Warning
Class II
React Health PHOENIX 5L Oxygen Concentrator
Devices which did not meet internal quality specifications were inadvertently distributed.
3B Medical
FDA Recalls
Page 31 of 40 · 1,986 total recalls
Recalls — Page 31
Warning
Class II
Dexamethasone Sodium Phosphate Injection
Failed Impurities/Degradation Specifications - OOS impurities result observed during long term stability testing at...
SOMERSET THERAPEUTICS LLC
Info
Class III
Pitavastatin Tablets
Presence of foreign tablets/capsules: one Pitavastatin tablet 1mg found in bottle of Pitavastatin tablets 2mg
Annora Pharma Private Limited
Warning
Class II
Coco's Italian Market Cannoli Making Kit with 6 Cannoli Shells & Cream, Net Wt
Label lists flour as a sub-ingredient of the shells, and ricotta cheese as a sub-ingredient of the cream but does...
Cocos Wholesale and Imports
Warning
Class II
Coco's Italian Market Heat-n-Eat Fettuccini Alfredo in homemade Alfredo Sauce, Net Wt
Label lists semolina and durum flour as sub-ingredients of the pasta, but does not declare wheat
Cocos Wholesale and Imports
Warning
Class II
Pure Factors Professional Nighttime Sleep Formula and Pure Formulas Sleep Reset
Label declares bovine colostrum but does not declare milk allergen.
Pure Solutions
Warning
Class II
On-X Mitral Heart Valve with Conform-X Sewing Ring, Model: ONXMC-25/33
Heart valves were released and distributed before all required testing was complete, so it cannot be confirmed that...
On-X Life Technologies
Critical
Class I
Kirkland Signature Costco item #1181272 Mini Beignets filled with Caramel 22CT
Undeclared hazelnut.
Costco Wholesale Corporation
Warning
Class II
Tiki Bar Candy Dark Chocolatey Peanut Butter & Pretzel
Ingredients List declares peanut but the Contains statement does not declare peanut
J2C Hawaii LLC
Critical
Class I
Karns Foods, Mini Dark Chocolate Raspberry Cups, 8 oz Clear plastic tamper evident packs, 36-42 packed per breakout
Product may contain undeclared peanuts.
Karns Prime And Fancy Foods
Critical
Class I
The Tuna Salad product container is mislabeled with a Chicken Salad lid
Undeclared fish allergen (tuna). Tuna Salad was mislabeled as Chicken Salad.
Reser's Fine Foods
Warning
Class II
a.) Preema brand Bright Red Food Colour Powder
Products contain banned color, carmoisine and undeclared FD&C Yellow 5 and FD&C Red 40
KPCM New York Inc.
Warning
Class II
Metoprolol Succinate Extended-Release Tablets
Failed Dissolution Specifications
Teva Pharmaceuticals USA
Warning
Class II
Metoprolol Succinate Extended-Release Tablets
Failed Dissolution Specifications
Teva Pharmaceuticals USA
Warning
Class II
Metoprolol Succinate Extended-Release Tablets
Failed Dissolution Specifications
Teva Pharmaceuticals USA
Warning
Class II
Metoprolol Succinate Extended-Release Tablets
Failed Dissolution Specifications
Teva Pharmaceuticals USA
Critical
Class I
Why Not Natural Moringa Capsules 120 capsule bottle marked with lot # A25G051 on the bottom and with an expiration date
Potential to be contaminated with Salmonella
Art Monkey LLC dba Why Not Natural
Critical
Class I
Fish Ball, Frozen, 40 pieces per pack, 200g Wt
Undeclared allergen ingredient (Wheat and Sesame)
MIN JIANG FOOD STORE INC DBA KOI KOI TRADING
Critical
Class I
Fish Ball, Frozen, 20 pieces per pack, 400g Wt
Undeclared allergen ingredient (Wheat and Sesame)
MIN JIANG FOOD STORE INC DBA KOI KOI TRADING
Critical
Class I
Fish Ball, Frozen, 4 pieces per pack, 5lbs Wt
Undeclared allergen ingredient (Wheat and Sesame)
MIN JIANG FOOD STORE INC DBA KOI KOI TRADING
Warning
Class II
Product is Frozen Half Shell Oysters in 15-16 pound blocks
Imported oysters potentially contaminated with Norovirus
Khee Trading
Warning
Class II
Diclofenac Sodium, Topical Gel, 3%, 100 g tube, Rx only, Mfd
Failed Viscosity Specifications: Out of Specification (OOS) [slightly lower than the limit] result in viscosity for...
SUN PHARMACEUTICAL INDUSTRIES INC
Warning
Class II
Repackaged M&Ms candies, Net Wt 1.3 oz
Undeclared allergens (milk, soy, and peanut)
Beacon Promotions Inc
Warning
Class II
Repackaged M&Ms Peanut candies, Net Wt 1.3 oz
Undeclared allergens (milk, soy, and peanut)
Beacon Promotions Inc
Warning
Class II
ESTRADIOL, 6 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-3006-32
Presence of Foreign substance - potential presence of metal particulate matter
F.H. INVESTMENTS
Warning
Class II
ESTRADIOL, 10 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-3010-32
Presence of Foreign substance - potential presence of metal particulate matter
F.H. INVESTMENTS
Warning
Class II
ESTRADIOL, 12.5 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79599-3012-32
Presence of Foreign substance - potential presence of metal particulate matter
F.H. INVESTMENTS
Warning
Class II
ESTRADIOL,15 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-3015-32
Presence of Foreign substance - potential presence of metal particulate matter
F.H. INVESTMENTS
Warning
Class II
ESTRADIOL, 18 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 3521, NDC: 79559-3018-32
Presence of Foreign substance - potential presence of metal particulate matter
F.H. INVESTMENTS
Warning
Class II
ESTRADIOL, 20 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-3020-32
Presence of Foreign substance - potential presence of metal particulate matter
F.H. INVESTMENTS
Warning
Class II
ESTRADIOL, 22 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-3022-32
Presence of Foreign substance - potential presence of metal particulate matter
F.H. INVESTMENTS
Warning
Class II
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
F.H. INVESTMENTS
Warning
Class II
ESTRADIOL, 37.5 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-3037-32
Presence of Foreign substance - potential presence of metal particulate matter
F.H. INVESTMENTS
Warning
Class II
Testosterone 100mg Anastrozole 4mg
Presence of Foreign substance - potential presence of metal particulate matter
F.H. INVESTMENTS
Warning
Class II
Testosterone 100mg
Presence of Foreign substance - potential presence of metal particulate matter
F.H. INVESTMENTS
Warning
Class II
Testosterone 100mg
Presence of Foreign substance - potential presence of metal particulate matter
F.H. INVESTMENTS
Warning
Class II
Testosterone 200mg
Presence of Foreign substance - potential presence of metal particulate matter
F.H. INVESTMENTS
Warning
Class II
Testosterone 75mg
Presence of Foreign substance - potential presence of metal particulate matter
F.H. INVESTMENTS
Warning
Class II
Testosterone 87.5mg
Presence of Foreign substance - potential presence of metal particulate matter
F.H. INVESTMENTS
Warning
Class II
Testosterone, 12.5 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-1012-32
Presence of Foreign substance - potential presence of metal particulate matter
F.H. INVESTMENTS
Warning
Class II
Testosterone, 18.0 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-1018-32
Presence of Foreign substance - potential presence of metal particulate matter
F.H. INVESTMENTS
Warning
Class II
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
F.H. INVESTMENTS
Warning
Class II
Testosterone, 37.5 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-1037-32
Presence of Foreign substance - potential presence of metal particulate matter
F.H. INVESTMENTS
Warning
Class II
Testosterone, 50.0 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-1050-32
Presence of Foreign substance - potential presence of metal particulate matter
F.H. INVESTMENTS
Warning
Class II
Testosterone, 62.5 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-1062-32
Presence of Foreign substance - potential presence of metal particulate matter
F.H. INVESTMENTS