Class II · Moderate risk
Hyoscyamine Sulfate ER
Labeling: Label Mixup; HYOSCYAMINE SULFATE ER Tablet, 0.375 mg may be potentially mislabeled as SERTRALINE HCL, Tablet, 50 mg, NDC 16714061204, Pedigree: W003575, EXP: 6/24/2014.
Is Hyoscyamine recalled?
Not under an active recall.
Hyoscyamine was recalled 28 times in the past — all now closed. Most recent: May 25, 2023.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Hyoscyamine. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Hyoscyamine recalls on record
none so far in 2026; 28 on record, newest first
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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