Archive
460 recalls were announced in January 2023.
Of the 460 recalls this month scored against our rubric, 1% are Critical, 10% are Severe.
Which agencies issued them
Cardinal Health recalls Jackson-Pratt Channel Drains (15 Fr) due to performance issues: broken tips, dull trocars, lack of radiopacity, and reduced flexibility affecting surgical wound drainage.
Klosterman Baking Company is recalling approximately 109,343 units of Sour Dough bread products due to insanitary production conditions. Products were distributed in Indiana, Ohio, and Tennessee.
Cardinal Health is recalling 750 units of Jackson-Pratt Channel Drains (10 mm) due to multiple performance issues including broken drain tips, lack of radiopacity, dull trocars, and reduced flexibility that could affect surgical outcomes.
Amerisource Health Services is recalling Rifampin Capsules USP 300 mg nationwide due to failed impurities and degradation specifications. Affected patients should contact their healthcare provider before using remaining inventory.
Klosterman Baking Company recalls seeded bread and bun products held under insanitary conditions. 109,343 units were distributed in Indiana, Ohio, and Tennessee.
Akorn, Inc. is voluntarily recalling over 2 million bottles of Tobramycin Ophthalmic Solution due to Current Good Manufacturing Practice deviations affecting four product lots distributed nationwide.
Cardinal Health is recalling Jackson-Pratt Channel Drains due to performance defects including dull trocars, broken tips, and radiopacity issues. 921 units affected worldwide.
Akorn, Inc. is recalling 36,455 cartons of Erythromycin Ophthalmic Ointment USP 0.5% nationwide due to manufacturing process deviations. The company voluntarily initiated this Class II recall.
Akorn, Inc. is voluntarily recalling Betaxolol ophthalmic solution (6,273 bottles, lot 1A08A, exp. 12/31/2022) due to manufacturing deviations. Consumers should consult their healthcare provider.
Bolton Medical has recalled 640 units of RELAY PRO thoracic stent-graft systems worldwide because the products may be shorter than their packaging indicates.
Akorn, Inc. is recalling 163,996 bottles of Olopatadine HCl Ophthalmic Solution 0.1% due to manufacturing process deviations. Affected lot numbers expire from October through December 2023.
Akorn, Inc. is voluntarily recalling 967,075 bottles of Artificial Tears Solution eye drops nationwide due to manufacturing process deviations identified during quality inspections.
Akorn, Inc. is recalling 2,082 tubes of Neomycin and Polymyxin B Sulfates, and Bacitracin Zinc Ophthalmic Ointment nationwide due to manufacturing process deviations. The recall is voluntary and initiated by the manufacturer.
Intersect ENT, Inc. is recalling 9,898 pouches of SINUVA sinus implants nationwide after detecting failed drug release specifications during stability testing. The implant may not deliver the medication as intended.
Akorn, Inc. is voluntarily recalling 51,601 bottles of PAREMYD eye medication nationwide due to manufacturing process deviations. The firm initiated the recall in October 2022.
Akorn, Inc. is recalling 1,752 bottles of Olopatadine HCL Ophthalmic Solution, USP 0.1% nationwide due to manufacturing quality control deviations. Lot 1L03A with expiration 10/31/2023 is affected.
Akorn, Inc. is recalling Proparacaine Hydrochloride Ophthalmic Solution due to manufacturing process deviations. The voluntary recall affects 23,026 bottles distributed nationwide.
Akorn, Inc. is recalling Olopatadine HCl Ophthalmic Solution due to manufacturing process deviations. The nationwide voluntary recall involves 121,176 bottles distributed across the United States.
Lannett Company is recalling Triamterene and Hydrochlorothiazide Capsules nationwide because the medication failed quality testing for impurity and degradation specifications. The recall affects 20,040 bottles.
Akorn, Inc. is recalling Ofloxacin Ophthalmic Solution 0.3% due to manufacturing quality deviations. The recall affects 65,006 bottles distributed nationwide.
Fisher Scientific voluntarily recalls HSANI500ML hand sanitizer (75% isopropyl alcohol) due to manufacturing practice deviations. The product was made under expired temporary FDA approval.
Akorn, Inc. is recalling 91,692 bottles of Tobramycin Ophthalmic Solution (0.3%) nationwide due to Current Good Manufacturing Practice deviations. The voluntary recall was initiated on October 13, 2022.
Akorn, Inc. is voluntarily recalling 2,369,258 tubes of Lidocaine Hydrochloride Jelly due to manufacturing quality deviations. The product, distributed nationwide, is available in 5 mL and 30 mL prescription-only tubes.
Akorn voluntarily recalled 196,254 bottles of GONAK ophthalmic solution nationwide due to CGMP manufacturing practice deviations. This professional-use eye solution is employed in gonioscopic examinations.
Klosterman Baking Company is recalling rye bread products held under insanitary conditions. Approximately 109,343 units were distributed to Indiana, Ohio, and Tennessee between December 12–16.
Klosterman Baking Company recalled focaccia bread held under insanitary conditions. The recall affects approximately 109,343 units distributed in Indiana, Ohio, and Tennessee.
Akorn, Inc. has voluntarily recalled 524,506 tubes of Sodium Chloride Ophthalmic Ointment, USP 5%, nationwide due to Current Good Manufacturing Practice deviations.
Akorn, Inc. recalls 1.1 million tubes of Erythromycin Ophthalmic Ointment nationwide due to manufacturing deviations. The voluntary, Class II recall was initiated by the firm.
Klosterman Baking Company is recalling garlic bread rolls and breadsticks held under insanitary conditions. Approximately 109,343 units were distributed in Indiana, Ohio, and Tennessee from December 12-16.
Klosterman Baking Company recalls 109,343 loaves of Cuban bread held under insanitary storage conditions. The affected products were distributed in Indiana, Ohio, and Tennessee between December 12 and 16.
Klosterman Baking Company is recalling ciabatta bread rolls distributed to Indiana, Ohio, and Tennessee because they were held under insanitary conditions. Consumers should dispose of affected products.
Lannett Company is recalling Triamterene and Hydrochlorothiazide Capsules nationwide because certain lots failed impurity and degradation quality specifications. Consumers taking affected lots should consult their pharmacist or physician.
Akorn, Inc. is recalling 2,563 bottles of Moxifloxacin Ophthalmic Solution nationwide due to manufacturing deviations. The recall is voluntary and affects lot 1E28A with expiration date 4/30/2023.
Akorn, Inc. is recalling 188,550 bottles of Cromolyn Sodium Ophthalmic Solution nationwide due to manufacturing quality control deviations.
Klosterman Baking Company recalls Old World brand blueberry bagels due to products being held under insanitary conditions. Approximately 109,343 units were distributed to Indiana, Ohio, and Tennessee.
R&D Systems is recalling one lot of CBC-3D Hematology Control due to potential microbial contamination that may cause hemolysis or deterioration in the Normal control level.
Akorn, Inc. is recalling Levofloxacin Ophthalmic Solution due to manufacturing process deviations. The voluntary recall affects 3,108 bottles distributed nationwide.
Fisher Scientific voluntarily recalls hand sanitizer due to manufacturing deviations. The recall affects products distributed after March 31, 2022.
Macleods Pharma USA recalls Levofloxacin Tablets 500 mg due to mismatched embossing on tablets versus the package insert labeling. The distributed bottles do not match the documented tablet markings.
Klosterman Baking Company is recalling approximately 109,343 Everything bagels distributed in Indiana, Ohio, and Tennessee because products were held under insanitary conditions.
Klosterman Baking Company is recalling cornmeal buns due to insanitary storage conditions. About 109,343 units distributed in IN, OH, and TN between December 12-16 are affected. No illnesses have been reported.
Olopatadine HCl Ophthalmic Solution 0.2% manufactured by Akorn, Inc. is being recalled nationwide due to Current Good Manufacturing Practice (CGMP) deviations affecting 173,928 bottles.
Abbott Laboratories recalled 70 cases of Alinity Reaction Vessels due to potential contamination that could affect optical performance. Units were distributed across multiple U.S. states.
Akorn, Inc. is recalling 1,584 bottles of Ciprofloxacin Ophthalmic Solution nationwide due to Current Good Manufacturing Practice (CGMP) deviations. This is a voluntary recall.
Klosterman Baking Company is recalling certain white bread and bun products due to storage under insanitary conditions. The recall affects products distributed in Indiana, Ohio, and Tennessee between December 12-16, 2022.
Klosterman Baking Company is recalling breads and buns distributed in Indiana, Ohio, and Tennessee due to products being held under insanitary conditions.
Autocar is recalling specific trucks because a worn parking brake valve may cause the brake to release unexpectedly, increasing the risk of a crash.
Mack Trucks is recalling 2019 and 2021-2023 LRBE electric trucks because a failing cabin heater relay can cause the coolant heater to overheat, increasing the risk of fire.
Autocar is recalling 2021-2023 Xpeditor natural gas vehicles due to a software error in the instrument cluster fuel gauge. The inaccurate fuel gauge may cause the vehicle to unexpectedly run out of fuel and stall, increasing crash risk.
Alamo Group is recalling 2018-2021 AllVac AVRB-18 vehicles because vibration can crack exhaust silencer welds, causing the silencer to detach and create a road hazard.
Certain 2022-2023 Isuzu, Chevrolet, and Hino commercial vehicles with improperly calibrated ABS and optional ADAS camera systems are being recalled. The miscalibration could prevent the automatic emergency braking and electronic steering control systems from functioning properly, increasing crash risk.
Ford is recalling 2021 Lincoln Aviators with 360-degree camera systems because the rearview camera video may fail to display, reducing driver rear visibility and increasing crash risk.
Ford is recalling certain 2023 Bronco Sport vehicles because valves inside the ABS module may have been damaged during manufacturing, causing an internal leak. This can lead to unexpected brake pedal travel or unexpected movement, increasing crash risk.
Autocar is recalling certain 2020-2023 Xpeditor vehicles because the external sun visor may obstruct roof-mounted clearance lights. The obstruction may increase crash risk.
Volvo Trucks is recalling 2019-2023 VNRE electric trucks because a faulty cabin heater relay may cause the coolant heater to overheat, increasing the risk of fire.
Subaru is recalling 2022 WRX vehicles with Eyesight because the owner's manual contains incorrect instructions for adjusting the High Beam Assist function. Owners will receive a corrected manual insert by mail.
Forest River is recalling 2016-2017 Ameralite Cargo trailers because welded drawbars may fracture, increasing crash risk.
Forest River Bus is recalling certain 2021 Berkshire coaches due to a faulty retractable awning that may extend unintentionally while the vehicle is in transit. The unintended extension could distract the driver or become a road hazard, increasing the risk of a crash.
Volvo is recalling 27,457 2023 vehicles because a software error may disable ABS, ESC, and traction control, increasing crash risk.
Selfie Craft Company children's pajama sets fail to meet federal flammability standards for sleepwear, posing a burn injury risk. About 38,740 units sold online and in boutiques from November 2017 through June 2022 are affected.
NewCosplay branded children's sleepwear fails to meet federal flammability standards, posing a burn risk. About 780 units sold on Amazon from November 2021 through May 2022 are subject to recall.
Ross Stores is recalling about 5,800 Taylor and Finch six-wick scented candles because they can combust while lit, causing the glass container to break and posing fire and injury hazards. Ross has received five reports of combustion, including one report of minor injury.
Vaenait Baby children's robes fail federal flammability standards for sleepwear, posing a burn injury risk. About 2,400 robes sold nationwide between December 2019 and June 2022 are affected.
Meguiar's is recalling about 140,000 units of Heavy Duty Headlight Sealant because the packaging does not meet federal child-resistant requirements. Young children could be poisoned if they swallow the contents.
NewCosplay children's sleepwear fails to meet federal flammability standards, posing a burn risk to children. About 3,300 units sold online at Amazon from October 2021 through May 2022.
About 2,140 units of NewCosplay children's sleepwear fail to meet federal flammability standards and pose a burn injury risk. The recalled garments were sold on Amazon from October 2021 through May 2022.
Hainan Chong Yu Industrial's NewCosplay children's sleepwear fails federal flammability standards and poses a burn injury risk. About 2,360 units sold on Amazon from October 2021 through May 2022 are affected.
Weihai Juanhai Decoration Material's NewCosplay children's sleepwear fails to meet federal flammability standards, posing a burn risk. About 280 units were sold on Amazon between December 2021 and May 2022.
Sakar International is recalling about 33,100 Credhedz Lizard, Crayola Dry-Erase, and Tony Hawk multi-purpose helmets because they do not meet federal safety standards for positional stability and retention, posing a risk of head injury in a crash.
Lifetime Brands has recalled about 2,700 hot chocolate pots sold at Williams-Sonoma because they are mislabeled as microwave safe. If microwaved, the metallic paint can spark and cause a fire.
USDA issued a public health alert for Hy-Vee beef pot roast entrées because the gravy may contain undeclared wheat. Consumers with wheat allergies should not eat these products.
Ove Decors' Vanessa 42-inch fire tables are recalled because the gas hose can melt when contacting the heat shield, causing the table to catch fire. About 470 units sold online from April 2020 through October 2022.
NewCosplay long-sleeved children's sleepwear fails to meet federal flammability standards and poses a burn hazard. The recalled garments were sold exclusively on Amazon from October 2021 through May 2022.
General Motors is recalling certain 2021-2022 Chevrolet Equinox and 2022 GMC Terrain vehicles because the fuel pump module may not provide sufficient fuel to the engine, causing it to stall and increasing crash risk.
Silicone foam in some Philips Garbin Ventilators may separate and block the air inlet, reducing therapy volume and causing alarms. Nine units are affected.
Silicone sound abatement foam in some Philips Trilogy 100 ventilators may separate and block the air inlet, potentially reducing delivered therapy volume or pressure and causing device alarms.
Covidien LP is recalling Mahurkar dialysis catheters for a potential leaking condition in the hub that may cause unanticipated fluid return during use. Over 359,000 units are affected worldwide.
Emergent Protective Products USA Inc recalls RSDL Decontamination Lotion Kits due to complaints of leaking packets. Approximately 4,000 units were distributed to Virginia, Canada, and Switzerland.
Silicone foam in some Philips Trilogy 100 and 200 ventilators may separate and block the air inlet, potentially reducing therapy delivery. This is an FDA Class I recall.
Philips is recalling fetal spiral electrodes used for labor monitoring because the spiral tip can break off during use, requiring surgery to remove the fragment from the newborn.
Sanders Candy LLC recalls Sanders Milk Chocolate Sea Salt Pecan Cluster due to foreign material—pieces of cleaning brush bristles—found in the product. The recall affects nearly 1 million units distributed nationwide and in Canada.
DeRoyal is recalling certain surgical procedure packs containing Medtronic non-absorbable sutures due to a manufacturing error that may breach the sterile barrier protecting the surgical field.
Vital Care Products' Neonatal PICC Tray kits may have pinhole leaks in the outer bag near the seal, potentially compromising sterility. Affected units were distributed nationwide.
Sanders Candy LLC is recalling Sanders Milk Chocolate Sea Salt Caramels due to potential cleaning brush bristles contamination. The product poses a choking and injury hazard.
Medtronic Neuromodulation is recalling 440 units of the Vanta/Seqenita LT Clinician Programmer Application due to software anomalies causing error messages that interfere with device control. Affected units were distributed worldwide.
International Medical Industries recalls 228,000 Prep-Fill Guarded Luer Connectors due to unsealed blister packages compromising product sterility. The Class II recall affects medical devices distributed nationwide.
TOHATO Nagewa Snack Salty Taste products are recalled for containing undeclared milk allergen (sodium caseinate). The recall affects 11,989 units distributed to Daiso stores in California, Washington, Nevada, Texas, New York, New Jersey, and Canada.
Stradis Healthcare is recalling approximately 1,175 Tacy Medical fluid filter transfer kits due to potential pinhole leaks in the outer bag that may compromise sterility. The kits were distributed nationwide in nine states.
Sanders Candy LLC is recalling Sanders Dark Chocolate Maple Sea Salt Caramel due to brush bristles found in the product. Consumers should not consume affected units.
Pietrzyk Foods is recalling The Holy Gouda Pierogi due to undeclared soy lecithin. Consumers with soy allergies should not consume this product.
Northern VA Compounders is recalling TriMix Injection due to lack of assurance of sterility. The affected lot (11142022@11, exp. 12/29/2022) was distributed nationwide. No illnesses have been reported.
Northern VA Compounders recalls TriMix Injectable due to lack of sterility assurance in 8 vials distributed nationwide. Patients should consult their healthcare provider about affected doses.
Ventana Medical Systems recalled 8,927 VENTANA PD-L1 (SP142) Assay kits worldwide due to light staining that can cause false-negative immunotherapy marker test results affecting cancer treatment decisions.
Stradis Healthcare is recalling McCormick Medical Distribution PORT TRAY units due to potential pinhole leaks in the outer bag that could compromise sterility. Affected units were distributed nationwide.
RED SUN TARO FLAVOR POWDER is recalled due to undeclared milk (sodium caseinate) and incorrect color additive labeling. The product was distributed in Iowa and may pose a risk to consumers with milk allergies.
Stradis Healthcare recalls 76,260 HCT 6 CC Syringe Kits due to potential pinhole leaks in outer packaging that may compromise sterility. The kits were distributed nationwide.
Northern VA Compounders is recalling QuadMix Plus injectable medication due to lack of assurance of sterility. The recall affects 78 vials distributed nationwide.
Stradis Healthcare is recalling HCT MAX BARRIER PICC Insertion Trays due to potential pinhole leaks in the outer bag that may compromise sterility. No illnesses have been reported, but affected healthcare facilities should immediately discontinue use of the affected lot.
Sanders Dark Chocolate Peppermint Sea Salt Caramel is recalled nationwide and in Canada due to contamination with cleaning brush bristles. Products with Best By dates from October and December 2023 are affected.
Medtronic recalls the Vanta/Seqenita LT Clinician Programmer Application due to software anomalies generating error messages that may affect device operation. The recall affects 22 units distributed worldwide.
Looking for a different month? Back to 2023.