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
289
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 289 (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.

751–775 of 1563

  • ModerateFDA (Drugs)·D-0729-2021·2021-08-25

    Acetaminophen 325 mg tablets recalled for discoloration and cGMP deviations

    Spirit Pharmaceuticals is recalling Acetaminophen 325 mg Regular Strength Pain Reliever tablets due to discoloration and current good manufacturing practice (cGMP) deviations. The recall affects one lot distributed nationwide.

    Product
    Acetaminophen 325 mg tablets, Regular Strength Pain Reliever, 100-count bottle, Distributed by: Walmart Inc., Bentoville, AR 72716, NDC 79903-052-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0699-2021·2021-08-11

    Pfizer Chantix Tablets Recalled for N-nitroso-varenicline Impurity

    Pfizer is recalling Chantix (varenicline tartrate) 0.5mg tablets nationwide due to the presence of N-nitroso-varenicline impurity above FDA's acceptable interim intake limit. The recall affects 59,232 bottles.

    Product
    CHANTIX — CHANTIX (VARENICLINE TARTRATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0697-2021·2021-08-11

    Global Hand Sanitizer Recalled Due to Denaturant Deficiency

    Cascade Kelly Holdings LLC is recalling Global Hand Sanitizer with moisturizer because the product does not meet the required denaturant specifications for alcohol-based antiseptics.

    Product
    Global Hand Sanitizer with moisturizer, Alcohol-based Antiseptic 80%, Non-sterile Topical Solution, 4 fl. oz./119 mL, Alcohol 80% v/v, Manufactured by: Cascade Kelly Holdings LLC, NDC 80253-001-01
    Category
    Drug
    Distribution
    9 states
  • ModerateFDA (Drugs)·D-0695-2021·2021-08-04

    Drug Recall: Estriol USP41 Micro Due to cGMP Deviations

    API Solutions Inc. is recalling Estriol USP41 Micro 25 Grams (Lot #ETL181001) due to cGMP deviations. The product was distributed to AL, AZ, CO, FL, and VA.

    Product
    Estriol USP41 Micro 25 Grams, Distributed by: A.P.I. Solutions 25309 Friendship Rd Daphne, AL Distributed by: Syntec Pharma Corp., NY MFT by: Wuhan Fortune Chemical Co., Ltd., China, NDC: 46144-300-01
    Category
    Drug
    Distribution
    5 states
  • ModerateFDA (Drugs)·D-0659-2021·2021-07-21

    Durisan Hand Sanitizing Wipes Recalled for CGMP Deviations

    Sanit Technologies, LLC is recalling Durisan Antimicrobial Solutions Hand Sanitizing Wipes (benzalkonium chloride, 0.13%) due to manufacturing deviations that could result in contaminated product.

    Product
    Durisan Antimicrobial Solutions (benzalkonium chloride) Hand Sanitizing Wipes, 0.13%, packaged in 80-count canister (UPC 8 52379 00632 5), b) 160-count canister (UPC 8 52379 00631 8), and c) 240-count canister (UPC 8 52379 00633 2); Sanit Technologies, LLC, 7810 25th Court East…
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0647-2021·2021-07-07

    Advance Hand Sanitizer Recalled for Methanol Contamination

    Dibar Labs is recalling Advance Hand Sanitizer (70% ethyl alcohol, 16 FL OZ) distributed nationwide because it was manufactured under the same conditions as lots found to contain methanol.

    Product
    ADVANCE HAND SANITIZER, (ethyl alcohol 70%), 16 FL OZ (473.2 mL), Imported by: Dibar Labs, LLC,.Sugar Land, TX 77479, Distributed by: Lifetime Health Services, Pharr, TX 78577, Made in Mexico, NDC; 79284-005-00. UPC 8 60004 06470 1
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Food)·F-0666-2021·2021-06-23

    BTREX PLUS Dietary Supplement Recalled for Damaged Tablets

    Lopez Gonzalez Santana Corporation is recalling BTREX PLUS dietary supplement 2-caplet bottles (Lot #30637, expiration 01.2022) due to the presence of damaged tablets resulting from Current Good Manufacturing Practice (CGMP) deviations.

    Product
    BTREX PLUS, Dietary Supplement 2 caplets bottles, UPC 05380930802 (Physician Samples)
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0459-2021·2021-06-02

    Cardinal Health Recalls Synjardy Tablets Due to Temperature Excursions

    Cardinal Health is recalling 751 bottles of Synjardy XR tablets distributed in Florida, Georgia, and South Carolina due to intermittent temperature exposure during storage.

    Product
    SYNJARDY — SYNJARDY (EMPAGLIFLOZIN, METFORMIN HYDROCHLORIDE)
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0522-2021·2021-06-02

    Cardinal Health Recalls Belsomra Tablets Due to Temperature Excursions

    Cardinal Health is recalling 119 cartons of Belsomra (suvorexant) 10 mg tablets due to intermittent temperature excursions during storage.

    Product
    Belsomra (suvorexant) tablets 10 mg Each tablet contains 10 mg suvorexant. This package contains 30 Tablets in 3 Blister Cards. Each Blister Card contains 10 Tablets Rx only NDC 00006-0033-30 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. Whitehouse Station, NJ…
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0585-2021·2021-06-02

    Cardinal Health Recalls Folivane-Plus Capsules Due to Temperature Excursions

    Cardinal Health is recalling 80 bottles of Folivane-Plus capsules because they were intermittently exposed to temperature excursions during storage.

    Product
    Folivane-Plus with Ascorbic Acid Precursors Iron/Folic Acid/Vitamin Supplement Capsules 90 Capsules Rx Only NDC 13811-539-90 Manufactured for: Trigen Laboratories, Inc., Sayreville, NJ 08872
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0587-2021·2021-06-02

    Cardinal Health Recalls Restora Omega-3 Supplement Due to Temperature Excursions

    Cardinal Health Inc. is recalling 31 cartons of Restora Omega-3 enhanced Lactobacillus Casei KE-99 30 Capsules due to intermittent exposure to temperature excursions during storage.

    Product
    Restora Omega-3 enhanced Lactobacillus Casei KE-99 30 Capsules 1 A Day Nutritional Supplement NDC 52747-200-30 Marketed by US Pharmaceutical Corporation, P.O. Box 360465, Decatur, GA 30036
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0432-2021·2021-06-02

    Cardinal Health Recalls Gemcitabine Injection Due to Temperature Excursions

    Cardinal Health is recalling Gemcitabine Injection 200mg/5.26ml vials due to intermittent temperature excursions during storage. The product was distributed in Florida, Georgia, and South Carolina.

    Product
    GEMCITABINE INJECTION 200MG/5.26ML; NDC/UPC 72485-221-02; RX; SINGLEDOSE VIAL
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0516-2021·2021-06-02

    Cardinal Health Recalls Vitamin D3 Tablets Due to Temperature Excursions

    Cardinal Health Inc. is recalling 19 bottles of Vitamin D3 25mcg tablets because they were intermittently exposed to temperature excursions during storage.

    Product
    VITAMIN D3 25MCG 180 TABLETS; NDC/UPC 880681168011; OTC; TABLETS
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0539-2021·2021-06-02

    Cardinal Health Recalls Zolpidem Tablets Due to Temperature Excursions

    Cardinal Health is recalling 55 boxes of Zolpidem Tartrate Sublingual Tablets 3.5 mg due to intermittent exposure to temperature excursions during storage.

    Product
    ZOLPIDEM TARTRATE SUBLINGUAL TABLET 3.5 MG 30 UNIT DOSE POUCHES; NDC/UPC 49884089911; RX; EACH POUCH CONTAINS ONE SUBLINGUAL TABLET
    Category
    Drug
    Distribution
    3 states