US Compounding Recalls Ephedrine Sulfate Syringes Due to Sterility Concerns
US Compounding Inc is recalling 1,686 syringes of Ephedrine Sulfate 50 mg/10 mL because the company cannot ensure the product is sterile.
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, which corresponds to a Severe rating under the rubric for significant injury risks such as sterility failures in injectable medications.
Plain-English summary
US Compounding Inc is recalling 1,686 single-use syringes of Ephedrine Sulfate, 50 mg/10 mL. The product is prescription-only and was distributed nationwide in the United States. The specific lot number is 20181812@2, with a beyond-use date of 06/16/2019.
The recall was initiated due to a lack of assurance of sterility. This means the manufacturer cannot guarantee that the medication is free from microorganisms, which poses a risk of infection if administered.
Consumers and healthcare providers should stop using the affected product immediately. Those who have received this medication should contact their healthcare provider for guidance on next steps and potential alternative treatments.
The recalled product
- Product
- Ephedrine Sulfate, 50 mg/10 mL, 10 mL Single Use Syringe, Rx only, US Compounding Pharmacy 1270 Don's Lane Conway, AR 800-718-3588, Barcode: 62295308407
- Manufacturer
- US Compounding Inc
- Category
- Drug — Injectable Medication
- Affected units
- 1,686
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: 20181812@2 BUD: 06/16/2019
Distribution
Distributed nationwide across the United States.
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
- 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
- SevereUS Compounding Recalls Choline Chloride Inositol Cyanocobalamin Injection Vials
FDA (Drugs) · 2015-11-25
Same hazard · sterility failure
See all →- SevereAvKare Carboxymethylcellulose Sodium Eye Drops Recalled for Sterility Concerns
FDA (Drugs) · 2026-09-30
- SevereAvKare Carboxymethylcellulose Sodium Eye Drops Recalled for Sterility Concerns
FDA (Drugs) · 2026-09-30
- 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
- SevereOne-Piece Introducer Tray kits recalled for sterility failure
FDA (Devices) · 2026-07-22
Similar recalls
- SevereUS Compounding Recalls ePHEDrine Sulfate Syringes Due to Sterility Concerns
FDA (Drugs) · 2015-11-25
- ModerateUS Compounding Recalls Mislabeled Ephedrine Sulfate Injection Syringes
FDA (Drugs) · 2014-08-27
- SevereCantrell Drug Recalls Ephedrine Sulfate Syringes Due to Sterility Concerns
FDA (Drugs) · 2017-08-16
- SevereBanner Pharmacy Recalls Ephedrine Sulfate Syringes Due to Sterility Concerns
FDA (Drugs) · 2017-11-01
- SeverePharMEDium Recalls ePHEDrine Sulfate Syringes Due to Sterility Assurance Issues
FDA (Drugs) · 2020-04-15
- SevereUS Compounding Recalls Phenylephrine PF Syringes Due to Sterility Concerns
FDA (Drugs) · 2015-11-25