Safety Recalls

15,379 recalls across FDA food, drug, and medical device recalls, CPSC consumer products, and NHTSA vehicles.

Showing 14,001–14,050 of 15,379

• Medical Device Recall · January 19, 2024

  Integra LifeSciences Corp.

  Ref No: INS7250 / Integra Cranial Access Kit. For access to the subarachnoid space or the lateral ventricles of the brain.

  A defect in the sterile packaging (header bag) of the Cranial Access Kit failing the required packaging integrity testing criteria. Therefore, product sterility maybe compromised.

  Class II

• Drug Recall · January 19, 2024

  Bestco LLC

  Family Wellness Cherry Cough Drops Menthol cough suppressant/Oral Anesthetic, 80 drops per bag, item number 20001187, Bestco, 288 Mazeppa Road, Mooresville, NC 28115

  CGMP Deviations: Potential Glass and Silicone particulates in product

  Class II

• Food Recall · January 19, 2024

  Lydia Pack 3 Inc

  Al Amir Fresh Foods Classic Hummus Creamy Garbanzo, packaged in round plastic clear container, net wt. 8oz. There are 12 containers per case. UPC on 8oz container: 7 55134 12341 4. The recalled pro

  Hummus product label declares Tahini but does not declare sesame.

  Class I

• Medical Device Recall · January 19, 2024

  STRATASYS LTD

  TrueDent Yellow, TDM140, Model No. OBJ-09169 Light-curable methacrylate-based resin that enables fabrication of dental appliances

  Customers unable to use cartridges due to formatting error in expiration date which leads to switching the day with the month. Or, the system will not recognize that a resin is expired and will not prevent the user from using an expired material.

  Class III

• Drug Recall · January 18, 2024

  SUN PHARMACEUTICAL INDUSTRIES INC

  Lurasidone Hydrochloride Tablets 60mg, Rx Only, 30 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Ltd., Su

  CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.

  Class II

• Drug Recall · January 18, 2024

  SUN PHARMACEUTICAL INDUSTRIES INC

  Zolpidem Tartrate Extended-Release Tablets, USP 12.5mg, Rx Only, 100 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical In

  CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.

  Class II

• Drug Recall · January 18, 2024

  SUN PHARMACEUTICAL INDUSTRIES INC

  Febuxostat Tablets 80 mg, Rx Only, 30 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Ltd., Survey No. 259/1

  CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.

  Class II

• Drug Recall · January 18, 2024

  SUN PHARMACEUTICAL INDUSTRIES INC

  Febuxostat Tablets 40mg, Rx Only, 30 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Ltd., Survey No. 259/15

  CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.

  Class II

• Drug Recall · January 18, 2024

  SUN PHARMACEUTICAL INDUSTRIES INC

  Zolpidem Tartrate Extended-Release Tablets, USP 6.25 mg, Rx Only, 100 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical I

  CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.

  Class II

• Consumer Product Recall · January 18, 2024

  Steamist Inc., of East Rutherford, New Jersey

  Tilt-Up Bath & Shower Seats

  The wall mounting bracket and seat rods supporting the Tilt-Up Bath & Shower Seat can corrode and break, posing fall and laceration hazards.

  Unclassified

• Consumer Product Recall · January 18, 2024

  Home Design Inc., of Silver Lake, Indiana

  Upholstered Low Profile Standard and Platform Beds

  The recalled beds can break, sag or collapse during use, posing fall and injury hazards to consumers.

  Unclassified

• Drug Recall · January 18, 2024

  SUN PHARMACEUTICAL INDUSTRIES INC

  Fexofenadine Hydrochloride Tablets, USP 180mg, Antihistamine, Allergy, 24 hour, a) 30 Tablets per bottle, NDC 51660-998-30; Distributed by: Ohm Laboratories Inc., New Brunswick, NJ 08901, Made in Indi

  CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.

  Class II

• Drug Recall · January 18, 2024

  Dr. Reddy's Laboratories, Inc.

  Glimepiride Tablets, USP 1mg, 500-count bottles, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Srikakulam-532 409 INDIA, NDC: 55111-320-05

  Misprint on tablet

  Class III

• Drug Recall · January 18, 2024

  SUN PHARMACEUTICAL INDUSTRIES INC

  Mesalamine Delayed-Release Tablets, USP 1.2 g per tablet, Rx Only, 120 Tablets per bottle, Once Daily, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pha

  CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.

  Class II

• Drug Recall · January 18, 2024

  SUN PHARMACEUTICAL INDUSTRIES INC

  Cinacalcet Tablets 60mg, Rx Only, 30 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Limited Survey No. 259/

  CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.

  Class II

• Drug Recall · January 18, 2024

  SUN PHARMACEUTICAL INDUSTRIES INC

  Lurasidone Hydrochloride Tablets 120mg, Rx Only, 30 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Ltd., S

  CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.

  Class II

• Drug Recall · January 18, 2024

  SUN PHARMACEUTICAL INDUSTRIES INC

  Niacin Extended-Release Tablets, USP 500mg, Rx Only, 90 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Limi

  CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.

  Class II

• Drug Recall · January 18, 2024

  SUN PHARMACEUTICAL INDUSTRIES INC

  Niacin Extended-Release Tablets, USP 1000mg, Rx Only, 90 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Lim

  CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.

  Class II

• Drug Recall · January 18, 2024

  Dr. Reddy's Laboratories, Inc.

  Glimepiride Tablets, USP 1mg, 100-count bottles, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Srikakulam-532 409 INDIA, NDC: 55111-320-01

  Misprint on tablet

  Class III

• Food Recall · January 18, 2024

  Whitley Peanut Factory, Inc.

  Whitley's Peanut Factory, Deluxe Nut Mix, 12oz (340g), Electrolytic tin-plated cans, with paper label. 12-pack case boxes.

  Undeclared Allergen (peanuts, milk, soy, wheat, and sesame).

  Class II

• Food Recall · January 18, 2024

  UNFI General Corporate

  Woodstock 5 Grain Cereal. Oats, Rye, Triticale, Barley, Golden Flax. Net Wt. 18.5 oz (1 lb 2.5 oz) 524g. UPC 0 42563-01772 9. Distributed by Woodstock, 313 Iron Horse Way, Providence, RI 02908.

  The ingredient Triticale is not identified as wheat.

  Class II

• Consumer Product Recall · January 18, 2024

  Anhui Zhongqinghonyu Home Textile Technology Co. LTD, of China

  Bokser Home 100% Cotton Mattress Pads

  The recalled mattress pads violate the mandatory federal flammability regulation for mattress pads, posing a fire hazard.

  Unclassified

• Food Recall · January 17, 2024

  Hans Kissle Company, LLC

  MEXICAN STYLE QUINOA SALAD

  contains undeclared soy and egg

  Class I

• Drug Recall · January 17, 2024

  Henry Schein Inc. and Glove Club HSI Gloves Inc.

  Adrenalin (epinephrine) Injection 1mg/mL, 1mL single dose vial, Rx only, Packaged By: Henry Schein, Inc., 80 Summit View Lane, Bastian, VA 24314, Original NDC 42023-159-25 Repack NDC 0404-9810-01

  Labeling: Incorrect or Missing Lot and/or Exp Date. The expiration date listed on the Repack Pouch Label is incorrect.

  Class II

• Medical Device Recall · January 17, 2024

  ConvaTec, Inc

  ConvaTec Natura Stomahesive Post-Operative / Surgical Ostomy System, REF 416938, 1 3/4 in. 45mm, Sterile.

  The kit contains a flange that has a 45mm coupling ring, however, the pouch within the kit is for a 57mm coupling ring.

  Class II

• Medical Device Recall · January 16, 2024

  Olympus Corporation of the Americas

  Water Filter MAJ-2318. This MAJ-2318 water filter has been designed to be used with Olympus endoscope reprocessor for prevent contamination of the rinse water. The MAJ-2318 water filter is compatible

  Water filter may have been assembled incorrectly, resulting in unfiltered tap water being used for reprocessing. This may expose a patient to a potentially contaminated device, presenting a risk of infection or sepsis.

  Class II

• Medical Device Recall · January 16, 2024

  Maquet Medical Systems USA

  Model No. BEQ-HLS 5050 USA, HLS Set Advanced 5.0, Product Code/Part Number 70106.9077. Used with the CARDIOHELP heart-lung machine.

  The Emergency Priming Line, a component of the HLS Set, may have a compromised sterile barrier due to nonconformities at the bag seal. This issue may result in inflammation, sepsis, or infection.

  Class II

• Medical Device Recall · January 16, 2024

  Avanos Medical, Inc.

  MIC* Gastric-Jejunal Feeding Tube, Endoscopic/Radiologic Placement, GJ-Tube: a) MIC* Gastric-Jejunal Feeding Tube Kit - Endoscopic/Radiologic Placement - 16 Fr, Product Code 0250-16; b) MIC* Gastri

  MIC* Gastric - Jejunal Feeding Tube Kits contain a sterile pre-filled syringe subsequently recalled by Nurse Assist.

  Class I

• Food Recall · January 16, 2024

  Alfred Louie Inc

  Pan Fry Noodle Fresh Noodles, Alfred Louie, Inc. 24 Lb. cartons, Keep Refrigerated. Deep Fry Noodle Fresh Noodles, Alfred Louie, Inc. 40Lb cartons, Keep Refrigerated.

  Undeclared allergen, wheat, from not declaring sub-ingredients of enriched flour.

  Class II

• Drug Recall · January 16, 2024

  Ascend Laboratories, LLC

  Fosfomycin Tromethamine Granules for Oral Solution, (equivalent to 3 grams of fosfomycin), single-dose sachet, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA. Distributed by: Ascend Laborato

  Failed Impurities/Degradation Specification: Out of specification for organic impurities

  Class II

• Medical Device Recall · January 16, 2024

  Avanos Medical, Inc.

  MIC* Gastric-Jejunal Feeding Tube with ENFit Connectors: a) MIC* Gastric-Jejunal Feeding Tube Kit with ENFit Connector - Endoscopic/Radiologic Placement - 16 Fr, Product Code 8250-16; b) MIC* G

  MIC* Gastric - Jejunal Feeding Tube Kits contain a sterile pre-filled syringe subsequently recalled by Nurse Assist.

  Class I

• Drug Recall · January 16, 2024

  Den-Mat Holdings, LLC

  Hydrogen Peroxide Oral Rinse, Significantly Reduces Bacteria, Fresh Mint Flavor, Alcohol Free, a)16 fl. oz. (473 mL) bottle, NDC 59883-202-16, UPC 3 59883 00009 7); b) 64 fl. oz. (1.89 L) bottle, NDC

  CGMP Deviations: products may not conform to the labeled specifications.

  Class II

• Medical Device Recall · January 16, 2024

  Maquet Medical Systems USA

  BEQ-HLS 7050 USA, HLS Set Advanced 7.0, Product Code/Part Number 70106.9078. Used with the CARDIOHELP heart-lung machine.

  The Emergency Priming Line, a component of the HLS Set, may have a compromised sterile barrier due to nonconformities at the bag seal. This issue may result in inflammation, sepsis, or infection.

  Class II

• Drug Recall · January 16, 2024

  Den-Mat Holdings, LLC

  OralProCare medicated lip treatment, Net Wt 9.9 g (0.35 oz) tube, Ethyl alcohol 6.0% Antibacterial, Manufactured by: Den-Mat Holdings, LLC, Lompoc, CA, 93436, USA, NDC 59883-500-01, UPC: 3 59883 00000

  CGMP Deviations: products may not conform to the labeled specifications.

  Class II

• Medical Device Recall · January 16, 2024

  Olympus Corporation of the Americas

  InstaClear Lens Cleaner-indicated for use during routine diagnostic procedures and during endoscopic sinus surgery. Model Number: LCS1500UNOL LCS1800UNST LCS4K00UNOL LCS1530BTOL LCS1830BTST LCS

  Japanese IFU version had slightly different language and illustrations from the English IFU, which could contribute to the tip and plate falling off. In order to maintain consistency globally, the Japanese IFU will be updated to reflect the instructions in the English IFU

  Class II

• Medical Device Recall · January 16, 2024

  W&H DENTALWERK BUERMOOS GMBH

  W&H Surgical handpiece S-12. For Surgical treatment of dental hard tissue Model Number: 30061000

  1:2 speed increasing surgical handpieces have been incorrectly laser marked during production. The specific laser marking should read 1:2, but instead it reads 1:1 on the body of the handpiece

  Class II

• Medical Device Recall · January 15, 2024

  Medical Action Industries, Inc. 306

  IV Start Kit, containing 1 Saline Syringe 5ml, REF 74654, 100 kits/case, Sterile.

  The kits contain saline flush syringes which were recalled by the supplier.

  Class II

• Drug Recall · January 15, 2024

  Amneal Pharmaceuticals of New York, LLC

  Phenoxybenzamine Hydrochloride Capsules, USP 10mg, 100-count bottle, Rx only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd, Oral Solid Dosage Unit, Ahmedabad 382213, India, Distributed by: Amneal

  Failed Impurities/Degradation Specifications: Out of specification for unknown impurity.

  Class II

• Medical Device Recall · January 15, 2024

  D.O.R.C. Dutch Opthalmic Research Center Intl B.V.

  Directional Laser Probe with Alcon / Lumenis connector (23 gauge / 0.6 mm)

  When using those products you may experience difficulties to extend or retract the laser fiber, and in some occasions may also have difficulties to direct the laser fiber tip precisely.

  Class II

• Medical Device Recall · January 15, 2024

  D.O.R.C. Dutch Opthalmic Research Center Intl B.V.

  Directional Laser Probe with Alcon / Lumenis connector (27 gauge / 0.4 mm)

  When using those products you may experience difficulties to extend or retract the laser fiber, and in some occasions may also have difficulties to direct the laser fiber tip precisely.

  Class II

• Medical Device Recall · January 15, 2024

  D.O.R.C. Dutch Opthalmic Research Center Intl B.V.

  Directional Laser Probe with Alcon / Lumenis connector (25 gauge / 0.5 mm)

  When using those products you may experience difficulties to extend or retract the laser fiber, and in some occasions may also have difficulties to direct the laser fiber tip precisely.

  Class II

• Food Recall · January 14, 2024

  8TH AVE PHARMACY

  Notoginseng Formula Special Gout Granule; 100% Natural; 8 G x 10 PACKS; CITI TRADE INT'L LIMITED; ADDRESS: 3/FINTERNATIONAL PLAZA 20 SHEUNG YUET RD, KOWLOON BAY, KOWLOON; "Nourish and helps the kidney

  Product contains undeclared Diclofenac and Dexamethasone Acetate

  Class II

• Food Recall · January 12, 2024

  Bluebonnet Nutrition Corporation (Dairy Ashford)

  EarthSweet¿ Chewables CellularActive¿ Methylfolate 1000 mcg; 90 chewable tablets packaged in an amber glass botte with purple lid

  Label error during reprint. Says 1000 mg instead of 1000 mcg on the center front panel of the label.

  Class III

• Food Recall · January 12, 2024

  United Natural Trading Inc. dba Woodstock Farms

  Odds & Ends Organic Chocolate Fruit & Nut Mix 14oz. plastic resealable bags . 12/14oz bags per case.

  Product contains stem / vegetation foreign material.

  Class II

• Drug Recall · January 12, 2024

  Golden State Medical Supply Inc.

  Budesonide Extended-Release Tablets, 9 mg, 30-count bottles, Rx only, Marketed by: GSMS, Incorporated, Camarillo, CA, UPC 5140782430, NDC 51407-824-30

  Failed Dissolution Specifications

  Class II

• Medical Device Recall · January 12, 2024

  3M Company - Health Care Business

  3M Specialty Blade Assembly, REF 9660,70-2011-8491-1, 7100213026, used with used with 3M Surgical Clipper Catalog Number 9661L

  3M has added the following cautionary statement regarding the use of the product: "Caution - To reduce the risk of burns, which if not avoided may result in minor injury: " Do not use on injured skin. " Do not leave clipper running unused in air without applying to skin for more than 1 minute as blade temperature may exceed 41¿C (105.8¿F). " Do not leave the clipper blade applied to the same location on the patient s skin for longer than 1 second as potential injury may occur; continuous motion of the clipper during use is required. Note: If clipper is left running unused in air for 10 minutes without applying to skin, the Model 9690 blade maximum temperature may reach 60¿C (140¿F) and the Model 9660 blade maximum temperature may reach 77¿C (170.6¿F)."

  Class II

• Drug Recall · January 12, 2024

  Neptune Resources, LLC

  Neptune's Fix, Tianeptine Tablets Extended Relief, Twenty Tablets per Box, Wide Awake, 3000 mg (150 mg Per Tablet), Distributed By Neptune Resources, LLC, 30 N. Gould Street, Ste R, Sheridan, WY 82801

  Marketed without an approved NDA/ANDA: Product contains tianeptine, a substance not FDA-approved for any medical use in the United States.

  Class I

• Drug Recall · January 12, 2024

  IntegraDose Compounding Services LLC

  Vasopressin 2 Unit/2 mL in 0.9% Sodium Chloride, 2 mL per syringe, Rx Only, 719 Kasota Ave SE, Minneapolis, MN. NDC 71139-0190-1

  Subpotent Drug

  Class II

• Medical Device Recall · January 12, 2024

  3M Company - Health Care Business

  3M Specialty Blade Assembly, REF 9660,70-2011-8462-2, 7100213114, used with used with 3M Surgical Clipper Catalog Number 9661L

  3M has added the following cautionary statement regarding the use of the product: "Caution - To reduce the risk of burns, which if not avoided may result in minor injury: " Do not use on injured skin. " Do not leave clipper running unused in air without applying to skin for more than 1 minute as blade temperature may exceed 41¿C (105.8¿F). " Do not leave the clipper blade applied to the same location on the patient s skin for longer than 1 second as potential injury may occur; continuous motion of the clipper during use is required. Note: If clipper is left running unused in air for 10 minutes without applying to skin, the Model 9690 blade maximum temperature may reach 60¿C (140¿F) and the Model 9660 blade maximum temperature may reach 77¿C (170.6¿F)."

  Class II

• Food Recall · January 12, 2024

  Wegmans Food Markets, Inc.

  Ready To Bake Double Chocolate Croissant (UPC 87-85300-05006-2)

  Product contains undeclared soy lecithin.

  Class II