US Compounding Recalls Mislabeled Ephedrine Sulfate Injection Syringes
US Compounding Inc is recalling 762 syringes of ephedrine sulfate injection due to a labeling error on the outer protective bags that could cause confusion regarding the drug's strength.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II and involves a minor labeling error on the outer packaging where the actual syringes were correctly labeled, fitting the criteria for moderate severity.
Plain-English summary
US Compounding Inc is recalling 762 syringes of ePHEDrine Sulfate Injection, USP 25 mg/5 mL (5 mg/mL). The recall is due to a labeling error on the outer light protective bags where the syringes are stored. The outer bags were mislabeled with "25 mg/mL" in large font and "5 mg/mL" in small font, although the actual syringes were correctly labeled as 25 mg/5 mL.
The product is a single-use 5 mL syringe intended for IV, IM, or SC injection. It is preservative-free and designated for office or hospital use only. The affected lot number is 20142104@30, with a use-by date of 10/18/2014.
The product was distributed nationwide. Healthcare providers and patients should stop using the affected product and contact US Compounding Inc at 800-718-3588 for further instructions.
The recalled product
- Product
- ePHEDrine Sulfate Injection, USP 25 mg/5 mL (5 mg/mL) Single Use 5 mL Syringe, For IV, IM, or SC injection, Preservative Free, For Office/Hospital Use Only, Protect from Light, 62295-3084-05, US Compounding Pharmacy, Conway, AR 800-718-3588
- Manufacturer
- US Compounding Inc
- Category
- Drug — Injection
- Hazard
- Affected units
- 762
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# 20142104@30 USE BY: 10/18/2014
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
- 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 · mis labeling
See all →- ModerateMedline Trach Tube Kit Recalled for Component Labeling Discrepancy
FDA (Devices) · 2026-09-02
- ModerateAVID Medical Recalls Halyard Total Joint Kits for Latex Labeling Deficiency
FDA (Devices) · 2026-09-02
- ModerateOlympus Recalls PowerSeal Sealer Due to Incorrect Outer Box Labeling
FDA (Devices) · 2026-09-02
- HighSura Tanmen Ramen Noodles Recalled for Undeclared Fish Allergens
FDA (Food) · 2026-09-02
- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-09-02