The Recall Desk

Hazard

Cgmp Deviation recalls

1,552 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
1,552
Critical
1
Severe
283
Most recent
2026-09-02

Of the 1,552 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 283 (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.

1–25 of 1552

  • SevereFDA (Drugs)·D-0790-2026·2026-09-02

    Zicam Cold Remedy Nasal Swabs Recalled for Microbiological Testing Failures

    Church & Dwight is recalling Zicam Cold Remedy Nasal Swabs because FDA inspections found out-of-limit microbiological testing results at the contract manufacturer.

    Product
    Zicam, Cold Remedy, Medicated Nasal Swabs, With Cooling Menthol & Eucalyptus, 20 Single-Use Swabs per carton, Zinc-Free Homeopathic, Distributed by Church & Dwight Co. Inc., Ewing, NJ 08628, UPC 732216301205.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0762-2026·2026-08-19

    Shoolin Pharma Recalls Tadalafil USP Due to CGMP Deviations

    Shoolin Pharma Chem LLP is recalling Tadalafil USP 1.00 KG bags due to Current Good Manufacturing Practice (CGMP) deviations noted during an FDA inspection.

    Product
    TADALAFIL USP, 1.00 KG, 1KG(1000gm)-bag, Rx only, "For Prescription Compounding Only", Shoolin Pharma Chem LLP, Block/Survey no 408, B/H Ratnamani Tubes, Near Maruti Inox, Indrad, Kadi, Mahesania, Gujarat, 382715, India, (CAS NO 171596-29-5), NDC 85702-001-08
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0761-2026·2026-08-19

    Shoolin Pharma Recalls Tadalafil USP Due to CGMP Deviations

    Shoolin Pharma Chem LLP is recalling Tadalafil USP 0.500 KG bags due to Current Good Manufacturing Practice (CGMP) deviations noted during an FDA inspection.

    Product
    TADALAFIL USP, 0.500 KG, 0.500KG(500gm)-bag, Rx only, "For Prescription Compounding Only", Shoolin Pharma Chem LLP, Block/Survey no 408, B/H Ratnamani Tubes, Near Maruti Inox, Indrad, Kadi, Mahesania, Gujarat, 382715, India, (CAS NO 171596-29-5), NDC 85702-002-04.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0763-2026·2026-08-19

    Sildenafil Citrate Recall Due to CGMP Deviations

    Shoolin Pharma Chem LLP is recalling Sildenafil Citrate USP 1.00KG bags due to CGMP deviations noted during an FDA inspection.

    Product
    SILDENAFIL CITRATE USP, 1.00KG, 1.00KG-bag Net Wt. Rx only " For Prescription Compounding Only", Shoolin Pharma Chem LLP, Block/Survey no 408, B/H Ratnamani Tubes, Near Maruti Inox, Indrad, Kadi, Mahesania, Gujarat, 382715, India, (CAS NO. 171599-83-0) NDC 85702-001-08.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0759-2026·2026-08-19

    Sildenafil Citrate USP Recalled for CGMP Deviations Noted During FDA Inspection

    Shoolin Pharma Chem LLP is recalling Sildenafil Citrate USP due to Current Good Manufacturing Practice (CGMP) deviations identified during an FDA inspection.

    Product
    SILDENAFIL CITRATE USP, 0.100 KG, 100 gm-bag Net Wt, RX ONLY "FOR Prescription Compounding Only", Shoolin Pharma Chem LLP, Block/Survey no 408, B/H Ratnamani Tubes, Near Maruti Inox, Indrad, Kadi, Mahesana, Gujarat, 382715, India, (CAS NO. 171599-83-0) NDC 85702-001-05
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0760-2026·2026-08-19

    Shoolin Pharma Recalls Tadalafil USP Due to CGMP Deviations

    Shoolin Pharma Chem LLP is recalling Tadalafil USP 0.100 KG bags due to Current Good Manufacturing Practice (CGMP) deviations noted during an FDA inspection.

    Product
    TADALAFIL USP, 0.100 KG, 0.1KG(100gm)-bag, Rx only, "For Prescription Compounding Only", Shoolin Pharma Chem LLP, Block/Survey no 408, B/H Ratnamani Tubes, Near Maruti Inox, Indrad, Kadi, Mahesania, Gujarat, 382715, India, (CAS NO 1715996-29-5), NDC 85702-002-02.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0691-2026·2026-07-15

    Clomiphene Citrate USP Active Pharmaceutical Ingredient Recalled for cGMP Deviations

    Shimoga Chemicals is voluntarily recalling Clomiphene Citrate USP active pharmaceutical ingredient in three package sizes due to current good manufacturing practice (cGMP) deviations. The product was distributed in California and Florida.

    Product
    Clomiphene Citrate USP Active Pharmaceutical Ingredient (CAS : 50-41-9), Net Weight a)1 KG (NDC 84849-000-01), b) 500 g (NDC 84849-000-02), (c) 100 g (NDC 84849-000-03), Rx Only, Shimoga Chemicals Address -W-57A, MIDC Kupwad Samgli, Maharashtra, 416436, India.
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0723-2026·2026-07-08

    Glucagon Emergency Kit Recalled for Manufacturing Process Deviation

    Lupin Pharmaceuticals is recalling Glucagon Emergency Kits (1mg) nationwide due to a manufacturing process deviation found during stability testing. The gliding force functionality test failed to meet specifications during 12-month testing.

    Product
    GLUCAGON — GLUCAGON (GLUCAGON)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0697-2026·2026-07-08

    Terpenicol Antifungal Solution Recalled for CGMP Deviations

    Blaine Labs Inc is recalling Terpenicol (Undecylenic Acid) antifungal solution because the firm discontinued required stability testing for products still on the market within their expiration dates.

    Product
    TERPENICOL — TERPENICOL (UNDECYLENIC ACID)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0699-2026·2026-07-08

    Revitaderm Wound Care Benzalkonium Chloride OTC Drug Recall

    Blaine Labs Inc is recalling Revitaderm Wound Care (Benzalkonium Chloride 0.1%) topical antiseptic gel due to current good manufacturing practice (CGMP) deviations. The product was manufactured in the same facility under the same conditions as a product found to be contaminated.

    Product
    REVITADERM WOUND CARE — REVITADERM WOUND CARE (BENZALKONIUM CHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • 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-0693-2026·2026-07-08

    Tridergel Benzalkonium Chloride Wound Care Gel Recalled

    Blaine Labs Inc is recalling Tridergel wound care gel nationwide due to current good manufacturing practice (CGMP) deviations. The product was manufactured in a facility under the same conditions as contaminated product.

    Product
    TRIDERGEL — TRIDERGEL (BENZALKONIUM CHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0695-2026·2026-07-08

    TERPENICOL Antifungal Cream Recalled for CGMP Deviations

    Blaine Labs Inc is recalling TERPENICOL Antifungal Cream due to CGMP deviations: the firm discontinued required stability testing for products still within expiry dates. The recall affects 22,143 bottles distributed nationwide.

    Product
    TERPENICOL — TERPENICOL (UNDECYLENIC ACID)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0698-2026·2026-07-08

    Fungal Fusion antifungal kit recalled for discontinued stability testing

    Blaine Labs Inc is recalling Fungal Fusion ERADICATION Solution kits nationwide because the manufacturer discontinued required stability testing for products still on the market within their expiration dates.

    Product
    Fungal Fusion ERADICATION Solution, Antifungal & Antimicrobial Kit. Contains, 1x2 oz bottle Fungal Fusion Antifungal (Miconazole Nitrate) Cream, 1x2oz bottle Fungal Fusion Antifungal Solution (25% Undecylenic Acid) and 1x1oz bottle of Fungal Fusion Eradication Antimicrobial Show
    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-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-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-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-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-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-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