Class II · Moderate risk
S-Atropine 0.02% Opthalmic Solution
Lack of Assurance of Sterility
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
S-Atropine 0.01% Ophthalmic Solution
Lack of Assurance of Sterility
Class II · Moderate risk
C-Atropine Sulf Ophth 0.02%
Lack of Assurance of Sterility: product sterility cannot be guaranteed.
Class II · Moderate risk
C-Atropine Sulf Ophth 0.01%
Lack of Assurance of Sterility: product sterility cannot be guaranteed.
Class II · Moderate risk
Papaverine/Phentolamine/Alprostadil/Atropine 30 mg/2 mg/50 mcg/0.15 mg/mL Injectable
Lack of Processing Controls
Class II · Moderate risk
Atropine Sulfate PF INJ
Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potential cross contamination and lack of product specific process validations that can result in a lack of sterility assurance.
Class II · Moderate risk
Prostaglandin Quad with Atropine 10:30:1:0.15
Lack of sterility assurance.
Class II · Moderate risk
Atropine 0.01% Eye Drops
Lack of sterility assurance.
Class II · Moderate risk
Trimix QM10 Papaverine 30 mg/Phentolamine 4 mg/Atropine 1 mg/PGE 150 mcg/mL Injectable
Lack of Assurance of Sterility
Class II · Moderate risk
QM-4A Quadmix 5 mL 30 PA-2PH-150A-Atropine 0.4 mg Aqueous Solution
Lack of Assurance of Sterility
Class II · Moderate risk
PRO/PA/PH/AT 18mcg/1.8mg/
Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.
Class II · Moderate risk
Atropine 0.01% Opth Solution
Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.
Class II · Moderate risk
Papaverine 9mg/Phentolamine 1mg/Atropine 0.1mg/Prostaglandinl 10mcg/ml
Lack of assurance of sterility: Upon review of recent 3rd party environmental certification documentation, it was determined that airflow patterns may not be sufficient to support the aseptic production of certain injectable drug products.
Class III · Low risk
Atropine Sulfate Ophthalmic 1% Solution
Failed Stability Specification: OOS low viscosity results discovered during retain testing.
Class II · Moderate risk
Atropine Sulfate Injection in all strengths
Lack of sterility assurance.
Class I · High risk
diphenoxylate hydrochloride and atropine sulfate tablets
SUPERPOTENT: Weight variations resulting in tablets that are sub and super potent
Class II · Moderate risk
Atropine Sulfate 0.5% Ophth
Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.
Class II · Moderate risk
Atropine Sulfate 0.01% Ophth
Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.
Class II · Moderate risk
Atropine Sulfate all strengths
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
Class II · Moderate risk
Quad Mix
Lack of Assurance of Sterility
Class II · Moderate risk
Quad Mix
Lack of Assurance of Sterility
Class II · Moderate risk
Quad Mix
Lack of Assurance of Sterility
Class II · Moderate risk
Quad Mix
Lack of Assurance of Sterility
Class II · Moderate risk
Quad Mix
Lack of Assurance of Sterility
Class II · Moderate risk
Quad Mix
Lack of Assurance of Sterility
Free recall alerts
Know the day your medication is recalled
Tell us what you take. When FDA posts a recall announcement or classifies a recall for one of your medications, we email you in plain English, with what to check. No account needed.