King Bio Recalls Dr. King's SafeCare Rx Sleep Aid Due to Microbial Contamination
King Bio Inc. is recalling Dr. King's SafeCare Rx Sleep Aid due to microbial contamination. The product was distributed in the U.S., Canada, and Australia.
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 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The agency classification is FDA Class I, which mandates a severity score of 5 according to the rubric.
Plain-English summary
King Bio Inc. is recalling 1,244 bottles of Dr. King's SafeCare Rx Sleep Aid, 2 fl. oz. (59 mL), due to microbial contamination. The product is identified by NDC 57955-2640-2 and UPC 357955263920.
The affected lots are 022318F (Exp. 02/20), 020416A (Exp. 02/19), and 080916N (Exp. 08/19). The product was distributed nationwide in the U.S.A., as well as in Canada and Australia.
Consumers should stop using the product and contact King Bio Inc. for further instructions.
The recalled product
- Product
- Dr. King's SafeCare Rx Sleep Aid, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Drive, Asheville, NC 28806 USA, UPC 357955263920, NDC 57955-2640-2
- Manufacturer
- King Bio Inc.
- Category
- Drug — Sleep Aid
- Hazard
- Affected units
- 1,244
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 (3)
- Lots: 022318F Exp. 02/20
- 020416A Exp. 02/19
- 080916N Exp. 08/19
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 465 recalled by King Bio Inc. 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 465 products in this recall →Related recalls
Same manufacturer · King Bio Inc.
See all →- CriticalKing Bio Recalls Dr. King's SafeCare Rx Calloused Due to Microbial Contamination
FDA (Drugs) · 2019-03-20
- SevereKing Bio Homeopathic Allergy Spray Recalled for Microbial Contamination
FDA (Drugs) · 2019-03-20
- CriticalKing Bio Recalls Heartburn Relief for Microbial Contamination
FDA (Drugs) · 2019-03-20
- SevereKing Bio Homeopathic Allergy Product Recalled for Microbial Contamination
FDA (Drugs) · 2019-03-20
- CriticalDr. King's Advanced Arnica Recalled for Microbial Contamination
FDA (Drugs) · 2019-03-20
Same hazard · microbial contamination
See all →- HighSV Labs Recalls Benzoyl Peroxide Wash Due to Microbial Contamination
FDA (Drugs) · 2026-10-07
- HighSV Labs Recalls Benzoyl Peroxide Wash Due to Microbial Contamination
FDA (Drugs) · 2026-10-07
- SevereMedline Ultrasound Breast Pack Recalled for Potential Sterility Breach
FDA (Devices) · 2026-09-09
- HighMedline Convenience Kits Recalled for Potential Sterility Breach
FDA (Devices) · 2026-09-09
- CriticalOptimal Balance Pharmacy Recalls Contaminated Glutathione Injection Vials
FDA (Drugs) · 2026-09-09
Similar recalls
- SevereLNK International Recalls Equate Nighttime Sleep Aid Due to Microbial Contamination
FDA (Drugs) · 2019-08-07
- HighNutrafuels Recalls CTFO Sleep Support Oral Spray Due to Microbial Contamination
FDA (Food) · 2019-02-27
- SevereRed Mountain Compounding Recalls S-Hydroxocobalamin Injection Due to Sterility Concerns
FDA (Drugs) · 2019-11-13
- SevereMuscle Rage King Test Capsules Recalled for Undeclared Milk
FDA (Food) · 2022-01-19
- ModerateSprayology Recalls SleepEase Homeopathic Oral Spray Due to CGMP Deviations
FDA (Drugs) · 2018-11-07
- SevereRXQ Compounding Recalls Hydroxocobalamin Injections Due to Sterility Concerns
FDA (Drugs) · 2019-08-14