2024 Product Recalls

4,022 recalls issued in 2024.

4,022
Total Recalls
657
FDA Drug
55
USDA
305
CPSC
FDA Drug 657 USDA 55 CPSC 305 FDA Device 527 NHTSA 1,077 FDA Food 1,401

Showing 4001–4020 of 4,022 recalls

FDA Class II

Ricola CherryHoney Herb Throat Drops (menthol, 1.8 mg), 10 Drops per roll, Manufacturer: Ricola Ltd., 4242 Laufen, Switzerland; Distributed by: Ricola USA Inc., 6 Campus Drive, 2nd Floor South, Parsippany, NJ 07054. NDC: 54305-507-10

CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
FDA Class II

Ipratropium Bromide and Albuterol Sulfate Inhalation Solution (0.5 mg/3 mg per 3 mL), 60 x 3 mL Sterile Unit-Dose Vials (2 pouches of 30 - 3 mL vials each), Manufactured By: The Ritedose Corporation, Columbia, SC 29203; Distributed By: Cipla USA Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059. NDC: 69097-840-64

CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
FDA Class II

Dicyclomine Hydrochloride Tablets, USP 20 mg, 100 Tablets, Rx only, Manufactured For: Teva Pharmaceuticals USA, Parsippany, NJ 07054. NDC: 0591-0795-01

CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
FDA Class II

Meloxicam Tablets, USP, 15 mg, 1000 Tablets per bottle, Rx Only, Manufactured by: Cipla Ltd., Kurkumbh, India; Manufactured for: Cipla USA, Inc., 9100 S. Dadeland Blvd., Suite 1500 Miami, FL 33156. NDC: 69097-159-15

CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
FDA Class II

CHLORTHALIDONE Tablets, USP, 25MG, 1000 Tablets, Rx only, Manufactured by: Appco Pharma LLC, Piscataway, NJ 08854 USA; Manufactured For: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540 USA. NDC: 43598-719-10

CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
FDA Class II

Asmanex Twisthaler (mometasone furoate inhalation powder, 220 mcg per actuation), 120 Metered Doses, Rx only, Manufactured for: Organon LLC, a subsidiary of Organon & Co., Jersey City, NJ 07302; Manufactured by: MSD International GmbH (Singapore Branch) Singapore 638030, Singapore. NDC: 78206-114-01

CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
FDA Class II

Jardiance (empagliflozin tablets), 25 mg, 30 tablets (3 blister cards with 10 tablets each), Rx only, Distributed by: Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT 06877. NDC: 0597-0153-37

CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
FDA Class II

CITALOPRAM Tablets, USP, 20MG, 100 Tablets, Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 USA. NDC: 0378-6232-01

CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
FDA Class II

FOLIC ACID TABLETS, USP, 1MG, 100 Tablets per bottle, Rx Only, Manufactured by: Leading Pharma, LLC, Fairfield, NJ 07004. NDC: 69315-127-10

CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
FDA Class II

ALBUTEROL SULFATE IN 90MCG per actuation, 200 Metered Inhalations, Rx Only, 8.5 g Net Contents, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202; Manufactured by: Lupin Limited, Pithampur (M.P.) 454 775, India. NDC: 68180-963-01

CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
FDA Class II

ALBUTEROL SULFATE HFA Inhalation Aerosol, 90MCG per actuation, 200 Metered Inhalations, Net Wt. 18 g, Rx Only, Manufactured for: Prasco Laboratories, Mason, OH 45040 USA. NDC: 66993-019-68

CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
FDA Class II

B-Complex, Thiamine HCI / Riboflavin / Niacinamide / Dexpanthenol / Pyridoxine HCI injection, 74/2/75/2/2 MG/ML, 30ML Sterile Multiple-Dose Vial, Rx only, AnazaoHealth, 7465 W Sunset Rd #1200, Las Vegas, NV 89113, NDC 72682-2230-3

Presence of Particulate Matter.
FDA Class III

'Rong Shing' Dried Peach; 6 oz; packaged in a clear plastic bottle; store at room temperature; UPC 6950296800195

Product contains undeclared cyclamates.
FDA Class II

EGG CUSTARD PIE, NET WT 25 OZ (1 LB 9 OZ) 709 g, packaged in paper carton with plastic film window, 6 cartons per case.

Undeclared Tree Nut (Coconut)
USDA Class I

Fratelli Beretta USA, Inc. Recalls Busseto Foods Brand Ready-to-Eat Charcuterie Meat Products Due to Possible Salmonella Contamination

Product Contamination
FDA

Milex Gellhorn Flexible under the following labels: 1) Gellhorn Flexible w/Short Stem Pessary, REF MXKPGSS2-1/4, 2-1/4" (57 mm) with Kit, 2) Gellhorn Flexible w/Short Stem Pessary, REF MXPGSS2-1/4, 2-1/4" (57 mm) without Kit, 3) Gellhorn Flexible w/Short Stem Pessary, REF MXPGSS2-3/4, 2-3/4" (70 mm)

The affected Milex Gellhorn pessaries were incorrectly manufactured with a long stem (2.170 ), instead of a short stem (1.670 or 1.960 nominal height) as required. The length discrepancy does not meet the released print dimensions.

On 01/21/2021, CooperSurgical issued Urgent Medical Device Recall notices to customers via certified mail. On 9/08/2021, CooperSurgical expanded the recall adding an additional lot and notified customers via courier service. Customers were advised to: - Discontinue use of and isolate all products subject to the recall. - Complete the Acknowledgement and Receipt Form, and return via email to recall@coopersurgical.com or fax to 203-601-9870. - Once the Acknowledgement Form is received, Cooper Surgical will arrange for Product replacement(s) and return of affected Product(s). The replacement Product(s) will be charged at the same price as the original order and your account will be credited back once the affected Product(s) are returned to CooperSurgical. If you do not have affected Product in inventory, please use the same Form to indicate that and return it to CooperSurgical. Customers with questions, please call 203-601-5200 ext. 3300.
FDA

IntelliVue 1.4 GHz Remote Antenna Used with Philips MX4O Monitors-The affected product is a 74 foot (22.6m) combined coax and unshielded twisted pair data cable bundle and is a component of the Philips Remote Antenna (PN 867151). The Remote Antenna is used with IntelliVue MX40 Patient Worn Monitors in the USA, to extend the coverage area of a Core Access Point for the wireless Smart-hopping system.

Remote Antenna Cable Used with Philips MX4O Monitors Does Not Have the Required Rating for Some Installations

Philips issued customer notification on 08/19/2019 and delivering on 08/23/2019 via priority mail. Letter states reason for recall, health risk and action to take: Customers with affected cables installed need not take any immediate action. The cables subject to this recall do not affect the normal operation of MX4O System with Smart Hopping Infrastructure. Philips Healthcare will contact you to schedule a service team to replace affected cables. If you need any further information or support concerning this issue, please contact your local Philips representative or Philips Customer Support at 1-800- SUPPORT 722-9377.
FDA

SICAT IMPLANT V2.0

A dentist found implant positions are not correctly exported from the implant planning software SICAT IMPLANT V2.0 - for the specific export format CMG.DXD.

On 07/15/2020 customer notification letter was sent to all users/customers who have the 2.0 version of the software installed in the system. These users are instructed to only use the system for specific cases as defined in the field safety notice. The firm plans on implementing a new software version in July 2020 to correct the issues found.
FDA Class III

Bowl & Basket Zero Calorie with Sucralose Sweetener 100 count, UPC 0-41190-06855-5, 12 retail cartons per wholesale case

Undeclared aspartame lack of phenylalanine warning
NHTSA

Lithium-Ion Battery Cells Can Fail While Charging

Battery cell failure increases the risk of a fire.

Cake will replace the battery pack, free of charge. As an interim action, owners will be instructed to check their battery serial number and if necessary, follow interim charging instructions until the remedy battery is available. Interim letters notifying owners of the safety risk were mailed January 19, 2024. A second notice will be sent once the remedy becomes available, anticipated March 2024. Owners may contact Cake customer service at service@ridecake.com.