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.

1426–1450 of 1563

  • ModerateFDA (Drugs)·D-0542-2017·2017-03-22

    Synergy Rx Recalls Retinoic Acid Solution Due to Sterility Concerns

    Synergy Rx is recalling all lots of Retinoic Acid Solution due to a lack of assurance of sterility and CGMP deviations.

    Product
    RETINOIC ACID SOLUTION in all strengths including 0.3%, 0.4%, 0.5%, 1%, RETINOIC ACID SOLUTION LIQUID, 0.4%, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0532-2017·2017-03-22

    Synergy Rx Recalls Betamethasone Creams and Ointments for Sterility Concerns

    Synergy Rx is recalling various betamethasone cream and ointment products due to a lack of assurance of sterility and CGMP deviations.

    Product
    BL 20%/4% CREAM, BLT 20%/6%/4% CREAM, BLT 20%/6%/6%, BLT 20% 8% 4% CREAM, BLT 20% 8% 4% OINTMENT, BLT 20% 8% 6% CREAM, BLT 20%/ 8% /8% OINTMENT, BLT 20%/ 8% /8% CREAM, BLT 20%/ 7%/ 7% CREAM, BLT 20%/ 10%/ 4% CREAM, BLT 20%/ 10%/ 10% CREAM, BLT 20%/ 20%/ 10% OINTMENT,BLT 7%/ 10%/
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0592-2017·2017-03-22

    Synergy Rx Recalls RETIN-A 0.05% Cream Due to Sterility Concerns

    Synergy Rx is recalling RETIN-A 0.05% Cream because of a lack of assurance of sterility and CGMP deviations.

    Product
    RETIN-A 0.05% CREAM, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0595-2017·2017-03-22

    Synergy Rx Recalls Metronidazole and Azelaic Acid Products for Sterility Concerns

    Synergy Rx is recalling Metronidazole 1% Gel and Metronidazole/Niacinamide/Azelaic Cream due to lack of assurance of sterility and CGMP deviations.

    Product
    METRONIDAZOLE 1% GEL, METRONIDAZOLE 1%/ NIACINAMIDE 4%/ AZELAIC CREAM 10% CREAM, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0539-2017·2017-03-22

    Synergy Rx Recalls Glycolic Acid Products Due to Sterility Concerns

    Synergy Rx is recalling specific glycolic acid prescription products due to a lack of assurance of sterility and CGMP deviations.

    Product
    GLYCOLIC ACID 15% LOTION, GLYCOLIC ACID 20% GEL, GLYCOLIC ACID 6% LOTION, GLYCOLIC ACID 5% CREAM, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0587-2017·2017-03-22

    Synergy Rx Recalls Hydroquinone 28% Solution Due to Sterility Concerns

    Synergy Rx is recalling Hydroquinone 28% Solution because it may not be sterile. The recall covers all lots distributed nationwide.

    Product
    HYDROQUINONE 28% SOLUTION, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0582-2017·2017-03-22

    Synergy Rx Enhanced Retin Cream Recalled for Sterility Assurance Issues

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

    Product
    ENHANCED RETIN ANTI-WRINKLE CREAM, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0558-2017·2017-03-22

    Synergy Rx Recalls Generic VI Peel Due to Sterility Concerns

    Synergy Rx is recalling Generic VI Peel products nationwide due to a lack of assurance of sterility and CGMP deviations.

    Product
    GENERIC VI 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
  • ModerateFDA (Drugs)·D-0484-2017·2017-03-01

    Cherry Hill Sales Recalls MakeSense First Aid Cream Due to CGMP Deviations

    Cherry Hill Sales Co. is voluntarily recalling 7,200 cartons of MakeSense First Aid Cream due to Current Good Manufacturing Practice (CGMP) deviations.

    Product
    MakeSense PHARMA FIRST AID CREAM Lidocaine HCL 0.5%, Phenol 0.5%, 1 oz.. (28 g) tube, Made in China, Distributed by Cherry Hill Associates, Chesapeake, VA 23320, NDC 69020-210-28
    Category
    Drug
    Distribution
    5 states
  • SevereFDA (Drugs)·D-0461-2017·2017-02-08

    VistaPharm Recalls Nystatin Oral Suspension Due to Water Contamination

    VistaPharm is recalling Nystatin Oral Suspension because the purified water used in manufacturing may have been contaminated with Burkholderia cepacia.

    Product
    Nystatin Oral Suspension, USP 500,000 Units/5 mL, a). 50 unit dose cups of 5 mL per case (NDC No. 66689-037-50), b). 100 unit dose cups of 5 mL per case (NDC 66689-037-99), Rx only, Manufactured by VistaPharm, Largo, FL 33771.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0464-2017·2017-02-08

    VistaPharm Recalls Oxycodone Hydrochloride Oral Solution Due to Water Contamination

    VistaPharm is recalling Oxycodone Hydrochloride Oral Solution because the purified water used in manufacturing may have been contaminated with Burkholderia cepacia.

    Product
    Oxycodone Hydrochloride Oral Solution, USP 5 mg/5 mL, a). 5 mL, 50 unit dose cups of 5 mL per case (NDC No. 66689-401-50), b). 500 mL, 12 bottles per case (NDC No. 66689-403-16), Rx only, Manufactured by VistaPharm, Largo, FL 33771.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0242-2017·2017-01-11

    Gentell Hydrogel Ag Saturated Gauze Recalled for CGMP Deviations

    Gentell, Inc. is voluntarily recalling 3,000 units of Hydrogel Ag Saturated Gauze in three sizes due to Current Good Manufacturing Practice (CGMP) deviations.

    Product
    Gentell Hydrogel Ag Saturated Gauze, 2"x2"(NDC 61551-112-20), 4x4(NDC 61554-114-24) and 4"x8"(NDC 61554-118-28), Manufactured by: Gentell, 2701 Bartram Road, Bristol, PA 19007
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0243-2017·2017-01-11

    Gentell Hydrogel Wound Dressing Recalled for CGMP Deviations

    Gentell, Inc. is voluntarily recalling Gentell Hydrogel Wound Dressing REGULAR, 4 oz. tubes due to Current Good Manufacturing Practice (CGMP) deviations.

    Product
    Gentell Hydrogel Wound Dressing REGULAR, 4 oz. tube, Manufactured by: Gentell, 2701 Bristol, PA 19007, NDC 61554-111-04
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0232-2017·2017-01-04

    CVS Health Homeopathic Infants Teething Tablets Recalled for CGMP Deviations

    Raritan Pharmaceuticals is voluntarily recalling CVS Health Homeopathic Infants Teething Tablets due to Current Good Manufacturing Practice (CGMP) deviations.

    Product
    CVS Health Homeopathic Infants Teething Tablets 135 count bottle Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895 NDC 59779-860-03 UPC 0504284162
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0231-2017·2016-12-28

    Sage Products Recalls Chlorhexidine Gluconate Cloth Due to CGMP Deviations

    Sage Products LLC is recalling 2% Chlorhexidine Gluconate Cloth due to CGMP deviations and potential contamination. The product was distributed nationwide and internationally.

    Product
    CHLORHEXIDINE GLUCONATE — CHLORHEXIDINE GLUCONATE (CHLORHEXIDINE GLUCONATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0161-2017·2016-12-07

    Burel Pharmaceuticals Recalls Phenazopyridine Hydrochloride Tablets Due to CGMP Deviations

    Burel Pharmaceuticals is recalling 17,788 bottles of Phenazopyridine Hydrochloride Tablets due to manufacturing deviations that may cause assay or content uniformity failures.

    Product
    Phenazopyridine Hydrochloride Tablets, USP, 100 mg, 100 count bottles, Rx only, Manufactured for: Burel Pharmaceuticals, Inc., Richland, MS --- NDC 35573-304-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0023-2017·2016-10-19

    Teva Recalls Amikacin Sulfate Injection Due to Manufacturing Deviations

    Teva Pharmaceuticals USA is voluntarily recalling 27,547 vials of Amikacin Sulfate Injection due to CGMP deviations. The recall covers lots distributed nationwide and in Puerto Rico.

    Product
    Amikacin Sulfate Injection, USP, 500 mg/2 mL (250 mg/mL) Rx Only, Manufactured in Hungary For: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0703-9032-01 (individual pack), NDC 0703-9032-03 (shelf-pack carton of 10 vials).
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1503-2016·2016-09-28

    Lupin Recalls Lisinopril Tablets Due to CGMP Deviations

    Lupin Pharmaceuticals is recalling 5,880 bottles of 40 mg Lisinopril tablets because they were manufactured using active pharmaceutical ingredients that failed specifications.

    Product
    LISINOPRIL — LISINOPRIL (LISINOPRIL)
    Category
    Drug
    Distribution
    0 states
  • LowFDA (Drugs)·D-1502-2016·2016-09-28

    Lupin Recalls Lisinopril Tablets Due to CGMP Deviations

    Lupin Pharmaceuticals is recalling 20,556 bottles of Lisinopril 30 mg tablets because they were manufactured using active pharmaceutical ingredients whose intermediates failed specifications.

    Product
    LISINOPRIL — LISINOPRIL (LISINOPRIL)
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-1495-2016·2016-09-14

    Teva Recalls Linezolid Injection Due to Manufacturing Deviations

    Teva North America is voluntarily recalling 92,480 containers of Linezolid Injection 600 mg/300 mL due to CGMP deviations. The recall covers products distributed nationwide and in Puerto Rico.

    Product
    Linezolid Injection 600 mg/300 mL Rx Only, Manufactured in Hungary for TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454, NDC# 0703-9060-31- (Single Use Container), NDC# 0703-9060-33 (Box of 10 Singe Use Containers)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1494-2016·2016-09-14

    Teva Recalls Argatroban Injection Due to Manufacturing Deviations

    Teva North America is voluntarily recalling 1,299 bags of Argatroban Injection due to Current Good Manufacturing Practice (CGMP) deviations.

    Product
    ARGATROBAN Injection in 0.9% Sodium Chloride 250 mg/250 mL (1 mg/mL) , Rx Only, Manufactured in Hungary for TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454, NDC# 0703-0020-31 (Single Use Bag), NDC # 0703-0020-32 (5 Single Use Bags in One Carton).
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1497-2016·2016-09-14

    Teva Recalls Ondansetron Injection Vials Due to Manufacturing Deviations

    Teva North America is recalling 13,223 vials of Ondansetron Injection USP due to CGMP deviations. The recall covers lots distributed nationwide and in Puerto Rico.

    Product
    Ondansetron Injection USP 40 mg/20 mL (2 mg/mL), Rx Only, Manufactured in Hungary for TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454 NDC # 0703-7226-01 (20 mL- Multi-dose Vial), NDC # 0703-72263-03 (10 Multi-dose Vials per carton)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1496-2016·2016-09-14

    Teva Recalls Eptifibatide Injection Vials Due to Manufacturing Deviations

    Teva North America is voluntarily recalling 14,661 vials of Eptifibatide Injection due to CGMP deviations. The recall covers lots distributed nationwide and in Puerto Rico.

    Product
    Eptifibatide Injection 75 mg/100 mL (0.75 mg/mL) single use vial, For Intravenous Use Only, Rx Only, Manufactured in Hungary for TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454, NDC# 0703-1179-01.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1493-2016·2016-09-14

    Lupin Recalls Amlodipine Besylate Tablets Due to CGMP Deviations

    Lupin Limited is recalling Amlodipine Besylate tablets because they were manufactured using active pharmaceutical ingredients that failed specifications.

    Product
    AMLODIPINE BESYLATE — AMLODIPINE BESYLATE (AMLODIPINE BESYLATE)
    Category
    Drug
    Distribution
    0 states