Class II · Moderate risk
ePHEDrine Sulfate In 0.9% Sodium Chloride
Subpotent Drug
Is Ephedrine recalled?
Yes — there is an active recall. 1 ongoing FDA recall mention Ephedrine (44 total). Check the affected lots below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Ephedrine. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Ephedrine recalls on record
none so far in 2026; 44 on record, newest first
Class II · Moderate risk
ePHEDrine sulfate 50 mg/10 ml syringes in 0.9% Sodium Chloride
Lack of Assurance of Sterility.
Class II · Moderate risk
Ephedrine Sulfate in 0.9% Sodium Chloride 5 mL
Lack of Sterility Assurance.
Class II · Moderate risk
Ephedrine Sulfate Injection Solution 1 mL
Lack of Sterility Assurance.
Class II · Moderate risk
Ephedrine Sulfate in 0.9% Sodium Chloride 5 mL
Lack of Sterility Assurance.
Class II · Moderate risk
Ephedrine Sulfate in 0.9% Sodium Chloride 10 mL
Lack of Sterility Assurance.
Class II · Moderate risk
ePHEDrine Sulfate 5 mg/mL in NS 5 mL Fill in 12 mL Syringe
Lack of Assurance of Sterility; product has the potential to leak.
Class II · Moderate risk
Ephedrine Sulfate all strengths
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
Class II · Moderate risk
Ephedrine Sulfate Injection
Lack of Assurance of Sterility: a recent FDA inspection at the manufacturing firm raised concerns that product sterility may be compromised.
Class II · Moderate risk
Ephedrine Sulfate Injection
Lack of Assurance of Sterility: An FDA inspection at the facility raised concerns that product sterility was potentially impacted.
Class II · Moderate risk
Ephedrine Sulfate 5 mg/mL in 0.9% Sodium Chloride
Lack of Assurance of Sterility
Class II · Moderate risk
Ephedrine Sulfate 5 mg/ml in 0.9% Sodium Chloride
Lack of Assurance of Sterility
Class II · Moderate risk
ePHEDrine Sulfate PF
Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.
Class II · Moderate risk
Ephedrine Sulfate 5 mg/mL in 0.9% Sodium Chloride
Stability data does not support expiry.
Class II · Moderate risk
ePHEDrine Sulfate
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
Class II · Moderate risk
ePHEDrine Sulfate
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
Class II · Moderate risk
ePHEDrine Sulfate
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
Class II · Moderate risk
ePHEDrine Sulfate Injection
Labeling: Label Error on Declared Strength; The outer light protective bags, where the ephedrine sulfate injection syringes are stored, were mislabeled with 25 mg/mL in big font and 5 mg/mL in small font, however, the actual syringes were correctly labeled as 25 mg/5 mL.
Class III · Low risk
Bronkaid Dual Action Formula
Labeling: Label lacks warning or Rx legend; Certain information was inadvertently excluded from the product carton label.
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