Class II · Moderate risk
ePHEDrine in 0.9% sodium chloride
Lack of assurance of sterility:
Is Ephedrine recalled?
Yes — there is an active recall. 1 ongoing FDA recall mention Ephedrine (44 total). Check the affected lots below.
Most common reason: Sterility / contamination (31 of these recalls)
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 in 0.9% sodium chloride
Lack of assurance of sterility: Lack of validation data for sanitization cycles
Class II · Moderate risk
Ephedrine Sulfate Injection
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II · Moderate risk
Ephedrine 25 Guaifenesin 200 Tablet
CGMP Deviations
Class II · Moderate risk
Ephedrine Plus
cGMP deviations
Class II · Moderate risk
ePHEDrine 25 mg/5 mL in 0.9% Sodium Chloride Injection
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Class II · Moderate risk
ePHEDrine Sulfate 50 mg/10mL in 0.9% Sodium Chloride Injection
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Class II · Moderate risk
ePHEDrine Sulfate
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Class II · Moderate risk
ePHEDrine Sulfate 10 mg per mL 50 mg per 5 mL in 0.9% 5 mL Sodium Chloride 5 mL syringe
Firm is recalling 46 lots of various products because of a lack of sterility assurance.
Class II · Moderate risk
ePHEDrine Sulfate 5 mg per mL 25 mg per 5 mL
Firm is recalling 46 lots of various products because of a lack of sterility assurance.
Class II · Moderate risk
ePHEDrine Sulfate
Firm is recalling 46 lots of various products because of a lack of sterility assurance.
Class II · Moderate risk
ePHEDrine Sulfate
Firm is recalling 46 lots of various products because of a lack of sterility assurance.
Class II · Moderate risk
ePHEDrine Sulfate in 0.9% Sodium Chloride
Lack of Assurance of Sterility
Class II · Moderate risk
ePHEDrine Sulfate in 0.9% Sodium Chloride
Lack of Assurance of Sterility
Class II · Moderate risk
ePHEDrine Sulfate in 0.9% Sodium Chloride
Lack of Assurance of Sterility
Class II · Moderate risk
Ephedrine 5mg/Ml
Lack of Assurance of Sterility
Class II · Moderate risk
Ephedrine Sulfate
Lack of assurance of sterility.
Class II · Moderate risk
5 mg/mL Ephedrine Sulfate
CGMP deviations: Product was released while a hood certification discrepancy was being investigated.
Class II · Moderate risk
ePHEDrine Sulfate
Lack of Assurance of Sterility: Potential leakage of bags.
Class II · Moderate risk
ePHEDrine Sulfate
Lack of Assurance of Sterility: Potential leakage of bags.
Class II · Moderate risk
ePHEDrine Sulfate
Lack of Assurance of Sterility: Potential leakage of bags.
Class II · Moderate risk
ePHEDrine 50mg
Lack of Assurance of Sterility: Potential leakage of bags.
Class II · Moderate risk
Ephedrine Sulfate Injection in all strengths
Lack of sterility assurance.
Class II · Moderate risk
Ephedrine Sulfate in 0.9% Sodium Chloride in all strengths
Lack of sterility assurance.
Class II · Moderate risk
Ephedrine sulfate 5 mg/mL in 0.9% Sodium Chloride 10 mL in Single Dose Syringe
Labeling: Incorrect or Missing Lot and/or Exp Date - product label was missing lot number and beyond use date.
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