Class II · Moderate risk
Atropine Sulfate injection
Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
Is Atropine recalled?
Yes — there is an active recall. 13 ongoing FDA recalls mention Atropine (125 total). Check the affected lots below.
Most common reason: Sterility / contamination (88 of these recalls)
Recalls are matched by product description. A recall usually affects specific lots, not every package of Atropine. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Atropine recalls in 2026
1 initiated in 2026, 125 in total — newest first
Class III · Low risk
Atropine Sulfate Ophthalmic Solution
Failed Impurities/Degradation Specifications
Class I · High risk
Atropine Sulfate Injection
Presence of Particulate Matter; identified as glass
Class II · Moderate risk
Atropine Sulfate Injection
Presence of Particulate Matter: Particulate matter identified as fiber.
Class II · Moderate risk
Atropine Sulfate Ophthalmic Solution
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class III · Low risk
Atropine Sulfate Ophthalmic Solution
Failed Stability Specifications: Out of specification test results for viscosity was identified at the 12M stability timepoint.
Class II · Moderate risk
QuadMix Injectable
Lack of Assurance of Sterility
Class II · Moderate risk
QuadMix Injectable
Lack of Assurance of Sterility
Class II · Moderate risk
QuadMix Super 002
Lack of Assurance of Sterility
Class II · Moderate risk
QuadMix Standard 001
Lack of Assurance of Sterility
Class II · Moderate risk
QuadMix Super 001
Lack of Assurance of Sterility
Class II · Moderate risk
QuadMix Standard 002
Lack of Assurance of Sterility
Class II · Moderate risk
QuadMix Plus
Lack of Assurance of Sterility
Class II · Moderate risk
Atropine sulfate 0.05%
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Class II · Moderate risk
PAP/PHEN/PROSTAG/ATROPINE INJ 150MG/7.5MG/75MCG/1MG bottle solution
Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products purported to be sterile.
Class II · Moderate risk
Atropine Sulfate Injection
Lack of Assurance of Sterility
Class II · Moderate risk
QM-3 Papaverine 30 mg/mL Phentolamine 3 mg/mL Alprostadil 150 mcg/mL Atropine 0.2 mg/mL
Lack of assurance of sterility.
Class II · Moderate risk
QM-2 Papaverine 30 mg/mL Phentolamine 3 mg/mL Alprostadil 60…
Lack of assurance of sterility.
Class II · Moderate risk
Formula F9 Papaverine 0.9 mg/mL Phentolamine 0.1 mg/mL PGE 20 mcg/mL Atropine 0.01 mg/mL
Lack of assurance of sterility.
Class II · Moderate risk
Formula F2 Papaverine 9 mg/mL Phentolamine 1 mg/mL Alprostadil 10…
Lack of assurance of sterility.
Class II · Moderate risk
Formula F1 Papaverine 1.8 mg/mL Phentolamine 0.2 mg/mL…
Lack of assurance of sterility.
Class II · Moderate risk
FA Papaverine 20 mg/mL Phentolamine 2 mg/mL Alprostadil 20 mcg/mL Atropine 0.2 mg/mL
Lack of assurance of sterility.
Class II · Moderate risk
AT-6 Papaverine 40 mg/mL Phentolamine 4 mg/mL Atropine 0.3 mg/mL
Lack of assurance of sterility.
Class II · Moderate risk
QM-4 Papaverine 30 mg/mL Phentolamine 3 mg/mL Alprostadil 300 mcg/mL Atropine 0.2 mg/mL
Lack of assurance of sterility.
Class II · Moderate risk
Isopto Atropine
cGMP deviations: Temperature abuse
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