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.

26–50 of 1563

  • ModerateFDA (Drugs)·D-0694-2026·2026-07-08

    TRIPENICOL S Antifungal Solution Recalled for CGMP Deviations

    Blaine Labs Inc is recalling TRIPENICOL S Antifungal Solution (Undecylenic Acid 25%) because the firm discontinued required stability testing for products still on the market within their expiration date.

    Product
    TRIPENICOL S — TRIPENICOL S (UNDECYLENIC ACID)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0613-2026·2026-07-01

    Sensipar (Cinacalcet Hydrochloride) Tablets Recalled for CGMP Deviations

    Amgen, Inc. is voluntarily recalling 9,565 bottles of Sensipar (cinacalcet) 30mg tablets nationwide due to CGMP manufacturing deviations. The recalled lot was distributed to patients taking the medication for secondary hyperparathyroidism.

    Product
    SENSIPAR — SENSIPAR (CINACALCET HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0614-2026·2026-07-01

    Sensipar Cinacalcet Tablets Recalled Due to CGMP Deviations

    Amgen, Inc. is recalling Sensipar (cinacalcet) 60 mg tablets nationwide due to Current Good Manufacturing Practice (CGMP) deviations. The recall affects 30-count bottles with Lot #1157055 and expiration date 1/31/2028.

    Product
    SENSIPAR — SENSIPAR (CINACALCET HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0616-2026·2026-07-01

    Sensipar cinacalcet hydrochloride tablets recalled for CGMP deviations

    Amgen, Inc. is recalling Sensipar (cinacalcet) 90mg tablets nationwide due to Current Good Manufacturing Practice (CGMP) deviations. The affected lot was distributed across the United States.

    Product
    SENSIPAR — SENSIPAR (CINACALCET HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0611-2026·2026-07-01

    Fenofibrate Capsules 200 mg Recalled for CGMP Manufacturing Deviations

    Ajanta Pharma USA Inc. is recalling Fenofibrate Capsules, USP 200 mg due to Current Good Manufacturing Practice (CGMP) deviations identified during production. The recall affects 3,648 bottles distributed nationwide.

    Product
    FENOFIBRATE — FENOFIBRATE (FENOFIBRATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0617-2026·2026-07-01

    Duloxetine 30 mg capsules recalled for impurity above FDA limits

    Direct Rx is recalling Duloxetine D/R 30 mg capsules (also sold as Cymbalta) distributed nationwide because the drug contains N-nitroso-duloxetine impurity above FDA-recommended interim limits.

    Product
    DULOXETINE D/R, a) 30 mg (NDC 61919-482-30), 30 Caps; b) 30 mg (NDC 61919-482-60), 60 Caps; CYMBALTA, Packaged and Distributed by Direct Rx.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0634-2026·2026-06-24

    Cura Hongos clotrimazole cream recalled over manufacturing practice deviations

    Cura Hongos Crema Antifungica, clotrimazole 1%, in 2 oz tubes is being recalled because of CGMP deviations and deficiencies observed during an FDA inspection. 84 tubes affected.

    Product
    Cura Hongos, Crema Antifungica, Clotrimazole 1%, 2oz (57g) tubes, Dist by/por: Pharmadel LLC, New Castle, DE 19720, Made in India, UPC 8 52924 00683 1.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0632-2026·2026-06-24

    Lil Drug Store triple antibiotic ointment recalled over manufacturing deviations

    Lil Drug Store Triple Antibiotic Ointment, 0.5 oz tubes, is being recalled because of CGMP deviations and deficiencies observed during an FDA inspection. 1,225 tubes affected.

    Product
    Lil Drug Store, Triple Antibiotic Ointment, Bacitracin Zinc (400 units), Neomycin Sulfate (3.5 mg), Polymyxin-B Sulfate (5000 units), net wt. 0.5 oz (14.2g), Product distributed by: Lil' Drug Store Products, Inc., 9300 Earhart Lane SW, Cedar Rapids, IA 52404, Made in India, UPC 3
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0641-2026·2026-06-24

    Med Pride triple antibiotic ointment packets recalled over manufacturing deviations

    Med Pride Triple Antibiotic Ointment in 0.9 g packets is being recalled because of CGMP deviations and deficiencies observed during an FDA inspection. 3,006 tubes affected.

    Product
    Med Pride, Triple Antibiotic Ointment, Bacitracin Zinc (equivalent to 400 units), Neomycin Sulfate 5 mg, Polymixin B 5000 units, 0.9g packets, 144 packets per box, 130g, Manufactured for: Shield Line LLC, 59 Hook Road, Bayonne, NJ 07002 USA, Made in India, UPC 1 03 52410 30253 1.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0640-2026·2026-06-24

    Med Pride hydrocortisone cream 1oz tubes recalled over manufacturing deviations

    Med Pride Hydrocortisone Cream 1%, 1 oz tubes, is being recalled because of CGMP deviations observed during an FDA inspection. 4,944 tubes are affected.

    Product
    Med Pride, HYDROCORTISONE CREAM 1%, Net Wt. 1 oz (28.3g) tubes, Manufactured for: Shield Line LLC, 59 Hook Road, Bayonne, NJ 07002 USA, Made in India, UPC 3 52410 30503 0.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0642-2026·2026-06-24

    Med Pride triple antibiotic ointment tubes recalled over manufacturing deviations

    Med Pride Triple Antibiotic Ointment in 1 oz tubes is being recalled because of CGMP deviations and deficiencies observed during an FDA inspection. 8,996 tubes are affected.

    Product
    Med Pride, Triple Antibiotic Ointment, Bacitracin Zinc 400 units, Neomycin Sulfate 5 mg, Polymyxin B 5000 units, 1oz (28.3g) tubes, Manufactured for: Shield Line LLC, 59 Hook Road, Bayonne, NJ 07002 USA, Made in India, UPC 3 52410 30255 8.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0637-2026·2026-06-24

    Med Pride bacitracin zinc ointment recalled over manufacturing practice deviations

    Med Pride Bacitracin Zinc Ointment, 1 oz tubes, is being recalled because of CGMP deviations and deficiencies observed during an FDA inspection. 1,185 tubes affected.

    Product
    Med Pride, Bacitracin Zinc Ointment, 1oz (28.3g) per tube, 72 tubes per case, Manufactured for: Shield Line LLC, 59 Hook Road, Bayonne, NJ 07002 USA, Made in India, UPC X004WB4LKT.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0635-2026·2026-06-24

    Med Pride bacitracin zinc packets recalled over manufacturing practice deviations

    Med Pride Bacitracin Zinc Ointment, 500 units in 0.9 g packets, is being recalled because of CGMP deviations observed during an FDA inspection. 1,087 tubes affected.

    Product
    Med Pride, Bacitracin Zinc Ointment, 500 units, 0.9g packets Net Wt 130g, 144 count box, Manufactured for: Shield Line LLC, 59 Hook Road, Bayonne, NJ 07002 USA, Made in India, UPC 3 52410 30352 4.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0629-2026·2026-06-24

    Lucky Super Soft athlete's foot cream recalled over manufacturing deviations

    Lucky Super Soft Antifungal Athlete's Foot Cream, clotrimazole 1%, is being recalled because of CGMP deviations and deficiencies observed during an FDA inspection. 1,102 tubes affected.

    Product
    Lucky Super Soft, Antifungal Athlete's Foot Cream, Clotrimazole 1% Cream, Net Wt. 1.5 oz (42.5g) Tubes, Manufactured for Delta Brands Inc., 580 White Plains Rd., Tarrytown, NY 10591 USA, Made in India, UPC 8 08829 10461 5.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0639-2026·2026-06-24

    Med Pride hydrocortisone cream 16oz tubes recalled over manufacturing deviations

    Med Pride Hydrocortisone Cream 1%, 16 oz tubes, is being recalled because of CGMP deviations observed during an FDA inspection. 4,738 tubes are affected.

    Product
    Med Pride, HYDROCORTISONE CREAM 1%, Net Wt. 16oz (454g) tubes, Manufactured for: Shield Line LLC, 59 Hook Road, Bayonne, NJ 07002 USA, Made in India, UPC 3 52410 305061.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0636-2026·2026-06-24

    Med Pride bacitracin zinc ointment 500 units recalled over manufacturing deviations

    Med Pride Bacitracin Zinc Ointment, 500 units per gram in 1 oz tubes, is being recalled because of CGMP deviations observed during an FDA inspection. 4,374 tubes affected.

    Product
    Med Pride, Bacitracin Zinc Ointment, 500 units, 1oz (28.3g) tubes, Manufactured for: Shield Line LLC, 59 Hook Road, Bayonne, NJ 07002 USA, Made in India, UPC 3 52410 30354 8.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0633-2026·2026-06-24

    Rapidol triple antibiotic first aid ointment recalled over manufacturing deviations

    Rapidol Triple Antibiotic First Aid Ointment, 2 oz tubes, is being recalled because of CGMP deviations observed during an FDA inspection. 84 tubes are affected.

    Product
    Rapidol, Triple Antibiotic First Aid Ointment, Bacitracin Zinc 400 units, Neomycin Sulfate 3.5 mg, Polymyxin-B Sulfate 5,000 units, net wt. 2oz (57g) tubes, Distributed by/por: Pharmadel LLC, New Castle, DE 19720, Made in India, UPC 8 10096 77162 9.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0630-2026·2026-06-24

    Lucky Super Soft triple antibiotic ointment recalled over manufacturing deviations

    Lucky Super Soft First Aid Triple Antibiotic Ointment, 0.5 oz tubes, is being recalled because of CGMP deviations observed during an FDA inspection. 2,503 tubes are affected.

    Product
    Lucky Super Soft, First Aid Triple Antibiotic Ointment, Bacitracin zinc 400 units, neomycin sulphate 3.5 mg, polymyxin B sulphate 5000 units, Net Wt. 0.5 oz (14g) tubes, Manufactured for Delta Brands Inc., 580 White Plains Rd., Tarrytown, NY 10591 USA, Made in India, UPC 8 08829
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0631-2026·2026-06-24

    Circle K triple antibiotic ointment recalled over manufacturing practice deviations

    Circle K Triple Antibiotic Ointment, 0.5 oz tubes, is being recalled because of CGMP deviations observed during an FDA inspection. 2,420 tubes are affected.

    Product
    Circle K, triple antibiotic ointment, Bacitracin Zinc (400 units), Neomycin Sulfate (3.5 mg), Polymyxin-B Sulfate (5000 units), net wt. 0.5 oz (14.2g) tubes, Product manufactured for Lil' Drug Store Products, Inc., 9300 Earhart Lane SW, Cedar Rapids, IA 52404, Made in India, UPC
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0638-2026·2026-06-24

    Med Pride clotrimazole antifungal cream recalled over manufacturing practice deviations

    Med Pride 1% Clotrimazole Antifungal Cream, 1 oz tubes, is being recalled because of CGMP deviations observed during an FDA inspection. 5,755 tubes are affected.

    Product
    Med Pride, 1% Clotrimazole Antifungal Cream, Net Wt. 1oz (28.3g), Manufactured for: Shield Line LLC, 59 Hook Road, Bayonne, NJ 07002 USA, Made in India, UPC 3 524103 0244 2.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0545-2026·2026-05-27

    Erythromycin 500 mg Tablets Recalled for Impurity Above Limits

    Zydus Pharmaceuticals is recalling erythromycin 500 mg tablets nationwide due to the presence of N-Nitroso-Desmethyl-Erythromycin above the recommended acceptable intake limit, resulting from manufacturing deviations.

    Product
    ERYTHROMYCIN — ERYTHROMYCIN (ERYTHROMYCIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0544-2026·2026-05-27

    Erythromycin Tablets Recalled for Impurity Above Acceptable Limits

    Zydus Pharmaceuticals is recalling Erythromycin Tablets, 250 mg, nationwide because certain lots contain N-Nitroso-Desmethyl-Erythromycin above the recommended acceptable intake limit due to CGMP deviations.

    Product
    ERYTHROMYCIN — ERYTHROMYCIN (ERYTHROMYCIN)
    Category
    Drug
    Distribution
    Distributed nationwide