DrugSep 20, 2017
Paroxetine tablets USP, 30mg, 30-count bottles recall — FDA D-1137-2017
Presence of Foreign tablets/capsules: risperidone Tablets were found in bottle of paroxetine Tablets
Class IIFDA: TerminatedZydus Pharmaceuticals USA Inc.
Monthly breakdown
2017 recalls by month
Select a month to review the recall records reported during that period.
December 2017112 records · 2 categoriesNovember 2017262 records · 2 categoriesOctober 201750 records · 2 categoriesSeptember 2017124 records · 2 categoriesAugust 2017178 records · 2 categoriesJuly 2017212 records · 2 categoriesJune 2017121 records · 3 categoriesMay 2017245 records · 3 categoriesApril 2017306 records · 2 categoriesMarch 2017226 records · 2 categoriesFebruary 2017106 records · 2 categoriesJanuary 2017396 records · 2 categories
2017 recalls — page 22
Records are ordered by the best available source date.
DrugSep 20, 2017
BESTHERBS COFFEE New Kopi Jantan Tradisional Natural Herbs Coffee recall — FDA D-1144-2017
Marketed without an approved NDA/ANDA: presence of undeclared desmethyl carbodenafil and undeclared milk.
Class IFDA: TerminatedBESTHERBS COFFEE LLC
DrugSep 20, 2017
Mid Valley Pharmaceutical Doctor Manzanilla Cough & Cold recall — FDA D-1136-2017
CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product contamination with the bacteria B. cepacia.
Class IIFDA: TerminatedMid Valley Pharmaceutical
DrugSep 20, 2017
MEDLINE INDUSTRIES Vitamin A&D Ointment (petroleum 93.5%), Skin Protectant, NET Wt. 0.18 OZ recall — FDA D-1138-2017
Labeling Mixup; the individual A&D ointment foil packets are incorrectly labeled as petroleum jelly. The boxes and outer case are correctly labeled as A&D ointment.
Class IIFDA: TerminatedMEDLINE INDUSTRIES Inc.
DrugSep 20, 2017
VistaPharm Hydrocodone Bitartrate and Acetaminophen Oral Solution 7.5 mg/325 mg per 15 mL recall — FDA D-1139-2017
Labeling: Not Elsewhere Classified; product is incorrectly labeled as Class III controlled substance instead of Class II controlled substance
Class IIIFDA: TerminatedVistaPharm, Inc.
DrugSep 20, 2017
Ninjacof recall — FDA D-1140-2017
Microbial contamination of Non-sterile Products; potential B. cepacia contamination
Class IIFDA: TerminatedCenturion Labs, LLC
DrugSep 20, 2017
Chiavna Saffron Super Panther 7K Capsules 1250 mg blend, a) 1 count blister cards shipped in recall — FDA D-1145-2017
Marketed without an Approved NDA/ANDA;FDA analysis found product to be tainted with sildendafil and tadalafil
Class IFDA: TerminatedChiavna Saffron LLC
DrugSep 20, 2017
Centurion Labs Ninjacof-A recall — FDA D-1141-2017
Microbial contamination of Non-sterile Products; potential B. cepacia contamination
Class IIFDA: TerminatedCenturion Labs, LLC
DrugSep 20, 2017
Aidarex Pharmaceuticals Phentermine, USP Capsules, 15 mg, 30 count bottles recall — FDA D-1162-2017
Failed Impurities/Degradation Specification; out-of-specification results for individual unknown impurities at the 30 month Room Temperature Retained Sample stability test
Class IIIFDA: TerminatedAidarex Pharmaceuticals LLC
DrugSep 20, 2017
AMLODIPINE BESYLATE TABLET, USP, 10 mg, 1000 count bottle recall — FDA D-1134-2017
PRESENCE OF FOREIGN TABLETS/CAPSULES: A 2.5 mg Amlodipine Besylate tablet was found co-mingled with 10 mg Amlodipine Besylate tablets in a bottle labeled as Amlodipine Besylate 10 mg.
Class IIIFDA: TerminatedAscend Laboratories LLC
DrugSep 20, 2017
Mid Valley Pharmaceutical Doctor Manzanilla Allergy & Decongestant Relief recall — FDA D-1135-2017
CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product contamination with the bacteria B. cepacia.
Class IIFDA: TerminatedMid Valley Pharmaceutical
FoodSep 13, 2017
Southeastern Mills Custom Seasoning Solutions Easy Drop Cheddar Garlic Drop Biscuit Mix, Net recall — FDA F-3537-2017
Products were manufactured from raw material (buttermilk solids) that may potentially be contaminated with Salmonella.
Class IFDA: TerminatedSoutheastern Mills Custom Seasoning Solutions
FoodSep 13, 2017
Southeastern Mills Custom Seasoning Solutions Biscuit Gravy Mix, Net Wt recall — FDA F-3534-2017
Products were manufactured from raw material (buttermilk solids) that may potentially be contaminated with Salmonella.
Class IFDA: TerminatedSoutheastern Mills Custom Seasoning Solutions
FoodSep 13, 2017
Madhava Naturally Sweet Deliciously Organic MMM recall — FDA F-3533-2017
Madhava Natural Sweeteners is recalling MMM... Chocolate Chip Cookie Mix because it may contain undeclared milk.
Class IFDA: TerminatedMadhava Honey Ltd
FoodSep 13, 2017
Rushing Waters Fisheries Whole Foods Smoked Traditional Atlantic Salmon Portion, packed recall — FDA F-3486-2017
Rushing Waters Fisheries is recalling 3 smoked fish products because they may have been underprocessed.
Class IIIFDA: TerminatedRushing Waters Fisheries, LLC
FoodSep 13, 2017
Litehouse 6/11.25 oz recall — FDA F-3514-2017
OPA by Litehouse Ranch was recalled due to undeclared egg.
Class IFDA: TerminatedLitehouse Inc.
FoodSep 13, 2017
Rushing Waters Fisheries Whole Foods Smoked Peppered Atlantic Salmon Portion, packed in recall — FDA F-3485-2017
Rushing Waters Fisheries is recalling 3 smoked fish products because they may have been underprocessed.
Class IIIFDA: TerminatedRushing Waters Fisheries, LLC
FoodSep 13, 2017
Southeastern Mills Custom Seasoning Solutions Shore Lunch, Fish Breading Batter Mix, Cajun recall — FDA F-3539-2017
Products were manufactured from raw material (buttermilk solids) that may potentially be contaminated with Salmonella.
Class IFDA: TerminatedSoutheastern Mills Custom Seasoning Solutions
FoodSep 13, 2017
Southeastern Mills Custom Seasoning Solutions Shore Lunch, Fish Breading Batter Mix recall — FDA F-3538-2017
Products were manufactured from raw material (buttermilk solids) that may potentially be contaminated with Salmonella.
Class IFDA: TerminatedSoutheastern Mills Custom Seasoning Solutions
FoodSep 13, 2017
Southeastern Mills Custom Seasoning Solutions Buttermilk Drop Biscuit Mix, Net Wt recall — FDA F-3536-2017
Products were manufactured from raw material (buttermilk solids) that may potentially be contaminated with Salmonella.
Class IFDA: TerminatedSoutheastern Mills Custom Seasoning Solutions
FoodSep 13, 2017
Southeastern Mills Custom Seasoning Solutions Country Biscuit Mix, Net Wt recall — FDA F-3535-2017
Products were manufactured from raw material (buttermilk solids) that may potentially be contaminated with Salmonella.
Class IFDA: TerminatedSoutheastern Mills Custom Seasoning Solutions
FoodSep 13, 2017
Rushing Waters Fisheries Whole Foods Smoked Whitefish Fillet, packed in bulk boxes recall — FDA F-3487-2017
Rushing Waters Fisheries is recalling 3 smoked fish products because they may have been underprocessed.
Class IIIFDA: TerminatedRushing Waters Fisheries, LLC
DrugSep 13, 2017
Mckesson Packaging Services Propafenone Hydrochloride tablets, 150 mg recall — FDA D-1128-2017
Failed moisture limits: Out of specification for moisture content.
Class IIIFDA: TerminatedMckesson Packaging Services
DrugSep 13, 2017
ImprimisRx CA, Inc., dba ImprimisRx Curcumin Emulsion 10mg/ml Injection, Sterile 10 mL recall — FDA D-1130-2017
Incorrect/Undeclared Excipient; non-pharmaceutical grade PEG 40 Castor Oil was used due to a mislabeling by the supplier
Class IIFDA: TerminatedImprimisRx CA, Inc., dba ImprimisRx
About the 2017 recall archive
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.