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.

21426–21450 of 32121

  • SevereFDA (Drugs)·D-0173-2016·2015-11-18

    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 sterility.

    Product
    PAPA/PGE1/PHENTO (22.5mg/8.33mcg/0.833mg/ml) Injection, 10 mL vial, Rx, B & B Health Mart Pharmacy, Bellflower, CA
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0202-2016·2015-11-18

    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) IN VERSABASE W/V (weight/volume) 2.5 : 25 :1.25MG/ML Transdermal cream, dispensed in 10 mL prefilled, amber syringes, Rx…
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0225-2016·2015-11-18

    The Compounder Recalls Transdermal Cream Due to Penicillin Cross-Contamination

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

    Product
    ESTRIOL 5 ESTRADIOL (Estradiol (E2) Trit (Yellow)) 0.95 ESTRONE (Estrone E1) Trit (Red)) 0.02 TEST (Testosterone USP) 0.75MG/ML W/V (weight/volume) transdermal cream, dispensed in 10 mL prefilled, amber syringes, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL…
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0204-2016·2015-11-18

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

    The Compounder is recalling BIEST TD 80/20 transdermal cream because 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) : TESTO (Testosterone USP) : DHEA (Dehydroepiandrosterone Micronized) W/V (weight/volume) VERSABASE 2.5 : 17.5 : 1.25 :0.25MG/ML Transdermal cream, dispensed in 10 mL…
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0188-2016·2015-11-18

    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. Patients should stop using the product and contact their healthcare provider.

    Product
    BIEST TD 50/50 (Estradiol USP Micronized (E2)/Estriol USP Micronized (E3)) W/V (weight /volume) 4.0 MG/ML transdermal cream packaged in 3mL syringes, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0183-2016·2015-11-18

    FDA Recalls Compounder Biest Troches Due to Penicillin Cross-Contamination

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

    Product
    BIEST 80/20 : PROGEST : DHEA : TESTOST (Estriol USP Micronized (E3)/Estradiol (E2) Trit (Yellow): Progesterone USP: Dehydroepiandrosterone Micronized (DHEA): Testosterone Trit ) 2.5 : 25 : 2.5 : 0.1MG TROCHE, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL…
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0216-2016·2015-11-18

    The Compounder Recalls Estradiol and Progesterone Cream Due to Penicillin Contamination

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

    Product
    ESTRIOL (E3) : PROGESTERONE W/V (weight/volume) 4.0 : 100 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-0177-2016·2015-11-18

    B&B Pharmacy Recalls PGE 30mcg/ml Injection Due to Sterility Concerns

    Pacific Healthcare, Inc dba B&B Pharmacy is recalling PGE 30mcg/ml Injection vials because an FDA inspection identified GMP violations that may impact sterility.

    Product
    PGE 30mcg/ml Injection, 10 mL vials, Rx, B & B Health Mart Pharmacy, Bellflower, CA
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0215-2016·2015-11-18

    The Compounder Recalls Estradiol Cream Due to Penicillin Cross-Contamination

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

    Product
    ESTRIOL (E3) : PROGESTERONE : DHEA (Dehydroepiandrosterone Micronized) W/V (weight/volume) VERSABASE 4.0 : 30 : 4MG/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-0227-2016·2015-11-18

    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. Patients should stop using the medication and consult a healthcare provider.

    Product
    TRIEST 80/10/10 (E1/E2 Trit - Estrone (E1)/Estradiol (E2) / Estriol USP (E3)) (23) 5MG capsules, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0201-2016·2015-11-18

    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 6.5 : 30: 1.25: 0.25 MG/ML Transdermal cream, dispensed in 10 mL…
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0166-2016·2015-11-18

    Nandrolone Injection Recalled Due to Sterility Assurance Concerns

    Pacific Healthcare is recalling Nandrolone 200 mg/ml Injection vials because an FDA inspection found GMP violations that may impact sterility.

    Product
    Nandrolone 200 mg/ml Injection, 10 mL and 20 mL vials, Rx, B & B Health Mart Pharmacy, Bellflower, CA
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0175-2016·2015-11-18

    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/40mcg/1mg/ml) Injection, 10 mL vial, Rx, B & B Health Mart Pharmacy, Bellflower, CA
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0174-2016·2015-11-18

    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 (30mg/10mg/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-0182-2016·2015-11-18

    The Compounder Recalls Biest 66/34 Due to Penicillin Cross-Contamination

    The Compounder is recalling Biest 66/34 hormone suspension because an active ingredient was contaminated with penicillin. Patients should stop using the product and consult a healthcare provider.

    Product
    BIEST 66/34: TESTOSTERONE : PROGESTERONE IN OLIVE OIL(Estradiol USP Micronized (ED)/Estriol USP Micronized (E3): Testosterone : Progesterone in Olive Oil) 3mg : 4 mg : 100 mg/mL suspension, Rx only, packaged in a 15 mL glass dropper bottle. The Compounder, 340 Marshall Avenue…
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0217-2016·2015-11-18

    The Compounder Recalls Transdermal Cream Due to Penicillin Cross-Contamination

    The Compounder is recalling specific lots of a compounded transdermal cream because an 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 : 35 : 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 (Devices)·Z-0247-2016·2015-11-18

    Maquet Adjustable Positioning Elements Recalled Due to Thromboembolic Events

    Maquet is recalling Adjustable Positioning Elements used in spine surgery after two serious thromboembolic events were reported.

    Product
    Maquet Getinge Group, Adjustable Positioning Elements (1007.28A0) Manufacturer: Maquet GmbH, Germany. Patient positioners. The MAQUET Adjustable Positioning Elements are designed for the placement and positioning of patients in the prone position immediately before, during and…
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Drugs)·D-0223-2016·2015-11-18

    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) VERSABASE 3MG/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-0226-2016·2015-11-18

    The Compounder Recalls TRIEST 70/20/10 Transdermal Cream Due to Penicillin Contamination

    The Compounder is recalling TRIEST 70/20/10 transdermal cream because the active ingredient was contaminated with penicillin. The recall covers 24 syringes per lot.

    Product
    TRIEST 70/20/10 ( Estriol USP / Estradiol USP (E2) / Estrone (E1) Triturate) [909] 12.5MG/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
  • SevereNHTSA·15V761000·2015-11-17

    Airstream Recalls 2016 Trailers Due to Propane Gas Leak Risk

    Airstream is recalling 904 model year 2016 recreational trailers because propane gas may leak from the regulator, increasing the risk of a fire.

    Product
    AIRSTREAM — AIRSTREAM INTERNATIONAL, SPORT, CLASSIC, LAND YACHT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereCPSC·16038·2015-11-17

    PetSmart Recalls Glass Fish Bowls Due to Laceration Hazard

    PetSmart is recalling Grreat Choice and Top Fin glass fish bowls because they can shatter during normal handling, posing a laceration risk.

    Product
    Glass fish bowls
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereNHTSA·15V759000·2015-11-16

    Hyundai Recalls 2011-2012 Sonata Vehicles Due to Brake Pedal Defect

    Hyundai is recalling 2011-2012 Sonata vehicles because a deteriorating brake pedal stopper pad may prevent the brake light switch from retracting, increasing crash risk.

    Product
    HYUNDAI — HYUNDAI SONATA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·15V756000·2015-11-16

    Hyundai Recalls 2013-2015 Genesis Coupe for Differential Bolt Loosening

    Hyundai is recalling 2013-2015 Genesis Coupes with manual transmissions because rear differential bolts may loosen, potentially causing loss of propulsion and increased crash risk.

    Product
    HYUNDAI — HYUNDAI GENESIS COUPE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·15V753000·2015-11-13

    Trails West Recalls 2015-2016 Trailers Due to Axle Weld Failure Risk

    Trails West is recalling 2015-2016 trailers because a weld on the rear axle may fail, causing the wheel assembly to separate and increasing crash risk.

    Product
    TRAILS WEST — TRAILS WEST SANTA FE II, SIERRA SELECT, SIERRA II, SIERRA
    Category
    Vehicle
    Distribution
    Distributed nationwide