Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Ephedrine Sulfate Injection Recalled by Allergy Laboratories, Inc. Due to Lack of Assurance of Sterility: An FDA inspection...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Allergy Laboratories, Inc. directly.
Affected Products
Ephedrine Sulfate Injection, USP, 50 mg/mL, Single Dose Vial, packaged in a) 1 mL fill in a 2 mL Vial (NDC: 69053-008-01); and b) 25 x 2 mL Vials (NDC 69053-008-02), Rx only, Manufactured for: Andersen Pharmaceutical, White Plains, NY 10605.
Quantity: 1,928,075 vials
Why Was This Recalled?
Lack of Assurance of Sterility: An FDA inspection at the facility raised concerns that product sterility was potentially impacted.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Allergy Laboratories, Inc.
Allergy Laboratories, Inc. has 2 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report