Severity 1 of 5

Low recalls

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

What “low” means here

Severity 1 (Low) recalls are typically cosmetic defects, documentation issues, packaging-only problems, and Class III administrative corrections. The product itself is unlikely to cause adverse health consequences. The manufacturer is correcting the issue to comply with FDA or USDA rules, not because anyone is at risk. You can almost always continue using a Severity-1 product without concern.

The full rubric is on the methodology page. Severity is computed deterministically from the agency’s own classification plus the source text — no editorial vibes.

451–475 of 2738

LowFDA (Devices)·Z-0409-2021·2020-11-11
Synthes SynMesh Cage System Recalled for Incorrect Statutory Labeling
Synthes (USA) Products LLC is recalling 18 units of the SynMesh Cage System because the statutory label incorrectly identified the device as a 'general medical device' instead of a 'specially controlled medical device.'
Product
END RING 12MM DIA/0 DEG (TI) Product Number: 495.385 - Product Usage: is a vertebral body replacement device for the cervical, thoracic and lumbar spine. Titanium implants in various footprints and heights enable the surgeon to choose the configuration that is best suited to…
Category
Medical Device
Distribution
0 states
LowFDA (Devices)·Z-0404-2021·2020-11-11
Synthes SYNMesh Vertebral Body Replacement Devices Recalled for Labeling Error
Synthes (USA) Products LLC is recalling 12 units of SYNMesh vertebral body replacement devices because the statutory label incorrectly identifies them as 'general medical devices' instead of 'specially controlled medical devices.'
Product
SYNMESH 12MM DIA 88MM HEIGHT (TI) Product Number: 495.357 - Product Usage: is a vertebral body replacement device for the cervical, thoracic and lumbar spine. Titanium implants in various footprints and heights enable the surgeon to choose the configuration that is best suited…
Category
Medical Device
Distribution
0 states
LowFDA (Devices)·Z-0406-2021·2020-11-11
Synthes Recalls SYN MESH Cages Due to Incorrect Labeling
Synthes (USA) Products LLC is recalling 9 units of SYN MESH vertebral body replacement devices because the statutory label incorrectly identifies them as 'general medical device' instead of 'specially controlled medical device.'
Product
SYNMESH 17MM X 22MM 88MM HEIGHT (TI) Product Number: 495-374 - Product Usage: is a vertebral body replacement device for the cervical, thoracic and lumbar spine. Titanium implants in various footprints and heights enable the surgeon to choose the configuration that is best…
Category
Medical Device
Distribution
0 states
LowFDA (Drugs)·D-0065-2021·2020-11-11
Aurobindo Recalls Children's Ibuprofen Suspension Due to Missing Dosing Cups
Aurobindo Pharma USA Inc. is recalling 7,440 bottles of Children's Ibuprofen Oral Suspension because the product is missing dosing cups.
Product
CHILDRENS IBUPROFEN — CHILDRENS IBUPROFEN (IBUPROFEN)
Category
Drug
Distribution
1 state
LowFDA (Devices)·Z-0407-2021·2020-11-11
Synthes SYNMesh Vertebral Body Replacement Recalled for Labeling Error
Synthes (USA) Products LLC is recalling 5 units of SYNMesh vertebral body replacement devices because the statutory label incorrectly identifies them as general medical devices.
Product
SYNMESH¿ 22MM X 28MM 88MM HEIGHT (TI) Product Number: 495.379 - Product Usage: is a vertebral body replacement device for the cervical, thoracic and lumbar spine. Titanium implants in various footprints and heights enable the surgeon to choose the configuration that is best…
Category
Medical Device
Distribution
0 states
LowFDA (Devices)·Z-0417-2021·2020-11-11
Synthes SynMesh Cages Recalled for Incorrect Statutory Labeling
Synthes (USA) Products LLC is recalling 18 units of SynMesh Cages due to incorrect statutory labeling. The devices were distributed only in Japan.
Product
3.0MM LOCKING SCREW LOW PROFILE (TI) Product Number: 495-491 - Product Usage: is a vertebral body replacement device for the cervical, thoracic and lumbar spine. Titanium implants in various footprints and heights enable the surgeon to choose the configuration that is best…
Category
Medical Device
Distribution
0 states
LowFDA (Devices)·Z-0403-2021·2020-11-11
DePuy Synthes SYNMESH CAGE System Recalled for Incorrect Labeling
Synthes (USA) Products LLC is recalling 10 units of DePuy Synthes SYNMESH CAGE System devices distributed in Japan due to incorrect statutory labeling.
Product
DePuy Synthes SYNMESH 10MM DIA 18MM HEIGHT (TI) Product Number: 495.344 - Product Usage: is a vertebral body replacement device for the cervical, thoracic and lumbar spine. Titanium implants in various footprints and heights enable the surgeon to choose the configuration that…
Category
Medical Device
Distribution
0 states
LowFDA (Devices)·Z-0405-2021·2020-11-11
Synthes SYN MESH Vertebral Body Replacement Recalled for Labeling Error
Synthes (USA) Products LLC is recalling 17 units of SYN MESH vertebral body replacement devices because the statutory label incorrectly identifies them as 'general medical devices' instead of 'specially controlled medical devices.'
Product
SYNMESH 15MM DIA 88MM HEIGHT (TI) Product Number: 495.366 - Product Usage: is a vertebral body replacement device for the cervical, thoracic and lumbar spine. Titanium implants in various footprints and heights enable the surgeon to choose the configuration that is best suited…
Category
Medical Device
Distribution
0 states
LowFDA (Drugs)·D-0066-2021·2020-11-11
Jubilant Recalls Subpotent Olanzapine Orally Disintegrating Tablets Nationwide
Jubilant Cadista Pharmaceuticals is voluntarily recalling 23,616 blister packs of Olanzapine Orally Disintegrating Tablets, 5 mg, because the product was found to be subpotent.
Product
Olanzapine Orally Disintegrating Tablets, 5 mg, 30 count (3x10 unit dose) blister pack, Rx only, Manufactured by: Jubilant Generics, Ltd., Roorkee, India, Marketed by: Jubilant Cardista Pharmaceuticals, Inc., Salisbury, MD NDC 59746-0306-32
Category
Drug
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0413-2021·2020-11-11
Synthes SynMesh Cage System Recalled for Incorrect Statutory Labeling
Synthes (USA) Products LLC is recalling 6 units of the SynMesh Cage System because the statutory label incorrectly identifies the device as a general medical device.
Product
END RING 22MM X 28MM LATERAL OR ANTERIOR/0 DEG (TI) Product Number: 495-396 - Product Usage: is a vertebral body replacement device for the cervical, thoracic and lumbar spine. Titanium implants in various footprints and heights enable the surgeon to choose the configuration…
Category
Medical Device
Distribution
0 states
LowFDA (Devices)·Z-0411-2021·2020-11-11
Synthes SynMesh Cage System Recalled for Incorrect Statutory Labeling
Synthes (USA) Products LLC is recalling 9 units of the SynMesh Cage System because the statutory label incorrectly identifies the device as a 'general medical device' rather than a 'specially controlled medical device.'
Product
END RING 17MM X 22MM LATERAL OR ANTERIOR/0 DEG (TI) Product Number: 495.392 - Product Usage: is a vertebral body replacement device for the cervical, thoracic and lumbar spine. Titanium implants in various footprints and heights enable the surgeon to choose the configuration…
Category
Medical Device
Distribution
0 states
LowFDA (Devices)·Z-0415-2021·2020-11-11
Synthes Vertebral Body Replacement Device Recalled for Labeling Error
Synthes (USA) Products LLC is recalling 7 units of the Standard Ring 17mm x 22mm (Ti) vertebral body replacement device due to an incorrect statutory label.
Product
STANDARD RING 17MM X 22MM (TI) Product Number: 495-405 - Product Usage: is a vertebral body replacement device for the cervical, thoracic and lumbar spine. Titanium implants in various footprints and heights enable the surgeon to choose the configuration that is best suited to…
Category
Medical Device
Distribution
0 states
LowFDA (Drugs)·D-0048-2021·2020-10-28
ANI Pharmaceuticals Recalls Amphetamine Capsules Due to Incorrect Expiration Date
ANI Pharmaceuticals is recalling 34,968 bottles of amphetamine extended-release capsules because they were labeled with a 24-month expiration date instead of 18 months.
Product
DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE — DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE (DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE)
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-0049-2021·2020-10-28
Mylan Recalls Candesartan Cilexetil and Hydrochlorothiazide Tablets Due to Impurity
Mylan Pharmaceuticals is recalling specific lots of Candesartan Cilexetil and Hydrochlorothiazide tablets due to out-of-specification organic impurities found during routine stability testing.
Product
CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE — CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE (CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE)
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-0045-2021·2020-10-28
ANI Pharmaceuticals Recalls Amphetamine Capsules Due to Incorrect Expiration Date
ANI Pharmaceuticals is recalling 13,248 bottles of amphetamine extended-release capsules because they were labeled with a 24-month expiration date instead of 18 months.
Product
DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE — DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE (DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE)
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-0042-2021·2020-10-28
FDA Recalls Desflurane Liquid for Inhalation Due to Container Leaks
eVenus Pharmaceutical Laboratories is recalling Desflurane Liquid for Inhalation because the containers may be leaking. The recall affects 9,210 units distributed in Colorado.
Product
DESFLURANE — DESFLURANE (DESFLURANE)
Category
Drug
Distribution
1 state
LowFDA (Drugs)·D-0044-2021·2020-10-28
ANI Pharmaceuticals Recalls Amphetamine Capsules Due to Incorrect Expiration Date
ANI Pharmaceuticals is recalling specific lots of amphetamine extended-release capsules because they were labeled with a 24-month expiration date instead of 18 months.
Product
DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE — DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE (DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE)
Category
Drug
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0126-2021·2020-10-28
Invivo MR Coils Recalled for Incorrect IPX1 Water Ingress Rating Label
Invivo Corporation is recalling 12,764 MR Coils because the labels were mistakenly printed with an IPX1 rating symbol, which indicates water ingress protection.
Product
MR Coils The MR Coil is intended to be used in conjunction with a Magnetic Resonance Scanner to produce diagnostic images of the anatomy of interest that can be interpreted by a trained physician.
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Drugs)·D-0043-2021·2020-10-28
ANI Pharmaceuticals Recalls Amphetamine Capsules Due to Incorrect Expiration Date
ANI Pharmaceuticals is recalling 408 bottles of amphetamine extended-release capsules because they were labeled with a 24-month expiration date instead of 18 months.
Product
DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE — DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE (DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE)
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-0046-2021·2020-10-28
ANI Pharmaceuticals Recalls Amphetamine Capsules Due to Incorrect Expiration Date
ANI Pharmaceuticals is recalling specific lots of amphetamine extended-release capsules because they were labeled with a 24-month expiration date instead of the correct 18-month date.
Product
DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE — DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE (DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE)
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-0047-2021·2020-10-28
ANI Pharmaceuticals Recalls Amphetamine Capsules Due to Incorrect Expiration Date
ANI Pharmaceuticals is recalling specific lots of amphetamine extended-release capsules because they were labeled with a 24-month expiration date instead of the correct 18-month date.
Product
DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE — DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE (DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE)
Category
Drug
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0104-2021·2020-10-21
Roche Recalls Albumin Gen.2 Reagents Due to Cross-Contamination
Roche Diagnostics is recalling Albumin Gen.2 reagents due to cross-contamination causing low quality recovery and invalid calibrations.
Product
Albumin Gen.2, Catalog 05166861190
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0103-2021·2020-10-21
Roche Recalls Tina-quant Complement C4 Reagents Due to Quality Issues
Roche Diagnostics is recalling 180 units of Tina-quant Complement C4 reagents due to cross-contamination causing invalid calibrations.
Product
Tina-quant Complement C4 ver.2, Catalog 05991994190
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Drugs)·D-0019-2021·2020-10-14
VistaPharm Recalls Nystatin Oral Suspension Due to Impurity
VistaPharm is recalling Nystatin Oral Suspension because one lot failed impurity specifications. The affected product was distributed nationwide.
Product
NYSTATIN ORAL SUSPENSION, USP 100,000 units per mL Contains: Alcohol 0.5% v/v (Bubblegum Flavored) 16 fl. oz. (480 mL) Manufactured by: VistaPharm, Inc. Largo FL 33771, USA NDC 66689-008-16 UPC 6668900816,
Category
Drug
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0070-2021·2020-10-14
Devicor Neoprobe GDS Control Unit Recalled for Software Version Mismatch
Devicor Medical Products Inc is recalling 49 Neoprobe GDS Control Units distributed to China because the installed software version does not match the approved version.
Product
Neoprobe GDS Control Unit, Model Number NPCU3
Category
Medical Device
Distribution
0 states