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 3861–3880 of 4,022 recalls

USDA

FSIS Issues Public Health Alert for Raw Frozen Pork Dumpling Products Produced without Benefit of Inspection

Produced Without Benefit of Inspection

FDA

API 50 CH, Model 50300

There is potential to provide an incorrect organism identification.

Notification letters were issued to customers via FedEx Priority Overnight mail during the week of October 4, 2021. Customers are asked to do the following: -Discontinue use of and discard any remaining inventory of lot 1008679230. -For tests previously performed using API 50 CH Ref. 50300 lot# 1008679230, we are asking you to identify any possible incorrect identification test result due to a false positive reaction of test 34, analyze the related risks and to determine appropriate actions, if relevant. -Complete the Acknowledgement Form in Attachment A and return it to your local bioMrieux representative to confirm receipt of this notice. -Distribute this information to all appropriate personnel in the laboratory, retain a copy in your files. -Contact your local bioMrieux representative for product compensation. Consignees will perform destruction activities at their site.

FDA

Hex Driver Part Number HXDRIVER-2.0 AO; Hex Driver Part Number HXDRIVR-2.5 AO; Hex Driver Part Number HXDRIVR-2.5CL AO; Hex Driver Part Number DVHX-2.5/130C AO; Hex Driver Part Number HXDRIVR-3.0 AO; Hex Driver Part Number HXDRIVER-3.5AO

Following the completion of sterilization cycle(s) of the impacted Hex Driver, the epoxy color band on the impacted Hex Driver can migrate down the shaft and/or potentially onto the sterilization tray or caddy.

Recall notification letters were sent to affected consignees on January 16, 2018. The consignee letter requests that the consignee return an initial Acknowledgement & Receipt Form to TriMed by January 23, 2018.

NHTSA

Incorrect Tire Size Information/FMVSS 120

Incorrect tire information could result in the wrong tires being installed on the vehicle, increasing the risk of a crash.

Heartland will send out replacement certification labels, free of charge. Owner notification letters were mailed February 22, 2024. Owners may contact Heartland customer service at 1-877-262-8032.

FDA Class I

Vigabatrin for Oral Solution, USP 500 mg per packet, 50 packets per box, Rx Only, Manufactured by: InvaGen Pharmaceuticals, Inc., (a subsidiary of Cipla Ltd.), Hauppauge, NY, 11788, Manufactured for: Cipla USA, Inc., Warren, NJ 07059, NDC 69097-964-53

Defective Container: powder may leak out of the pouch

FDA Class II

Desloratadine Tablets USP 5mg a) 100 count (NDC 68180-153-01) and b) 500 count (NDC 68180-153-02) bottles, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202.

CGMP Deviations: N-Nitroso Desloratadine impurity result exceeded the acceptable intake limit.

FDA Class II

Tacrolimus Capsules, USP 1mg, 100-Count Bottles, Rx Only, Manufactured by: Dr. Reddy's Laboratories Limited, Bachupally, 500 090, INDIA, NDC 55111-526-01

Presence of Foreign Tablets/Capsules: One 0.5 mg Tacrolimus capsule found in a bottle of 1 mg Tacrolimus capsules.

FDA Class II

Tizanidine Tablets, USP 4mg, 150-count bottle, Rx only, Mfd. By: Dr. Reddy's Laboratories Limited, Srikakulam - 532 409 INDIA, NDC 55111-180-15

Presence of Foreign tablets/capsules - identified as tizanidine 2 mg tablets.

FDA Class II

buPROPion Hydrochloride Extended-Release Tablets, USP (XL) 150mg, 30-count bottles, Rx Only, Manufactured for: Rising Pharma Holdings, Inc. East Brunswick, NJ 08816 Manufactured by: Graviti Pharmaceuticals Pvt. Ltd. Telangana - 502307, INDIA, NDC 16571-862-03

Presence of Foreign Tablets/Capsules

FDA Class I

Chocolate Walnut Fudge, 8oz, packaged in clear, plastic clamshell.

Undeclared egg

FDA Class I

Peanut Butter Fudge, 8oz, packaged in clear, plastic clamshell.

Undeclared egg

FDA Class III

Brand Name: SUPREX Plant Based Nutrition. Product Name: Carb & Sugar Block. Product Size: 120 Vegetable Cellulose Capsules per bottle. Container description: White Plastic Bottle 300CC with white cap sealed with clear plastic Total Package size: Master Case with 81 Bottles containing 120 capsules each one. Lot no. 2633, Exp. 07/25 Manufactured in the US

FDA lab analysis of product sampled revealed Chromium content was determined subpotent as 16 mcg/serving or 16% of declared.

FDA Class I

Eban's Bakehouse Sweet Indulgences - Turtle Brownie (12 pieces/cookies) packaged in 11.85oz cardboard candy box with clear plastic cover. Retail sales are by box, Wholesale are 6 boxes per case.

Undeclared Allergens - Milk and Soy

FDA Class III

Shiloh Farms Organic Salt Free 7 Grain Bread UPC 0-47593-02113-5

Daily recommended consumption of Cholesterol and Sodium are listed in grams instead of milligrams. Product content information is accurate.

FDA Class I

Eban's Bakehouse Sweet Indulgences - Peanut Butter Chocolate Chunk (12 pieces/cookies) packaged in 11.85oz cardboard candy box with clear plastic cover. Retail sales are by box, Wholesale are 6 boxes per case.

Undeclared Allergens - Milk and Soy

FDA Class I

Eban's Bakehouse Sweet Indulgences - Chocolate Chili Coconut (12 pieces/cookies) packaged in 11.85oz cardboard candy box with clear plastic cover. Retail sales are by box, Wholesale are 6 boxes per case.

Undeclared Allergens - Milk and Soy

FDA Class I

Eban's Bakehouse Sweet Indulgences - Brown Butter Snickerdoodle (12 pieces/cookies) packaged in 11.85oz cardboard candy box with clear plastic cover. Retail sales are by box, Wholesale are 6 boxes per case.

Undeclared Allergens - Milk and Soy

FDA Class I

Eban's Bakehouse Sweet Indulgences - Brown Butter Honey Pistachio (12 pieces/cookies) packaged in 11.85oz cardboard candy box with clear plastic cover. Retail sales are by box, Wholesale are 6 boxes per case.

Undeclared Allergens - Milk and Soy

FDA Class III

Shiloh Farms Bread for Life Organic 7 Grain UPC 0-47593-02812-7

Daily recommended consumption of Cholesterol and Sodium are listed in grams instead of milligrams. Product content information is accurate.

FDA Class I

Chocolate Fudge, 8oz, packaged in clear, plastic clamshell.

Undeclared egg