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.

51–75 of 1552

  • HighFDA (Food)·H-0796-2026·2026-05-27

    VitaminAlly FulviLife Complex recalled over manufacturing practice deviations

    VitaminAlly FulviLife Complex oral liquid is being recalled over deviations from current Good Manufacturing Practices that could lead to bacterial pathogen and possible C. botulinum concerns.

    Product
    FulviLife Complex. Dosage:2 tablespoons (30mL). Liquid. Packaging: Plastic Bottle. Net Volume:16 fl oz (480 ml). Firm Address: VitaminAlly LLC Chandler, AZ 85225.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0804-2026·2026-05-27

    VitaminAlly prenatal multivitamin drops recalled over manufacturing practice deviations

    VitaminAlly Liposomal Prenatal+Postnatal Liquid Multivitamin Drops, iron free, are being recalled over cGMP deviations that could lead to bacterial pathogen and possible C. botulinum concerns.

    Product
    Liposomal Prenatal+Postnatal Liquid Multivitamin Drops - Iron Free. Dosage: 3mL Liquid. Packaging: Aluminum bottle. 90 ml. Firm Address: Vitaminally LLC Chandler, AZ 85225
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0801-2026·2026-05-27

    VitaminAlly liposomal collagen booster recalled over manufacturing practice deviations

    VitaminAlly Liposomal Collagen Booster is being recalled over deviations from current Good Manufacturing Practices that could lead to bacterial pathogen and possible C. botulinum concerns.

    Product
    Liposomal Collagen Booster. Dosage: 3mL Liquid. Packaging: Aluminum bottle. 90 ml. Firm Address: Vitaminally LLC Chandler, AZ 85225.
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0502-2026·2026-05-06

    Injectable Phenylephrine Hydrochloride Solution Recall Due to cGMP Deviations

    Wells Pharma of Houston LLC is recalling Phenylephrine Hydrochloride Injectable Solution, 40 mg, 250 mL IV bags nationwide due to cGMP deviations. The recall affects 13,070 IV bags with multiple lot numbers and expiration dates through July 2026.

    Product
    Phenylephrine Hydrochloride Injectable Solution, 40mg, 250*mL Bag, wells pharma of Houston, NDC 73702-122-03
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0503-2026·2026-05-06

    Fentanyl Citrate Injectable Solution Recalled for cGMP Deviations

    Wells Pharma is recalling fentanyl citrate injectable solution (1000 mcg/100 mL, 10 mcg per mL) distributed nationwide due to current good manufacturing practice (cGMP) deviations. The recall affects 4,030 IV bags with various lot numbers and expiration dates between April and June 2026.

    Product
    fentaNYL Citrate Injectable Solution, NARCOTIC, Cii, 1000 mcg/100 mL (10 mcg per mL), 100 mL bag, Wells Pharma in Houston, NDC 73702-202-02.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0501-2026·2026-05-06

    Similasan iVIZIA Sterile Lubricant Eye Drops Recall Due to Sterility Assurance

    Thea Pharma, Inc. is recalling Similasan iVIZIA Sterile Lubricant Eye Drops due to the lack of assurance of sterility caused by manufacturing deviations found by the FDA.

    Product
    Similasan, iVIZIA, Sterile Lubricant Eye Drops (Povidone 0.5%), 0.33 Fl oz (10 mL), Made in France, Distributed by: Thea Pharma Inc., Waltham, MA 02451, NDC 59262-700-11
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0507-2026·2026-05-06

    Ketamine Hydrochloride Injectable Solution Recalled for cGMP Deviations

    Wells Pharma of Houston LLC is recalling 4,975 syringes of Ketamine Hydrochloride Injectable Solution (50 mg/mL) distributed nationwide due to current Good Manufacturing Practice (cGMP) deviations.

    Product
    Ketamine Hydrochloride Injectable Solution, 50mg/ml, (50 mg per mL) Volume: 1 mL, 5265 Kitty Drive, Houston, TX 77054, NDC 73702-302-31.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0504-2026·2026-05-06

    Fentanyl Citrate Injectable Solution Recalled for cGMP Deviations

    Wells Pharma of Houston is voluntarily recalling 2,940 IV bags of fentanyl citrate injectable solution due to cGMP (current good manufacturing practice) deviations. The product was distributed nationwide.

    Product
    fentaNYL Citrate injectable Solution in 0.9% Sodium Chloride, Narcotic, (2500 mcg/ 250 mL) (10 mcg per mL), 250 mL bag, wells pharma of Houston, NDC 73702-202-03.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0450-2026·2026-04-22

    Cipla cinacalcet 60 mg tablets exceed the nitrosamine daily intake limit

    Cipla is recalling Cinacalcet Hydrochloride Tablets, 60 mg, over CGMP deviations and the presence of N-Nitroso Cinacalcet above the acceptable daily intake limit. 96,096 bottles are affected.

    Product
    CINACALCET — CINACALCET (CINACALCET)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0451-2026·2026-04-22

    Cipla cinacalcet 90 mg tablets exceed the nitrosamine daily intake limit

    Cipla is recalling Cinacalcet Hydrochloride Tablets, 90 mg, over CGMP deviations and the presence of N-Nitroso Cinacalcet above the acceptable daily intake limit. 63,192 bottles are affected.

    Product
    CINACALCET — CINACALCET (CINACALCET)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0449-2026·2026-04-22

    Cipla cinacalcet 30 mg tablets exceed the nitrosamine daily intake limit

    Cipla is recalling Cinacalcet Hydrochloride Tablets, 30 mg, over CGMP deviations and the presence of N-Nitroso Cinacalcet above the acceptable daily intake limit. 113,336 bottles are affected.

    Product
    CINACALCET — CINACALCET (CINACALCET)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0472-2026·2026-04-15

    Teva clonidine transdermal patches recalled over unapproved raw material use

    Teva is recalling two lots of Clonidine Transdermal System, USP, 0.1 mg/day, citing CGMP deviations involving the use of an unapproved raw material. 124,054 cartons are affected.

    Product
    CLONIDINE TRANSDERMAL SYSTEM — CLONIDINE TRANSDERMAL SYSTEM (CLONIDINE)
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0473-2026·2026-04-15

    Teva clonidine 0.2 mg patches recalled over unapproved raw material use

    Teva is recalling two lots of Clonidine Transdermal System, USP, 0.2 mg/day, citing CGMP deviations involving the use of an unapproved raw material. 62,136 cartons are affected.

    Product
    CLONIDINE TRANSDERMAL SYSTEM — CLONIDINE TRANSDERMAL SYSTEM (CLONIDINE)
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0474-2026·2026-04-15

    Teva clonidine 0.3 mg patches recalled over unapproved raw material use

    Teva is recalling three lots of Clonidine Transdermal System, USP, 0.3 mg/day, citing CGMP deviations involving the use of an unapproved raw material. 113,943 cartons are affected.

    Product
    CLONIDINE TRANSDERMAL SYSTEM — CLONIDINE TRANSDERMAL SYSTEM (CLONIDINE)
    Category
    Drug
    Distribution
    0 states
  • CriticalFDA (Drugs)·D-0332-2026·2026-02-11

    Rheumacare capsules recalled after the product was found to contain lead

    Handelnine Global is recalling four bottles of Rheumacare capsules after the product was found to contain lead.

    Product
    Rheumacare capsules, 30 count bottle, Mfg in India by: Virgo UAP Pharma Pvt. Ltd., Ahmedabad, India UPC 8 904218 700313
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0301-2026·2026-02-11

    Bisoprolol and hydrochlorothiazide tablets recalled over a nitrosamine impurity

    Unichem Pharmaceuticals USA is recalling a lot of Bisoprolol Fumarate and Hydrochlorothiazide tablets, 2.5 mg/6.25 mg, for not meeting the N-Nitroso Bisoprolol impurity specification limits.

    Product
    BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE — BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE (BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1046-2026·2026-01-21

    Advil products recalled over insanitary conditions at a distribution center

    Gold Star Distribution is recalling Advil products over CGMP deviations, citing insanitary conditions including rodent exposure and activity at its distribution center.

    Product
    SMV BodyTrack, System, Tomography, Computed, Emission
    Category
    Drug
    Distribution
    0 states
  • HighFDA (Devices)·Z-1082-2026·2026-01-21

    Swan rubbing alcohol recalled over insanitary conditions at a distribution center

    Gold Star Distribution is recalling Swan White Clear Alcohol over CGMP deviations, citing insanitary conditions including rodent exposure and activity at its distribution center.

    Product
    Brand Name: PALACOS Product Name: PALACOS MV+G pro 40; PALACOS MV+G pro 80 Model/Catalog Number: 5081290; 5081291 Software Version: N/A Product Description: Radiopaque, poly(methyl methacrylate)-based (PMMA) bone cement, pre-filled into a mixing and application system, suita
    Category
    Drug
    Distribution
    0 states
  • HighFDA (Drugs)·D-0286-2026·2026-01-21

    Deodorant products recalled over insanitary conditions at a distribution center

    Gold Star Distribution is recalling Deodorant products over CGMP deviations, citing insanitary conditions including rodent exposure and activity at its distribution center.

    Product
    Deodorant: a) Axe, Body Spray, Wild Spice, 6CT, 150ML, UPC: 600108736469; b) LUCKY MENS STICK DEODORANT, SPRING FRESH, 24CT, 2.5 OZ, UPC: 808829111668; c) LUCKY MENS STICK DEODORANT, FRESH COMFORT, 24CT, 1.6 OZ, UPC: 808829089103; d) LADY DEODORANT, CHERRY BLOSSOSM, 24CT, 1.8oz,
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0281-2026·2026-01-21

    Ice gel recalled over insanitary conditions at a distribution center

    Gold Star Distribution is recalling Personal Care Ice Gel over CGMP deviations, citing insanitary conditions including rodent exposure and activity at its distribution center.

    Product
    Personal Care, Ice Gel, 8oz, 12 count, UPC 048155903463
    Category
    Drug
    Distribution
    Distributed nationwide