The Recall Desk

Severity 4 of 5

Severe recalls

Illness, injury, or structural failure has been reported. 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.

9926–9950 of 29157

  • SevereFDA (Drugs)·D-0947-2020·2020-03-11

    Axia Pharmaceutical Recalls Coenzyme Q10 Injection Due to Sterility Concerns

    Fusion IV Pharmaceuticals is recalling Coenzyme Q10 Injection due to a lack of assurance of sterility. The product was distributed in the U.S., Puerto Rico, Barbados, and the Dominican Republic.

    Product
    Coenzyme Q10 Injection,COENZYME Q-10 20MG/ML OIL INJ SOLN, For IM Use, 10 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0411-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0979-2020·2020-03-11

    Axia Pharmaceutical Recalls Iohexol Injection Due to Sterility Concerns

    Fusion IV Pharmaceuticals is recalling Iohexol Injection due to a lack of assurance of sterility. The affected product is distributed nationwide and in specific international locations.

    Product
    Iohexol (PF) Injection,OMNIPAQUE INJECTION [5ML] 300MG I/ML INJECTABLE, For IA Use, 5 mL Single Use Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-1413-5
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0941-2020·2020-03-11

    Axia Pharmaceutical Recalls B-Complex 110 Injectable Due to Sterility Concerns

    Axia Pharmaceutical is recalling B-Complex 110 Injectable vials due to a lack of assurance of sterility. The affected lots were distributed nationwide and in several international locations.

    Product
    B-COMPLEX 110 INJECTABLE, For IV, IM, SC Use, Refrigerate, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0212-3
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0956-2020·2020-03-11

    Axia Pharmaceutical Recalls hCG Injection Due to Sterility Concerns

    Axia Pharmaceutical is recalling specific lots of Human Chorionic Gonadotropin (hCG) Injection due to a lack of assurance of sterility.

    Product
    Human Chorionic Gonadotropin (hCG) Injection, HCG [10ML] 1000 IU/ML INJECTABLE, For IM, SC Use, Refrigerate,10 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0533-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0796-2020·2020-03-11

    Premiere Choice Peanut Butter Cookie Dough Recalled for Undeclared Milk

    Choice Products LLC is recalling 275 tubs of Premiere Choice Peanut Butter Cookie Dough because the product may contain undeclared milk.

    Product
    Premiere Choice 3lb. Peanut Butter Cookie Dough, item 412, Net Wt. 48 oz (1360g) UPC 6 98240 00412 6. Made by: Club's Choice Fundraising, Eau Claire, WI 54703
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0934-2020·2020-03-11

    Axia Pharmaceutical Recalls Alprostadil Injection Due to Sterility Concerns

    Axia Pharmaceutical is recalling Alprostadil/Papaverine/Phentolamine/Atropine Injection due to a lack of assurance of sterility. The product is distributed in the U.S., Puerto Rico, Barbados, and the Dominican Republic.

    Product
    Alprostadil/Papaverine Hydrochloride/Phentolamine Mesylate/Atropine Sulfate Injection, 60 mcg/30 mg/2 mg/0.15mg/ml, For Intracavernosal Use, Freeze, 2.5 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0550-2
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0933-2020·2020-03-11

    Axia Pharmaceutical Recalls Alprostadil Injection Due to Sterility Concerns

    Axia Pharmaceutical is recalling Alprostadil/Papaverine/Phentolamine/Atropine Injection due to a lack of assurance of sterility.

    Product
    Alprostadil/Papaverine Hydrochloride/Phentolamine Mesylate/Atropine Sulfate Injection, 40 mcg/25 mg/0.5mg/0.01mg/ml, For Intracavernosal Use, Freeze, 2.5 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0549-2
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0932-2020·2020-03-11

    Axia Pharmaceutical Recalls Alprostadil Injection Due to Sterility Concerns

    Axia Pharmaceutical is recalling Alprostadil/Papaverine/Phentolamine/Atropine Injection due to a lack of assurance of sterility. The product was distributed nationwide and in Puerto Rico, Barbados, and the Dominican Republic.

    Product
    Alprostadil/Papaverine Hydrochloride/Phentolamine Mesylate/Atropine Sulfate Injection, 18 mcg/1.8mg/0.2mg/0.02mg/mL, For Intracavernosal Use, Freeze, 2.5 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0547-2
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0935-2020·2020-03-11

    Axia Pharmaceutical Recalls Alprostadil Injectable Due to Sterility Concerns

    Axia Pharmaceutical is recalling Alprostadil injectable vials due to a lack of assurance of sterility. The affected product is distributed in the U.S., Puerto Rico, Barbados, and the Dominican Republic.

    Product
    Alprostadil (prostaglandin E1)150 MCG/ML Injectable, For Intracavernosal Use, Freeze, 2.5 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0538-2
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0945-2020·2020-03-11

    Axia Pharmaceutical Recalls Biotin Injectable Suspension Due to Sterility Concerns

    Axia Pharmaceutical is recalling Biotin Injectable Suspension due to a lack of assurance of sterility. The product was distributed in the U.S., Puerto Rico, Barbados, and the Dominican Republic.

    Product
    Biotin (Vitamin H) Injectable Suspension, BIOTIN 10 MG/ML INJ SUSP, For IM Use, Refrigerate, Shake Well, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0220-3
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0958-2020·2020-03-11

    Axia Pharmaceutical Recalls Hydroxyprogesterone Caproate Injection Due to Sterility Concerns

    Axia Pharmaceutical is recalling Hydroxyprogesterone Caproate Injection because the product lacks assurance of sterility. The recall covers specific lots distributed nationwide and in Puerto Rico, Barbados, and the Dominican Republic.

    Product
    Hydroxyprogesterone Caproate Injection, HYDROXYPROGESTERONE CAPROATE [4ML] 250 MG/ML INJECTABLE, For IV, IM Use, Refrigerate, 4 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0532-5
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0962-2020·2020-03-11

    Axia Pharmaceutical Recalls Lidocaine HCL Injection Due to Sterility Concerns

    Axia Pharmaceutical is recalling Lidocaine HCL Injection due to a lack of assurance of sterility. The product is distributed in the U.S., Puerto Rico, Barbados, and the Dominican Republic.

    Product
    Lidocaine HCL (PF) Injection, LIDOCAINE HCL 4% (PF) 40 MG/ML INJECTABLE, For ocular injection, Preservative free, discard unused portion, protect from light, 5 mL Single-use Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-1011-5
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0992-2020·2020-03-11

    Axia Pharmaceutical Recalls Vitamin D3 Injection Due to Sterility Concerns

    Axia Pharmaceutical is recalling specific lots of Vitamin D3 Injection due to a lack of assurance of sterility. The affected product was distributed nationwide and in Puerto Rico, Barbados, and the Dominican Republic.

    Product
    Cholecalciferol (Vitamin D3) Injection, VITAMIN D3 [P] 1,000 IU/ML INJECTABLE, For IM Use, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0210-3
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0950-2020·2020-03-11

    Axia Pharmaceutical Recalls Deoxycholic Acid Sodium Injection Due to Sterility Concerns

    Axia Pharmaceutical is recalling Deoxycholic Acid Sodium Injection because the product lacks assurance of sterility. The recall covers specific lots distributed nationwide and in Puerto Rico, Barbados, and the Dominican Republic.

    Product
    Deoxycholic Acid Sodium Injection,DEOXYCHOLIC ACID SODIUM 1.67% INJECTABLE, For SC Use, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0462-3
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0954-2020·2020-03-11

    Axia Pharmaceutical Recalls Glycerin Injection Due to Sterility Concerns

    Axia Pharmaceutical is recalling Glycerin (PF) Injection due to a lack of assurance of sterility. The affected product is distributed nationwide and in several international locations.

    Product
    Glycerin (PF) Injection,GLYCERIN 99% INJECTABLE, For IV Use,10 mL Single-use Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0464-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0980-2020·2020-03-11

    Axia Pharmaceutical Recalls Pyridoxine Hydrochloride Injection Due to Sterility Concerns

    Fusion IV Pharmaceuticals is recalling specific lots of Pyridoxine Hydrochloride Injection due to a lack of assurance of sterility. The product was distributed nationwide and in several Caribbean territories.

    Product
    Pyridoxine Hydrochloride Injection, PYRIDOXINE HCL 100 MG/ML INJECTABLE, For IV, IM Use, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0216-3
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0991-2020·2020-03-11

    Axia Pharmaceutical Recalls Triamcinolone Diacetate Injectable Suspension Due to Sterility Concerns

    Axia Pharmaceutical is recalling specific lots of Triamcinolone Diacetate Injectable Suspension because the product lacks assurance of sterility.

    Product
    Triamcinolone Diacetate Injectable Suspension, TRIAMCINOLONE DIACETATE [10ML] CMC 80 MG/ML INJ SUSP, For IM, IA, IT Use, 10 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0634-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0965-2020·2020-03-11

    Axia Pharmaceutical Recalls Methionine Injection Due to Sterility Concerns

    Axia Pharmaceutical is recalling Methionine/Inositol/Choline Injection due to a lack of assurance of sterility. The affected product is distributed in the U.S., Puerto Rico, Barbados, and the Dominican Republic.

    Product
    Methionine/Inositol/Choline Injection, METHIONINE/INOSITOL/CHOLINE 25MG/50MG/50MG/ML INJECTABLE, For IM Use, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0215-3
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0985-2020·2020-03-11

    Axia Pharmaceutical Recalls Testosterone Cypionate Injection Due to Sterility Concerns

    Axia Pharmaceutical is recalling specific lots of Testosterone Cypionate/Progesterone Injection due to a lack of assurance of sterility.

    Product
    Testosterone Cypionate/Progesterone Injection, TESTOSTERONE CYP/PROGESTERONE [2ML] 200MG/2.5MG/ML INJECTABLE, For IM Use, 2 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0531-2
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0938-2020·2020-03-11

    Axia Pharmaceutical Recalls Alprostadil Injection Due to Sterility Concerns

    Axia Pharmaceutical is recalling Alprostadil/Papaverine/Phentolamine Injection due to a lack of assurance of sterility. The product was distributed in the U.S., Puerto Rico, Barbados, and the Dominican Republic.

    Product
    Alprostadil/Papaverine Hydrochloride/Phentolamine Mesylate Injection 40MCG/30MG/2MG/ML Injectable, For Intracavernosal Use, Freeze, 2.5 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0546-2
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0951-2020·2020-03-11

    Axia Pharmaceutical Recalls Dexamethasone Injectable Suspension Due to Sterility Concerns

    Axia Pharmaceutical is recalling Dexamethasone (LA) Injectable Suspension because the product lacks assurance of sterility. The recall covers specific lots distributed in the U.S., Puerto Rico, Barbados, and the Dominican Republic.

    Product
    Dexamethasone (LA) Injectable Suspension, DEXAMETHASONE LA [10ML] 16MG INJ SUSP, For IM, IA Use, Shake Well, 10 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0630-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0961-2020·2020-03-11

    Axia Pharmaceutical Recalls Levocarnitine Injection Due to Sterility Concerns

    Axia Pharmaceutical is recalling specific lots of Levocarnitine Injection because the company cannot guarantee the product's sterility.

    Product
    Levocarnitine Injection, LEVOCARNITINE 500 MG/ML INJECTABLE, For IV Use, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-9260-3
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0963-2020·2020-03-11

    Axia Pharmaceutical Recalls Lysine Hydrochloride Injection Due to Sterility Concerns

    Axia Pharmaceutical is recalling specific lots of Lysine Hydrochloride Injection because the company cannot ensure the product is sterile.

    Product
    Lysine Hydrochloride Injection, LYSINE HCL 100MG/ML INJECTABLE, For IV, IM Use, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0342-3
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0969-2020·2020-03-11

    Axia Pharmaceutical Recalls Methylprednisolone Acetate/Bupivacaine Injectable Suspension

    Axia Pharmaceutical is recalling Methylprednisolone Acetate/Bupivacaine Injectable Suspension due to a lack of assurance of sterility.

    Product
    Methylprednisolone Acetate/Bupivacaine Hydrochloride Injectable Suspension, METHYLPRED ACETATE/BUPIVACAINE HCL [10ML] CMC 80MG/5MG/ML INJ SUSP, For IM, IA Use, Shake Well, 10 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0977-2020·2020-03-11

    Axia Pharmaceutical Recalls Nicotinamide Adenine Dinucleotide Injection Due to Sterility Concerns

    Axia Pharmaceutical is recalling specific lots of Nicotinamide Adenine Dinucleotide (PF) Injection because the FDA determined there is a lack of assurance of sterility.

    Product
    Nicotinamide Adenine Dinucleotide (PF) Injection, NICOTINAMIDE ADENINE DINUCLEOTIDE (PF) 50 MG/ML INJECTABLE, For IV, IM Use, Refrigerate, 10 mL Single Use Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0306-1
    Category
    Drug
    Distribution
    Distributed nationwide