The Recall Desk

Agency

U.S. Food and Drug Administration

The FDA regulates food, drugs, biologics, medical devices, and tobacco. We aggregate Class I, II, and III enforcement actions across its three recall streams.

Visit the official FDA site →

About FDA recalls

The FDA is the single biggest source of US product recalls by volume. Its enforcement workload splits into three streams — Foods (everything from infant formula to leafy greens to nutritional supplements), Drugs (prescription medicines, over-the-counter products, and active pharmaceutical ingredients), and Medical Devices (everything from implants to home blood-pressure monitors). The Recall Desk ingests all three from the openFDA enforcement endpoint every six hours.

FDA classifies every recall as Class I, II, or III. Class I means there is a reasonable probability that using the product will cause serious health consequences or death — these are the recalls you should treat as urgent. Class II means the product may cause temporary or medically reversible harm. Class III means the product is unlikely to cause adverse health consequences but still violates FDA rules. We map these classifications into our 1–5 severity score using the rubric on the methodology page.

Medical-device recalls are the highest-volume stream by far — software-update letters, calibration corrections, and IFU updates all show up in enforcement reports alongside genuine hazard recalls. We try to surface the severe ones first, but when in doubt, click through to the FDA notice itself for the clinical detail.

24451–24475 of 88183

  • ModerateFDA (Drugs)·D-0866-2022·2022-05-18

    FDA Recalls Subpotent Nandrolone Decanoate Compounding Ingredient

    Fagron, Inc initiated a nationwide recall of Nandrolone Decanoate compounding ingredient due to subpotency. The affected lot may contain below-strength concentrations of the active pharmaceutical ingredient.

    Product
    Nandrolone Decanoate, USP, 1 kg per plastic container, Rx Only, For Prescription Compounding, Distributed by: Humco, 7400 Alumax Road, Texarkana, TX 75501. NDC 0395-8212-43
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1052-2022·2022-05-18

    Bwell Bird's Nest Beverage Coconut Flavor Recalled for Deficient Packaging

    Eastland Food Corporation is recalling Bwell Bird's Nest Beverage Coconut Flavor due to deficient packaging material that could lead to premature spoilage. Approximately 1,699 cases were distributed to retail stores across multiple states.

    Product
    Bwell Bird's Nest Beverage Coconut Flavor NET 8.45 FL OZ (250mL) UPC 8373726344 24 bottles per case
    Category
    Food
    Distribution
    34 states
  • ModerateFDA (Devices)·Z-1060-2022·2022-05-18

    First Aid Kits and Cabinets Recalled for Manufacturing Deviations

    Certified Safety Mfg Inc is recalling first aid kits and cabinets containing Medi-First medication components due to manufacturing practice deviations at the component supplier.

    Product
    The following first aid kits and cabinets containing components Medi-First XS Non-Aspirin, Product #80450, 2 tablets/packet, 25 packets/box; and Sinus Pain & Pressure, Product #81950, 2 tablets/packet, 25 packets/box. Product number and description: (1) K614-020 16PW…
    Category
    Medical Device
    Distribution
    36 states
  • ModerateFDA (Drugs)·D-0864-2022·2022-05-18

    FDA Recalls Subpotent Nandrolone Decanoate Compounding Ingredient from Fagron

    Fagron Inc. initiated a voluntary recall of 68 containers of Nandrolone Decanoate USP in March 2022 after the product was found subpotent, containing less active ingredient than labeled. The recall affects compounding pharmacies nationwide.

    Product
    Nandrolone Decanoate, USP, 1 kg per plastic container, Rx Only, For Prescription Compounding, Fagron, Inc. 2400 Pilot Knob Rd., St Paul, MN 55120. NDC 51552-1564-07
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0858-2022·2022-05-18

    Bupropion Extended-Release Tablets Recalled for Activated Carbon Contamination

    Sun Pharmaceutical is recalling Bupropion Extended-Release 200mg tablets after customers found activated carbon particles inside bottles from the desiccant canister.

    Product
    BUPROPION HYDROCHLORIDE — BUPROPION HYDROCHLORIDE (BUPROPION HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1054-2022·2022-05-18

    Bwell Bird's Nest Beverage Recalled Due to Deficient Packaging

    Bwell Bird's Nest Beverage is being recalled due to deficient packaging material that could lead to premature spoilage. The recall affects 1,699 cases distributed across 34 states.

    Product
    Bwell Bird's Nest Beverage Rock Sugar Flavor NET 4.45 FL OZ (250mL) UPC 8373726348 24 bottles per case
    Category
    Food
    Distribution
    34 states
  • ModerateFDA (Food)·F-1056-2022·2022-05-18

    Bwell Bird's Nest Sugar-Free Xylitol Beverage Recalled for Deficient Packaging Material

    Bwell Bird's Nest Beverage Sugar-Free Xylitol is recalled due to deficient packaging material that may lead to premature spoilage. The FDA Class II recall affects 1,699 cases distributed across 34 U.S. states.

    Product
    Bwell Bird's Nest Beverage Sugar-Free Xylitol NET 8.45 FL OZ (250mL) UPC 8373726352 24 bottles per case
    Category
    Food
    Distribution
    34 states
  • ModerateFDA (Food)·F-1072-2022·2022-05-18

    New Seasons Market Truffle Valencia Almonds recalled for potential foreign material contamination

    New Seasons Market LLC is recalling Truffle Valencia Almonds due to potential foreign materials contamination. The affected product was distributed in Oregon and Washington.

    Product
    New Seasons Market Truffle Valencia Almonds, packaged in a round plastic tub with lid, sold by various weights. Packaged is labeled with a black and white scale label, UPC 207456 308081
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Drugs)·D-0861-2022·2022-05-18

    Esomeprazole Magnesium Delayed-Release Capsules Recalled for Failed Quality Specifications

    Mylan Institutional is recalling Esomeprazole Magnesium Delayed-Release Capsules 40 mg due to failed impurity specifications found during stability testing, affecting 885 cartons nationwide.

    Product
    Esomeprazole Magnesium Delayed-Release Capsules, USP 40 mg, packaged in Unit Dose Blister Cards of 6 (10 cards of 6 Capsules each per carton), Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 USA. NDC 42292-010-16
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1059-2022·2022-05-18

    Roasted Peanut Product Recalled for Containing Unapproved Food Additive

    Rong Shing Trading NY Inc is recalling 'KORICA' roasted peanuts due to the presence of cyclamate, an unapproved additive. The product was distributed across multiple U.S. states.

    Product
    'KORICA' ROASTED PEANUT; 10.6OZ (300G); packaged in plastic bags; Ingredients: Peanuts, Salt, Licorice, Anise, Cinnamon, Food Additives (Cyclamate); Product of P.R.C.; Manufacturer: Jianmen Xinhui Green Day Food Co. Ltd.; RONG SHING TRADING NY INC. 47-57 BRIDGEWATER STREET…
    Category
    Food
    Distribution
    12 states
  • LowFDA (Devices)·Z-1056-2022·2022-05-18

    Bone Graft Syringe Recall: Patient Chart Labels List Incorrect Part Numbers

    Cerapedics is recalling putty i-FACTOR Peptide Enhanced Bone Graft syringes because patient chart labels contain incorrect Part Numbers and volume amounts. The company discovered the labeling discrepancy in 572 units distributed nationwide.

    Product
    putty i-FACTOR Peptide Enhanced Bone Graft 1.0cc Syringe REF 700-010, PUTTY
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1044-2022·2022-05-11

    TOP SAVOR Licorice Flavored Olive Recalled for Undeclared Sulfites

    A & C Best Food Trading is recalling TOP SAVOR Licorice Flavored Olive products for containing undeclared sulfites. The recalled item was distributed across 12 U.S. states.

    Product
    Olive; TOP SAVOR Licorice Flavored Olive; Net wt: 500g (17.63oz); Ingredients: olive, sugar, salt, licorice extract, food additives (citric acid, saccharin sodium, sodium benzoate, potassium sorbate), edible spices; Store in a cool and dry place. Away from direct sunlight.…
    Category
    Food
    Distribution
    12 states
  • CriticalFDA (Food)·F-1046-2022·2022-05-11

    Pickled Plums Recalled for Undeclared Sulfites and Prohibited Food Dye

    A & C Best Food Trading is recalling Wife Plum pickled plums in 500g jars for containing undeclared sulfites and prohibited Amaranth dye. The product poses serious health risks to sulfite-sensitive consumers.

    Product
    BEAUTIFUL AND DELICIOUS TASTE; TOP SAVOR; Wife Plum; Net wt. 500g (17.63oz); Ingredients: plum (grafting); sugar, salt, food additives (citric acid, DL malic acid, stevioside, sodium saccharine, potassium sorbate, sodium benzoate), edible spices.; Distributed by A & C best food…
    Category
    Food
    Distribution
    12 states
  • SevereFDA (Drugs)·D-0877-2022·2022-05-11

    The Mandalorian Hand Sanitizer Recalled Nationwide for Benzene Contamination

    The Mandalorian Hand Sanitizer has been recalled nationwide due to FDA-detected benzene contamination. The recall affects 346,320 bottles with lot number 20E21.

    Product
    The Mandalorian Hand Sanitizer, ethyl alcohol 68%, 2.11 oz./60 mL bottles, Best Brands Consumer Products, Inc., c/o Best Brands Sales Company LLC, New York, NY NDC 74530-012-02
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0876-2022·2022-05-11

    Hand Sanitizer Product Recalled for Methanol Chemical Contamination

    Mickey Mouse Hand Sanitizer (ethyl alcohol 68%, 2.11 oz. bottles) is being recalled nationwide by Best Brands Consumer Products, Inc. due to methanol contamination in Lot #20D21 (expiration 06/30/2022).

    Product
    Mickey Mouse Hand Sanitizer, ethyl alcohol 68%, 2.11 oz./to mL bottle, Best Brands Consumer Products, Inc., c/o Best Brands Sales Company LLC, New York, NY NDC 74530-013-02
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1068-2022·2022-05-11

    Salsa Texan tortillas recalled for undeclared wheat and whey allergens

    The Salsa Texan tortillas (coconut flour and blended flour varieties) are being recalled for potentially containing undeclared wheat and whey. Products were distributed online and at farmers markets.

    Product
    The Salsa Texan Coconut Flour Tortilla regular and burrito size packaged in clear flexible plastic; The Salsa Texan Blended Flour Tortilla regular and burrito size packaged in clear flexible plastic; Unlabeled tortillas sold at farmer's market in Dallas, TX area
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0944-2022·2022-05-11

    COVID-19 Rapid Test Kits Recalled for Lacking FDA Authorization

    SML Distribution is recalling 209,450 units of Skippack COVID-19 rapid test kits that were distributed without FDA authorization or clearance. The kits were distributed nationwide across Alabama, Florida, Georgia, Missouri, New York, Texas, and Wyoming.

    Product
    Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold); COVID 19 Test
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1043-2022·2022-05-11

    Whole Foods red lentil dal recalled for possible Listeria contamination

    Whole Foods Market red lentil dal (12 oz) may contain Listeria monocytogenes. The affected product was distributed to nine states. Consumers should not consume the product.

    Product
    WHOLE FOODS MARKET red lentil dal NET WT. 12 OZ (340g) DISTRIBUTED BY: WHOLE FOODS MARKET AUSTIN, TX 78703 UPC 1 95515 02394 8
    Category
    Food
    Distribution
    9 states
  • HighFDA (Drugs)·D-0839-2022·2022-05-11

    Losartan Potassium Tablets Recalled Due to Unacceptable Chemical Impurity Levels

    Lupin Pharmaceuticals is recalling 1.47 million bottles of Losartan Potassium Tablets due to chemical impurities exceeding acceptable limits. The affected batches were distributed nationwide.

    Product
    LOSARTAN POTASSIUM — LOSARTAN POTASSIUM (LOSARTAN POTASSIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0849-2022·2022-05-11

    FDA Recalls Lidocaine Prilocaine Cream Due to Manufacturing Compliance Issue

    McKesson Corporation has recalled Lidocaine Prilocaine Cream 2.5%/2.5% because the manufacturer, Teligent Pharma, Inc., discontinued its stability study program, a deviation from manufacturing standards.

    Product
    Lidocaine Prilocaine Cream USP, 2.5%/2.5% Net Wt. 30 gram tube, Rx Only, Distributed by: McKesson Corporation dba Sky Packaging 4971 Southridge Blvd., Suite 101 Memphis, TN 38141 Manufactured by: Teligent Pharma, Inc., Buena, NJ 08310, NDC 63739-054-66
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0847-2022·2022-05-11

    Halobetasol Propionate Ointment 0.05% Recalled Due to Manufacturing Practice Deviations

    McKesson Corporation is recalling Halobetasol Propionate Ointment 0.05% nationwide after the manufacturer discontinued its stability study program, creating CGMP deviations. Over 13,200 tubes distributed in the United States, Guam, and the Northern Mariana Islands are affected.

    Product
    Halobetasol Propionate Ointment 0.05% Net Wt., 50 gram tube, Rx Only, Manufactured by: Teligent Pharma, Inc. Buena, NJ 08310, Distributed by: McKesson Corporation dba Sky Packaging 4071 Southridge Blvd., Suite 101 Memphis, TN 38141, NDC 63739-998-67
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1030-2022·2022-05-11

    Restrata Medical Device Recall: Misprinted Expiration Date on Shelf-Box Packaging

    Acera Surgical Inc is recalling 83 units of the Restrata RWM1-2X2 medical device (Lot Number 51745) due to a misprinted expiration date on the shelf-box packaging distributed nationwide.

    Product
    Restrata, Part Number RWM1-2X2
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1023-2022·2022-05-11

    Medical Diagnostic Test Kit Issues Falsely Elevated Estradiol Results

    Siemens Healthcare is recalling ADVIA Centaur Enhanced Estradiol diagnostic kits because plasma specimens may show falsely elevated results, potentially leading clinicians to misinterpret patient test results.

    Product
    ADVIA Centaur Enhanced Estradiol (eE2) 100T - In vitro diagnostic use in the quantitative determination of estradiol SMN: 10490889 All lots
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0835-2022·2022-05-11

    Losartan potassium and hydrochlorothiazide tablets recalled for manufacturing quality deviations

    Macleods Pharma USA is recalling Losartan Potassium and Hydrochlorothiazide tablets due to manufacturing quality issues with chemical impurity levels above acceptable limits. Affected lots were distributed nationwide in 30-, 90-, and 1000-count bottles.

    Product
    LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE — LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE (LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1031-2022·2022-05-11

    First Aid Kits Recalled Due to Defective Acetaminophen

    ASO LLC is recalling approximately 73,668 first aid kits sold under Equate, Meijer, and Care Science brands that contain previously recalled acetaminophen. Affected kits were distributed nationwide.

    Product
    First Aid Kits containing acetaminophen under brand names Equate (Walmart), Meijer, and Care Science (Amazon)
    Category
    Medical Device
    Distribution
    Distributed nationwide