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.

21401–21425 of 32121

  • SevereFDA (Drugs)·D-0178-2016·2015-11-18

    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 an FDA inspection found GMP violations that may affect sterility.

    Product
    PAPA/PHENTO (15mg/0.8333mg/ml) Injection, 5 mL vial, Rx, B & B Health Mart Pharmacy, Bellflower, CA
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0187-2016·2015-11-18

    The Compounder Recalls BIEST TD 50/50 Transdermal Cream Due to Penicillin Contamination

    The Compounder is recalling BIEST TD 50/50 transdermal cream because the active ingredient was contaminated with penicillin by a supplier.

    Product
    BIEST TD 50/50 (Estradiol USP Micronized (E2)/Estriol USP Micronized (E3)) W/V (weight /volume) 2.5 MG/ML transdermal cream, dispensed in 10 mL prefilled syringes, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0214-2016·2015-11-18

    The Compounder Recalls Estriol Capsules Due to Penicillin Contamination

    The Compounder is recalling Estriol 4.0mg capsules because the active ingredient was contaminated with penicillin. Patients should stop using the product and consult a healthcare provider.

    Product
    ESTRIOL (E3) 4.0MG capsules, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0205-2016·2015-11-18

    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) : TESTO (Testosterone USP) W/V (weight/volume) 5.0 :20 :1 MG/ML Transdermal cream, dispensed in 5 mL prefilled, amber syringes, Rx only, The Compounder, 340 Marshall…
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0209-2016·2015-11-18

    The Compounder Recalls Biest TD 83/17 Cream Due to Penicillin Contamination

    The Compounder is recalling Biest TD 83/17 transdermal cream because the active ingredient was contaminated with penicillin. The recall is nationwide.

    Product
    BIEST TD 83/17 (Estradiol (E2) Trit (Yellow)/Estriol USP Micronized (E3) W/V (weight/volume) 1.2 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 (Drugs)·D-0176-2016·2015-11-18

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

    B&B Pharmacy is recalling specific vials of PAPA/PGE1/PHENTO Injection because FDA inspections found GMP violations that may affect sterility.

    Product
    PAPA/PGE1/PHENTO (15mg/5mcg/0.5mg/ml) Injection, 5 mL and 10 mL vials, Rx, B & B Health Mart Pharmacy, Bellflower, CA
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0208-2016·2015-11-18

    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 by a supplier.

    Product
    BIEST TD 80/20 (Estradiol (E2) Trit (Yellow)/Estriol USP Micronized (E3) VAN CR (vanishing cream) W/V (weight/volume) (4812) 2.5MG/ML Transdermal cream, dispensed in a) 1mL and b)3 mL prefilled, amber syringes, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL…
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0211-2016·2015-11-18

    The Compounder Recalls Biest TD 89/11 Transdermal Cream Due to Penicillin Contamination

    The Compounder is recalling Biest TD 89/11 transdermal cream because the active ingredient was contaminated with penicillin. Patients should stop using the product and consult their healthcare provider.

    Product
    BIEST TD 89/11 (Estradiol (E2) Trit (Yellow)/Estriol USP Micronized (E3) W/V (weight/volume) VERSABASE 2.25MG/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-0221-2016·2015-11-18

    The Compounder Recalls Estradiol Suppositories Due to Penicillin Contamination

    The Compounder is recalling Estradiol suppositories because the active ingredient was contaminated with penicillin. Patients should stop using the product and contact their healthcare provider.

    Product
    ESTRIOL (E3) 2.5MG suppositories, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0185-2016·2015-11-18

    The Compounder Recalls BIEST CP 80/20 Capsules Due to Penicillin Contamination

    The Compounder is recalling BIEST CP 80/20 capsules because the active ingredient was contaminated with penicillin. Patients should stop using the product and consult their healthcare provider.

    Product
    BIEST CP 80/20 (Estradiol (E2) Trit (Yellow)/Estriol USP Micronized (E3)) 1.25 MG capsules, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0207-2016·2015-11-18

    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 by a supplier.

    Product
    BIEST TD 80/20 (Estradiol (E2) Trit (Yellow)/Estriol USP Micronized (E3) : TESTO (Testosterone USP) W/V (weight/volume) 1.0 :4.0 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-0219-2016·2015-11-18

    The Compounder Recalls Estradiol and Testosterone Cream Due to Penicillin Contamination

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

    Product
    ESTRIOL (E3) : ESTRADIOL (E2) (Estradiol (E2) Trit (Yellow)) : TESTO (Testosterone USP) W/V (weight/volume) 2.0: 0.1: 0.5MG/ML Transdermal cream, dispensed in 5 mL prefilled, amber syringes, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0171-2016·2015-11-18

    PGE 20mcg/ml Injection Recalled Due to Sterility Assurance Concerns

    Pacific Healthcare, Inc dba B&B Pharmacy is recalling PGE 20mcg/ml Injection vials due to FDA inspection findings of GMP violations that may impact sterility.

    Product
    PGE 20mcg/ml Injection, 10 mL vial, Rx, B & B Health Mart Pharmacy, Bellflower, CA
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Food)·F-0186-2016·2015-11-18

    Appeeling Fruit Recalls Fresh Sliced Apples Due to Listeria Risk

    Appeeling Fruit is voluntarily recalling fresh sliced apples with specific best-if-used-by dates due to potential Listeria monocytogenes contamination.

    Product
    Appeeling Fruit, Tart Fresh, Apple Edges, Net Wt. 12 oz., UPC: 6 58324 00950, Best if used by: 09/21/2015, packed 6 packages/case.
    Category
    Food
    Distribution
    5 states
  • SevereFDA (Drugs)·D-0228-2016·2015-11-18

    The Compounder Recalls TRIEST 80/10/10 Capsules Due to Penicillin Contamination

    The Compounder is recalling TRIEST 80/10/10 capsules because the active ingredient was contaminated with penicillin. This recall affects nationwide distribution.

    Product
    TRIEST 80/10/10 (Estrone (E1) Trit / Estradiol (E2) Trit / Estriol USP (E3)) 1.875MG capsules, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0192-2016·2015-11-18

    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 (Estradiol USP Micronized (E2)/Estriol USP Micronized (E3)) W/V (weight /volume) 12.5 MG/ML 1.25MG/0.1ML 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-0194-2016·2015-11-18

    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 by a supplier.

    Product
    BIEST TD 80/20 (Estradiol (E2) Trit (Yellow)/Estriol USP Micronized (E3)) W/V (weight/volume) 5 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 (Drugs)·D-0169-2016·2015-11-18

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

    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 (30mg/20mcg/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-0186-2016·2015-11-18

    The Compounder Recalls BIEST CP 80/20 Capsules Due to Penicillin Contamination

    The Compounder is recalling BIEST CP 80/20 capsules because the active ingredient was contaminated with penicillin. The recall is nationwide.

    Product
    BIEST CP 80/20 (Estradiol (E2) Trit (Yellow)/Estriol USP Micronized (E3)) 2.5 MG capsules, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0198-2016·2015-11-18

    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 5.0 : 30 : 2.5 : 0.25 MG/ML Transdermal cream, dispensed in 10 mL…
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0224-2016·2015-11-18

    The Compounder Recalls Estriol Cream Due to Penicillin Contamination

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

    Product
    ESTRIOL (E3) W/V (weight/volume) VERSABASE [4714] 0.05% (0.5MG/ML) transdermal cream, dispensed in a) 1 mL and b) 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-0211-2016·2015-11-18

    Boston Scientific Recalls RotaWire Elite Guidewires Due to Wire Fracture Complaints

    Boston Scientific is recalling RotaWire Elite Guidewires and wireClip Torquer devices because of 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, Floppy. REF H802223301 (5-pack outer package), REF H802223300 (single unit). The Rotablator rotational atherectomy system consists of a diamond tipped burr capable of high speed rotation…
    Category
    Medical Device
    Distribution
    17 states
  • SevereFDA (Drugs)·D-0203-2016·2015-11-18

    FDA 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 consult their healthcare provider.

    Product
    BIEST TD 80/20 (Estradiol (E2) Trit (Yellow)/Estriol USP Micronized (E3) : PROG (Progesterone USP Micronized) : DHEA (Dehydroepiandrosterone Micronized) IN VERSABASE W/V (weight/volume) 4 : 67.5 :10MG/ML Transdermal cream, dispensed in 10 mL prefilled, amber syringes, Rx only…
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0181-2016·2015-11-18

    Appeeling Fruit Recalls Fresh Sliced Apple Wedges Due to Listeria Risk

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

    Product
    Appeeling Fruit, Sweet Fresh, Apple Wedges, Net Wt. 16 oz. 8 2 oz. bags, UPC: 6 58324 08400, Best If Used By: 9/21/2015, Packed 6 - 8 unit packages/case; Appeeling Fruit, Sweet Fresh, Apple Wedges, Net Wt. 12 oz., , Best If Used By: 9/21/2015, Packed 6 packages/case…
    Category
    Food
    Distribution
    5 states
  • SevereFDA (Drugs)·D-0222-2016·2015-11-18

    The Compounder Recalls Estriol Cream Due to Penicillin Cross-Contamination

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

    Product
    ESTRIOL (E3) W/V (weight/volume) PGF 0.1% (1.0MG/ML) Transdermal cream, is dispensed in 3 mL prefilled, amber syringes, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.
    Category
    Drug
    Distribution
    Distributed nationwide