DrugJun 2, 2021
Lamotrigine Extended-Release Tablets 250 mg 30 Tablets recall — FDA D-0538-2021
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class IIFDA: TerminatedCardinal Health Inc.
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 81
Records are ordered by the best available source date.
DrugJun 2, 2021
Rectiv (nitroglycerin) Ointment 0.4% For Intra-anal Use Only 30 g recall — FDA D-0419-2021
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class IIFDA: TerminatedCardinal Health Inc.
DrugJun 2, 2021
Auryxia (ferric citrate) tablets 210 mg* 200 Tablets recall — FDA D-0499-2021
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class IIFDA: TerminatedCardinal Health Inc.
DrugJun 2, 2021
Trelegy Ellipta recall — FDA D-0482-2021
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class IIFDA: TerminatedCardinal Health Inc.
DrugJun 2, 2021
Narcan (naloxone HCl) Nasal Spray 4 mg Two Pack This box contains two (2) 4-mg doses of recall — FDA D-0473-2021
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class IIFDA: TerminatedCardinal Health Inc.
DrugJun 2, 2021
Steglatro (ertugliflozin) tablets 15 mg 30 Tablets recall — FDA D-0524-2021
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class IIFDA: TerminatedCardinal Health Inc.
DrugJun 2, 2021
Chantix (varenicline) Tablets Starting Pack Contains: 1 Starting Week (0.5 mgx11 tablets) 3 recall — FDA D-0556-2021
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class IIFDA: TerminatedCardinal Health Inc.
DrugJun 2, 2021
Desvenlafaxine Extended-Release Tablets 25 mg 30 Tablets recall — FDA D-0581-2021
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class IIFDA: TerminatedCardinal Health Inc.
DrugJun 2, 2021
Cardinal Health Ferrous Sulfate 75 mg (equivalent to 15 mg Iron) Per 1.0 mL Alcohol 0.2% v/v recall — FDA D-0504-2021
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class IIFDA: TerminatedCardinal Health Inc.
DrugJun 2, 2021
Cardinal Health Belsomra (suvorexant) tablets 10 mg Each tablet contains 10 mg suvorexant recall — FDA D-0522-2021
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class IIFDA: TerminatedCardinal Health Inc.
DrugJun 2, 2021
Orilissa elagolix tablets 150 mg per tablet equivalent to 155.2 mg elagolix sodium, 28 recall — FDA D-0403-2021
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class IIFDA: TerminatedCardinal Health Inc.
DrugJun 2, 2021
Spiriva HandiHaler recall — FDA D-0453-2021
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class IIFDA: TerminatedCardinal Health Inc.
DrugJun 2, 2021
NP THYROID 15 NP Thyroid 30 Thyroid Tablets, USP 1/2 grain (30 mg) recall — FDA D-0396-2021
Subpotent Drug
Class IFDA: TerminatedAcella Pharmaceuticals, LLC
DrugJun 2, 2021
NP THYROID 15 NP Thyroid 120 Thyroid Tablets, USP 2 grain (120 mg) recall — FDA D-0399-2021
Subpotent Drug
Class IFDA: TerminatedAcella Pharmaceuticals, LLC
DrugJun 2, 2021
Triumeq recall — FDA D-0486-2021
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class IIFDA: TerminatedCardinal Health Inc.
DrugJun 2, 2021
xigduo XR recall — FDA D-0435-2021
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class IIFDA: TerminatedCardinal Health Inc.
VehicleJun 2, 2021
Volvo Car USA fuses and circuit breakers recall — NHTSA campaign 21V414000
Volvo Car USA, LLC (Volvo Car) is recalling certain 2019-2020 V90, XC60, S60, V60, V60CC, S90, V90CC, S90L, and XC90 vehicles. The low-pressure fuel pump can blow a fuse and fail.
fuses and circuit breakersVolvo Car USA, LLC
VehicleMay 29, 2021
F-150 gear box (other than rack and pinion) recall — NHTSA campaign 21V407000
Ford Motor Company (Ford) is recalling certain 2021 F-150 vehicles. The steering gear may have internal damage, which could result in difficulty steering, or the inability to rotate the…
gear box (other than rack and pinion)Ford Motor Company
VehicleMay 27, 2021
Chrysler lugs/nuts/bolts/studs recall — NHTSA campaign 21V398000
Chrysler (FCA US, LLC) is recalling certain 2012-2021 RAM 3500, 3500 Cab Chassis, 4500 Cab Chassis, and 5500 Cab Chassis vehicles. Incorrect information in the Service and Owner's Manuals…
lugs/nuts/bolts/studsChrysler (FCA US, LLC)
Medical DeviceMay 26, 2021
Medtronic recall — FDA Z-1618-2021
Use of the continuous glucose monitoring system while actively taking hydroxyurea, an anti-neoplastic drug could result in inaccurate elevated sensor glucose readings.
Class IIFDA: OngoingMedtronic Inc.
Medical DeviceMay 26, 2021
Medtronic REF: MMT-7020C1 Guardian Sensor (3) for the following packaging: GS3 5PK OUS1/ recall — FDA Z-1607-2021
Use of the continuous glucose monitoring system while actively taking hydroxyurea, an anti-neoplastic drug could result in inaccurate elevated sensor glucose readings.
Class IIFDA: OngoingMedtronic Inc.
Medical DeviceMay 26, 2021
Bard Access Systems REF 7617408, Groshong NXT ClearVue Catheter, Full Kit, 4F, Single-Lumen recall — FDA Z-1654-2021
Catheters contain two issues: 1. the inner diameter of the distal connector may be reduced resulting in inability to pass the catheter through the connector and 2. the catch slot on the…
Class IIFDA: TerminatedBard Access Systems Inc.
Medical DeviceMay 26, 2021
Medtronic REF: MMT-7008B, Enlite Glucose Sensor for the following packaging: ENLITE PLUS 23L recall — FDA Z-1600-2021
Use of the continuous glucose monitoring system while actively taking hydroxyurea, an anti-neoplastic drug could result in inaccurate elevated sensor glucose readings.
Class IIFDA: OngoingMedtronic Inc.
Medical DeviceMay 26, 2021
Bioseal recall — FDA Z-1623-2021
Pre-op skin prep component ChloraPrep included within kits may allow the growth of Aspergillus penicillioides, which may penetrate the packaging resulting in a breach of the package…
Class IIFDA: CompletedBioseal Corporation
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.