FoodMar 24, 2021
Laboratorios Pisa Sa De Cv Electrolit Ponche/Fruit Punch recall — FDA F-0363-2021
Product contains undeclared FD&C Red No. 40.
Class IIIFDA: TerminatedLaboratorios Pisa Sa De Cv
Monthly breakdown
2021 recalls by month
Select a month to review the recall records reported during that period.
December 2021194 records · 4 categoriesNovember 2021210 records · 4 categoriesOctober 2021342 records · 4 categoriesSeptember 2021300 records · 4 categoriesAugust 2021279 records · 4 categoriesJuly 2021251 records · 4 categoriesJune 2021361 records · 4 categoriesMay 2021226 records · 4 categoriesApril 2021279 records · 4 categoriesMarch 2021241 records · 4 categoriesFebruary 2021320 records · 4 categoriesJanuary 2021226 records · 4 categories
2021 recalls — page 106
Records are ordered by the best available source date.
FoodMar 24, 2021
Laboratorios Pisa Sa De Cv Electrolit Fruit Punch Zero, 625ML/21OZ packaged in a recall — FDA F-0364-2021
Product contains undeclared FD&C Red No. 40.
Class IIIFDA: TerminatedLaboratorios Pisa Sa De Cv
FoodMar 24, 2021
Flying Food Group Amazon Kitchen, Avocado Chicken Salad Sandwich, Net Wt recall — FDA F-0381-2021
Flying Food Group, LLC , initiated a recall of Amazon Kitchen Avocado Chicken Salad Sandwich . The soy allergen is undeclared on the finish product label. The label does have the following…
Class IFDA: TerminatedFlying Food Group LLC
FoodMar 24, 2021
KAREEM MART Tahina Sesame Paste packaged in 1lb and 2lb plastic jars and recall — FDA F-0341-2021
Product tested positive for Salmonella.
Class IFDA: TerminatedKAREEM MART Inc.
DrugMar 24, 2021
Phenylephrine HCl Injection, USP, 10 mg per mL, 1 mL per Single-Dose Vial recall — FDA D-0305-2021
Lack of Assurance of Sterility: customer complaints of loose crimped vial overseals which may result in a non-sterile product.
Class IIFDA: TerminatedSagent Pharmaceuticals Inc.
DrugMar 24, 2021
Edge Pharma Methacholine Challenge 5-Syringe Test Kits, Sterile Inhalation Solution recall — FDA D-0306-2021
Temperature Abuse; labeled with the incorrect room temperature (15-25 ¿C) storage conditions rather than the correct refrigerated (2 - 8 ¿C) storage conditions
Class IIIFDA: TerminatedEdge Pharma, LLC
DrugMar 24, 2021
Bryant Ranch Prepack, Inc. dba BRP Spironolactone Tablets, USP, 25 mg recall — FDA D-0303-2021
Labeling: Label Mix-Up - Prepackaged bottles labeled spironolactone 25 mg may contain spironolactone 50 mg tablets.
Class IFDA: OngoingBryant Ranch Prepack, Inc. dba BRP Pharmaceuticals
DrugMar 24, 2021
Direct Rx Nortriptyline HCL capsules, 10 mg recall — FDA D-0300-2021
cGMP deviations: The quantity of active ingredient used for the product lot was inadvertently taken from an ingredient lot from an alternate supplier before that specific lot was formally…
Class IIFDA: TerminatedDirect Rx
DrugMar 24, 2021
Breckenridge Pharmaceutical Omeprazole Delayed-Release Capsules, USP, 20 mg, 1000 count recall — FDA D-0308-2021
Failed Impurities/Degradation Specifications: Out-of-Specification results obtained for unknown impurities during stability testing.
Class IIFDA: TerminatedBreckenridge Pharmaceutical, Inc.
DrugMar 24, 2021
Akorn Gabapentin Oral Solution, 250 mg/5 mL, 5 mL per unit dose cup, four unit dose cups per recall — FDA D-0301-2021
Failed Impurities/Degradation Specifications; out of specification for unknown impurity observed during 6 month stability testing
Class IIFDA: TerminatedAkorn, Inc.
DrugMar 24, 2021
Bryant Ranch Prepack, Inc. dba BRP Spironolactone Tablets, USP, 50 mg recall — FDA D-0304-2021
Labeling: Label Mix-Up - Prepackaged bottles labeled spironolactone 50 mg may contain spironolactone 25 mg tablets.
Class IIFDA: OngoingBryant Ranch Prepack, Inc. dba BRP Pharmaceuticals
VehicleMar 18, 2021
General Motors seat belts recall — NHTSA campaign 21V190000
General Motors, LLC (GM) is recalling certain 2021 Cadillac Escalade, Escalade ESV, GMC Yukon, Yukon XL, Chevrolet Suburban, and Tahoe vehicles with third-row seating. The third-row…
seat beltsGeneral Motors, LLC
Medical DeviceMar 17, 2021
Howmedica Osteonics Prosthesis, knee, patello/femorotibial, semi-constrained, uncemented recall — FDA Z-1186-2021
Stryker has discovered that the internal profile of the Triathlon Tritanium Tibial Component (Baseplate), size 4, is potentially oversized. Due to a manufacturing issue in Lot Number…
Class IIFDA: TerminatedHowmedica Osteonics Corp.
Medical DeviceMar 17, 2021
Brainlab AG ExacTrac Dynamic recall — FDA Z-1185-2021
In case of a failed automatic marker detection, a software error causes parts of the display to incorrectly behave as if the current patient position is within predefined tolerances and may…
Class IIFDA: TerminatedBrainlab AG
Medical DeviceMar 17, 2021
RTI Surgical CervAlign Anterior Cervical Plate System-Cervalign, 5 Level, 105mm Material recall — FDA Z-1237-2021
Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision
Class IIFDA: OngoingRTI Surgical, Inc. (dba Pioneer Surgical Technology,…
Medical DeviceMar 17, 2021
RTI Surgical CervAlign Anterior Cervical Plate System-Cervalign, 1 Level, 16mm Material recall — FDA Z-1207-2021
Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision
Class IIFDA: OngoingRTI Surgical, Inc. (dba Pioneer Surgical Technology,…
Medical DeviceMar 17, 2021
RTI Surgical CervAlign Anterior Cervical Plate System-Cervalign, 2Level, 32mm Material recall — FDA Z-1214-2021
Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision
Class IIFDA: OngoingRTI Surgical, Inc. (dba Pioneer Surgical Technology,…
Medical DeviceMar 17, 2021
SUNSTAR G.U.M. HYDRAL DRY MOUTH RELIEF On-the-go Oral Spray, 2 FL.OZ. UPC0 70942 30713 0 recall — FDA Z-1182-2021
The product may be contaminated with Burkholderia cepacia
Class IIFDA: TerminatedSunstar Americas, Inc.
Medical DeviceMar 17, 2021
Draeger Medical VentStar Basic (N) 180- Drager Breathing Circuits/Anesthesia Sets Order recall — FDA Z-1178-2021
Y-piece may become detached from the ventilation hose either before or during the ventilation process, a leak will be caused that can hinder ventilation of the patient.
Class IIFDA: TerminatedDraeger Medical, Inc.
Medical DeviceMar 17, 2021
RTI Surgical CervAlign Anterior Cervical Plate System-Cervalign, 2Level, 26mm Material recall — FDA Z-1212-2021
Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision
Class IIFDA: OngoingRTI Surgical, Inc. (dba Pioneer Surgical Technology,…
Medical DeviceMar 17, 2021
RTI Surgical CervAlign Anterior Cervical Plate System-Cervalign, 4Level, 84mm Material recall — FDA Z-1234-2021
Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision
Class IIFDA: OngoingRTI Surgical, Inc. (dba Pioneer Surgical Technology,…
Medical DeviceMar 17, 2021
Tosoh Bioscience Thyroglobulin Antibody (TgAB) Calibrator - Product Usage: intended for IN recall — FDA Z-1187-2021
Some combinations of Calibrator lots and AlA PACKS resulted in Calibrator #6 not giving a value, making the calibration unacceptable.
Class IIFDA: TerminatedTosoh Bioscience Inc.
Medical DeviceMar 17, 2021
RTI Surgical CervAlign Anterior Cervical Plate System-Cervalign, 5 Level, 85mm Material recall — FDA Z-1240-2021
Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision
Class IIFDA: OngoingRTI Surgical, Inc. (dba Pioneer Surgical Technology,…
Medical DeviceMar 17, 2021
RTI Surgical CervAlign Anterior Cervical Plate System-Cervalign, 1 Level, 24m Material recall — FDA Z-1210-2021
Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision
Class IIFDA: OngoingRTI Surgical, Inc. (dba Pioneer Surgical Technology,…
About the 2021 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.