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.

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-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-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-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-0580-2021·2021-06-02

    Cardinal Health Recalls Levalbuterol Inhalers Due to Temperature Excursions

    Cardinal Health is recalling 828 Levalbuterol tartrate HFA inhalers distributed in Florida, Georgia, and South Carolina due to intermittent temperature excursions during storage.

    Product
    LEVALBUTEROL TARTRATE HFA INHALATION — LEVALBUTEROL TARTRATE HFA INHALATION (LEVALBUTEROL TARTRATE)
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0500-2021·2021-06-02

    Cardinal Health Recalls Livalo Tablets Due to Temperature Excursions

    Cardinal Health is recalling 453 bottles of Livalo (pitavastatin calcium) 2 mg tablets due to intermittent exposure to temperature excursions during storage.

    Product
    LIVALO — LIVALO (PITAVASTATIN CALCIUM)
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0560-2021·2021-06-02

    Cardinal Health Recalls Intrarosa Prasterone Vaginal Inserts Due to Temperature Excursions

    Cardinal Health Inc. is recalling 205 cartons of Intrarosa Prasterone Vaginal Inserts due to intermittent temperature excursions during storage.

    Product
    Intrarosa Prasterone Vaginal Inserts 6.5 mg 28 inserts/applicators Rx Only Manufactured for: Ednoceutics, Inc. Quebec City, Canada, G1V 4M7 Distributed by: AMAG Pharmaceuticals, Inc. Waltam, MA 02451, NDC 64011-601-28
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0445-2021·2021-06-02

    Cardinal Health Recalls MURO-128 Eye Drops Due to Temperature Excursions

    Cardinal Health is recalling MURO-128 2% eye drops due to intermittent temperature excursions during storage. The affected units were distributed in Florida, Georgia, and South Carolina.

    Product
    MURO-128 2% 15ML OPTH; NDC/UPC 324208276150; OTC; DROPS
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0448-2021·2021-06-02

    Cardinal Health Recalls Belbuca Due to Temperature Excursions

    Cardinal Health is recalling 96 cartons of Belbuca buccal film due to intermittent exposure to temperature excursions during storage.

    Product
    BELBUCA — BELBUCA (BUPRENORPHINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0442-2021·2021-06-02

    Cardinal Health Recalls Nuedexta Due to Temperature Excursions

    Cardinal Health is recalling 255 bottles of Nuedexta capsules due to intermittent exposure to temperature excursions during storage.

    Product
    NUEDEXTA — NUEDEXTA (DEXTROMETHORPHAN HYDROBROMIDE AND QUINIDINE SULFATE)
    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-0496-2021·2021-06-02

    Cardinal Health Recalls Enbrace HR Prenatal Vitamins Due to Temperature Excursions

    Cardinal Health is recalling 11 bottles of Enbrace HR prenatal vitamins due to intermittent temperature excursions during storage. The product was distributed in Florida, Georgia, and South Carolina.

    Product
    ENBRACE HR — ENBRACE HR (LEVOMEFOLATE MAGNESIUM, LEUCOVORIN, FOLIC ACID, FERROUS CYSTEINE GLYCINATE, MAGNESIUM ASCORBATE, ZINC ASCORBATE, COCARBOXYLASE, FLAVIN ADENINE DINUCLEOTIDE, NADH, PYRIDOXAL PHOSPHATE ANHYDROUS, COBAMAMIDE, BETAINE, MAGNESIUM L-THREONATE, 1,2-DOCOSAHEXANOYL-SN-GLYCERO-3-PHOSPHOSERINE CALCIUM, 1,2-ICOSAPENTOYL-SN-GLYCERO-3-PHOSPHOSERINE CALCIUM, AND PHOSPHATIDYL SERINE)
    Category
    Drug
    Distribution
    3 states