Silver Star Brands Healthful Naturals Leg Cramp Support Oral Spray, 2 fl oz (59 mL) per recall — FDA D-0256-2019
CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
Browse U.S. drug recall enforcement reports from the FDA in a structured, searchable format. Review the recalled product, reason, firm, status, dates, distribution information and FDA classification when available.
10,690 detailed records are currently available in this category.
CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
Microbial Contamination of Non-Sterile Product
Labeling: Incorrect or Missing Lot and/or Expiration Date; vial indicates a 1 year expiration date instead of a 6 month expiration date
CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
Lack of Assurance of Sterility
CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
Defective Container: Repetitive complaints received indicating pump not working.
Failed Impurities/Degradation Specifications:Out of specification result noticed for total impurities observed during stability analysis
CGMP deviations: Notice received from supplier of a voluntary recall of all their nasal products and baby oral gels due to the possibility of microbial contamination. No positive results…
Lack of assurance of sterility: loss of container integrity.
Lack of Assurance of Sterility: complaints received about dried powder on the outside of the bottle
Subpotent drug: During testing of the retention sample, the firm discovered that the product was sub-potent.
Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release.
CGMP deviations: Notice received from supplier of a voluntary recall of all their nasal products and baby oral gels due to the possibility of microbial contamination. No positive results…
Failed dissolution specifications: Out-of-Specification dissolution test result obtained during routine stability testing.
Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release.
CGMP Deviations: Detection of trace amounts of NDMA, a possible impurity or contaminant in an active pharmaceutical ingredient.
Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release.
CGMP Deviations: cleaning procedures during manufacturing caused out of specification results for unknown impurities.
A drug recall record can include the reason for recall, firm, status, distribution pattern, quantity and FDA classification. This site does not provide medical advice; it organizes public recall information and links users back to official sources.
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