Complete FDA and NHTSA recall records dated in August 2018.
These records include useful source details for the selected month.
There is a potential for imaging artifact to mimic calcifications on patient's mammograms
Mislabeled hook pouch included a transport/storage label rather than the product label containing key product information such as part number, lot number, and expiration date, etc
Some containers of ice cream in a Peanut Butter Cup flavor container have a Butter Pecan flavor lid and are filled with Butter Pecan ice cream.
Product contains undeclared ingredients, Hydroxypropyl Methylcellulose (HPMC), Titanium Dioxide, Polyethylene Glycol (PEG), Triacetin, FD&C Yellow #6 (Sunset Yellow FCF), FD&C Red #40…
Severino Pasta Manufacturing, Inc. has initiated a recall of their Severino Pasta Super Fresh Cheese Raviolini due to undeclared eggs. The retail unit has the correct label on top, Cheese…
FDA inspection found two lots of supplements that did not declare shellfish as an ingredient on the product label; shellfish is properly declared on website.
Saratoga Food Specialties, has initiated a voluntary recall of Pizza Hut Seasonings following their supplier's recall of dry whey powder due to the potential presence of Salmonella
Mediterranean Salad Vegan is recalled because milk is declared in the Ingredients statement but it is not declared in the Contains statement.
Failed Impurities/Degradation Specifications - OOS was observed for ATV Cyclo FP Impurity and Total Degradation Impurities tested at the 18 month stability time point in Atorvastatin…
Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.
Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.
Presence of Foreign Substance: Product complaint was received of metal contaminant observed in one tablet.
Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.
Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.
Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.
Microbial Contamination of a Non-Sterile Product
Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.
Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.
Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.
Subpotent drug: The product active ingredient level not matching the exact levels indicated on the packaging label.
Use this page to compare the recalls reported during the month, then open an individual record for the exact reason, classification, company, remedy or distribution information available from the official source. Monthly counts are descriptive, not a safety rating.
