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.

23051–23075 of 88183

  • ModerateFDA (Drugs)·D-1324-2022·2022-08-17

    Asthmanefrin Racephinephrine Inhalation Solution Recalled Due to Improper Storage

    Asthmanefrin Racephinephrine Inhalation Solution is being recalled because batches were stored outside the conditions specified on the drug label. The recall affects products distributed nationwide.

    Product
    Asthmanefrin Racephinephrine Inhalation Solution Bronchodilator, For temporary relief of mild symptoms of intermittent asthma, Preservative Free, Sterile, For Oral Inhalation Only, 30 vials per box, Nephron Pharmaceuticals Corporation, NDC 0487-2784-01.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1305-2022·2022-08-17

    Prescription Drug Recall: Telmisartan-Hydrochlorothiazide Tablets Due to Defective Packaging

    Glenmark Pharmaceuticals recalls 72,288 units of Telmisartan-Hydrochlorothiazide 80/25 mg tablets nationwide due to defective blister packaging that is difficult to open and causes tablets to break.

    Product
    TELMISARTAN AND HYDROCHLOROTHIAZIDE — TELMISARTAN AND HYDROCHLOROTHIAZIDE (TELMISARTAN AND HYDROCHLOROTHIAZIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1323-2022·2022-08-17

    FDA Recalls Dakin's Solution Due to Storage Condition Deviations

    McKesson Medical-Surgical recalled 113 bottles of Dakin's Solution (sodium hypochlorite) nationwide due to improper storage outside label specifications. Products may have compromised stability.

    Product
    DAKINS QUARTER — DAKINS QUARTER (SODIUM HYPOCHLORITE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1318-2022·2022-08-17

    Earwax Removal Aid Debrox Recalled Nationwide for Improper Storage Conditions

    Debrox earwax removal aid is recalled nationwide because 131 boxes of the product were stored outside label-specified conditions. Consumers should discontinue use and consult a healthcare provider if needed.

    Product
    DEBROX — DEBROX (CARBAMIDE PEROXIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1322-2022·2022-08-17

    FDA Recalls A&D Original Ointment due to improper storage conditions

    A&D Original Ointment 16 oz jars are being recalled nationwide because products were stored outside manufacturer specifications. The recall affects all NDC 11523-0096-3 units distributed in the USA.

    Product
    A&D Original Ointment, Diaper Rash Ointment & Skin Protectant, 16 oz. Jar, Bayer Healthcare Pharmaceutica, NDC 11523-0096-3.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1508-2022·2022-08-17

    Cholestech LDX cholesterol test cassettes require bilirubin interference label update

    Alere is updating the package insert for Cholestech LDX cholesterol test cassettes to disclose that samples with elevated bilirubin can produce inaccurate triglyceride and HDL results. Approximately 436,990 units are affected.

    Product
    The Cholestech LDX¿ System combines enzymatic methodology and solidphase technology to measure total cholesterol, HDL cholesterol, triglycerides and glucose. Samples used for testing can be whole blood from a fingerstick (collected in a lithium heparin-coated capillary tube)…
    Category
    Medical Device
    Distribution
    31 states
  • ModerateFDA (Drugs)·D-1325-2022·2022-08-17

    Racepinephrine Inhalation Solution Recalled for Improper Storage Conditions

    Mckesson Medical-Surgical is recalling S2 Racepinephrine Inhalation Solution due to storage that deviated from label specifications. This Class II recall affects 23 cartons distributed nationwide.

    Product
    S2 — S2 (RACEPINEPHRINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1513-2022·2022-08-10

    Pecan Deluxe Candy Double Fudge Blend recalled for undeclared peanut allergen

    Pecan Deluxe Candy Company is recalling Double Fudge Blend candy due to potential undeclared peanut content, which poses a risk to consumers with peanut allergies.

    Product
    Double Fudge Blend (04-3118-35) 35lbs. (15.88 KG) packaged in a blue plastic bag (ZZ500) inside a printed corrugated box (ZZ240),
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-1515-2022·2022-08-10

    FDA Recalls Vital Honey Supplement Containing Undeclared Tadalafil

    The FDA has recalled Dose Vital VIP Products Vital Honey With Caviar and Tongkat Ali Powder due to undeclared Tadalafil. The product was distributed in seven states and poses serious health risks.

    Product
    Dose Vital VIP Products Vital Honey With Caviar and Tongkat Ali Powder; 12 sachets-15g
    Category
    Food
    Distribution
    7 states
  • SevereFDA (Food)·F-1514-2022·2022-08-10

    Honey supplement recalled nationwide for undeclared sildenafil content

    Kingdom Honey Royal Honey VIP is recalled due to undeclared sildenafil, a pharmaceutical ingredient. The product was distributed nationwide; all lots are affected.

    Product
    Kingdom Honey Royal Honey VIP The Ultimate Power Source; 12 sachets-20g; UPC 555755 800036
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1333-2022·2022-08-10

    SANGTER Energy Supplement Capsules Recalled for Undisclosed Sildenafil

    Distributor RFR, LLC is recalling SANGTER Energy Supplement Capsules because FDA analysis found they contain undisclosed sildenafil without FDA approval. The product was distributed nationwide and internationally.

    Product
    SANGTER Energy Supplement Capsules, 3000mg x 7 grain, 7-count blister pack within a carton, Distributed by: Distributor RFR, LLC, (800) 519-0204 Miami 33172 FL, USA; UPC 0 705632 523285
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1401-2022·2022-08-10

    SARS-CoV-2 Rapid Antigen Test Kits Distributed Without FDA Approval

    North American Diagnostics is recalling SARS-CoV-2 rapid antigen test kits that were distributed without FDA approval or clearance. Approximately 122,366 units were sold to consumers across multiple US states and internationally.

    Product
    SARS CoV 2 rapid antigen test kits packaged under the following brands: Oral Rapid Test, Oral Rapid Antigen Test, SML LDT Kits, SML Brand Finished Kits, SML Brand BT Test Kits, SML Brand BT Antigen Test Kit LDT
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1350-2022·2022-08-10

    SUSTANGO supplement capsules recalled for undisclosed tadalafil content

    SUSTANGO capsules contain the undisclosed pharmaceutical ingredient tadalafil and were marketed without FDA approval. Approximately 750 cartons were distributed nationwide via Amazon.

    Product
    SUSTANGO (Pendenadril Tytrate Blend) Capsules, 400 mg, 10-count blisters per carton, Formulated by: Male FX Labs, Bangor, ME, ASIN X0024468I9.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1482-2022·2022-08-10

    PRESTIGE RETRACTION GRASPER recalled due to potential weld separation

    The FDA is recalling 399 units of the PRESTIGE RETRACTION GRASPER surgical instrument due to risk of weld separation between the handle and shaft. This defect could cause device malfunction during surgical procedures.

    Product
    PRESTIGE RETRACTION GRASPER, W/PORT DUAL ACTION, ROTATING 5mm DIAM., 36cm LENGTH. Product Code 8361-10
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1498-2022·2022-08-10

    Atellica CH Iron_2 Diagnostic Device Produces False Microalbumin Results from Reagent Carryover

    Siemens Atellica CH Iron_2 in vitro diagnostic devices are being recalled because they produce falsely elevated microalbumin test results when a microalbumin test immediately follows an iron test. No illnesses have been reported.

    Product
    Atellica CH Iron_2 (Iron_2) is for in vitro diagnostic use in the quantitative determination of iron in human serum and (lithium heparin) plasma samples.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1303-2022·2022-08-10

    Matzim LA Extended-Release Tablets Recalled for Dissolution Specification Failure

    Matzim LA Extended-Release Tablets, 240 mg are being recalled due to failed dissolution specifications. Patients taking this medication should consult their doctor about their treatment.

    Product
    Matzim LA (Diltiazem Hydrochloride) Extended-Release Tablets, 240 mg, 30-count bottles, Rx Only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL USA 33314, USA, Distributed by: Actavis Pharma Inc., Parsippany, NJ 07054 USA; NDC 58544-692-30.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1537-2022·2022-08-10

    Vicks ZzzQuil Melatonin Syrup recalled for unapproved manufacturing process

    Procter & Gamble is recalling 90,522 cases of Vicks ZzzQuil Liquid Melatonin Syrup due to being an acidified/low-acid dietary supplement without an FDA-approved manufacturing process.

    Product
    Vicks ZzzQuil Liquid Melatonin Syrup Adult 8oz plastic bottle sold as single and twin pack
    Category
    Food
    Distribution
    45 states
  • HighFDA (Devices)·Z-1481-2022·2022-08-10

    Endoscopic Grasper Instruments Recalled Due to Weld Separation Risk

    Aesculap Implant Systems is recalling PRESTIGE ATRAUMATIC GRASPER surgical instruments because the weld connecting the handle to the shaft may separate during use.

    Product
    PRESTIGE ATRAUMATIC GRASPER W/PORT DUAL ACTION, ROTATING 5mm DIAM., 36cm LENGTH. Product Code 8360-10
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1530-2022·2022-08-10

    Grandpa's Yogurt Muffins Recalled Due to Temperature Abuse During Delivery

    United Natural Foods, Inc. is recalling Grandpa's brand yogurt muffins sold in Alabama and Mississippi due to temperature abuse during delivery to retail stores. No illnesses have been reported.

    Product
    NON-SHELF STABLE BAKED GOODS 1. GRANDPAS GRANDPAS ALMD PPY YGRT MFFN UPC 75563912378 5 OZ MORRISONS PASTRY COR 2. GRANDPAS GRANDPAS BRY BLST YGRT MFFN UPC 75563912363 5 OZ MORRISONS PASTRY COR 3. GRANDPAS GRANDPAS BB CRMB YGRT MFFN UPC…
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-1518-2022·2022-08-10

    Frozen deli salads recalled due to temperature abuse during delivery

    United Natural Foods, Inc. recalls frozen deli salads and prepared foods distributed in Alabama and Mississippi due to temperature abuse during delivery to retail stores.

    Product
    DELI SALADS 1. ASK ASK FOODS LOADED BAKED POTATO SALAD UPC 4742641052 5 LB ASK FOODS INC 2. ASK ASK FOODS SMOKEY MOZZARELLA PASTA SALAD UPC 4742650893 2 5 LB ASK FOODS INC 3. ASK ASK FOODS SMOKEY…
    Category
    Food
    Distribution
    2 states
  • HighFDA (Drugs)·D-1302-2022·2022-08-10

    Prescription Drug Matzim LA Extended-Release Tablets Recalled for Failed Dissolution

    Teva Pharmaceuticals is recalling Matzim LA (Diltiazem Hydrochloride) 180 mg tablets because they failed to meet dissolution specifications. The recall affects approximately 8,022 bottles distributed nationwide in the United States and Puerto Rico.

    Product
    MATZIM LA — MATZIM LA (DILTIAZEM HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1535-2022·2022-08-10

    Vicks Children's Botanicals Liquid Nighttime Recalled for Improper Processing

    The Procter & Gamble Company is recalling Vicks Children's Botanicals Liquid Nighttime due to manufacturing without an approved acidification process. The product's preservation safety cannot be assured.

    Product
    Vicks Children's Botanicals Liquid Nighttime 4oz plastic bottle
    Category
    Drug
    Distribution
    45 states
  • HighFDA (Food)·F-1524-2022·2022-08-10

    Frozen Foods Recalled Due to Temperature Abuse During Delivery

    United Natural Foods, Inc. is recalling multiple brands of frozen prepared foods distributed to retail stores in Alabama and Mississippi due to temperature abuse during delivery. The temperature-abused foods may have been exposed to unsafe conditions allowing bacterial growth.

    Product
    FROZEN PREPARED FOODS 1. FRESH MARKET GLUTEN FREE COMBO PIZZA UPC 73709421202 12 OZ DI MANUFACTURING 2. FRESH MARKET GLUTEN FREE PEPPERONI PIZZA UPC 73709421016 12 OZ DI MANUFACTURING 3. FRESH MARKET GF MARGHRITA PIZZA…
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-1521-2022·2022-08-10

    Frozen Seafood Products Recalled Due to Temperature Abuse During Delivery

    Multiple frozen seafood products from various brands distributed in Alabama and Mississippi were recalled due to temperature abuse during delivery to retail stores. No illnesses have been reported.

    Product
    1. SPENCE SMOKED SALMON PINWHEELS 4 OZ UPC 76333600866 4 OZ ACME SMOKED FISH COR 2. ISABELLES HMSTYL TUNA SALAD UPC 71070840624 5LB SALAD BAR TENDERS 3. ISABELLES MD MACARONI SHRIMP SALAD 5 LB UPC 71070843184 5 LB…
    Category
    Food
    Distribution
    2 states