Medical DeviceNov 15, 2023
Family Dollar Stores, LLC MEDIC's CHOICE CONTACT LENS SOLUTION 12FLOZ, SKU 998935 recall — FDA Z-0269-2024
Products were stored outside of labeled temperature requirements.
Class IIFDA: OngoingFamily Dollar Stores, LLC.
November 2023 recalls — page 11
These records include useful source details for the selected month.
Medical DeviceNov 15, 2023
Pulmonx Zephyr Endobronchial Valve (EBV) 5.5-LP, REF: EBV-TS-5.5-LP recall — FDA Z-0235-2024
Endobronchial implant devices may have been labeled with a shortened expiration date but they can be used until the correct expiration date: 08 December 2024.
Class IIFDA: OngoingPulmonx, Corp.
Medical DeviceNov 15, 2023
Olympus Corporation of the Americas EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS Model Number recall — FDA Z-0194-2024
There is a risk of endobronchial combustion if high-frequency cauterization is performed while supplying oxygen [and/or] the electrode section of the electrosurgical accessory is too close…
Class IFDA: OngoingOlympus Corporation of the Americas
FoodNov 15, 2023
WANABANA USA Net Weight: 2.50 oz recall — FDA F-0402-2024
North Carolina Department of Health and Human Services (NCDHHS) sampled product and found it to contain high levels of lead.
Class IFDA: TerminatedWANABANA USA LLC
FoodNov 15, 2023
Abbott Laboratories Similac Probiotic Tri-Blend - 0.017oz recall — FDA F-0328-2024
Marketed towards preterm infants without approval as a new drug or licensed biologic, as well as unsafe food additive
Class IIFDA: TerminatedAbbott Laboratories
FoodNov 15, 2023
WANABANA USA Weis CINNAMON APPLE SAUCE, Net Weight: 3.2 oz recall — FDA F-0403-2024
North Carolina Department of Health and Human Services (NCDHHS) sampled product and found it to contain high levels of lead.
Class IFDA: TerminatedWANABANA USA LLC
FoodNov 15, 2023
Cookies-n-Milk Edible Cookie Dough Chocolate Chip packaged in 6 oz plastic recall — FDA F-0325-2024
Undeclared Peanut Butter; Packaged Peanut Butter Dough in Chocolate Chip packaging.
Class IFDA: TerminatedCookies-n-Milk Inc.
FoodNov 15, 2023
Nutricia KetcoCal 4:1 LQ Unflavored in 237ml recall — FDA F-0406-2024
Incorrect product in packaging
Class IIFDA: TerminatedNutricia North America
FoodNov 15, 2023
WANABANA USA Schnucks APPLE SAUCE FRUIT POUCH, CINNAMON Net Weight: 3.2 oz recall — FDA F-0404-2024
North Carolina Department of Health and Human Services (NCDHHS) sampled product and found it to contain high levels of lead.
Class IFDA: TerminatedWANABANA USA LLC
FoodNov 15, 2023
Greenhead Lobster Products Frozen and fresh RTE Lobster meat recall — FDA F-0321-2024
Lobster meat may be contaminated with Listeria monocytogenes.
Class IFDA: TerminatedGreenhead Lobster Products LLC
DrugNov 15, 2023
LIDOCAINE HYDROCHLORIDE 1% Lidocaine HCl Injection, USP, 50mg/5mL(10mg/mL), Glass ABBOJECT recall — FDA D-0101-2024
Presence of Particulate Matter: identified as glass.
Class IFDA: TerminatedPfizer Inc.
DrugNov 15, 2023
Ranolazine Extended-Release Tablets 500mg, 60 Tablets per bottle recall — FDA D-0092-2024
Failed Dissolution Specifications: Out of specification for dissolution.
Class IIFDA: OngoingGlenmark Pharmaceuticals Inc., USA
DrugNov 15, 2023
REMEDY ANTIFUNGAL Clinical TREAT Antifungal Powder, Vanilla Scent, 3 OZ (85 g) tube, Active recall — FDA D-0091-2024
CGMP deviations: the product was shipped from the Manufacturer to a Medline warehouse and released to stock while it was still under investigation for low assay results on the active…
Class IIFDA: TerminatedMEDLINE INDUSTRIES, LP - Northfield
DrugNov 15, 2023
SYNTHROID recall — FDA D-0088-2024
Labeling: Wrong Barcode- One (1) of every forty (40) unit dose blister will contain incorrect barcode information that causes a 125mcg unit dose is scanned as 200mcg unit dose.
Class IIIFDA: OngoingAbbVie Inc.
DrugNov 15, 2023
Oxybutynin Chloride Extended-Release Tablet USP, 10 mg, 100 count bottles recall — FDA D-0097-2024
Failed Dissolution Specifications-out-of-specification (OOS) test results observed for dissolution at the 6 month long term time point.
Class IIFDA: CompletedZydus Pharmaceuticals (USA) Inc.
DrugNov 15, 2023
Montelukast Sodium Tablets, USP 10 mg recall — FDA D-0086-2024
Presence of Foreign Tablet(s)/Capsule(s): A foreign tablet was found in a bottle of Montelukast Sodium Tablets, USP 10mg, identified as metoprolol 25 mg.
Class IIFDA: TerminatedDr. Reddy's Laboratories, Inc.
DrugNov 15, 2023
Hydrocortisone 1% and Acetic Acid 2% Otic Solution USP, 10ml dropper bottle recall — FDA D-0089-2024
Failed Impurities/Degradation Specifications:Out-of-Specification result for Hydrocortisone related impurity and slightly lower than the established level of the Hydrocortisone Assay…
Class IIIFDA: TerminatedTaro Pharmaceuticals Inc.
DrugNov 15, 2023
Grato Holdings V-FORCE Homeopathic, 1 FL OZ (30 ml) per glass bottle recall — FDA D-0099-2024
Incorrect Product Formulation: product contains Active Ingredient Glandula Suprarenalis Suis 8X instead of Glandula Suprarenalis Bovine 8X (as stated on the product label).
Class IIIFDA: TerminatedGrato Holdings, Inc.
DrugNov 15, 2023
Pfizer 4.2% Sodium Bicarbonate Injection, USP 5 mEq/10 mL (0.5mEq/mL), Glass ABBOJECT Unit recall — FDA D-0100-2024
Presence of Particulate Matter: identified as glass.
Class IFDA: TerminatedPfizer Inc.
DrugNov 15, 2023
Oxybutynin Chloride Extended-Release Tablet USP, 15 mg, 100 count bottles recall — FDA D-0098-2024
Failed Dissolution Specifications-out-of-specification (OOS) test results observed for dissolution at the 6 month long term time point.
Class IIFDA: CompletedZydus Pharmaceuticals (USA) Inc.
DrugNov 15, 2023
LIDOCAINE HYDROCHLORIDE 2% Lidocaine HCl Injection, USP, 100mg/5mL(20mg/mL), Glass ABBOJECT recall — FDA D-0102-2024
Presence of Particulate Matter: identified as glass.
Class IFDA: TerminatedPfizer Inc.
DrugNov 15, 2023
Oxybutynin Chloride Extended-Release Tablet USP, 5 mg, 100 count bottles recall — FDA D-0096-2024
Failed Dissolution Specifications-out-of-specification (OOS) test results observed for dissolution at the 6 month long term time point.
Class IIFDA: CompletedZydus Pharmaceuticals (USA) Inc.
VehicleNov 13, 2023
Honda hard parts internal/mechanical recall — NHTSA campaign 23V751000
Honda (American Honda Motor Co.) is recalling certain 2015-2020 Acura TLX, 2016-2020 Acura MDX, 2016 and 2018-2019 Pilot, 2017 and 2019 Ridgeline, and 2018-2019 Odyssey vehicles. Due to a…
hard parts internal/mechanicalHonda (American Honda Motor Co.)
VehicleNov 9, 2023
Subaru of park/neutral start interlock switch recall — NHTSA campaign 23V755000
Subaru of America, Inc. is recalling certain model year 2021 Crosstrek, 2022 Forester, 2021-2023 Legacy, and Outback vehicles. An insufficient weld may allow water to enter the inhibitor…
park/neutral start interlock switchSubaru of America, 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.