US Compounding Recalls ePHEDrine Sulfate Syringes Due to Sterility Concerns
US Compounding Inc is recalling 12,191 syringes of ePHEDrine Sulfate PF (50 mg/10 mL) nationwide due to deficient practices that may impact sterility assurance.
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 recall is classified as FDA Class II and involves a lack of sterility assurance for an injectable drug, which poses a significant risk of serious injury or infection.
Plain-English summary
US Compounding Inc is recalling 12,191 syringes of ePHEDrine Sulfate PF (50 mg/10 mL), 10 mL Single-Use Syringe, For IV or IM Use. The product is compounded by US Compounding Pharmacy in Conway, Arkansas, and carries the NDC 62295-3084-07. The recall is classified as Class II by the FDA.
The recall is being conducted due to a lack of assurance of sterility. The firm identified deficient practices that may have an impact on sterility assurance for all sterile preparations within their expiry. The affected lots include 20151706@45, 20151707@16, 20150904@17, 20151703@19, 20153003@7, and 20153006@42, with best-use dates ranging from September 2015 to January 2016.
The product was distributed nationwide. Healthcare providers and patients should discontinue use of the affected syringes and contact their healthcare provider or the recalling firm for further instructions.
The recalled product
- Product
- ePHEDrine Sulfate PF (50 mg/10 mL), 10 mL Single-Use Syringe, For IV or IM Use Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3084-07
- Manufacturer
- US Compounding Inc
- Affected units
- 12,191
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 (6)
- Lot Numbers: 20151706@45 BUD: 12/14/2015
- 20151707@16 BUD: 1/13/2016
- 20150904@17 BUD: 10/6/2015
- 20151703@19 BUD: 9/13/2015
- 20153003@7 BUD: 9/26/2015
- 20153006@42 BUD: 12/27/2015
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 failure
See all →- SevereROHTO DIGI-EYE Eye Drops Recalled Over Sterility Assurance Gap
FDA (Drugs) · 2026-07-29
- HighROHTO DRY-AID Eye Drops Recalled Due to Sterility Concerns
FDA (Drugs) · 2026-07-29
- SevereTransvenous Pacing Electrode Tray with Bipolar Balloon Pacing Electrode Recalled
FDA (Devices) · 2026-07-22
- SevereArterial Line Kit with Lidocaine HCL Injection Fails Sterility Testing
FDA (Devices) · 2026-07-22
- SevereOne-Piece Introducer Tray kits recalled for sterility failure
FDA (Devices) · 2026-07-22