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.

16351–16375 of 29206

  • SevereFDA (Drugs)·D-0594-2017·2017-03-22

    Synergy Rx Recalls Azelaic Acid 15% Cream Due to Sterility Concerns

    Synergy Rx is recalling Azelaic Acid 15% Cream because the product lacks assurance of sterility and has CGMP deviations.

    Product
    AZELAIC ACID 15% CREAM, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0552-2017·2017-03-22

    Synergy Rx Recalls Calming Cream Due to Sterility Assurance Concerns

    Synergy Rx is recalling Calming Cream (Hydrocortisone 2.5%) because the product lacks assurance of sterility and has CGMP deviations.

    Product
    CALMING CREAM (Hydrocortisone 2.5%, Aloe vera powder), Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·17V195000·2017-03-22

    Newmar Recalls Motorhomes Due to Front Suspension Ball Joint Defect

    Newmar is recalling 595 motorhomes because front suspension ball joints can loosen and separate, potentially causing a loss of steering control.

    Product
    NEWMAR — NEWMAR LONDON AIRE, KING AIRE, ESSEX, DUTCH STAR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0555-2017·2017-03-22

    Synergy Rx Recalls CLEAR 2 Due to Sterility Assurance Concerns

    Synergy Rx is recalling all lots of CLEAR 2 (Benzoyl Peroxide 2.5%, Clindamycin 1.2%) because the product lacks assurance of sterility and has CGMP deviations.

    Product
    CLEAR 2 (Benzoyl Peroxide 2.5%, Clindamycin 1.2% ), Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0581-2017·2017-03-22

    Synergy Rx Recalls Betamethasone 0.25% Due to Sterility Assurance Issues

    Synergy Rx is recalling Betamethasone 0.25% cream because it may not be sterile. The recall covers all lots distributed nationwide.

    Product
    BETAMETHASONE 0.25%, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0536-2017·2017-03-22

    Synergy Rx Recalls Erythromycin Cream Due to Sterility Assurance Issues

    Synergy Rx is recalling Erythromycin 2% in CeraVe Cream and Erythromycin 3% / Retinoic Acid 0.05% due to lack of assurance of sterility and CGMP deviations.

    Product
    ERYTHROMYCIN 2% IN CERAVE CREAM, ERYTHROMYCIN 3% / RETINOIC ACID 0.05%, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0567-2017·2017-03-22

    Synergy Rx Recalls Quad Bleaching Cream Due to Sterility Concerns

    Synergy Rx is recalling Quad Bleaching Cream because it lacks assurance of sterility and has CGMP deviations.

    Product
    QUAD BLEACHING CREAM (retinoic acid 0.05%, hydroquinone 6%, kojic aid 3%, hydrocortisone 1%), Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0584-2017·2017-03-22

    Synergy Rx Recalls HCG Products Due to Sterility Assurance Issues

    Synergy Rx is recalling all lots of HCG products nationwide due to a lack of assurance of sterility and CGMP deviations.

    Product
    HCG in all strength including: 2,400, 9600,12,000 UNIT POWDER VIAL DROPS, HCG 11,000/B-12 UNITS SOLUTION, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0524-2017·2017-03-22

    Synergy Rx Recalls HCG Tablets Due to Sterility Assurance Concerns

    Synergy Rx is recalling HCG and HCG with resveratrol tablets nationwide due to a lack of assurance of sterility and CGMP deviations.

    Product
    HCG and HCG with resveratrol Human Chorionic Gonadotropin in different strengths: HCG 300 UNITS/RESVERATROL 50MG S.L. Tablet, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0568-2017·2017-03-22

    Synergy Rx Recalls QUAD PEEL Due to Sterility Assurance Concerns

    Synergy Rx is recalling QUAD PEEL chemical peels nationwide due to a lack of assurance of sterility and CGMP deviations.

    Product
    QUAD PEEL (Sal Acid 2%, TCA 7%, Phenol 7%, Retinoic acid 0.4%), Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0530-2017·2017-03-22

    Synergy Rx Recalls Topical Gels and Creams Due to Sterility Concerns

    Synergy Rx is recalling specific prescription topical gels and creams because they may lack assurance of sterility and have CGMP deviations.

    Product
    ADAPALENE 0.1%, BENZOYL PEROXIDE 2.5% GEL, ADAPELENE 0.3%, BENZOYL PEROXIDE 2,5% GEL, AZELAIC ACID 15% CREAM, AZELAIC ACID 20% IN OI FREE CREAM, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0600-2017·2017-03-22

    Synergy Rx Recalls Gentle Supreme Bleaching Cream Due to Sterility Concerns

    Synergy Rx is recalling Gentle Supreme Bleaching Cream because the product lacks assurance of sterility and has CGMP deviations.

    Product
    GENTLE SUPREME BLEACHING CREAM, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0599-2017·2017-03-22

    Synergy Rx Custom Lightening Cream Recalled for Sterility Assurance Issues

    Synergy Rx is recalling Custom Lightening/Brightening Cream due to lack of assurance of sterility and CGMP deviations.

    Product
    CUSTOM LIGHTENING/BRIGHTENING CREAM, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0569-2017·2017-03-22

    Synergy Rx Recalls Rosacea Cream Due to Sterility Assurance Concerns

    Synergy Rx is recalling Rosacea Cream because the product lacks assurance of sterility and has CGMP deviations.

    Product
    ROSACEA CREAM ( Metronidazole 1%, Niacinamide 4%), Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0597-2017·2017-03-22

    Synergy Rx Recalls Sulfacetamide and Hydrocortisone Cream for Sterility Concerns

    Synergy Rx is recalling Sulfacetamide 10%/Hydrocortisone 1% Cream due to lack of assurance of sterility and CGMP deviations.

    Product
    SULFACETAMIDE 10%/HYDROCORTISONE 1% CREAM, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0583-2017·2017-03-22

    Synergy Rx Enhanced Retin Cream Recalled for Sterility Assurance Issues

    Synergy Rx is recalling Enhanced Retin Anti-Wrinkle Cream products due to a lack of assurance of sterility and CGMP deviations.

    Product
    ENHANCED RETIN ANTI-WRINKLE CREAM, ENHANCED RETIN ANTI-WRINKLE CREAM 0.1%, ENHANCED RETIN 0.025% and 0.05%, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0540-2017·2017-03-22

    Synergy Rx Recalls Glycolic Acid Solution Due to Sterility Concerns

    Synergy Rx is recalling all strengths of Glycolic Acid Solution because the product lacks assurance of sterility and has CGMP deviations.

    Product
    GLYCOLIC ACID SOLUTION, all strengths including 10%, 20%, 30%, 50%, and 60%, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0523-2017·2017-03-22

    Synergy Rx Recalls Cantharidin and Podophyllum Solutions Due to Sterility Concerns

    Synergy Rx is recalling Cantharidin 0.7% Solution and Cantharidan/Podophyllum Solution due to lack of assurance of sterility and CGMP deviations.

    Product
    CANTHARADIN 0.7% SOLUTION and CANTHARIDAN / PODOPHYLLUM SOLUTION, CANTHARIDIN/PODOPHYLLUM RESIN MIXTURE, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0518-2017·2017-03-22

    Isomeric Pharmacy Recalls Triamcinolone Injection Vials Due to CGMP Deviations

    Isomeric Pharmacy Solution is recalling 6,999 vials of Triamcinolone 40 mg/mL injection due to Current Good Manufacturing Practice (CGMP) deviations.

    Product
    Triamcinolone 40 mg/mL 2 mL Single-Dose Vial for Injection, Preservative Free, Rx only, Compounded by Isomeric Pharmacy Solutions, Salt Lake City, UT 84109, NDC 70285-1920-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0572-2017·2017-03-22

    Synergy Rx Supreme Cream Recalled for Sterility Assurance Issues

    Synergy Rx is recalling Supreme Cream due to a lack of assurance of sterility and CGMP deviations.

    Product
    SUPREME CREAM (Retinoic acid 0.05%, hydroquinone 6%, kojic acid 3%, Alpha Arbutin otc 2%, Azeliac acid 2%), Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0547-2017·2017-03-22

    Synergy Rx Recalls Hydroquinone Cream Due to Sterility Assurance Issues

    Synergy Rx is recalling Hydroquinone Cream in all strengths due to a lack of assurance of sterility and CGMP deviations.

    Product
    HYDROQUINONE CREAM in all strengths including 4%, 5%,6%, 7%, 8%, HYDROQUINONE 5%/KOJIC ACID 3% CREAM, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0550-2017·2017-03-22

    Synergy Rx Recalls ACNE SOLUTION Due to Sterility Assurance Issues

    Synergy Rx is recalling ACNE SOLUTION, a prescription topical medication, due to a lack of assurance of sterility and CGMP deviations.

    Product
    ACNE SOLUTION (Salicylic acid 2%, Hydrocortisone 2%, Niacinamide 4%, Azelaic acid 2%, Clindamycin 1%), Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0596-2017·2017-03-22

    Synergy Rx Recalls Hydrocortisone Cream Due to Sterility Assurance Issues

    Synergy Rx is recalling Hydrocortisone 2.5% with Aloe Vera Cream because the product lacks assurance of sterility and has CGMP deviations.

    Product
    HYDROCORTISONE 2.5% WITH ALOE VERA CREAM, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1594-2017·2017-03-22

    Box Mill Farm Apple Cider Recalled for Inadequate Pasteurization

    Box Mill Farm is recalling pasteurized apple cider in gallon and half-gallon containers due to inadequate pasteurization. The product was distributed in Massachusetts.

    Product
    Box Mill Farm Pasteurized Apple Cider in 1 gallon containers and Half-Gallon containers
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0556-2017·2017-03-22

    Synergy Rx Recalls DUO Cream Due to Sterility Assurance Concerns

    Synergy Rx is recalling DUO Cream because the product lacks assurance of sterility and has CGMP deviations. The recall covers all lots distributed nationwide.

    Product
    DUO Cream (Retinoic Acid 0.05%, Hydroquinone 6%, Kojic Acid 3%, Hydrocortisone 0.1%), Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
    Category
    Drug
    Distribution
    Distributed nationwide