D NATURAL PET (D) (Dog) Allergies 081715A, 033016M, 052516B, 071116K, 090816G & 101016B 357955440147
4402D NATURAL PET (D) (Dog) Skin & Itch 081315H, 011916B, 033016L, 051116B, 062016C, 071116M, 081016D, 101016D & 101016D 357955440246
4403D NATURAL PET (D) (Dog) Digestive Upsets 040616AA, 071116L & 020317C 357955440345
4404D NATURAL PET (D) (Dog) Muscle,Joint & Arthr 082015C, 051116A, 062816H, 071116N, 081216A & 011617E 357955440444
4405D NATURAL PET Appetite & Weight (Dog) 033016N, 071116J & 042717B 357955440543
4406D NATURAL PET Teeth & Gums (Dog) 102215K, 041316A, 052516AC & 083116A 357955440642
4407D NATURAL PET (D) (Dog) Anxiety & Stress 081715B, 051716Q, 072916C & 100716A 357955440741
4408D NATURAL PET (D) (Dog) Yeast Control 030916L & 020317D 357955440840
4409D NATURAL PET Allergies (Dog) (NP) 120217S & 041518B 357955440147
4410D NATURAL PET Skin & Itch (Dog) (NP) 020118E 357955440246
4411D NATURAL PET Digestive Upsets (Dog) (NP) 011918D 357955440345
4412D NATURAL PET Muscle,Joint&Arth. (Dog) (NP) 010418A 357955440444
4414D NATURAL PET Oral Health (Dog) (NP) 102717D 357955442042
4415D NATURAL PET Anxiety & Stress (Dog) (NP) 092617D 357955440741
4416D NATURAL PET Yeast Control (Dog) (NP) 110317F 357955440840

Consumers and pets who use these products could have an increased risk of serious infection, that could require medical attention, due to the high levels of microbial contamination. An infection could be a life-threatening event for immunocompromised patients. Consumers and pet owners who have purchased these products should contact their health care professional if they have concerns or observe signs of an infection after use of these products.

The FDA recently inspected King Bio’s facility and collected product samples. The FDA is currently testing and analyzing product samples collected at the facility. According to the company, several microbial contaminants were found in its products, including Burkholderia Multivorans, which is a strain of bacteria called Burkholderia cepacia complex (BCC) that can cause illness in people with compromised immune systems. Additionally, evidence collected during the FDA’s inspection indicates recurring microbial contamination associated with the water system used to manufacture drug products.

In July 2018, King Bio voluntarily recalled three human drug products labeled as homeopathic due to confirmed microbial contamination. On August 22, 2018, the company then expanded its voluntary recall to include an additional 32 drug products. Then on August 23, 2018, the FDA contacted King Bio and recommended the company again expand its recall to include all products that use water as an ingredient, including drug products for humans and animals, which the company did.

To date, no illnesses have been reported as a result of this recall. For reporting adverse drug events in animals to the FDA, please see How to Report Animal Drug Side Effects and Product Problems.

Click here to read the full FDA alert.