Class II · Moderate risk
Quad Mix
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
Trimix with Atropine Injectable 30 mg/3 mg/60 mcg/0.2 mg/mL
Lack of Assurance of Sterility
Class II · Moderate risk
Trimix with Atropine Injectable 30 mg/3 mg/300 mcg/0.2 mg/mL
Lack of Assurance of Sterility
Class II · Moderate risk
Trimix with Atropine Injectable 30 mg/3 mg/150 mcg/0.2 mg/mL
Lack of Assurance of Sterility
Class II · Moderate risk
Tri 2 (Pap/Phen/Atropine)
Lack of Assurance of Sterility
Class II · Moderate risk
Tri 1 (Pap/Phen/Atropine)
Lack of Assurance of Sterility
Class II · Moderate risk
Atropine Sulfate 0.01% in 0.9% Sodium Chloride
Lack of Assurance of Sterility; all compounded products within expiry produced using recalled filters
Class II · Moderate risk
C-PAP/PHEN/PROST/Atrop 150/7.5
Lack of Assurance of Sterility
Class II · Moderate risk
C-Pap/Phen/Prost/Atrop 150/5/5
Lack of Assurance of Sterility
Class II · Moderate risk
ATROPINE SULFATE 0.5% Ophthalmic Drops
Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
Class II · Moderate risk
Atropine Sulfate 0.4mg/mL 2.5 mL fill in a 3 mL syringe
Lack of Assurance of Sterility
Class II · Moderate risk
Formula 2 (Papaverine 9 mg, Phentolamine 1 mg, Atropine 0.1 mg, PGE 10 mcg/mL)
Stability Does Not Support Expiry: manufactured with an active ingredient that expired before the labeled Beyond Use Date.
Class II · Moderate risk
Formula 3 (Papaverine 20 mg, Phentolamine 3 mg, Atropine 0.2 mg, PGE 20 mcg/mL)
Stability Does Not Support Expiry: manufactured with an active ingredient that expired before the labeled Beyond Use Date.
Class II · Moderate risk
Formula 1
Stability Does Not Support Expiry: manufactured with an active ingredient that expired before the labeled Beyond Use Date.
Class II · Moderate risk
Formula 9
Lack of Assurance of Sterility: incomplete or missing data regarding production.
Class II · Moderate risk
Formula 4 (Papaverine 18 mg, Phentolamine 2 mg, Atropine 0.2 mg/mL)
Lack of Assurance of Sterility: incomplete or missing data regarding production.
Class II · Moderate risk
Formula 2 (Papaverine 9 mg, Phentolamine 1 mg, Atropine 0.1 mg, PGE 10 mcg/mL)
Superpotent Drug: one ingredient was found to be above assay specification.
Class II · Moderate risk
Atropine 0.01% Ophth Solution
Lack of Assurance of Sterility
Class III · Low risk
Donnatal
Labeling: Not elsewhere classified - Product label incorrectly lists Scopolamine Hydrocodone as an active ingredient on the side panel instead of Scopolamine Hydrobromide.
Class I · High risk
Atropine Sulfate Injection Solution
Subpotent Drug
Class II · Moderate risk
Papaverine/Phentolamine/Atropine/Prostaglandin
Lack of Assurance of Sterility; all sterile human compounded drugs within expiry
Class II · Moderate risk
Papaverine/Phentolamine/Atropine/Prostaglandin
Lack of Assurance of Sterility; all sterile human compounded drugs within expiry
Class II · Moderate risk
atropine Sulfate Injection
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
Class II · Moderate risk
atropine Sulfate Injection
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
Class II · Moderate risk
Phenobarbital/Hyoscyamine/ Atropine/Scopolamine…
Labeling: Label Error on Declared Strength: Label incorrectly identifies product dose as 5ml instead of 10 ml.
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.