The Recall Desk

Hazard

Cgmp Deviation recalls

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

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 547

  • HighFDA (Drugs)·D-0634-2025·2025-09-17

    Chlorpromazine hydrochloride tablets recalled for N-nitroso impurity above limits

    Zydus Pharmaceuticals recalls specific lots of chlorpromazine hydrochloride 50-mg tablets due to the presence of N-nitroso desmethyl chlorpromazine above acceptable limits.

    Product
    CHLORPROMAZINE HYDROCHLORIDE — CHLORPROMAZINE HYDROCHLORIDE (CHLORPROMAZINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0598-2025·2025-09-03

    Prescription Sucralfate Tablets Recalled Due to Quality Assurance Failure

    Amerisource Health Services LLC is recalling Sucralfate tablets nationwide because the company filed for bankruptcy and cannot ensure products meet quality standards.

    Product
    SUCRALFATE — SUCRALFATE (SUCRALFATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0572-2025·2025-08-13

    FDA Recalls Xolair Injectable for Temperature Storage Deviation

    The FDA is recalling Xolair (omalizumab) 75 mg subcutaneous injection due to exposure to temperatures outside labeled storage requirements during distribution. No adverse events have been reported.

    Product
    XOLAIR — XOLAIR (OMALIZUMAB)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0547-2025·2025-08-06

    Sucralfate Tablets Recalled Nationwide Due to CGMP Deviations

    Nostrum Laboratories is recalling 60,608 bottles of Sucralfate Tablets nationwide. The manufacturer cannot assure the tablets meet required quality and purity standards due to Current Good Manufacturing Practice deviations.

    Product
    Sucralfate Tablets, USP 1 gram, packaged in a) 100-count bottles NDC 29033-0003-01, and b) 500-count bottles, NDC 29033-0003-05), Rx Only, Manufactured by: Nostrum Laboratories, Inc., Kansas City, MO 64120.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0539-2025·2025-07-30

    Prescription Drug Recall: EVENITY Injection Due to Temperature Excursion Risk

    Mckesson is recalling EVENITY (romosozumab-aqqg) injectable medication due to manufacturing compliance deviations and potential temperature excursions during shipping. The recall affects lot 1178382 distributed to Ohio, Virginia, and Florida.

    Product
    EVENITY — EVENITY (ROMOSOZUMAB-AQQG)
    Category
    Drug
    Distribution
    3 states
  • HighFDA (Drugs)·D-0540-2025·2025-07-30

    BENLYSTA biologic injection recalled for potential temperature excursions

    McKesson Medical-Surgical is recalling BENLYSTA (belimumab) due to potential temperature excursions during transit that may affect drug potency. The recall involves product distributed in Ohio, Virginia, and Florida.

    Product
    BENLYSTA — BENLYSTA (BELIMUMAB)
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0548-2025·2025-07-23

    Antiperspirant Deodorant Recalled Nationwide for Manufacturing Compliance Deviations

    A.P. Deauville is recalling Power Stick for Her Roll-On Antiperspirant Deodorant nationwide due to manufacturing compliance deviations. The recall affects 21,265 cases distributed across the United States.

    Product
    POWER STICK FOR HER ROLL- ON ANTIPERSPIRANT DEODORANT POWDER FRESH — POWER STICK FOR HER ROLL- ON ANTIPERSPIRANT DEODORANT POWDER FRESH (ALUMINUM SESQUICHLOROHYDRATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0514-2025·2025-07-16

    Sunscreen product recalled due to manufacturing practice violations

    GreenScreen sunscreen (Zinc Oxide SPF 32) is being recalled by KABANA SKIN CARE due to manufacturing practice deviations. The recall affects 174 tubes distributed in New Jersey, Florida, and Michigan.

    Product
    GreenScreen, kabana organic skincare, Bread Spectrum UVA & UVB, Zinc Oxide Sunscreen, Organic Ingredients, Fragrance Free, Biodegradable, Chemical Free, Non-Nano, Baby Safe, Original, SPF 32, Totally Green personal care, Zinc Oxide USP 25%, 3.4 FL OZ/115 G Tube, NDC: 73369-0001-1
    Category
    Drug
    Distribution
    3 states
  • HighFDA (Drugs)·D-0448-2025·2025-06-04

    Glenmark recalls Carvedilol tablets for genotoxic impurity above limits

    Glenmark Pharmaceuticals is recalling certain lots of Carvedilol 3.125mg tablets nationwide due to N-Nitroso Carvedilol I, a genotoxic impurity, exceeding FDA's acceptable intake limit.

    Product
    CARVEDILOL — CARVEDILOL (CARVEDILOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0450-2025·2025-06-04

    Carvedilol tablets recalled due to manufacturing deviation and nitrosamine impurity

    Glenmark Pharmaceuticals recalls Carvedilol 12.5 mg tablets nationwide due to presence of N-Nitroso Carvedilol I impurity above acceptable limits and manufacturing deviations. Affected patients should consult their physician.

    Product
    CARVEDILOL — CARVEDILOL (CARVEDILOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0440-2025·2025-05-28

    Nature Mint Toothpaste Recalled for Manufacturing Practice Deviations

    Nature Mint Anticavity Fluoride Toothpaste is being recalled due to CGMP deviations at the manufacturing facility. Approximately 160,848 tubes distributed to Delaware and North Carolina are affected.

    Product
    Nature Mint, Anticavity Fluoride Toothpaste, Sodium monofluorophosphate 0.76%, NET WT 2.75 OZ (78g) Tube, Made in India, Dist. by Bob Barker Co. Inc., Fuquay-Varina, NC 27526, NDC 53247-131-05
    Category
    Drug
    Distribution
    2 states
  • ModerateFDA (Drugs)·D-0435-2025·2025-05-28

    FDA Recalls Nature Mint Toothpaste for Manufacturing Quality Deviations

    The FDA has recalled Nature Mint Anticavity Fluoride Toothpaste due to manufacturing quality control violations. The affected product was distributed to Delaware and North Carolina.

    Product
    Nature Mint, Anticavity Fluoride Toothpaste, Sodium monofluorophosphate 0.76%, NET WT 4.6 OZ (130 grams) Tube, Made in India, Dist. by Bob Barker Co. Inc., Fuquay-Varina, NC 27526, NDC 53247-131-06
    Category
    Drug
    Distribution
    2 states
  • ModerateFDA (Drugs)·D-0436-2025·2025-05-28

    Nature Mint Toothpaste Recalled for Manufacturing Process Deviations

    Nature Mint anticavity fluoride toothpaste is being recalled due to manufacturing process deviations. The recall affects approximately 498,960 tubes distributed in Delaware and North Carolina.

    Product
    Nature Mint, Anticavity Fluoride Toothpaste, Sodium monofluorophosphate 0.76%, NET WT 0.6 OZ (17g) Tube, Made in India, Dist. by Bob Barker Co. Inc., Fuquay-Varina, NC 27526, NDC 53247-131-02
    Category
    Drug
    Distribution
    2 states
  • ModerateFDA (Drugs)·D-0424-2025·2025-05-28

    Topical Salicylic Acid Drug Recalled Over Manufacturing Process Deviations

    Kingskin SacaCallos (17% salicylic acid solution) is being recalled due to manufacturing process deviations. The recalled product was distributed in Delaware and North Carolina.

    Product
    Kingskin, SacaCallos, 17% Salicylic acid, 0.5 fl oz (14.8mL) Bottle, Dist. by: Pharmadel LLC, New Castle, DE 19720, Made in India, NDC 55758-423-15, UPC 8 10096 77163 6.
    Category
    Drug
    Distribution
    2 states
  • ModerateFDA (Drugs)·D-0430-2025·2025-05-28

    Cinnafresh Anticavity Gel Toothpaste Recalled for Manufacturing Deviations

    Cinnafresh anticavity gel toothpaste made in India is being recalled due to CGMP manufacturing deviations. The recall affects 383,904 tubes distributed in Delaware and North Carolina.

    Product
    Cinnafresh anticavity gel toothpaste, sodium fluoride 0.22%, Bold Cinnamon Flavor, NET WT. 0.85 OZ (24 grams) Tube, Made in India, Dist. by Bob Barker Co. Inc., Fuquay-Varina, NC 27526, NDC 53247-133-01
    Category
    Drug
    Distribution
    2 states
  • ModerateFDA (Drugs)·D-0423-2025·2025-05-28

    CURA HONGOS Antifungal Cream recalled for manufacturing practice deviations

    CURA HONGOS Antifungal Cream (Clotrimazole 1%) is being recalled due to Current Good Manufacturing Practice deviations. The recall affects 10,788 tubes distributed in Delaware and North Carolina.

    Product
    CURA HONGOS, Antifungal Cream, Clotrimazole 1%, Net Wt/ Peso Neto 2 oz (56.7g) Tube, Distributed by: Pharmadel LLC, New Castle, DE 19720, Made in India, UPC 8 997110 011052.
    Category
    Drug
    Distribution
    2 states
  • ModerateFDA (Drugs)·D-0426-2025·2025-05-28

    KOFAL Topical Pain Relief Ointment Recalled for Manufacturing Practice Deviations

    KOFAL, an external analgesic ointment containing methyl salicylate, is being recalled from Delaware and North Carolina markets due to manufacturing practice deviations. The voluntary recall affects approximately 11,808 jars.

    Product
    KOFAL — KOFAL (METHYL SALICYLATE)
    Category
    Drug
    Distribution
    2 states
  • ModerateFDA (Drugs)·D-0439-2025·2025-05-28

    FDA Recalls Nature Mint Fluoride Toothpaste Due to Manufacturing Deviations

    Nature Mint Anticavity Fluoride Toothpaste is being recalled by the FDA for manufacturing quality violations (CGMP deviations). The voluntary recall affects 150,768 tubes distributed in Delaware and North Carolina.

    Product
    Nature Mint Anticavity Fluoride Toothpaste, Sodium monofluorophosphate 0.76%, NET WT 1.5 OZ (43 grams) Tube, Made in India, Dist. by Bob Barker Co. Inc., Fuquay-Varina, NC 27526, NDC 53247-131-04
    Category
    Drug
    Distribution
    2 states
  • ModerateFDA (Drugs)·D-0422-2025·2025-05-28

    Drug Recall: CURA HONGOS Antifungal Lotion Due to Manufacturing Deviations

    CURA HONGOS antifungal lotion is being recalled due to manufacturing process deviations. The recall affects 10,128 bottles distributed in Delaware and North Carolina.

    Product
    CURA HONGOS, Antifungal, 1% Clotrimazole, Topical Lotion, 0.76 fl oz (22.5 mL) Bottle, Dist by/por: Pharmadel LLC, New Castle, DE 19720, Made in India, NDC 55758-34-01, UPC 8 10096 77170 4.
    Category
    Drug
    Distribution
    2 states
  • ModerateFDA (Drugs)·D-0434-2025·2025-05-28

    Maximum Security Toothpaste Recalled for Manufacturing Practice Violations

    Maximum Security Anticavity Gel Toothpaste made by KENIL HEALTHCARE is recalled from DE and NC due to CGMP deviations. This voluntary Class II recall was terminated in February 2026.

    Product
    Maximum Security, Anticavity Gel Toothpaste, Sodium Fluoride 0.22%, Fresh Mint Flavor, NET WT 1.5 OZ (43 g) Tube, Made in India, Dist. by Bob Barker Co. Inc., Fuquay-Varina, NC 27526, NDC 53247-132-04
    Category
    Drug
    Distribution
    2 states
  • ModerateFDA (Drugs)·D-0432-2025·2025-05-28

    Toothpaste product recalled for Current Good Manufacturing Practice deviations

    Maximum Security Anticavity Gel Toothpaste is being recalled due to Current Good Manufacturing Practice (CGMP) deviations. The recall affects tubes distributed to Delaware and North Carolina.

    Product
    Maximum Security, Anticavity Gel Toothpaste, Sodium Fluoride 0.22%, Fresh Mint Flavor, NET WT 0.85 oz (24 g) Tube, Made in India, Dist. by Bob Barker Co. Inc. Fuquay-Varnia, NC 27526, NDC 53247-132-03
    Category
    Drug
    Distribution
    2 states
  • ModerateFDA (Drugs)·D-0446-2025·2025-05-28

    Phentermine Hydrochloride Capsules Recalled Due to Manufacturing Quality Deviations

    KVK Tech, Inc. is recalling Phentermine Hydrochloride Capsules 30mg due to manufacturing quality deviations. The recall affects approximately 9,680 bottles distributed nationwide.

    Product
    PHENTERMINE HYDROCHLORIDE — PHENTERMINE HYDROCHLORIDE (PHENTERMINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0427-2025·2025-05-28

    Optim V anti-itch cream recalled for manufacturing deviations

    Optim V anti-itch cream is recalled for manufacturing defects. The FDA Class II recall affects tubes distributed in Delaware and North Carolina.

    Product
    Optim V, Anti-Itch Cream, Benzocaine 20% & Resorcinol 3% - External analgesic, Net Wt. Peso Neto 1 oz (28g) Tube, Distributed by: Pharmadel LLC, New Castle, DE 19720, Made in India, NDC 55758-300-01, UPC 8 59424 00420 6.
    Category
    Drug
    Distribution
    2 states