Complete FDA and NHTSA recall records dated in 2018, 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.
The products exhibit an unpleasant odor due to microbial contamination with Yarrowia lipolytica.
Baxter Healthcare will be installing new firmware on all Prismaflex control units to address the potential for a small number of these units to exhibit a failure mode with the pump module…
Omega LIF interbody implants labeled as having 11 degrees of lordosis was assembled using components manufactured with 4 degrees of lordosis.
The affected products were inadvertently packaged with the inner packaging pouch being sealed together with the outer pouch.
Baxter Healthcare will be installing new firmware on all Prismaflex control units to address the potential for a small number of these units to exhibit a failure mode with the pump module…
Specific lots of EXACTAMIX Inlets listed below due to incorrectly performed over-labeling. The inlets were over-labeled with a blank label, or with a label containing an extended expiration…
Baxter Healthcare will be installing new firmware on all Prismaflex control units to address the potential for a small number of these units to exhibit a failure mode with the pump module…
The product contains pecans which are not declared on the product labeling.
Firm was notified by manufacturer in Italy that Pistachio Gelato contained the color sodium copper chlorophyllins (SCC), which is not authorized by FDA as a color additive for this product…
An FDA inspection revealed products that contained Yellow 5 and soy lecithin failed to declare the presence of Yellow 5 and soy.
Morgan Foods, Inc. is voluntarily recalling Great Value Brand Gluten Free Tomato Soup due to undeclared allergen milk.
Undeclared allergens: Product was mislabeled due to undeclared Milk and Soy
Undeclared allergens: Product was mislabeled due to undeclared Milk and Soy
It was discovered that peanuts were not listed in the Contains Statement on Raley's Peanut Butter Brownies; peanuts are listed in the statement of identity and correctly listed as an…
An FDA inspection revealed products that contained Yellow 5 and soy lecithin failed to declare the presence of Yellow 5 and soy.
CGMP Deviations: Products manufactured with an ingredient that exceed the benzene levels allowed in drug products.
GMP Deviations: a recent FDA inspection of the manufacturing site revealed multiple cGMP violations that would place Loxapine at risk for cross contamination
Labeling: Label Mix-Up: bottle labeled as Diclofenac Sodium and Misoprostol 75 mg/0.2 mg contained Diclofenac Sodium and Misoprostol 50 mg/0.2 mg tablets.
Marketed Without an Approved NDA/ANDA: 2-pack configuration did not receive appropriate regulatory approval prior to release.
Marketed Without an Approved NDA/ANDA: 2-pack configuration did not receive appropriate regulatory approval prior to release.
Marketed Without An Approved NDA/ANDA: FDA analysis found the product to contain undeclared tadalafil. The presence of tadalafil makes Rhino Extreme 50000 an unapproved drug for which…
Subpotent
GMP Deviations: a recent FDA inspection of the manufacturing site revealed multiple cGMP violations that would place Loxapine at risk for cross contamination
CGMP Deviations: Products manufactured with an ingredient that exceed the benzene levels allowed in drug products.
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.
