28 FDA recalls mention Hyoscyamine. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Hyoscyamine.
Reason CGMP Deviations: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity…
Reason Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Reason cGMP deviations
Reason cGMP deviations
Reason cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Reason cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Reason Superpotent Drug: Subpotent Drug. FDA analysis found this product to be Out of Specification for assay which could result in either Subpotent and/or…
Reason CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures
Reason CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures
Reason CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures
Reason CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures
Reason CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures
Reason CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures
Reason Failed Content Uniformity Specifications: resulting in both superpotent and subpotent tablets.
Reason Failed Content Uniformity Specifications: resulting in both superpotent and subpotent tablets.
Reason Failed Content Uniformity Specifications: resulting in both superpotent and subpotent tablets.
Reason Chemical Contamination: Bottles may contain broken dessicants
Reason Labeling: Not elsewhere classified - Product label incorrectly lists Scopolamine Hydrocodone as an active ingredient on the side panel instead of…
Reason Labeling: Label Error on Declared Strength: Label incorrectly identifies product dose as 5ml instead of 10 ml.
Reason Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they…
Reason Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry…
Reason Labeling: Label Mixup: HYOSCYAMINE SULFATE SL, Tablet, 0.125 mg may have potentially been mislabeled as one of the following drugs: guanFACINE HCl…
Reason Labeling: Label Mixup: HYOSCYAMINE SULFATE ODT, Tablet, 0.125 mg may have potentially been mislabeled as the following drug: FLUoxetine HCl…
Reason Labeling:Label Mixup; HYOSCYAMINE SULFATE SL Tablet, 0.125 mg may be potentially mislabeled as azaTHIOprine, Tablet, 50 mg, NDC 00054408425…
Reason Labeling:Label Mixup; PHENobarbital/ HYOSCYAMINE/ ATROPINE/ SCOPOLAMINE, Tablet, 16.2 mg/0.1037 mg/0.0194 mg/0.0065 mg may be potentially mislabeled…
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