The Recall Desk

Recalls

All US Product Recalls

Searchable archive of product recalls from the FDA, USDA FSIS, CPSC, NHTSA, and EPA — translated into plain English, severity-scored from objective criteria, and always linked back to the original government notice.

How to read this listing

Every recall on this list has been scored 1–5 against an objective rubric from the agency’s own classification, presence of reported injuries or deaths, distribution scope, and hazard type. The colored severity badge on each card is the score — 5 (Critical) means deaths or serious injuries are reported, 4 (Severe) means significant injury or hospitalization risk, and 3 (High) means a known hazard with no confirmed harm yet. Filter to 3+ (High and above) if you want to skip routine Class-III notices.

The agency chips above control which streams are visible. FDA spans food, drugs, and medical devices. USDA FSIS is meat, poultry, and processed egg products. CPSC is household consumer products. NHTSA is vehicles, tires, and child seats. Nationwide on a card means the recall affects every US state — most do — while a state list means distribution was limited.

Click any recall to see the full summary, affected lot codes and model numbers, the agency’s own classification, and a direct link back to the original government notice for verification.

Filters

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All agenciesFDA (Food)FDA (Drugs)FDA (Devices)USDA FSISCPSCNHTSAEPA

Category

All categoriesFoodDrugMedical DeviceVehicleConsumer Product

Minimum severity

Any3+ (High and above)4+ (High and above)5+ (High and above)

Clear filters

2201–2225 of 8589

  • SevereFDA (Drugs)·D-1434-2019·2019-07-03

    American Health Packaging Recalls Pramipexole Dihydrochloride Tablets Due to GMP Deviations

    American Health Packaging is recalling Pramipexole Dihydrochloride Tablets due to GMP deviations and possible cross-contamination from cleaning failures.

    Product
    Pramipexole Dihydrochloride Tablets, 1.0 mg, 30 Tablets (6 tablets per blister card), Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217 NDC Blister Card: 68084-982-95; NDC Carton: 68084-982-25
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1433-2019·2019-07-03

    Pramipexole Dihydrochloride Tablets Recalled for GMP Deviations and Cross-Contamination Risk

    American Health Packaging is recalling Pramipexole Dihydrochloride Tablets due to GMP deviations and a cleaning procedure failure that may have caused cross-contamination.

    Product
    Pramipexole Dihydrochloride Tablets, 0.5 mg, 30 Tablets (6 tablets per blister card), Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217 NDC Blister Card: 68084-974-95; NDC Carton: 68084-974-25
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1429-2019·2019-07-03

    Acetaminophen Children's Liquid Recalled for Microbial Contamination Risk

    H J Harkins Company is recalling 40 bottles of Acetaminophen Children's Liquid due to potential contamination with Burkholderia cepacia and Ralstonia pickettii.

    Product
    Acetaminophen Children's Liquid, 160 mg/5 mL, 4 oz bottle, Manufactured by Torrent Pharma, Inc., Levittown, PA 19057, NDC 52959-0309-04
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1421-2019·2019-07-03

    Premier Pharmacy Labs Recalls Naloxone HCL Injection Due to Sterility Concerns

    Premier Pharmacy Labs is recalling Naloxone HCL Preserved Injection because FDA inspections found insufficient environmental controls and lack of process validations, raising concerns about sterility assurance.

    Product
    Naloxone HCL Preserved INJ, 500mg/50mL (10mg/mL), 50mL Sterile MDV, Rx only, Premier Pharmacy Labs, 8265 Commercial Way, Weeki Wachee, FL 34613, NDC: 69623-235-39, barcode 6 69623 23539 0.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1420-2019·2019-07-03

    Premier Pharmacy Labs Recalls Mitomycin Irrigation Due to Sterility Concerns

    Premier Pharmacy Labs is recalling 1,834 vials of Mitomycin Preservative Free Irrigation because FDA inspections found insufficient environmental controls that may compromise sterility.

    Product
    Mitomycin Preservative Free Irrigation, 40mg/10mL (4mg/mL), 10mL SDV, Rx only, Premier Pharmacy Labs, 8265 Commercial Way, Weeki Wachee, FL 34613, NDC: 69623-160-35, barcode 5 69623 16035 0.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1411-2019·2019-07-03

    Premier Pharmacy Labs Recalls Atropine Sulfate Injection Due to Sterility Concerns

    Premier Pharmacy Labs is recalling 745 syringes of Atropine Sulfate Injection because FDA inspections found insufficient environmental controls that may compromise sterility.

    Product
    Atropine Sulfate PF INJ, 0.8 mg/2 mL (0.4 mg/mL), 2mL Single Dose Syringe, Rx only, Premier Pharmacy Labs, 8265 Commercial Way, Weeki Wachee, FL 34613, NDC: 69623-131-12, barcode 0 69623 13112 6.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1419-2019·2019-07-03

    Premier Pharmacy Labs Recalls Lidocaine and Phenylephrine Injection Vials

    Premier Pharmacy Labs is recalling 323 vials of Lidocaine 0.5%/Phenylephrine 0.75% Injection due to a lack of sterility assurance identified during an FDA inspection.

    Product
    Lidocaine 0.5%/Phenylephrine 0.75% P.F. INJ, 1mL Sterile SDV, Rx only, Premier Pharmacy Labs, 8265 Commercial Way, Weeki Wachee, FL 34613, NDC: 69623-176-31, barcode 6 69623 17631 0.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1413-2019·2019-07-03

    Premier Pharmacy Labs Recalls Chlorpromazine Injection Due to Sterility Concerns

    Premier Pharmacy Labs is recalling 824 vials of Chlorpromazine HCL Injection because an FDA inspection found insufficient environmental controls that may compromise sterility.

    Product
    ChlorproMAZINE HCL INJ, 25mg/mL, *Contains Sulfites*, 1mL in a 5mL Sterile SDV, Rx only, Premier Pharmacy Labs, 8265 Commercial Way, Weeki Wachee, FL 34613, NDC: 69623-122-28, barcode 7 69623 12228 4.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1412-2019·2019-07-03

    Premier Pharmacy Labs Recalls Brilliant Blue Ophthalmic Injection for Sterility Concerns

    Premier Pharmacy Labs is recalling 578 vials of Brilliant Blue Ophthalmic Injection due to a lack of assurance of sterility identified during an FDA inspection.

    Product
    Brilliant Blue Ophthalmic PF INJ, 0.5mg/mL (0.05%), 1 mL SDV, Rx only, Premier Pharmacy Labs, 8265 Commercial Way, Weeki Wachee, FL 34613, NDC: 69623-211-31, barcode 2 69623 21131 0.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1428-2019·2019-07-03

    Premier Pharmacy Labs Recalls Succinylcholine Chloride Syringes for Sterility Concerns

    Premier Pharmacy Labs is recalling 1,721 syringes of Succinylcholine Chloride due to FDA findings of insufficient environmental controls and lack of sterility assurance.

    Product
    SUCCINYLcholine Chloride, 200mg/10mL (20mg/mL), 10mL Sterile Single Dose Syringe, Rx only, Premier Pharmacy Labs, 8265 Commercial Way, Weeki Wachee, FL 34613, NDC: 69623-239-16, barcode 9 69623 23916 0.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1430-2019·2019-07-03

    Diphenhydramine Liquid Recalled for Potential Microbial Contamination

    H J Harkins Company is recalling Diphenhydramine HCL Liquid due to potential contamination with Burkholderia cepacia and Ralstonia pickettii.

    Product
    Diphenhydramine HCL Liquid, 12.5 mg/5 mL, 4 oz bottle, Manufactured by Torrent Pharma, Inc., Levittown, PA 19057, NDC 52959-0123-03.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1417-2019·2019-07-03

    Premier Pharmacy Labs Recalls Isoproterenol HCL Bags Due to Sterility Concerns

    Premier Pharmacy Labs is recalling 1,235 bags of Isoproterenol HCL in D5W nationwide because FDA inspections found insufficient environmental controls and lack of sterility assurance.

    Product
    Isoproterenol HCL in D5W (Non Sterile to Sterile), 200mcg/50mL (4mcg/mL), 50mL Sterile Single-Dose Bag, Rx only, Premier Pharmacy Labs, 8265 Commercial Way, Weeki Wachee, FL 34613, NDC: 69623-240-57, barcode 0 69623 24057 7.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1414-2019·2019-07-03

    Premier Pharmacy Labs Recalls Dexamethasone Syringes Due to Sterility Concerns

    Premier Pharmacy Labs is recalling 86 syringes of Dexamethasone Sodium Phosphate due to potential sterility issues found during an FDA inspection.

    Product
    Dexamethasone Sodium Phosphate Preservative Free Sterile Solution for INJ, 24mg/mL, 1mL Sterile Single-Use Syringe, Rx only, Premier Pharmacy Labs, 8265 Commercial Way, Weeki Wachee, FL 34613, NDC: 69623-252-10, barcode 0 69623 25210 4.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1425-2019·2019-07-03

    Premier Pharmacy Labs Recalls Riboflavin 5-Phosphate Sodium Ophthalmic Solution

    Premier Pharmacy Labs is recalling 125 bottles of Riboflavin 5-Phosphate Sodium Ophthalmic Solution due to a lack of assurance of sterility.

    Product
    Riboflavin 5-Phosphate Sodium Ophthalmic Solution, 19.05mg/3mL (6.35 mg/mL), 3 mL Dropper Bottle, Rx only, Premier Pharmacy Labs, 8265 Commercial Way, Weeki Wachee, FL 34613, NDC: 69623-106-61, barcode 1 69623 10661 9.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1409-2019·2019-06-26

    P & L Developments Recalls Cetirizine Oral Solution Due to Bacterial Contamination

    P & L Developments is recalling 124,512 bottles of Up & Up Children's Cetirizine Oral Solution due to potential contamination with Burkholderia cepacia and Ralstonia pickettii.

    Product
    Cetirizine Oral Solution 1 mg/mL, Up & Up, Children's allergy relief, Antihistamine, Dye Free, Grape Flavor, 4 FL. oz. (118 mL) Bottle, Distributed by Target Corporation, Minneapolis, MN 55403, NDC 11673-178-04, UPC 359726178044.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1440-2019·2019-06-26

    Zydus Recalls Anastrozole Tablets Due to Cross-Contamination

    Zydus Pharmaceuticals is recalling Anastrozole tablets due to cross-contamination from cleaning failures. The recall covers 1.4 million bottles distributed nationwide.

    Product
    ANASTROZOLE — ANASTROZOLE (ANASTROZOLE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1408-2019·2019-06-26

    P & L Developments Recalls Cetirizine Oral Solution Due to Bacterial Contamination

    P & L Developments, LLC is recalling 17,664 bottles of Cetirizine Oral Solution due to potential contamination with Burkholderia cepacia and Ralstonia pickettii.

    Product
    Cetirizine Oral Solution 1 mg/mL, Children's Allergy, Antihistamine, Dye Free, Grape Flavor, 4 FL. oz. Bottle, Distributed by C.D.M.A. Inc., Novi, MI 48376, Quality Choice, NDC 63868-430-04, UPC 635515992474.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1452-2019·2019-06-26

    Zydus Recalls Pramipexole Dihydrochloride Tablets Due to Cross-Contamination Risk

    Zydus Pharmaceuticals USA Inc. is recalling Pramipexole Dihydrochloride Tablets 1.5 mg due to cross-contamination caused by cleaning failures.

    Product
    Pramipexole Dihydrochloride Tablets 1.5 mg 90-count bottle, Rx only Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ NDC 68382-200-16
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1443-2019·2019-06-26

    Zydus Recalls Pramipexole Dihydrochloride Tablets Due to Cross-Contamination

    Zydus Pharmaceuticals USA Inc. is recalling Pramipexole Dihydrochloride Tablets 0.125 mg due to cross-contamination caused by cleaning failures.

    Product
    Pramipexole DihydrochlorideTablets 0.125 mg, 90-count bottle, Rx Only, Manufactured by: Cadila Healthcare Ltd Ahmedabad, India. Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534. NDC 68382-196-16
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1407-2019·2019-06-26

    P & L Developments Recalls Cetirizine HCL Oral Solution Due to Contamination

    P & L Developments, LLC is recalling 202,068 bottles of Cetirizine HCL Oral Solution due to potential contamination with Burkholderia cepacia and Ralstonia pickettii.

    Product
    Cetirizine HCL Oral Solution 1 mg/mL, Children's Allergy, Antihistamine, Dye Free, Gluten Free, Grape Flavor, 5 mg/5mL, 4 FL. oz. Bottle, Distributed by Dolgencorp, LLC, 100 mission ridge, Goodlettsville, TN 37072, NDC 55910-878-04, UPC 359726178051.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1410-2019·2019-06-26

    Preferred Pharmaceuticals Recalls Robafen DM Due to Potential Bacterial Contamination

    Preferred Pharmaceuticals is recalling specific lots of Robafen DM cough syrup due to potential contamination with Burkholderia cepacia and Ralstonia pickettii.

    Product
    Robafen DM, Generic for Robitussin DM, In each teaspoonful (5mL): Dextromethorphan HBr, USP 10mg,/Guaifenesin, USP 100mg, 118mL (4oz) bottle, Manufactured for Preferred Pharmaceuticals, Inc., Anaheim, CA 92807 by Major Pharmaceuticals, Livonia, MI 48152, NDC 68788-0841-01
    Category
    Drug
    Distribution
    2 states
  • CriticalFDA (Drugs)·D-1398-2019·2019-06-19

    Heritage Pharmaceuticals Recalls Amikacin Sulfate Injection Due to Microbial Growth

    Heritage Pharmaceuticals is recalling Amikacin Sulfate Injection vials because microbial growth was detected in a sub-lot. The affected product is distributed nationwide in the USA.

    Product
    AMIKACIN SULFATE — AMIKACIN SULFATE (AMIKACIN SULFATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-1344-2019·2019-06-19

    Aphrodisiac Platinum 40000 Recalled for Unapproved Sildenafil Contamination

    Select Distributions LLC is recalling Aphrodisiac Platinum 40000 because FDA analysis found the product is tainted with sildenafil and was marketed without an approved NDA/ANDA.

    Product
    Aphrodisiac Platinum 40000, Proprietary Raw Material 6000 mg, 1 count blister card, 24 cards per box, Distributed by: APhrodisiac. UPC Code 644118128135
    Category
    Drug
    Distribution
    2 states