Class II · Moderate risk
Nitroglycerin injection
Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
Is Nitroglycerin recalled?
Yes — there is an active recall. 3 ongoing FDA recalls mention Nitroglycerin (19 total). Check the affected lots below.
Most common reason: Stability / shelf life (4 of these recalls)
Recalls are matched by product description. A recall usually affects specific lots, not every package of Nitroglycerin. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Nitroglycerin recalls in 2026
1 initiated in 2026, 19 in total — newest first
Class II · Moderate risk
Nitroglycerin Sublingual Tablets 0.3MG
CGMP Deviations
Class II · Moderate risk
Nitroglycerin Sublingual Tablets 0.4MG 100-count carton
CGMP Deviations
Class II · Moderate risk
Nitrostat (Nitroglycerin Sublingual Tablets, USP)
cGMP deviations: Temperature abuse
Class II · Moderate risk
Nitroglycerin Lingual Spray
Defective Delivery System
Class II · Moderate risk
Rectiv (nitroglycerin)
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
NitroGlycerin
Stability Data Does Not Support Expiry: lots do not have stability that supports the use of the container system.
Class II · Moderate risk
NitroGlycerin
Stability Data Does Not Support Expiry: lots do not have stability that supports the use of the container system.
Class II · Moderate risk
NitroGlycerin 100 mcg/mL QS 5% Dextrose Inj
Stability Data Does Not Support Expiry: lots do not have stability that supports the use of the container system.
Class II · Moderate risk
NitroGlycerin 1 mg/10 mL in 5% Dextrose Inj
Stability Data Does Not Support Expiry: lots do not have stability that supports the use of the container system.
Class I · High risk
NitroGlycerin
Subpotent Drug: found to be below the specification for labeled assay.
Class I · High risk
NitroGlycerin
Subpotent Drug: found to be below the specification for labeled assay.
Class I · High risk
NitroGlycerin 1 mg/10 mL in 5% Dextrose Inj
Subpotent Drug: found to be below the specification for labeled assay.
Class II · Moderate risk
Nitroglycerin all strengths
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
Class II · Moderate risk
All Nitro Paste
Lack of Processing Controls
Class II · Moderate risk
Nitroglycerin Transdermal System 0.4 mg/hr
Failed Impurities/Degradation Specifications: Two lots failed specification for unknown impurity at the 24 month stability testing.
Class II · Moderate risk
Nitroglycerin Transdermal System 0.2 mg/hr
Failed Impurities/Degradation Specifications: failed specification for unknown impurity at the 24 month stability testing.
Class II · Moderate risk
Nitroglycerin 0.2% Compd Cream
Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated with certain quality control procedures that present a risk to sterility and quality assurance.
Class I · High risk
50 mg Nitroglycerin in 5% Dextrose Injection
Presence of Particulate Matter; particulate matter in one vial identified as silicone rubber and EPDM rubber from the vial stopper.
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