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.

12376–12400 of 29164

  • SevereFDA (Drugs)·D-1048-2019·2019-03-27

    Losartan Potassium Tablets Recalled Due to Impurity Detection

    Legacy Pharmaceutical Packaging LLC is recalling Losartan Potassium Tablets, 25 mg, because an impurity was detected. The recall involves 456,732 bottles distributed by Wal-Mart.

    Product
    Losartan Potassium Tablets, USP, 25 mg, 30 tablet bottles, Rx Only, Distributed by: Wal-Mart, Bentonville, AR 72716, Manufactured for: Camber Pharmaceuticals, Inc. Piscataway, NJ 08854, Packaged by: Legacy Pharmaceutical Packaging LLC, Earth City, MO 63045 NDC 68645-577-54
    Category
    Drug
    Distribution
    5 states
  • SevereFDA (Drugs)·D-1051-2019·2019-03-27

    Preferred Pharmaceuticals Recalls Losartan Potassium Tablets Due to Impurity

    Preferred Pharmaceuticals is recalling Losartan Potassium 50 mg tablets because an impurity, N-Methylnitrosobutyric acid (NMBA), was identified.

    Product
    Losartan Potassium Tablets, USP, 50 mg, a) 30-count bottle (NDC: 68788-0048-03), b) 90-count bottle (NDC: 68788-0048-09), Rx Only, Mfg: Torrent Pharma Inc. Basking Ridge, NJ. Relabeled by: Preferred Pharmaceuticals, Inc. 1250 N. Lakeview Ave., Suite O, Anaheim, CA 92807.
    Category
    Drug
    Distribution
    3 states
  • SevereFDA (Drugs)·D-1044-2019·2019-03-27

    AvKARE Recalls Losartan Potassium Tablets Due to Impurity

    AvKARE Inc. is recalling Losartan Potassium Tablets 50 mg because an impurity, N-Methylnitrosobutyric acid (NMBA), was identified.

    Product
    Losartan Potassium Tablets USP 50 mg 50 Tablets (5x10) Unit Dose boxes, Rx Only, Manufactured for: AvKARE Inc. Pulaski, TN 38478 ---- NDC 50268-517-15
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1008-2019·2019-03-27

    FDA Recalls Volumex Iodinated I-131 Albumin Due to Sterility Concerns

    Iso-Tex Diagnostics is recalling 54 syringes of Volumex (Iodinated I-131 Albumin) because environmental monitoring results exceeded limits, meaning sterility cannot be assured.

    Product
    VOLUMEX — VOLUMEX (IODINATED I-131 ALBUMIN)
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1023-2019·2019-03-27

    Advanced Pharma Recalls Phenylephrine Syringes Due to Sterility Concerns

    Advanced Pharma Inc. is recalling 22,900 syringes of Phenylephrine HCl injectable solution nationwide due to a lack of assurance of sterility.

    Product
    Phenylephrine HCl, 1 mg in 0.9% Sodium Chloride, QS 10 mL Injectable Solution 1 mg/10 mL (100 mcg per mL), Sterile single use syringe, NDC: 42852-830-61 Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1040-2019·2019-03-27

    Macleods Pharma Recalls Losartan Potassium and Hydrochlorothiazide Tablets Due to Carcinogen

    Macleods Pharma USA is recalling specific bottles of Losartan Potassium and Hydrochlorothiazide tablets because a carcinogen impurity was detected in the active ingredient.

    Product
    Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/25 mg, 90 count bottles, Rx Only, Manufactured for: Macleods Pharma USA, Inc., Plainsboro, NJ 08536, Manufactured by: Macleods Pharmaceuticals Ltd., Baddi, Himachal Pradesh, India. NDC 33342-0052-10
    Category
    Drug
    Distribution
    3 states
  • SevereFDA (Food)·F-1172-2019·2019-03-27

    Dahlicious Organic Lassi Recalled for Improper Pasteurization

    Dahlicious is recalling 2,175 bottles of Organic Lassi India-Style Drinkable Yogurt because the product was improperly pasteurized.

    Product
    DAHlicious ORGANIC Lassi India -Style DRINKABLE YOGURT, Grassland Plain, , 32 FL OZ (946 mL), UPC: 7 93573 01459 7
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Drugs)·D-1055-2019·2019-03-27

    Rising Pharmaceuticals Recalls Valsartan Tablets Due to NDEA Impurity

    Rising Pharmaceuticals is recalling Valsartan Tablets 320 mg due to CGMP deviations and the detection of a trace amount of the impurity N-nitrosodiethylamine (NDEA).

    Product
    Valsartan Tablets 320 mg USP, 90 tablet bottles, Distributed by: Acetris Health, LLC, Saddle Brook, NJ 07663, Manufactured by: Aurolife Pharma LLC, Dayton, NJ 08810 --- NDC 52343-125-90
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-1034-2019·2019-03-27

    Advanced Pharma Recalls Phenylephrine Injectable Solution Due to Sterility Concerns

    Advanced Pharma Inc. is recalling 975 units of Phenylephrine HCl injectable solution due to a lack of assurance of sterility. The product was distributed nationwide.

    Product
    Phenylephrine HCl, 1,200 mcg in 0.9% Sodium Chloride, QS 10 mL Injectable Solution 1,200 mcg/10 mL (120 mcg per mL), Sterile single use syringe, NDC: 42852-882-61 Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1013-2019·2019-03-27

    Mylan Recalls Alprazolam Tablets Due to Elevated Impurity Levels

    Mylan Institutional, Inc. is recalling specific lots of Alprazolam Tablets, 0.25 mg, because elevated levels of a known impurity were detected during stability testing.

    Product
    Alprazolam Tablets, USP, 0.25 mg, 10x10 per carton, Rx Only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 USA. NDC: 51079-788-20
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1030-2019·2019-03-27

    Advanced Pharma Recalls Heparin Syringes Due to Sterility Concerns

    Advanced Pharma Inc. is recalling 500 syringes of Heparin 10 Units/10 mL due to a lack of assurance of sterility. The product was distributed nationwide.

    Product
    Heparin 10 Units/10 mL 10 Units in 0.45% Sodium Chloride, QS 10 mL, Injectable Solution, Dwell, 10mL Sterile single use syringe, NDC: 42852-725-61 Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1054-2019·2019-03-27

    Rising Pharmaceuticals Recalls Valsartan Tablets Due to NDEA Impurity

    Rising Pharmaceuticals is recalling Valsartan Tablets 160 mg due to CGMP deviations and the detection of a trace amount of the impurity NDEA.

    Product
    Valsartan Tablets 160 mg USP, 90 tablet bottles, Rx only, Distributed by: Acetris Health, LLC, Saddle Brook, NJ 07663, Manufactured by: Aurolife Pharma LLC, Dayton, NJ 08810 ---- NDC 52343-124-90
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-1020-2019·2019-03-27

    Advanced Pharma Recalls Phenylephrine HCl Syringes Due to Sterility Concerns

    Advanced Pharma Inc. is recalling 16,075 syringes of Phenylephrine HCl injectable solution nationwide due to a lack of assurance of sterility.

    Product
    Phenylephrine HCl, 500 mcg in 0.9% Sodium Chloride, QS 5 mL Injectable Solution 500 mcg/5 mL (100 mcg per mL), 5mL Sterile single use syringe, NDC: 42852-830-67 Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1037-2019·2019-03-27

    Aurobindo Pharma Recalls Valsartan Tablets Due to NDEA Impurity

    Aurobindo Pharma USA Inc. is recalling specific lots of Valsartan 40 mg tablets because FDA analysis found trace amounts of the impurity N-nitrosodiethylamine (NDEA).

    Product
    VALSARTAN — VALSARTAN (VALSARTAN)
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-1027-2019·2019-03-27

    Advanced Pharma Recalls Lidocaine Syringes Due to Sterility Concerns

    Advanced Pharma Inc. is recalling 1,980 syringes of 2% Lidocaine HCl Injectable Solution nationwide due to a lack of assurance of sterility.

    Product
    2% Lidocaine HCl Injectable Solution, 100 mg/5 mL (20 mg per mL), 5mL Sterile single use syringe, NDC: 42852-011-67 Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1018-2019·2019-03-27

    Advanced Pharma Recalls Fentanyl Injectable Solution Due to Sterility Concerns

    Advanced Pharma Inc. is recalling 180 bags of fentanyl injectable solution nationwide due to a lack of assurance of sterility.

    Product
    fentaNYL 2500 mcg/250 mL Injectable Solution, Fentanyl 0.9% Sodium Chloride, QS, Sterile single use bags, NDC: 42852-210-25 Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1030-2019·2019-03-27

    CTL Medical Hex Driver Recalled Due to Anti-Toggle Ring Separation Risk

    CTL Medical is recalling 133 Hex Drivers because the anti-toggle ring may separate during surgery, potentially causing pedicle screw construct failure.

    Product
    CTL Medical Hex Driver, 1/4" Square QC, 4.0 Ratcheting Ref 015.7050
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Drugs)·D-1022-2019·2019-03-27

    Advanced Pharma Recalls Phenylephrine Syringes Due to Sterility Concerns

    Advanced Pharma Inc. is recalling 1,575 syringes of Phenylephrine HCl injectable solution because the company cannot guarantee the product is sterile.

    Product
    Phenylephrine HCl, 400 mcg in 0.9% Sodium Chloride, QS 10 mL Injectable Solution 400 mcg/10 mL (40 mcg per mL), Sterile single use syringe, NDC: 42852-876-61 Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1052-2019·2019-03-27

    Rising Pharmaceuticals Recalls Valsartan Tablets Due to NDEA Impurity

    Rising Pharmaceuticals is recalling Valsartan Tablets 40 mg due to CGMP deviations and the detection of a trace amount of the impurity NDEA.

    Product
    Valsartan Tablets 40 mg USP, 30 tablet bottles, Rx, Only, Distributed by: Acetris Health, LLC, Saddle Brook, NJ, Manufactured by: Aurolife Pharma LLC, Dayton, NJ ---- NDC 52343-122-30
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-1026-2019·2019-03-27

    Advanced Pharma Recalls Lidocaine Syringes Due to Sterility Concerns

    Advanced Pharma Inc. is recalling 1,540 syringes of 2% Lidocaine HCl Injectable Solution because the company cannot assure the product's sterility.

    Product
    2% Lidocaine HCl Injectable Solution, 60 mg/3 mL (20 mg per mL), 3mL Sterile single use syringe, NDC: 42852-011-22 Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1049-2019·2019-03-27

    Losartan Potassium Tablets Recalled Due to Impurity Presence

    Legacy Pharmaceutical Packaging LLC is recalling Losartan Potassium Tablets, 50 mg, due to the presence of an impurity, N-Methylnitrosobutyric acid (NMBA).

    Product
    Losartan Potassium Tablets, USP, 50 mg, 30 tablet bottles, Rx Only, Distributed by: Wal-Mart, Bentonville, AR 72716, Manufactured for: Camber Pharmaceuticals, Inc. Piscataway, NJ 08854, Packaged by: Legacy Pharmaceutical Packaging LLC, Earth City, MO 63045. NDC 68645-578-54
    Category
    Drug
    Distribution
    5 states
  • SevereFDA (Food)·F-1174-2019·2019-03-27

    Smoked Alaska Silver Salmon Recalled for Botulism Risk

    Smoked Alaska Seafoods is recalling 6.5 oz. jars and cans of Smoked Silver Salmon due to potential Clostridium botulinum contamination.

    Product
    Smoked Silver Salmon, brand Smoked Alaska, packaged in 6.5 oz. glass jars or cans. The product label is read in parts: "***SMOKED WILD ALASKA SILVER SALMON*** SMOKED ALASKA*** NET WT. 6.5 OZS. Ingredients: Natural Alder Smoked Silver Salmon, Brown Sugar, Salt *** PO BOX…
    Category
    Food
    Distribution
    1 state
  • SevereCPSC·19090·2019-03-26

    Universal Rechargeable Power Banks Recalled Due to Fire Hazard

    Daniel M. Friedman & Associates is recalling about 170,500 universal rechargeable power banks due to a fire hazard. The devices can overheat, causing property damage.

    Product
    Universal rechargeable power banks
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereNHTSA·19V233000·2019-03-25

    North American Repower Recalls One 2005 International 1652SC CNG Vehicle

    North American Repower is recalling one 2005 International 1652SC vehicle due to a potential CNG valve defect that could cause stem ejection, injury, or fire.

    Product
    INTERNATIONAL — INTERNATIONAL 1652SC
    Category
    Vehicle
    Distribution
    Distributed nationwide