Ephedrine Sulfate Injection (Allergy) – Sterility Concerns (2016)
Class II: 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
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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.
Brand
Allergy Laboratories, Inc.
Lot Codes / Batch Numbers
Lot #s: 102814, 102914, 103014, 103114, Exp 10/16, 110314, 110414, 110514, 110614, 110714, 111014, Exp 11/16, 121014, 121114, 121214, 121514, Exp 12/16, 011415, 011515, 011615, 012015, 012115, Exp 01/17, 021315, 021715, 021815, 021915, 022015, Exp 02/17, 030415, 030515, 030615, 031015, 031715, Exp 03/17, 042415, 042815, 042915, 043015, Exp 04/17, 050115, 050515, 052815, 052915, Exp 05/17, 060315, 060415, 061615, 061715, Exp 06/17
Products Sold
Lot #s: 102814, 102914, 103014, 103114, Exp 10/16; 110314, 110414, 110514, 110614, 110714, 111014, Exp 11/16; 121014, 121114, 121214, 121514, Exp 12/16; 011415, 011515, 011615, 012015, 012115, Exp 01/17; 021315, 021715, 021815, 021915, 022015, Exp 02/17; 030415, 030515, 030615, 031015, 031715, Exp 03/17; 042415, 042815, 042915, 043015, Exp 04/17; 050115, 050515, 052815, 052915, Exp 05/17; 060315, 060415, 061615, 061715, Exp 06/17
Allergy Laboratories, Inc. is recalling Ephedrine Sulfate Injection, USP, 50 mg/mL, Single Dose Vial, packaged in a) 1 mL fill in a 2 mL Via due to Lack of Assurance of Sterility: An FDA inspection at the facility raised concerns that product sterility was potentially impacted.. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Lack of Assurance of Sterility: An FDA inspection at the facility raised concerns that product sterility was potentially impacted.
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 7, 2026