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.

21376–21400 of 32121

  • SevereNHTSA·15V774000·2015-11-19

    Utility Trailer Recalls 2015 VS2RA Models Due to Brake Caliper Bolt Issue

    Utility Trailer is recalling 2015 VS2RA Refrigerated Van trailers because improperly tightened caliper bolts may detach, reducing braking performance and increasing crash risk.

    Product
    UTILITY — UTILITY VS2RA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0179-2016·2015-11-18

    B&B Pharmacy Recalls PAPA/PGE1/PHENTO Injection Due to Sterility Concerns

    Pacific Healthcare, Inc dba B&B Pharmacy is recalling PAPA/PGE1/PHENTO injection vials because an FDA inspection found GMP violations that may affect sterility.

    Product
    PAPA/PGE1/PHENTO (35mg/12mcg/1.5mg/ml), Injection, 10 mL vial, Rx, B & B Health Mart Pharmacy, Bellflower, CA
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0212-2016·2015-11-18

    The Compounder Recalls Biest TD 91/9 Transdermal Cream Due to Penicillin Contamination

    The Compounder is recalling specific lots of Biest TD 91/9 transdermal cream because the active ingredient was contaminated with penicillin.

    Product
    BIEST TD 91/9 (Estriol USP Micronized (E3)/Estradiol (E2) Trit (Yellow)) : PROGESTERONE W/V (weight/volume) PLO (Pluronic F127 20% or Polox 20% gel) 3.3 MG/ML : 40 MG/ML Transdermal cream, dispensed in 10 mL prefilled, amber syringes, Rx only, The Compounder, 340 Marshall…
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0168-2016·2015-11-18

    Testosterone Propionate Injection Recalled for Sterility Assurance Concerns

    Pacific Healthcare, Inc dba B&B Pharmacy is recalling Testosterone Propionate Injection due to FDA inspection findings of GMP violations that may impact sterility.

    Product
    Testosterone prop. 200 mg/ml Injection, 10 mL vial, Rx, B & B Health Mart Pharmacy, Bellflower, CA
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0184-2016·2015-11-18

    The Compounder Recalls Biest CP 76/24 DHEA Capsules Due to Penicillin Contamination

    The Compounder is recalling Biest CP 76/24 DHEA capsules because an active ingredient was contaminated with penicillin. The recall is nationwide.

    Product
    BIEST CP 76/24: DHEA (Estriol USP Micronized (E3)/Estradiol (E2) Trit (Yellow) : Dehydroepiandrosterone Micronized (DHEA) 2.625 MG : 10 MG capsules, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0189-2016·2015-11-18

    The Compounder Recalls Biest TD 67/33 Transdermal Cream Due to Penicillin Contamination

    The Compounder is recalling Biest TD 67/33 transdermal cream because the active ingredient was contaminated with penicillin. The recall covers 10 syringes per lot distributed nationwide.

    Product
    BIEST TD 67/33 (Estradiol (E2) TRIT (YELLOW)/Estriol USP Micronized (E3)) W/V (weight /volume) 1.5 MG/ML Transdermal cream, dispensed in 3 mL prefilled, amber syringes, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0196-2016·2015-11-18

    The Compounder Recalls Biest TD 80/20 Transdermal Cream Due to Penicillin Contamination

    The Compounder is recalling Biest TD 80/20 transdermal cream because it was made with an active ingredient contaminated with penicillin.

    Product
    BIEST TD 80/20 (Estradiol (E2) Trit (yellow) / Estriol USP Micronized (E3)): PROG (Progesterone USP Micronized) W/V 2.5MG:100MG/ML Transdermal cream, dispensed in 3 mL prefilled, amber syringes, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0212-2016·2015-11-18

    Boston Scientific Recalls RotaWire Elite Guidewires Due to Fracture Complaints

    Boston Scientific is recalling RotaWire Elite Guidewires and wireClip Torquer devices due to complaints of wire fracture. The devices are used with the Rotablator Rotational Atherectomy System.

    Product
    RotaWire Elite and wireClip Torquer, Guidewire and Guidewire Manipulation Device, Extra Support. REF H802233301 (5-pack outer package), REF H802233300 (single unit). The Rotablator rotational atherectomy system consists of a diamond tipped burr capable of high speed…
    Category
    Medical Device
    Distribution
    17 states
  • SevereFDA (Drugs)·D-0218-2016·2015-11-18

    FDA Recalls Compounder Transdermal Cream Due to Penicillin Contamination

    The Compounder is recalling specific lots of a compounded transdermal hormone cream because the active ingredient was contaminated with penicillin.

    Product
    ESTRIOL (E3) : ESTRADIOL (E2) (Estradiol (E2) Trit (Yellow)) : PROGEST (Progesterone USP) : TESTO (Testosterone USP) W/V (weight/volume) 2 :0.1 : 30 : 0.5 MG/ML Transdermal cream, dispensed in 10 mL prefilled, amber syringes, Rx only, The Compounder, 340 Marshall Avenue Unit…
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0200-2016·2015-11-18

    The Compounder Recalls BIEST TD 80/20 Cream Due to Penicillin Contamination

    The Compounder is recalling BIEST TD 80/20 transdermal cream because an active ingredient was contaminated with penicillin.

    Product
    BIEST TD 80/20 (Estradiol (E2) Trit (Yellow)/Estriol USP Micronized (E3) : PROG (Progesterone USP Micronized) : DHEA (Dehydroepiandrosterone Micronized) : TESTO (Testosterone Trit) W/V (weight/volume) VERSABASE 3: 25: 1.25: 0.25 MG/ML Transdermal cream, dispensed in 10 mL…
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0195-2016·2015-11-18

    The Compounder Recalls Biest TD 80/20 Transdermal Cream Due to Penicillin Contamination

    The Compounder is recalling Biest TD 80/20 transdermal cream because the active ingredient was contaminated with penicillin. Patients should stop using the product and contact their healthcare provider.

    Product
    BIEST TD 80/20 (Estriol USP Micronized (E3)/Estradiol (E2) Trit (Yellow)) W/V(weight/volume) [2977] 6.25MG/ML Transdermal cream, dispensed in 1 mL prefilled, amber syringes, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0197-2016·2015-11-18

    The Compounder Recalls BIEST TD 80/20 Cream Due to Penicillin Contamination

    The Compounder is recalling BIEST TD 80/20 transdermal cream because an active ingredient was contaminated with penicillin. Patients should stop using the product and contact their healthcare provider.

    Product
    BIEST TD 80/20 (Estradiol (E2) Trit (Yellow)/Estriol USP Micronized (E3) : PROG (Progesterone USP Micronized): DHEA (Dehydroepiandrosterone Micronized) : TESTO (Testosterone Trit) W/V (weight/volume) VERSABASE 2.5: 30 : 2.5 : 0.25 MG/MLTransdermal cream, dispensed in 10 mL…
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0180-2016·2015-11-18

    PGE 25mcg/ml Injection Recalled Due to Sterility Assurance Concerns

    Pacific Healthcare, Inc dba B&B Pharmacy is recalling PGE 25mcg/ml Injection vials because an FDA inspection identified GMP violations that may impact sterility.

    Product
    PGE 25mcg/ml, Injection, 10 mL vial, Rx, B & B Health Mart Pharmacy, Bellflower, CA
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0170-2016·2015-11-18

    B&B Pharmacy Recalls PAPA/PHENTO Injection Due to Sterility Concerns

    Pacific Healthcare, Inc dba B&B Pharmacy is recalling PAPA/PHENTO Injection vials because FDA inspections identified GMP violations that may affect sterility.

    Product
    PAPA/PHENTO (30mg/1mg/ml) Injection, 5 mL and 10 mL vials, Rx, B & B Health Mart Pharmacy, Bellflower, CA
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0206-2016·2015-11-18

    The Compounder Recalls Biest TD 80/20 Cream Due to Penicillin Contamination

    The Compounder is recalling Biest TD 80/20 transdermal cream because an active ingredient was contaminated with penicillin. Patients should stop using the product and contact their healthcare provider.

    Product
    BIEST TD 80/20 (Estradiol (E2) Trit (Yellow)/Estriol USP Micronized (E3) : PROG (Progesterone USP Micronized) : TESTO (Testosterone USP) W/V (weight/volume) 1.25:100:0.625 MG/ML Transdermal cream, dispensed in 10 mL prefilled, amber syringes, Rx only,The Compounder, 340…
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0193-2016·2015-11-18

    The Compounder Recalls Biest TD 80/20 Cream Due to Penicillin Contamination

    The Compounder is recalling Biest TD 80/20 transdermal cream because the active ingredient was contaminated with penicillin. Patients should stop using the product and consult their healthcare provider.

    Product
    BIEST TD 80/20 (estradiol (E2) Trit (Yellow)/Estriol USP Micronized (E3)) W/V (weight/volume) 2.5MG/ML Transdermal cream, dispensed in a) 3 mL and b) 10 mL prefilled, amber syringes, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0190-2016·2015-11-18

    The Compounder Recalls BIEST TD 80/20 Transdermal Cream Due to Penicillin Contamination

    The Compounder is recalling BIEST TD 80/20 transdermal cream because the active ingredient was contaminated with penicillin by a supplier.

    Product
    BIEST TD 80/20 (Estradiol USP Micronized (E2)/Estriol USP Micronized (E3)) W/V (weight /volume) 8 MG/ML transdermal cream, dispensed in 3 mL prefilled, amber syringes, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0220-2016·2015-11-18

    FDA Recalls Estradiol and Testosterone Cream Due to Penicillin Contamination

    The Compounder is recalling Estradiol and Testosterone transdermal cream because the active ingredient was contaminated with penicillin.

    Product
    ESTRIOL (E3) : TESTO (Testosterone USP) WV (weight/volume) 0.5MG : 2MG/ML Transdermal cream, dispensed in 3 mL prefilled, amber syringes, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0172-2016·2015-11-18

    B&B Pharmacy Recalls PAPA/PGE1/PHENTO Injection Due to Sterility Concerns

    Pacific Healthcare, Inc dba B&B Pharmacy is recalling PAPA/PGE1/PHENTO injection vials because an FDA inspection identified GMP violations that may impact product sterility.

    Product
    PAPA/PGE1/PHENTO (30mg/50mcg/0.5mg/ml), Injection, 10 mL vial, Rx, B & B Health Mart Pharmacy, Bellflower, CA
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0191-2016·2015-11-18

    The Compounder Recalls Biest TD 80/20 Transdermal Cream Due to Penicillin Contamination

    The Compounder is recalling Biest TD 80/20 transdermal cream because the active ingredient was contaminated with penicillin. This recall affects nationwide distribution.

    Product
    BIEST TD 80/20 (Estradiol USP Micronized (E2)/Estriol USP Micronized (E3)) W/V (weight /volume) 0.25 MG/ML Transdermal cream, dispensed in 10 mL prefilled, amber syringes, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0184-2016·2015-11-18

    Appeeling Fruit Recalls Fresh Sliced Apples Due to Listeria Risk

    Appeeling Fruit, Inc. is voluntarily recalling fresh sliced apples due to potential contamination with Listeria monocytogenes.

    Product
    Snack Fresh, Red Apple Slices, Net Wt. 2 oz., UPC: 0 74641 00982, Best If Used By: 9/21/2015; Distributed by Country Fresh, LLC. , Houston, TX 77090; packed 100-2 oz. pouches to a case
    Category
    Food
    Distribution
    5 states
  • SevereFDA (Drugs)·D-0199-2016·2015-11-18

    The Compounder Recalls BIEST TD 80/20 Cream Due to Penicillin Contamination

    The Compounder is recalling BIEST TD 80/20 transdermal cream because an active ingredient was contaminated with penicillin. Patients should stop using the product and contact their healthcare provider.

    Product
    BIEST TD 80/20 (Estradiol (E2) Trit (Yellow)/Estriol USP Micronized (E3) : PROG (Progesterone USP Micronized) : DHEA (Dehydroepiandrosterone Micronized) : TESTO (Testosterone Trit) W/V (weight/volume) 2.5 : 20 : 1.25 : 0.25 MG/ML TRANSDERMAL (Cream)Transdermal cream, dispensed…
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0165-2016·2015-11-18

    Stanozolol Injection Recalled Due to Sterility Assurance Concerns

    Pacific Healthcare, Inc. is recalling Stanozolol 200 mg/ml Injection vials due to FDA inspection findings of GMP violations that may impact sterility.

    Product
    Stanozolol 200 mg/ml Injection, 20 mL vial, Rx, B & B Health Mart Pharmacy, Bellflower, CA
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0167-2016·2015-11-18

    Testosterone Cypionate Injection Recalled Due to Sterility Assurance Concerns

    Pacific Healthcare, Inc dba B&B Pharmacy is recalling Testosterone Cypionate 250 mg/mL Injection due to FDA inspection findings of GMP violations that may impact sterility.

    Product
    Testosterone Cypionate 250 mg/mL Injection, 10 mL vial, Rx, B & B Health Mart Pharmacy, Bellflower, CA
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Devices)·Z-0248-2016·2015-11-18

    Maquet Universal Frame Recalled Due to Thromboembolic Event Reports

    Maquet is recalling Universal Frames and Adjustable Positioning Elements after two serious thromboembolic events were reported during lumbar spine surgery.

    Product
    Maquet Getinge Group, Universal Frame for Positioning Patients (1007.24XX) Manufacturer: Maquet GmbH, Germany The MAQUET Adjustable Positioning Elements are designed for the placement and positioning of patients in the prone position immediately before, during and after…
    Category
    Medical Device
    Distribution
    3 states