US Compounding Recalls Docusate Oral Syringes Due to B. cepacia Contamination
US Compounding Inc is recalling 10,665 Docusate Oral 10 mg/mL syringes distributed in Texas due to microbial contamination with B. cepacia.
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 classification is FDA Class I, which per the rubric mandates a minimum score of 4 (Severe).
Plain-English summary
US Compounding Inc is recalling 10,665 syringes of Docusate Oral 10 mg/mL Oral Syringe. The product is packaged in 1 mL, 2 mL, and 5 mL syringes and was distributed in Texas. The recall covers all lots of the product.
The recall was initiated because the non-sterile product was found to be microbially contaminated with B. cepacia. B. cepacia is a bacterium that can cause infections, particularly in individuals with compromised immune systems or those with indwelling medical devices.
Consumers who have this product should stop using it and contact their healthcare provider or pharmacist for further instructions. The recalling firm is US Compounding Inc, located in Conway, Arkansas.
The recalled product
- Product
- Docusate Oral 10 mg/mL Oral Syringe, packaged in a) 1 mL (62295-0601-01), b) 2 mL ( 62295-0601-02), and c) 5 mL syringes (62295-0601-05), US Compounding, Conway, AR
- Manufacturer
- US Compounding Inc
- Category
- Drug — Oral Liquid
- Affected units
- 10,665
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 (1)
- All Lots
Distribution
Distributed in 1 state:
Related recalls
Same manufacturer · US Compounding Inc
See all →- LowUS Compounding Recalls Succinylcholine Chloride Injection Due to Labeling Error
FDA (Drugs) · 2021-01-20
- LowUS Compounding Recalls Neostigmine Methylsulfate Syringes Due to Missing Labels
FDA (Drugs) · 2021-01-06
- SevereUS Compounding Recalls Ephedrine Sulfate Syringes Due to Sterility Concerns
FDA (Drugs) · 2019-02-27
- ModerateUS Compounding Recalls LET Gel 4% Syringes Due to Missing Lot and Expiration Dates
FDA (Drugs) · 2019-02-20
- SevereUS Compounding Recalls Acetylcysteine 10% Ophthalmic Solution for Sterility Concerns
FDA (Drugs) · 2015-11-25
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
- SevereUS Compounding Recalls Glycopyrrolate Syringes Due to Sterility Assurance Concerns
FDA (Drugs) · 2015-11-25
- SevereUS Compounding Recalls Hyaluronic Acid Syringes Due to Sterility Concerns
FDA (Drugs) · 2015-11-25
- SevereUS Compounding Recalls Succinylcholine Chloride Syringes Due to Sterility Concerns
FDA (Drugs) · 2015-11-25
- SevereUS Compounding Recalls Lidocaine Syringes Due to Sterility Assurance Concerns
FDA (Drugs) · 2015-11-25
- SevereUS Compounding Recalls Zinc Sulfate Vials Due to Sterility Concerns
FDA (Drugs) · 2015-11-25
- SevereUS Compounding Recalls Betamethasone Vials Due to Sterility Concerns
FDA (Drugs) · 2015-11-25