FDA Recalls
Food safety, medications, medical devices, and cosmetics
Archive by Year
Recent Recalls
Brass Pital Pot 4-quart. Sticker label: BRASS HAMMERED HANDI NO 3 UPC 7 023672 414398 US $ 74.99 Sticker label: IKM INDIAN KITCHEN MART
Potential contamination with leachable lead.
Aluminum Kadai with Metal Handles Size 5. A-Cook MADE IN INDIA SIZE 5 Sticker label: $$24.99+TX
Potential contamination with leachable lead.
Why Not Natural Moringa Capsules 120 capsule bottle marked with lot # A25G051 on the bottom and with an expiration date of 07/2028 stamped on the bottom.
Potential to be contaminated with Salmonella
Pure Factors Professional Nighttime Sleep Formula and Pure Formulas Sleep Reset, Net Wt., 1 fl oz (30 ml) liquid dietary supplement, Glass bottle with dropper cap. (Individual 1 fl oz bottles (not sold in case lots)
Label declares bovine colostrum but does not declare milk allergen.
The Tuna Salad product container is mislabeled with a Chicken Salad lid, which states: Molly Kitchen's Chicken Salad, (item#) 789953, NET WT. 5 LB (2.26 kg) per plastic tub. UPC 7 5810830149 8. Distributed by US Foods, Inc. Rosemont, IL 60018 Contains: Eggs, Milk, Wheat. The immediate 5-lb tub has no side labeling (besides the lid). The master cardboard case label is correct and states: Molly Kitchen's Tuna Salad, (item #) 794599, 2/5 LB tubs per case, Net Wt. 10 LB (4.53 kg). UPC 075810876447
Undeclared fish allergen (tuna). Tuna Salad was mislabeled as Chicken Salad.
Frozen Cooked Medium Shrimp Peeled & Deveined, Tail Off-White Shrimp; 1 lbs retail plastic bag. UPC: 041220333035
Product manufactured under insanitary conditions whereby it may have been contaminated with Cesium-137 (Cs-137)
IKM Aluminum Saucepan 9" with Wooden Handle. Sticker label: ALUMINIUM PAN 2 SIDE POUTED WOODEN HANDLE 9" UPC 7 023672 411878 US $ 17.99 Sticker label: IKM INDIAN KITCHEN MART
Potential contamination with leachable lead.
Brass Tope. Sticker label: $29.99+TAX
Potential contamination with leachable lead.
Woodland Gourmet Arrowroot Flour item code H59EE86, Net Wt. 55 lb., bag in box
Possible presence of Foreign Material
Testosterone, 100 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC:79559-1100-32.
Presence of Foreign substance - potential presence of metal particulate matter
UDENYCA, pegfilgrastim-cbqv injection, 6 mg/0.6mL Single Dose Prefilled Syringe, Rx only, Manufactured by Accord BioPharma, Inc., 8041 Arco Corporate Drive, Suite 200, Raleigh, NC 27617, NDC 69448-025-63
Temperature Abuse. 116 cartons with specific serial numbers of Lot 2199821, were stored incorrectly in a controlled room temperature environment instead of the required refrigerated environment.
Pro Numb Tattoo Numbing Spray, 5% Lidocaine, [1 FL OZ/28.4 ML or 4 oz/120 mL] per bottle, Distributed by: Pro Numb Tattoo numbing spray LLC, Melbourne, FL 32907, NDC 83389-111-11
cGMP deviations
thiamine HCl, 500 mg, 500 mg added to 100 mL, 0.9% Sodium Chloride Injection, USP, Fagron Sterile Services, 20 Dan Road, Canton, MA 02021, NDC 71506-079-56.
Lack of Assurance of Sterility
ketamine HCl, 1,000 mg, 1,000 mg per 100 mL (10 mg per mL) in Sodium Chloride Injection, Fagron Sterile Services, 20 Dan Road, Canton, MA 02021, NDC 71506-050-56
Lack of Assurance of Sterility
Oxycodone Hydrochloride Tablets, USP (CII), 5 mg, 100-Count (10 x 10) blister cards per carton, Rx Only, The drug product contained in this package is from NDC # 10702-018, KVK-Tech Inc. Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC 68084-354-01.
Defective container: Multiple customer complaints received for card seal defects observed on the subject lots. Customers reported card seal defects (weak/non-existent seals), leading to the tablets falling out of their cavities.
Testosterone, 200 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-1200-43.
Presence of Foreign substance - potential presence of metal particulate matter
Testosterone, 25.0 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-1025-32.
Presence of Foreign substance - potential presence of metal particulate matter
ESTRADIOL, 25 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-3025-32.
Presence of Foreign substance - potential presence of metal particulate matter