The Recall Desk

Hazard

Cgmp Deviation recalls

1,563 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
1,563
Critical
1
Severe
288
Most recent
2026-09-09

Of the 1,563 cgmp deviation recalls we have scored against our rubric, 1 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 288 (18%) are Severe.

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all cgmp deviation recalls regardless of agency”, “all listeria recalls in California”, “all airbag recalls in 2025”. The tags are extracted from each recall’s source text during the LLM rewrite step and validated against a fixed schema.

A recall can carry multiple tags — a Listeria recall might also be tagged ready-to-eat and undeclared-allergen. Use the full-text search if you want to combine hazard tags with brand or category filters.

1351–1375 of 1563

  • ModerateFDA (Drugs)·D-0881-2017·2017-06-14

    Spectrum Laboratory Estradiol API Recalled for CGMP Deviations

    Spectrum Laboratory Products is recalling Estradiol active pharmaceutical ingredient due to Good Manufacturing Practice deviations found during an FDA inspection.

    Product
    Estradiol (17-B-Estradiol; Estra-1,3,5(10)-triene-3, 17B-diol; Oestradiol) Plant Base, Micronized, U.S.P active pharmaceutical ingredient, packaged in 1g, 5g, 25g, 6 x 25g, and 100g containers, Rx only, Spectrum Chemical Mfg. Corp, Gardena, CA 90248, New Brunswick, NJ 08901, Pr
    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-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
  • 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-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-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-0602-2017·2017-03-22

    Synergy Rx Recalls Kojic Acid and Azelaic Acid Cream Due to Sterility Concerns

    Synergy Rx is recalling Kojic Acid 8%/Azelaic Acid 15% Cream because it lacks assurance of sterility and has CGMP deviations.

    Product
    KOJIC ACID 8%/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-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-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-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-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-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 (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-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-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
  • 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-0533-2017·2017-03-22

    Synergy Rx Bleaching Cream Recalled for Sterility Assurance Issues

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

    Product
    BLEACHING CREAM 0.1% CREAM, BLEACHING CREAM HQ4%, BLEACHING CREAM-NO HQ, 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-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-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-0528-2017·2017-03-22

    Synergy Rx Recalls Minoxidil Products Due to Sterility Assurance Concerns

    Synergy Rx is recalling Minoxidil and Minoxidil/Retinoic Acid products nationwide due to a lack of assurance of sterility and CGMP deviations.

    Product
    MINOXADIL all strength including 2%, 5% and MINOXIDIL / RETINOIC ACID 5% / 0.025, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0541-2017·2017-03-22

    Synergy Rx Recalls Retinoic Acid Products Due to Sterility Concerns

    Synergy Rx is recalling various retinoic acid products due to a lack of assurance of sterility and CGMP deviations.

    Product
    RETINOIC ACID all strengths including 0.025%, 0.05% and 0.1% CREAM, RETINOIC ACID 0.025%/CLINDAMYCIN 1.2% GEL, RETINOIC ACID 0.025%/ HYALURONIC ACID CREAM, RETINOIC ACID 0.05%/HYALURONIC ACID CREAM, RETINOIC ACID 0.1% IN CERAVE CREAM, RETINOIC ACID POWDER 1 GRAM, RETINOIC ACID
    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-0562-2017·2017-03-22

    Synergy Rx Recalls LP Cream Due to Sterility Assurance Issues

    Synergy Rx is recalling LP Cream (Lidocaine 15%/Prilocaine 5%) because the product lacks assurance of sterility and has CGMP deviations.

    Product
    LP CREAM (Lidocaine 15%/Prilocaine 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-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