Class II · Moderate risk
Scopolamine Hydrobromide 0.25% Oph Solution
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Is Scopolamine recalled?
Not under an active recall.
Scopolamine was recalled 11 times in the past — all now closed. Most recent: Dec 22, 2022.
Most common reason: Labeling / mix-up (4 of these recalls)
Recalls are matched by product description. A recall usually affects specific lots, not every package of Scopolamine. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Scopolamine recalls on record
none so far in 2026; 11 on record, newest first
Class II · Moderate risk
Transderm Scop
cGMP deviations: Temperature abuse
Class II · Moderate risk
Scopolamine Transdermal Therapeutic System
Defective delivery system
Class II · Moderate risk
Transderm Scop
Labeling: Incorrect Instructions:outer carton contains the incorrect instructions for Step 2 stating "Do cut the patch" rather than the correct instructions of "Do not cut the patch". The pouch containing the patch is labeled correctly.
Class II · Moderate risk
Transderm Scop
Defective Delivery System; reports of damaged product that may alter the predicted release of scopolamine following transdermal application.
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 II · Moderate risk
Phenobarbital/Hyoscyamine/ Atropine/Scopolamine…
Labeling: Label Error on Declared Strength: Label incorrectly identifies product dose as 5ml instead of 10 ml.
Class II · Moderate risk
Scopolamine 0.25 opth.
Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.
Class II · Moderate risk
PHENobarbital/ HYOSCYAMINE/ ATROPINE/ SCOPOLAMINE
Labeling:Label Mixup; PHENobarbital/ HYOSCYAMINE/ ATROPINE/ SCOPOLAMINE, Tablet, 16.2 mg/0.1037 mg/0.0194 mg/0.0065 mg may be potentially mislabeled as VALSARTAN, Tablet, 160 mg, NDC 00078035934, Pedigree: W003639, EXP: 6/25/2014.
Class II · Moderate risk
Belladonna Alkaloids/PB
Presence of Foriegn Substance:The manufacturer, West-ward Pharmaceutical, recalled product because of the presence of black spots on tablets. In response, the repackager initiated its own recall.
Class II · Moderate risk
Belladonna Alkaloids
Presence of Foreign Substance: Uncharacteristic blacks spots were found in tablets.
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