FoodMay 26, 2021
South Georgia Pecan Company FANCY SEED PECAN HALVES 750 STERILIZED NET WT 30.00 recall — FDA F-0546-2021
The firm received complaints of peanuts in their cases of pecans.
Class IIFDA: TerminatedSouth Georgia Pecan Company
May 2021 recalls — page 4
These records include useful source details for the selected month.
FoodMay 26, 2021
Hi Tech Pharmaceuticals ISOMORPH 28 PURE WHEY iSOLATE CHOCOLATE MILKSHAKE DIETARY recall — FDA F-0500-2021
During an inspection by the FDA the firm was notified by FDA that the product contains undeclared milk, wheat & soy.
Class IFDA: OngoingHi Tech Pharmaceuticals
FoodMay 26, 2021
Hi Tech Pharmaceuticals IFN iFORCE NUTRITION MASS GAINZ PROTEIN MATRIX BROWN SUGAR recall — FDA F-0510-2021
During an inspection by the FDA the firm was notified by FDA that the product contains undeclared egg, milk, wheat & soy.
Class IFDA: OngoingHi Tech Pharmaceuticals
FoodMay 26, 2021
Hi Tech Pharmaceuticals ISOMORPH 28 PURE WHEY iSOLATE COOKIES N CREAM DIETARY recall — FDA F-0502-2021
During an inspection by the FDA the firm was notified by FDA that the product contains undeclared milk, wheat & soy.
Class IFDA: OngoingHi Tech Pharmaceuticals
DrugMay 26, 2021
Preferred Pharmaceuticals Inc., Metformin HCl, Extended Release Tab recall — FDA D-0385-2021
CMGP Deviations: Presence of NDMA impurity detected in product and exceed the Acceptable Daily Intake Limit (ADI) of 96ng/day.
Class IIFDA: OngoingPreferred Pharmaceuticals, Inc.
DrugMay 26, 2021
Cequa recall — FDA D-0391-2021
Subpotent and Presence of Particulates .
Class IIIFDA: TerminatedSUN PHARMACEUTICAL INDUSTRIES Inc.
DrugMay 26, 2021
Sterile Water for Inj., USP, 25 x 100 mL Single Dose Vials per carton recall — FDA D-0384-2021
Presence of Particulate Matter: particulate matter identified as an insect in one vial.
Class IIFDA: TerminatedPfizer Inc.
DrugMay 26, 2021
Asenapine Sublingual Tablets, 10 mg recall — FDA D-0380-2021
Incorrect Product Formulation; product was manufactured with the incorrect Art Cherry Flavor flavoring agent instead of Art Black Cherry Flavor flavoring agent
Class IIIFDA: TerminatedSigmaPharm Laboratories LLC
DrugMay 26, 2021
Teva Pharmaceuticals USA Leucovorin Calcium for Injection, equivalent to leucovorin 350 recall — FDA D-0374-2021
Lack of Assurance of Sterility
Class IIFDA: TerminatedTeva Pharmaceuticals USA
DrugMay 26, 2021
Asenapine Sublingual Tablets, 5 mg recall — FDA D-0379-2021
Incorrect Product Formulation; product was manufactured with the incorrect Art Cherry Flavor flavoring agent instead of Art Black Cherry Flavor flavoring agent
Class IIIFDA: TerminatedSigmaPharm Laboratories LLC
DrugMay 26, 2021
Bit & Bet Thumbs Up 7 Blue 69K, 10 capsules recall — FDA D-0388-2021
Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of sildenafil and tadalafil.
Class IIFDA: TerminatedBit & Bet LLC
DrugMay 26, 2021
Fresenius Medical Care Delflex Peritoneal Dialysis Solution with 1.5% Dextrose, LM/LC recall — FDA D-0389-2021
Labeling; Label Mix-up; 4.25% DEXTROSE bag was found inside a 1.5% DEXTROSE box.
Class IIFDA: TerminatedFresenius Medical Care, North America
VehicleMay 25, 2021
Tesla caliper recall — NHTSA campaign 21V387000
Tesla, Inc. (Tesla) is recalling certain 2019-2021 Model 3 and 2020-2021 Model Y vehicles. The brake caliper bolts may be loose, allowing the brake caliper to separate and contact the wheel…
caliperTesla, Inc.
VehicleMay 25, 2021
Tesla seat belts recall — NHTSA campaign 21V389000
Tesla, Inc. (Tesla) is recalling certain 2018-2020 Model 3 and 2019-2021 Model Y vehicles. One or both fasteners that secure the front seat shoulder belt to the b-pillar may not be properly…
seat beltsTesla, Inc.
VehicleMay 25, 2021
Model Y retractor recall — NHTSA campaign 21V388000
Tesla, Inc. (Tesla) is recalling certain 2019-2021 Model Y vehicles. One or both fasteners that secure the left and right second row seat belt retractors may not be properly attached.
retractorTesla, Inc.
VehicleMay 24, 2021
F-150 driveshaft recall — NHTSA campaign 21V381000
Ford Motor Company (Ford) is recalling certain 2021 F-150 vehicles. The two-piece driveshafts may have been improperly assembled, which could result in driveshaft separation.
driveshaftFord Motor Company
Medical DeviceMay 19, 2021
St. Jude Medical, Cardian Rhythm Management ASSURITY Pulse Generator REF PM**** SN ********* recall — FDA Z-1530-2021
Due to a manufacturing issue associated with the mixing process of the epoxy used in the manufacture of pacemaker from years 2015 through 2018, the affected devices may malfunction caused…
Class IFDA: OngoingSt. Jude Medical, Cardian Rhythm Management Division
Medical DeviceMay 19, 2021
ICU Medical REF CH2020 20mL Syringe w/Spinning Spiros, Red Cap - Product Usage: provides recall — FDA Z-1576-2021
Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the inactivated position.
Class IIFDA: OngoingICU Medical, Inc.
Medical DeviceMay 19, 2021
GE Healthcare NM/CT 850 Nuclear Medicine / CT Scanners recall — FDA Z-1545-2021
GE Healthcare has become aware of a potential issue on 800 family NM/CT Scanners that could cause a shift in CT radiation exposure range of up to 5cm compared to the intended radiation…
Class IIFDA: OngoingGE Healthcare, LLC
Medical DeviceMay 19, 2021
ICU Medical REF 011-CH3967 Admin Set w/ClaveTM, SpirosTM - Product Usage: provides access recall — FDA Z-1581-2021
Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the inactivated position.
Class IIFDA: OngoingICU Medical, Inc.
Medical DeviceMay 19, 2021
ICU Medical REF CH3034 5" (13 cm) Bag Spike Adapter w/Spiros" w/Red Cap, Vented Cap recall — FDA Z-1587-2021
Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the inactivated position.
Class IIFDA: OngoingICU Medical, Inc.
Medical DeviceMay 19, 2021
ICU Medical REF Spinning Spiros Closed Male Luer - Product Usage: provides access for the recall — FDA Z-1569-2021
Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the inactivated position.
Class IIFDA: OngoingICU Medical, Inc.
Medical DeviceMay 19, 2021
Musculoskeletal Transplant Foundation AFT Straight Tube (3/4 Filled) - Human Allograph recall — FDA Z-1562-2021
3/4 AFT Straight Fill Tubes (227007) filled only 1/2 way instead of 3/4, may cause delay of surgery
Class IIFDA: TerminatedMusculoskeletal Transplant Foundation, Inc.
Medical DeviceMay 19, 2021
ICU Medical REF CL4151 45" (114 cm) Appx 1.7 ml, Smallbore Ext Set w/Spiros w/Red Cap recall — FDA Z-1575-2021
Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the inactivated position.
Class IIFDA: OngoingICU Medical, Inc.
How to use this monthly recall archive
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.