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.

16376–16400 of 29206

  • SevereFDA (Drugs)·D-0573-2017·2017-03-22

    Synergy Rx Recalls TCA Peel Solutions Due to Sterility Concerns

    Synergy Rx is recalling TCA Peel Solutions in all strengths due to a lack of assurance of sterility and CGMP deviations.

    Product
    TCA PEEL SOLUTION in all strengths including: 5%, 10%, 15%, 18%, and 20%, TCA 10%/LACTIC ACID 12%, TCA 6%/ LACTIC ACID12%, TCA 7%/SALICYLIC ACID 2% 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-0553-2017·2017-03-22

    Synergy Rx Clarifying Cream Recalled for Sterility Assurance Failures

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

    Product
    CLARIFYING CREAM (Retinoic acid 0.025%, Salicylic Acid 1%, Green tea powder, Ascorbic 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-0531-2017·2017-03-22

    Synergy Rx Recalls Benzoyl Peroxide and Clindamycin Due to Sterility Concerns

    Synergy Rx is recalling Benzoyl Peroxide 5% Clindamycin 1.2% due to lack of assurance of sterility and CGMP deviations.

    Product
    BENZOYL PEROXIDE 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-0598-2017·2017-03-22

    Sulfur 5% Cream Recalled for Lack of Sterility Assurance

    Synergy Rx is recalling Sulfur 5% Cream due to a lack of assurance of sterility and CGMP deviations.

    Product
    SULFUR 5% 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-0580-2017·2017-03-22

    Synergy Rx Recalls Diclofenac Lip Balm Due to Sterility Concerns

    Synergy Rx is recalling Diclofenac Lip Balm products because they may not be sterile. The recall covers all lots distributed nationwide.

    Product
    DICLOFENAC 3% and 5% LIP BALM and DICLOFENAC 5% SPF 30 LIP BALM, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0527-2017·2017-03-22

    Synergy Rx Recalls Fluorouracil Creams Due to Sterility Assurance Issues

    Synergy Rx is recalling Fluorouracil creams due to a lack of assurance of sterility and CGMP deviations.

    Product
    5-FLUOROURACIL IN VANICREAM, FLUOROURACIL in all strengths including 0.05%, 5% CREAM, FLUOROURACIL 4.9% IN CERAVE CREAM, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0548-2017·2017-03-22

    Synergy Rx Recalls Hydroquinone Solution Due to Sterility Concerns

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

    Product
    HYDROQUINONE SOLUTION in all strengths including 4%, 28%, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0535-2017·2017-03-22

    Synergy Rx Recalls Clobetasol Products Due to Sterility Assurance Concerns

    Synergy Rx is recalling Clobetasol 0.05% products because the FDA identified a lack of assurance of sterility and CGMP deviations.

    Product
    CLOBETASOL 0.05% IN OLEA BASE, CLOBETASOL 0.05% IN OROBASE, CLOBETASOL 0.05% OINTMENT, CLOBETASOL 0.05%/ SODIUM, SULFACETAMIDE 10% 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-0554-2017·2017-03-22

    Synergy Rx Recalls CLEAR Gel Due to Sterility Assurance Concerns

    Synergy Rx is recalling all lots of CLEAR (Benzoyl Peroxide 3.75%, Clindamycin 1.2% Gel) due to a lack of assurance of sterility and CGMP deviations.

    Product
    CLEAR (Benzoyl Peroxide 3.75%, Clindamycin 1.2% Gel), Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1460-2017·2017-03-22

    Arkon Anesthesia Delivery System Recalled for Unannounced Power Supply Failure

    Del Mar Reynolds Medical is recalling Arkon Anesthesia Delivery Systems because the power supply can fail without triggering normal battery alarms.

    Product
    Arkon Anesthesia Delivery System, Model 99999. Product Usage: Continuous Ventilator The Arkon Anesthesia Delivery System is designed to provide emergency oxygen, vaporized agent delivery and manual ventilation in the event of a power failure scenario. Clinicians are able to…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0546-2017·2017-03-22

    Synergy Rx Recalls Vitamin K Oxide Due to Sterility Concerns

    Synergy Rx is recalling Vitamin K Oxide 5% because it lacks assurance of sterility and has CGMP deviations.

    Product
    VITAMIN K OXIDE 5%, HQ 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-0551-2017·2017-03-22

    Synergy Rx Brightening Cream Recalled for Sterility Assurance Issues

    Synergy Rx is recalling Brightening Cream due to a lack of assurance of sterility and CGMP deviations. The product is distributed nationwide.

    Product
    BRIGHTENING CREAM (Retinoic acid 0.1%, Hydroquinone 4%, kojic acid 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 (Food)·F-1577-2017·2017-03-22

    Dietary Supplement Recalled for Presence of Banned Ephedra Alkaloid

    Kingsway Trading Inc is recalling Xanthium & Siler Combo (Bi Yan Pian) dietary supplements because they contain Ephedrae Herba (ma huang), a banned ephedra alkaloid.

    Product
    Xanthium & Siler Combo (Bi Yan Pian) DIETARY SUPPLEMENT, Net cont: 100 tablets (300mg each), Net Wt. 1.06oz (30g)
    Category
    Drug
    Distribution
    17 states
  • SevereFDA (Drugs)·D-0591-2017·2017-03-22

    Synergy Rx Recalls Purified Water Due to Sterility Assurance Concerns

    Synergy Rx is recalling all lots of Purified Water due to a lack of assurance of sterility and CGMP deviations.

    Product
    PURIFIED WATER, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0560-2017·2017-03-22

    Synergy Rx Recalls HI-LITE Cream Due to Sterility Assurance Concerns

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

    Product
    HI-LITE Cream (Retinoic Acid 0.05%, Hydroquinone 4%, Fluocinolone 0.01%), Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0517-2017·2017-03-22

    Teva Recalls Buprenorphine and Naloxone Sublingual Tablets Due to Impurities

    Teva Pharmaceuticals is recalling specific lots of Buprenorphine and Naloxone Sublingual Tablets because they failed impurity and degradation specifications.

    Product
    Buprenorphine and Naloxone Sublingual Tablets 8 mg/2 mg, 30 count HDPE bottles, Rx Only, Distributed by TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454, NDC 0093-5721-56
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0559-2017·2017-03-22

    Synergy Rx Recalls Gentle Bleaching Cream Due to Sterility Concerns

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

    Product
    GENTLE BLEACHING CREAM (Retinoic Acid 0.025, Kojic Acid 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-0578-2017·2017-03-22

    Synergy Rx Recalls VI PEEL Chemical Peel Due to Sterility Concerns

    Synergy Rx is recalling VI PEEL chemical peel products nationwide due to a lack of assurance of sterility and CGMP deviations.

    Product
    VI PEEL (Sal Acid 2%, TCA 17%, 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-0526-2017·2017-03-22

    Synergy Rx Recalls Tacrolimus Ointment Due to Sterility Concerns

    Synergy Rx is recalling all lots of Tacrolimus 0.1% Ointment and Tacrolimus 0.1%/Ketoconazole 2% due to lack of assurance of sterility and CGMP deviations.

    Product
    TACROLIMUS 0.1% Ointment and TACROLIMUS 0.1%/KETOCONAZOLE 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-0564-2017·2017-03-22

    Synergy Rx Recalls Malek's Magic Plus Due to Sterility Concerns

    Synergy Rx is recalling Malek's Magic Plus prescription cream because it lacks assurance of sterility and has CGMP deviations.

    Product
    MALEK'S MAGIC PLUS (retinoic acid 0.1%, hydroquinone 6%, kojic acid 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-0585-2017·2017-03-22

    Synergy Rx Recalls Human Chorionic Gonadotropin Tablets Due to Sterility Concerns

    Synergy Rx is recalling Human Chorionic Gonadotropin tablets because the product lacks assurance of sterility and has CGMP deviations.

    Product
    HUMAN CHORIONIC GONADOTROPIN in 300IU and 500 IU TABLETS, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0565-2017·2017-03-22

    Synergy Rx Recalls LTP Ophthalmic Solution Due to Sterility Concerns

    Synergy Rx is recalling LTP (Lidocaine 10%, Tetracaine 2%, Phenylephrine 0.5%) ophthalmic solution nationwide due to lack of assurance of sterility and CGMP deviations.

    Product
    LTP (Lidocaine 10%, Tetracaine 2%, Phenylephrine 0.5%), Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0571-2017·2017-03-22

    Synergy Rx Supreme Bleaching Cream Recalled for Sterility Assurance Issues

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

    Product
    SUPREME BLEACHING CREAM (Retinoic acid 0.05%, hydroquinone 6%, kojic acid 3%, Alpha Arbutin OTC 2%, Azeliac acid OTC 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-0537-2017·2017-03-22

    Synergy Rx Recalls Fluorouracil Creams Due to Sterility Concerns

    Synergy Rx is recalling Fluorouracil creams because of a lack of assurance of sterility and CGMP deviations.

    Product
    FLUORORACIL 0.05% CREAM, FLUORORACIL 5% CREAM, FLUOROURACIL 4.9% IN CERAVE 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-0522-2017·2017-03-22

    Synergy Rx Recalls Human Chorionic Gonadotropin Vials Due to Sterility Concerns

    Synergy Rx is recalling 1,809 vials of Human Chorionic Gonadotropin (HCG) because the product lacks assurance of sterility and has CGMP deviations.

    Product
    Human Chorionic Gonadotropin (HCG) 5,000 units/vial and 11,000 units/vial, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
    Category
    Drug
    Distribution
    Distributed nationwide