Class II · Moderate risk
Formula F2
CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated
Is Atropine recalled?
Yes — there is an active recall. 13 ongoing FDA recalls mention Atropine (125 total). Check the affected lots below.
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 on record
none so far in 2026; 125 on record, newest first
Class II · Moderate risk
FA, Papaverine 20 mg/mL . Phentolamine 2 mg/mL . Alprostadil 20…
CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated
Class II · Moderate risk
Qm-4
CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated
Class II · Moderate risk
Qm-3
CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated
Class II · Moderate risk
At-1
CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated
Class II · Moderate risk
At-6
CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated
Class II · Moderate risk
Formula F9
CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated
Class II · Moderate risk
QM-2 Papaverine 30 mg/mL. Phentolamine 3 mg/mL . Alprostadil 60…
CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated
Class III · Low risk
Formula F9
Sub Potent
Class II · Moderate risk
Quad-Mix Papav 30/Phentol 4/Pge-1 40/Atropine 0.4 Inj *c6* Injectable
Lack of assurance of sterility
Class II · Moderate risk
Quad-Mix Papav 30/Phentol 3/Pge-1 100/Atropine 0.2 Inj Injectable
Lack of assurance of sterility
Class II · Moderate risk
Quad-Mix Papav 30/Phentol 2/Pge-1 30/Atropine 0.2 Inj Injectable
Lack of assurance of sterility
Class II · Moderate risk
Quad-Mix Papav 30/Phentol 2/Pge-1 200/Atropine 0.02 Inj Injectable
Lack of assurance of sterility
Class II · Moderate risk
Quad-Mix Papav 30/Phentol 2/Pge-1 20/Atropine 0.2 Inj *c5* Injectable
Lack of assurance of sterility
Class II · Moderate risk
Quad-Mix Papav 30/Phentol 1/Pge-1 20/Atropine 0.1 Inj Injectable
Lack of assurance of sterility
Class II · Moderate risk
Quad-Mix Papav 30/Phentol 1/Pge-1 10/Atropine 0.15 Inj Injectable
Lack of assurance of sterility
Class II · Moderate risk
Quad-Mix Papav 20/Phentol 2/Pge-1 25/Atropine 0.2 Inj Injectable
Lack of assurance of sterility
Class II · Moderate risk
Atropine Sulfate Ophthalmic Solution
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
Atropine Sulfate Injection
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Class II · Moderate risk
Alprostadil/Papaverine Hydrochloride/Phentolamine Mesylate/Atropine Sulfate Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Alprostadil/Papaverine Hydrochloride/Phentolamine Mesylate/Atropine Sulfate Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Alprostadil/Papaverine Hydrochloride/Phentolamine Mesylate/Atropine Sulfate Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Quadmix # 19
Lack of Assurance of Sterility
Class II · Moderate risk
Quadmix #13A
Lack of Assurance of Sterility
Class II · Moderate risk
S-Atropine 0.5% Opth Soln
Lack of Assurance of Sterility
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