The Recall Desk

Severity 4 of 5

Severe recalls

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

What “severe” means here

Severity 4 (Severe) recalls have a real, documented risk of significant injury, hospitalization, or property damage even if no deaths have been reported. The agency classification is FDA Class II with hospitalization reports, USDA Class I, or a structural vehicle defect. These need attention quickly — not five-alarm urgency but not something to put off. Examples include allergen mislabeling on common allergens for products eaten by children, drug potency out of specification by a margin that could cause measurable harm, and vehicle defects affecting braking or steering.

The full rubric is on the methodology page. Severity is computed deterministically from the agency’s own classification plus the source text — no editorial vibes.

13676–13700 of 29188

  • SevereFDA (Drugs)·D-1148-2018·2018-09-05

    Pharmcore Recalls Human Chorionic Gonadotropin Vials Due to Sterility Concerns

    Pharmcore Inc. is recalling 864 vials of Human Chorionic Gonadotropin 11000 IU due to a lack of assurance of sterility. The affected lots were distributed nationwide.

    Product
    Human Chorionic Gonadotropin 11000 IU Vial Lyophilized 1109 East Hallandale Beach Blvd. Hallandale Beach, FL 33009
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1133-2018·2018-09-05

    AvKARE Recalls Valsartan Tablets Due to Carcinogen Impurity

    AvKARE Inc. is recalling Valsartan Tablets 320 mg because a carcinogen impurity was detected in the active pharmaceutical ingredient.

    Product
    Valsartan Tablets, USP 320 mg Rx Only 30 Tablets (6x5) Unit Dose NDC 50268-786-13 Manufactured for: AvKARE, Inc. Pulaski, TN 38478
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·076-2018·2018-09-05

    Wayne Farms Recalls Frozen Chicken Products Due to Metal Contamination

    Wayne Farms is recalling approximately 438,960 pounds of frozen, fully cooked chicken products that may contain metal pieces. Consumers are advised not to consume these items.

    Product
    Wayne Farms LLC — Wayne Farms, LLC Recalls Fully Cooked Chicken Products due to Possible Foreign Matter Contamination
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1906-2018·2018-09-05

    Coca-Cola Recalls Minute Maid Tropical Blend Juice Due to Glass

    The Coca-Cola Company is recalling 432 bottles of Minute Maid Tropical Blend juice because foreign matter believed to be glass was found in retained samples.

    Product
    Consumer Packaging (PET bottle): Minute Maid TROPICAL BLEND Flavored Juice Beverage 12 FL OZ (355mL), JAN0719NPA, UPC: 0 25000 06229 2. Master Case: packaged 24/12 fl.oz., GTIN number 00025000062414 (no UPC)
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1130-2018·2018-09-05

    AvKARE Recalls Valsartan Tablets Due to Carcinogen Impurity in API

    AvKARE is recalling Valsartan Tablets 40 mg because a carcinogen impurity was detected in the active pharmaceutical ingredient used to manufacture the drug.

    Product
    Valsartan Tablets, USP 40 mg Rx Only NDC 50268-783-15 50 Tablets (5x10) Unit Dose Manufactured for: AvKARE, Inc. Pulaski, TN 38478
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1157-2018·2018-09-05

    Auro Pharmacies Recalls Calcium Gluconate Injectable Due to Sterility Concerns

    Auro Pharmacies is recalling 167 vials of Calcium Gluconate injectable because processes and equipment were inadequate to assure sterility.

    Product
    Calcium Gluconate injectable, 10%, 50 ml Single Dose vial, Rx only, Central Drugs Compounding Pharmacy, 520 W. La Habra Blvd, La Habra, CA 90631
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1165-2018·2018-09-05

    Auro Pharmacies Recalls Testosterone Enanthate/Cypionate Injectable Due to Sterility Concerns

    Auro Pharmacies is recalling 11 vials of Testosterone Enanthate/Cypionate injectable because the manufacturer could not assure the sterility of the product.

    Product
    Testosterone Enanthate/Cypionate injectable, 126/54 mg/mL, packaged in a) 3 mL and b) 5 mL Multiple Dose vials, Rx only, Central Drugs Compounding Pharmacy, 520 W. La Habra Blvd, La Habra, CA 90631
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1161-2018·2018-09-05

    Auro Pharmacies Recalls Methyl-Cobalamin Injectable Due to Sterility Concerns

    Auro Pharmacies, Inc. is recalling 90 vials of Methyl-Cobalamin injectable because inadequate processes and equipment were used to assure sterility.

    Product
    Methyl-Cobalamin injectable, 5 mg/mL, 30 mL Multiple Dose vial, Rx only, Central Drugs Compounding Pharmacy, 520 W. La Habra Blvd, La Habra, CA 90631
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1151-2018·2018-09-05

    Pharmcore Recalls Human Chorionic Gonadotropin Vials Due to Sterility Concerns

    Pharmcore Inc. is recalling 2,085 vials of Human Chorionic Gonadotropin 4000 IU nationwide due to a lack of assurance of sterility.

    Product
    Human Chorionic Gonadotropin 4000 IU Vial Lyophilized 1109 East Hallandale Beach Blvd. Hallandale Beach, FL 33009
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1158-2018·2018-09-05

    Auro Pharmacies Recalls Dexpanthenol Injectable Vials Due to Sterility Concerns

    Auro Pharmacies, Inc. is recalling 91 vials of Dexpanthenol injectable due to inadequate processes and equipment to assure sterility.

    Product
    Dexpanthenol injectable, 250 mg/mL, 10 mL Single Dose vial, Rx only, Central Drugs Compounding Pharmacy, 520 W. La Habra Blvd, La Habra, CA 90631
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1137-2018·2018-09-05

    Torrent Pharma Recalls Amlodipine and Valsartan Tablets Due to Carcinogen Impurity

    Torrent Pharma Inc. is recalling Amlodipine and Valsartan Tablets because a carcinogen impurity was detected in the active pharmaceutical ingredient.

    Product
    Amlodipine and Valsartan Tablets, USP, 10 mg/320 mg, 30 tablets per bottle, Rx Only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382 721, India. NDC: 13668-204-30
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1131-2018·2018-09-05

    AvKARE Recalls Valsartan Tablets Due to Carcinogen Impurity

    AvKARE is recalling specific lots of Valsartan 80 mg tablets because a carcinogen impurity was detected in the active pharmaceutical ingredient.

    Product
    Valsartan Tablets, USP 80 mg Rx Only 50 Tablets (5x10) Unit Dose NDC 50268-784-15 Manufactured for: AvKARE, Inc. Pulaski, TN 38478
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1134-2018·2018-09-05

    Torrent Pharma Recalls Valsartan Tablets Due to Carcinogen Impurity

    Torrent Pharma Inc. is recalling specific batches of Valsartan Tablets USP, 80mg, because a carcinogen impurity was detected in the active pharmaceutical ingredient.

    Product
    Valsartan Tablets USP, 80mg, 90 tablets per bottle, Rx Only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382 721, India. NDC: 13668-068-90
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2878-2018·2018-09-05

    Biosense Webster Recalls WaveCrest Left Atrial Appendage Occlusion System Devices

    Biosense Webster is recalling 25 units of the WaveCrest Left Atrial Appendage Occlusion System (32 mm) because the delivery sheath may buckle during recapture.

    Product
    WaveCrest Left Atrial Appendage (LAA), Occlusion System (32 mm), Catalog Numbers WCR1523 and WCR2523.
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Drugs)·D-1145-2018·2018-09-05

    Torrent Pharma Recalls Amlodipine, Valsartan, and Hydrochlorothiazide Tablets Due to Impurity

    Torrent Pharma Inc. is recalling Amlodipine, Valsartan, and Hydrochlorothiazide tablets because a carcinogen impurity was detected in the active ingredient.

    Product
    Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP, 5 mg/160 mg/25 mg, 30 tablets per bottle, Rx Only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382 721, India. NDC: 13668-329-30
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V588000·2018-09-05

    Navistar Recalls International Trucks Due to Fuel Line Burst Risk

    Navistar is recalling specific International trucks because a restricted fuel pump screen may cause the fuel line to burst, leading to fuel leaks or engine stalling.

    Product
    INTERNATIONAL — INTERNATIONAL PROSTAR, LONESTAR, PAYSTAR, HX
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1167-2018·2018-09-05

    Auro Pharmacies Recalls Methyl-Cobalamin Injectable Due to Sterility Concerns

    Auro Pharmacies is recalling 74 vials of Methyl-Cobalamin injectable because the manufacturer could not assure the sterility of the product.

    Product
    Methyl-Cobalamin injectable, 2 mg/mL, 30 ml Multiple Dose vial, Rx only, Central Drugs Compounding Pharmacy, 520 W. La Habra Blvd, La Habra, CA 90631
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·075-2018·2018-09-05

    Caito Foods Recalls Chicken Salad for Undeclared Walnut Allergen

    Caito Foods is recalling 242 pounds of chicken salad containing undeclared walnuts. The products were distributed to retail locations in four states.

    Product
    Caito Foods, LLC — Caito Foods, LLC Recalls Chicken Salad Products due to Misbranding and an Undeclared Allergen
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Drugs)·D-1154-2018·2018-09-05

    Pharmcore Recalls Methylcobalamin Vials Due to Sterility Concerns

    Pharmcore Inc. is recalling 1,115 vials of Methylcobalamin 10 mg due to a lack of assurance of sterility. The product was distributed nationwide.

    Product
    Methylcobalamin 10 mg vial Lyophilized 1109 East Hallandale Beach Blvd. Hallandale Beach, FL 33009
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1139-2018·2018-09-05

    Torrent Pharma Recalls Amlodipine and Valsartan Tablets Due to Impurity

    Torrent Pharma Inc. is recalling Amlodipine and Valsartan Tablets because a carcinogen impurity was detected in the active pharmaceutical ingredient.

    Product
    Amlodipine and Valsartan Tablets, USP, 10 mg/160mg, 30 tablets per bottle, Rx Only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382 721, India. NDC: 13668-206-30
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1155-2018·2018-09-05

    Pharmcore Recalls Ipamorelin Vials Due to Sterility Assurance Concerns

    Pharmcore Inc. is recalling 599 vials of Ipamorelin 9 mg because the company cannot assure the sterility of the product.

    Product
    Ipamorelin 9 mg vial Lyophilized 1109 East Hallandale Beach Blvd. Hallandale Beach, FL 33009
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1136-2018·2018-09-05

    Torrent Pharma Recalls Valsartan Tablets Due to Carcinogen Impurity

    Torrent Pharma Inc. is recalling specific batches of Valsartan Tablets USP, 320mg, because a carcinogen impurity was detected in the active pharmaceutical ingredient.

    Product
    Valsartan Tablets USP, 320mg, 90 tablets per bottle, Rx Only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382 721, India. NDC: 13668-070-90
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1146-2018·2018-09-05

    RemedyRepack Recalls Amlodipine/Valsartan/HCTZ Tablets Due to NDMA Contamination

    RemedyRepack Inc. is recalling Amlodipine/Valsartan/HCTZ tablets in South Carolina due to trace amounts of NDMA, a possible impurity.

    Product
    Amlodipine/Valsartan/HCTZ 10mg/320mg/25mg Tablet, Rx Only (HDPE 90cc Bottles in cardboard trays) MFG Torrent Pharma LTD, Indrad, India 38272, NDC #70518-1220-0
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1164-2018·2018-09-05

    Auro Pharmacies Recalls Testosterone Cypionate/Enanthate Injectable Due to Sterility Concerns

    Auro Pharmacies is recalling 32 vials of Testosterone Cypionate/Enanthate injectable because inadequate processes and equipment failed to assure the sterility of the product.

    Product
    Testosterone Cypionate/Enanthate injectable, 200/50 mg/mL, packaged in a) 5 mL and 8 mL Multiple Dose vials, Rx only, Central Drugs Compounding Pharmacy, 520 W. La Habra Blvd, La Habra, CA 90631
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1132-2018·2018-09-05

    AvKARE Recalls Valsartan Tablets Due to Carcinogen Impurity in API

    AvKARE, Inc. is recalling specific lots of Valsartan Tablets 160 mg because a carcinogen impurity was detected in the active pharmaceutical ingredient used to manufacture the drug.

    Product
    Valsartan Tablets, USP 160 mg Rx Only 50 Tablets (5x10) Unit Dose NDC 50268-785-15 Manufactured for: AvKARE, Inc. Pulaski, TN 38478
    Category
    Drug
    Distribution
    Distributed nationwide