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.

18751–18775 of 88183

  • HighFDA (Drugs)·D-0701-2023·2023-05-31

    FDA Recalls Epinephrine Injection Due to Sterility Assurance Failure

    Central Admixture Pharmacy Services is recalling 3,338 bags of epinephrine injectable solution nationwide. The FDA raised concerns about sterility assurance during an inspection.

    Product
    EPINEPHrine added to dextrose 5%, 2 mg/250 mL* (8 mcg/mL), 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-6030-1.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0934-2023·2023-05-31

    Meijer Sweet & Salty Trail Mix recalled for undeclared wheat and sesame

    Meijer Inc is recalling Meijer Sweet & Salty Trail Mix (12oz pouches) due to undeclared wheat and sesame ingredients. Consumers allergic to these allergens should not consume the product.

    Product
    Meijer Sweet & Salty Trail Mix 12oz. pouch, UPC 7 08820 10371 9
    Category
    Food
    Distribution
    7 states
  • HighFDA (Devices)·Z-1620-2023·2023-05-31

    Aligned Medical Solutions hand pack light covers may separate during use

    Windstone Medical Packaging recalls the Aligned Medical Solutions Minor Hand Pack because light handle covers may detach during procedures. This could delay surgery and compromise the sterile field, risking patient injury.

    Product
    Aligned Medical Solutions Minor Hand Pack, REF: AMS6539E, containing P 2 Cover Light Handle Blue STE, Sterile EO
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Drugs)·D-0671-2023·2023-05-31

    Cardioplegia Solution Recalled for Lack of Sterility Assurance

    Central Admixture Pharmacy Services recalls Cardioplegia Solution (Maintenance 4:1 in Ringer's) due to lack of sterility assurance confirmed by FDA inspection. The product is used during cardiac surgery and distributed nationwide.

    Product
    Cardioplegia Solution, Maintenance 4:1 in Ringer's, low potassium, 12 mEq K, packaged in 504.8 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0205-1.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0717-2023·2023-05-31

    Vancomycin injection recalled due to sterility assurance concerns

    Central Admixture Pharmacy Services is recalling vancomycin injections (1 g/250 mL) nationwide due to concerns about sterility assurance identified during FDA inspection. The recall affects 4,390 bags.

    Product
    vancomycin added to 0.9% sodium chloride, 1 g/250 mL* (4 mg/mL), 25 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-6064-1.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0710-2023·2023-05-31

    Oxytocin Injectable Solution Recalled for Sterility Assurance Questions

    Central Admixture Pharmacy Services is recalling oxytocin injectable solution after FDA inspection questioned sterility. Over 104,000 bags distributed nationwide are affected.

    Product
    oxyTOCIN 30 units added to 0.9% sodium chloride 500 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-6044-1.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0915-2023·2023-05-31

    Country Cookie Banana Cake Recalled for Missing Milk Allergen Declaration

    Country Cookie Banana Cake products are being recalled because their allergen statement does not declare milk. Consumers with milk allergies should not consume these products.

    Product
    Country Cookie Banana Cake, plastic clamshell
    Category
    Food
    Distribution
    2 states
  • HighFDA (Drugs)·D-0730-2023·2023-05-31

    Prescription Injectable Epinephrine and Dextrose Solution Recalled for Sterility Assurance Failure

    Central Admixture Pharmacy Services has recalled nationwide 2,542 bags of prescription-only injectable epinephrine and dextrose solution due to lack of sterility assurance following an FDA inspection.

    Product
    EPINEPHrine added to dextrose 5%, 8 mg/250 mL* (32 mcg/mL), 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-7019-1.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0709-2023·2023-05-31

    Injectable oxyTOCIN solution recalled nationwide after sterility assurance questioned

    Central Admixture Pharmacy Services is recalling oxyTOCIN 20 units in 0.9% sodium chloride injectable solution nationwide after an FDA inspection raised questions about the products' sterility assurance.

    Product
    oxyTOCIN 20 units added to 0.9% sodium chloride 1,000 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 72185-6043-1.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0718-2023·2023-05-31

    Vancomycin Injectable Solution Recalled Due to Sterility Assurance Concerns Nationwide

    Central Admixture Pharmacy Services is recalling 3,075 bags of vancomycin injectable solution nationwide due to lack of assurance of sterility following an FDA inspection.

    Product
    vancomycin added to 0.9% sodium chloride, 750 mg/250 mL* (3 mg/mL), 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-6071-1.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0661-2023·2023-05-31

    FDA Recalls Cardioplegia Solution for Sterility Assurance Failure

    Central Admixture Pharmacy Services is recalling cardioplegia solution due to sterility assurance concerns identified in an FDA inspection. The recall affects 269 bags distributed nationwide.

    Product
    Cardioplegia Solution, Maintenance 4:1 low potassium, 20 mEq K, packaged in 810 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0103-1.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0713-2023·2023-05-31

    Injectable Diltiazem Recalled Over Sterility Assurance Concerns from FDA Inspection

    Central Admixture Pharmacy Services is recalling 3,040 bags of prescription diltiazem injection after FDA inspection raised concerns about product sterility. The medication was distributed nationwide.

    Product
    dilTIAZem added to 0.9% sodium chloride, 125 mg/125 mL* (1 mg/mL), 125 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-6055-1.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0745-2023·2023-05-31

    Drug Recall: NORepinephrine Injectable Solution Due to Sterility Concerns

    Central Admixture Pharmacy Services is recalling NORepinephrine injectable solution nationwide after an FDA inspection questioned the product's sterility assurance. The recall affects 4,994 bags.

    Product
    NORepinephrine added to 0.9% sodium chloride, 4 mg/250 mL* (16 mcg/mL), 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-8097-1.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0668-2023·2023-05-31

    Cardioplegia Solution Recalled for Lack of Sterility Assurance

    Central Admixture Pharmacy Services is recalling its Cardioplegia Solution, del Nido Formula, nationwide after an FDA inspection questioned the product's sterility.

    Product
    Cardioplegia Solution, del Nido Formula, packaged in 1,052.8 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0202-1.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0743-2023·2023-05-31

    NORepinephrine Injectable Solution Recalled for Sterility Assurance Failure

    Central Admixture Pharmacy Services recalls 2890 bags of NORepinephrine injection due to lack of sterility assurance following FDA inspection. The product, distributed nationwide, has affected lots with expiration dates through July 2023.

    Product
    NORepinephrine added to dextrose 5%, 16 mg/250 mL* (64 mcg/mL), 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-8095-1.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0699-2023·2023-05-31

    Neonatal TPN Starter Bags Recalled for Lack of Sterility Assurance

    Central Admixture Pharmacy Services is recalling 60 Neonatal TPN Starter Bags distributed nationwide due to sterility assurance concerns identified during an FDA inspection.

    Product
    Neonatal TPN Starter Bag, Amino Acids (Trophamine) 6%/Dextrose 10% with low calcium and HEPARIN, packaged in 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0430-1.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0733-2023·2023-05-31

    Phenylephrine Injectable Solution Recalled Over Sterility Assurance Failure

    Central Admixture Pharmacy Services recalls 13,953 bags of phenylephrine injectable solution nationwide due to FDA concerns about sterility assurance identified during inspection.

    Product
    PHENYLephrine added to 0.9% sodium chloride, 20 mg/250 mL* (80 mcg/mL), 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-7025-1.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0935-2023·2023-05-31

    Turkey and Havarti Sandwich Recalled for Undeclared Sesame Allergen

    Garden Highway Southwest is recalling turkey and havarti sandwiches due to undeclared sesame allergen. Products distributed to KS, NE, MO, LA, and TX with sell-by dates through April 29, 2023 pose a risk to consumers with sesame allergies.

    Product
    Turkey and Havarti Sandwich Net Wt 8.55 oz (242g) UPC 826766155842 packaged in plastic clamshell container
    Category
    Food
    Distribution
    5 states
  • HighFDA (Food)·F-0927-2023·2023-05-31

    Cocktail Sauce Recalled for Undeclared Fish and Soy Allergens

    Washington Crab & Seafood Company is recalling 52 cups of 8-ounce Cocktail Sauce distributed in North Carolina and South Carolina due to undeclared fish and soy allergens.

    Product
    COCKTAIL SAUCE Ingredients: Ketchup horseradish, vinegar Worcestershire sauce garlic salt Net Wt 8 oz WASHINGTON CRAB Carolina seafood
    Category
    Food
    Distribution
    2 states
  • HighFDA (Drugs)·D-0724-2023·2023-05-31

    FDA Recalls Injectable Phenylephrine Solution Due to Sterility Assurance Issue

    Central Admixture Pharmacy Services is recalling 14,205 bags of injectable phenylephrine solution nationwide following FDA inspection findings regarding sterility assurance. The product is prescription-only with nationwide distribution.

    Product
    PHENYLephrine added to 0.9% sodium chloride, 40 mg/250 mL* (160 mcg/mL), 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-6092-1.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0905-2023·2023-05-31

    Country Cookie Chocolate Chocolate Chip Cookies Recalled for Undeclared Milk

    Country Cookie LLC. is recalling Country Cookie Chocolate Chocolate Chip cookies because the allergen statement does not declare milk. The recall affects cookies distributed in Missouri and Kansas.

    Product
    Country Cookie Chocolate Chocolate Chip cookie, plastic wrapped
    Category
    Food
    Distribution
    2 states
  • HighFDA (Drugs)·D-0676-2023·2023-05-31

    FDA Recalls Cardioplegia Solution Due to Sterility Assurance Issues

    Central Admixture Pharmacy Services is recalling Cardioplegia Solution due to FDA concerns about sterility assurance. The recall affects 52 bags distributed nationwide.

    Product
    Cardioplegia Solution, Induction 4:1 Plasmalyte, HIGH POTASSIUM, HIGH K, packaged in 542 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0212-1.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0742-2023·2023-05-31

    FDA recalls epinephrine injection for lack of sterility assurance

    Central Admixture Pharmacy Services recalled 8171 bags of epinephrine injection nationwide due to FDA concerns about sterility. The recalled prescription-only product was distributed across multiple lot numbers with expiration dates in 2023.

    Product
    EPINEPHrine added to 0.9% sodium chloride, 4 mg/250 mL* (16 mcg/mL), 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-8093-1.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0691-2023·2023-05-31

    Neonatal Injectable TPN Bags Recalled Over Sterility Assurance Concerns

    Central Admixture Pharmacy Services recalled 877 bags of neonatal TPN starter bags nationwide due to lack of sterility assurance following an FDA inspection.

    Product
    Neonatal TPN Starter Bag, Amino Acids (Trophamine) 3%/Dextrose 10% with CALCIUM and HEPARIN, packaged in 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0420-1.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0744-2023·2023-05-31

    FDA Recalls NORepinephrine Injection Due to Sterility Concerns

    Central Admixture Pharmacy Services recalled 6,414 bags of NORepinephrine injection nationwide after an FDA inspection questioned the sterility of the product. Healthcare facilities should stop using and quarantine affected lots.

    Product
    NORepinephrine added to 0.9% sodium chloride, 8 mg/250 mL* (32 mcg/mL), 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-8096-1.
    Category
    Drug
    Distribution
    Distributed nationwide