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.
What this means for you
Illness, injury, or structural failure has been reported. 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 →- CriticalVictory Medical Center Pharmacy Recalls Glutathione Vials Due to Contamination
FDA (Drugs) · 2026-08-19
- HighMedline Medical Convenience Kits Recalled Due to Potential Bacillus Contamination
FDA (Devices) · 2026-07-29
- HighMedline Convenience Kits Recalled Over Bacillus Contamination
FDA (Devices) · 2026-07-29
- HighROHTO Cooling Eye Drops Recalled Over Sterility Assurance Concerns
FDA (Drugs) · 2026-07-29
- SeverePemetrexed for Injection Recalled Due to Lack of Sterility Assurance
FDA (Drugs) · 2026-07-15