Complete FDA and NHTSA recall records dated in 2019, organized for browsing by month, category and recalling company.
Select a month to review the recall records reported during that period.
Records are ordered by the best available source date.
Firm is voluntarily recalling specific lots of Harmless Harvests Dairy-Free Yogurt Drink beverages after identifying a possible packaging defect that may result in premature spoilage
FDA inspection at the facility found that the firm was using Yellow 5 & 6 which were not declared on product labeling.
The products outer holiday wrap has an information panel that is incorrect. The information panel does not declare that pecans are in product. The actual box under wrapping correctly…
The box has in it a pretzel containing a milk allergen that was packaged in a box labeled for a pretzel that does not contain a milk allergen. Mislabeled product.
Product may contain undeclared peanuts
Presence of Precipitate: Appearance is Out of Specification for the reconstituted solution during 24-month stability time point analysis.
CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level of 0.96 parts per…
CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level.
Labeling: Not Elsewhere Classified: Full cases may contain canisters that incorrectly state the net weight is 2.75 oz. rather than the correct net weight of 2.0 oz.
Sub-potency
Labeling: Not Elsewhere Classified: canisters incorrectly state the net weight is 2.75 oz. rather than the correct net weight of 2.0 oz.
CGMP Deviations: Detection of trace amounts of N-Methylnitrosobutyric acid (NMBA) impurity found in the Active Pharmaceutical Ingredient (API)
Lack of assurance of sterility for injectables and solutions intended to be sterile.
Lack of assurance of sterility for injectables and solutions intended to be sterile.
Lack of assurance of sterility for injectables and solutions intended to be sterile.
CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level.
Lack of assurance of sterility for injectables and solutions intended to be sterile.
CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level.
CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level of 0.96 parts per…
Lack of assurance of sterility for injectables and solutions intended to be sterile.
Lack of assurance of sterility for injectables and solutions intended to be sterile.
Lack of assurance of sterility for injectables and solutions intended to be sterile.
CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level of 0.96 parts per…
Lack of assurance of sterility for injectables and solutions intended to be sterile.
This archive groups records by their reported or recall date. It does not imply that every recall was initiated, announced and resolved during the same calendar year. Open the individual record for the exact dates and source details supplied by FDA or NHTSA.
