US Compounding Recalls Phenylephrine Vials Due to Sterility Assurance Concerns
US Compounding Inc is recalling 11 vials of Phenylephrine due to deficient practices that may impact sterility assurance.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 recall is classified as FDA Class II and involves a sterile injectable medication where sterility assurance is compromised, posing a significant risk of infection or serious injury.
Plain-English summary
US Compounding Inc is recalling 11 vials of Phenylephrine (1 mg/mL), 5 mL Multi-Dose Vial, NDC 62295-3289-05. The product is a prescription-only medication intended for subcutaneous, intramuscular, intravenous, or penile injection. The specific lot code is 20150904@11 with a beyond-use date of 10/6/2015.
The recall was initiated because of deficient practices that may have an impact on sterility assurance. The firm is recalling all sterile preparations that are within expiry due to these concerns. The distribution pattern for this recall is nationwide.
Consumers and healthcare providers should stop using the affected vials and contact their healthcare provider or the recalling firm for further instructions.
The recalled product
- Product
- Phenylephrine (1 mg/mL), 5 mL Multi-Dose Vial, For SC, IM, IV or penile injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3289-05
- Manufacturer
- US Compounding Inc
- Affected units
- 11
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)
- Lot Code: 20150904@11 BUD: 10/6/2015
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 59 recalled by US Compounding 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 59 products in this recall →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 Docusate Oral Syringes Due to B. cepacia Contamination
FDA (Drugs) · 2016-12-28
Same hazard · sterility assurance
See all →- HighArrowhead DE LLC Recalls Arrow-LOK Implants Due to Sterility Assurance Concerns
FDA (Devices) · 2026-08-26
- SevereChloraPrep One-Step Applicators Recalled for Potential Packaging Seal Defects
FDA (Drugs) · 2026-07-22
- SeverePemetrexed for Injection Recalled Due to Lack of Sterility Assurance
FDA (Drugs) · 2026-07-15
- SevereChloraPrep One-Step Applicators Recalled Due to Sterility Assurance Failure
FDA (Drugs) · 2026-07-08
- SevereArrow access trays and PSI kits contain recalled supplier drugs
FDA (Devices) · 2026-06-24
Similar recalls
- SeverePhenylephrine Injection Recalled Due to Lack of Sterility Assurance
FDA (Drugs) · 2019-04-24
- HighFDA Recalls Phenylephrine 1 mg/mL Vials for Lack of Sterility Assurance
FDA (Drugs) · 2022-06-01
- ModerateWell Care Compounding Pharmacy Recalls Phenylephrine Vials Due to Sterility Concerns
FDA (Drugs) · 2016-06-15
- HighPhenylephrine injection lacks sterility assurance; FDA recalls vials
FDA (Drugs) · 2023-03-08
- SevereLidocaine and Epinephrine Vials Recalled for Sterility Assurance Concerns
FDA (Drugs) · 2015-09-23
- SevereFDA Recalls Morphine, Fentanyl, and Bupivacaine Solution Due to Sterility Concerns
FDA (Drugs) · 2015-09-23