Most common reason: Wrong potency / content (10 of these recalls)
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.
CGMP Deviations: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess.
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
cGMP deviations
cGMP deviations
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Superpotent Drug: Subpotent Drug. FDA analysis found this product to be Out of Specification for assay which could result in either Subpotent and/or Superpotent tablets.
CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures
CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures
CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures
CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures
CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures
CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures
Failed Content Uniformity Specifications: resulting in both superpotent and subpotent tablets.
Failed Content Uniformity Specifications: resulting in both superpotent and subpotent tablets.
Failed Content Uniformity Specifications: resulting in both superpotent and subpotent tablets.
Chemical Contamination: Bottles may contain broken dessicants
Labeling: Not elsewhere classified - Product label incorrectly lists Scopolamine Hydrocodone as an active ingredient on the side panel instead of Scopolamine Hydrobromide.
Labeling: Label Error on Declared Strength: Label incorrectly identifies product dose as 5ml instead of 10 ml.
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.
Labeling: Label Mixup: HYOSCYAMINE SULFATE SL, Tablet, 0.125 mg may have potentially been mislabeled as one of the following drugs: guanFACINE HCl, Tablet, 2 mg, NDC 65162071310, Pedigree: AD21790_13, EXP: 5/1/2014; CYCLOBENZAPRINE HCL, Tablet, 5 mg, NDC 00591325601, Pedigree: AD46265_4, EXP: 5/15/2014; guanFACINE HCl, Tablet, 2 mg, NDC 65162071310, Pedigree: W003678, EXP: 6/25/2014; guanFACIN
Labeling: Label Mixup: HYOSCYAMINE SULFATE ODT, Tablet, 0.125 mg may have potentially been mislabeled as the following drug: FLUoxetine HCl, Capsule, 10 mg, NDC 16714035103, Pedigree: W003613, EXP: 6/25/2014.
Labeling:Label Mixup; HYOSCYAMINE SULFATE SL Tablet, 0.125 mg may be potentially mislabeled as azaTHIOprine, Tablet, 50 mg, NDC 00054408425, Pedigree: AD56832_1, EXP: 5/21/2014; CHOLECALCIFEROL, Tablet, 1000 units, NDC 00904582460, Pedigree: W003464, EXP: 6/20/2014.
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.
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