The Recall Desk

Hazard

Manufacturing Deviation recalls

314 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 manufacturing 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.

176–200 of 314

  • ModerateFDA (Drugs)·D-0371-2023·2023-03-08

    Prescription Drug Recall: Atorvastatin Calcium Tablets for Manufacturing Deviations

    Accord Healthcare is recalling Atorvastatin Calcium 10 mg tablets distributed in the United States, Puerto Rico, and Canada following FDA inspection findings of manufacturing deviations.

    Product
    ATORVASTATIN CALCIUM — ATORVASTATIN CALCIUM (ATORVASTATIN CALCIUM)
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0409-2023·2023-03-08

    Simvastatin tablets recalled due to manufacturing process deviations

    Accord Healthcare is recalling Simvastatin 10 mg tablets distributed in the U.S., Puerto Rico, and Canada due to manufacturing process deviations discovered during FDA inspection. Patients should contact their pharmacy or healthcare provider.

    Product
    SIMVASTATIN — SIMVASTATIN (SIMVASTATIN)
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0386-2023·2023-03-08

    Prescription Doxazosin Tablets Recalled Due to Manufacturing Practice Deviations

    Accord Healthcare is recalling 44,068 bottles of Doxazosin 1 mg tablets distributed in the US, Puerto Rico, and Canada due to Current Good Manufacturing Practice deviations found during an FDA inspection.

    Product
    DOXAZOSIN — DOXAZOSIN (DOXAZOSIN)
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0428-2023·2023-03-08

    Ropinirole Tablets Recalled by Accord Healthcare Following FDA Inspection

    Accord Healthcare is recalling 25,344 bottles of Ropinirole 2 mg tablets due to manufacturing deviations discovered during an FDA inspection. The recall affects medications distributed in the United States, Puerto Rico, and Canada.

    Product
    ROPINIROLE — ROPINIROLE (ROPINIROLE)
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0387-2023·2023-03-08

    Prescription Doxazosin Tablets Recalled for Manufacturing Deviations

    Accord Healthcare is recalling Doxazosin 2 mg tablets distributed across the United States, Puerto Rico, and Canada due to manufacturing practice deviations identified during an FDA inspection.

    Product
    DOXAZOSIN — DOXAZOSIN (DOXAZOSIN)
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0404-2023·2023-03-08

    Rosuvastatin Tablets 5mg Recalled Due to Manufacturing Practice Deviations

    Accord Healthcare is recalling Rosuvastatin tablets 5mg due to manufacturing practice deviations found during an FDA inspection. The recall involves 63,247 bottles distributed across the U.S., Puerto Rico, and Canada.

    Product
    ROSUVASTATIN — ROSUVASTATIN (ROSUVASTATIN)
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0401-2023·2023-03-08

    Accord Healthcare recalls phenylephrine injection vials due to manufacturing deviations

    Accord Healthcare is recalling Phenylephrine Hydrochloride Injection vials due to manufacturing deviations found during FDA inspection. No illnesses or injuries have been reported.

    Product
    Phenylephrine Hydrochloride Injection, USP 10 mg/mL Rx Only, 1 mL Single Dose Vial, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA; Vial NDC 16729-464-63, UPC 3 16729 46463 5; Carton ND
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0389-2023·2023-03-08

    Accord Healthcare Doxazosin Tablets Recalled for Manufacturing Deviations

    Accord Healthcare recalls 31,116 bottles of Doxazosin Tablets USP 8 mg due to manufacturing practice deviations identified during FDA inspection. Distribution covered the US, Puerto Rico, and Canada.

    Product
    DOXAZOSIN — DOXAZOSIN (DOXAZOSIN)
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0370-2023·2023-03-08

    Prescription drug aripiprazole tablets recalled for manufacturing practice deviations

    Accord Healthcare is recalling aripiprazole tablets (30 mg) due to manufacturing practice deviations found during an FDA inspection. The recall covers 88,728 bottles distributed to the United States, Puerto Rico, and Canada.

    Product
    ARIPIPRAZOLE — ARIPIPRAZOLE (ARIPIPRAZOLE)
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0376-2023·2023-03-08

    Accord Healthcare Recalls Buspirone Hydrochloride Due to Manufacturing Deviations

    Accord Healthcare is recalling 24,408 bottles of Buspirone Hydrochloride tablets due to Current Good Manufacturing Practice deviations discovered during an FDA inspection.

    Product
    BUSPIRONE HYDROCHLORIDE — BUSPIRONE HYDROCHLORIDE (BUSPIRONE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0383-2023·2023-03-08

    Prescription Drug Dofetilide Recalled Due to Manufacturing Compliance Deviations

    Accord Healthcare is recalling Dofetilide antiarrhythmic capsules due to manufacturing deviations found during an FDA inspection. The recall involves 37,790 bottles distributed across the United States, Puerto Rico, and Canada.

    Product
    DOFETILIDE — DOFETILIDE (DOFETILIDE)
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0392-2023·2023-03-08

    Finasteride 5 mg Tablets Recalled Due to Manufacturing Process Deviations

    Accord Healthcare is recalling Finasteride 5 mg tablets due to manufacturing process deviations discovered during FDA inspection. Over 2.7 million bottles distributed in the US, Puerto Rico, and Canada are affected.

    Product
    FINASTERIDE — FINASTERIDE (FINASTERIDE)
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0395-2023·2023-03-08

    Accord Healthcare Recalls Glimepiride Tablets Due to CGMP Deviations

    Accord Healthcare is recalling Glimepiride 4 mg tablets due to Current Good Manufacturing Practice deviations discovered during an FDA inspection. Approximately 1.16 million bottles across the United States, Puerto Rico, and Canada are affected.

    Product
    GLIMEPIRIDE — GLIMEPIRIDE (GLIMEPIRIDE)
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0326-2023·2023-02-22

    FDA Recalls Humatrix Microclysmic Gel for Manufacturing Practice Violations

    Consolidated Chemical, Inc. is recalling 3186 bottles of Humatrix Microclysmic Gel nationwide due to deviations from proper manufacturing practices.

    Product
    Humatrix Microclysmic Gel, 8 oz per bottle, Care-Tech Laboratories, Inc., Saint Louis, Missouri 63139.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0259-2023·2023-02-08

    Hand Sanitizer Recalled Due to Manufacturing Practice Deviations

    Frenda Corporation has recalled Global Care Antibacterial Hand Sanitizer due to manufacturing practice deviations. The recall affects 124 bottles with lot number C013121 distributed in Puerto Rico.

    Product
    Global Care Antibacterial Hand Sanitizer Alcohol Etilico 70% Original, 1 Gallon (128 FL OZ) 3785.41 mL, Dist. by Target Price, Inc. Catano, PR, UPC 8 70373 01326 2
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0258-2023·2023-02-08

    Easy Clean Ethyl Alcohol Bottles Recalled Due to Manufacturing Deviations

    Frenda Corporation voluntarily recalled 44,140 bottles of Easy Clean 75% Ethyl Alcohol sold in Puerto Rico due to manufacturing practice deviations.

    Product
    Easy Clean 75% Ethyl Alcohol, packaged in a) 1 Gallon (128 fl. oz.) UPC 8 91857 00045 5; b) 16 fl. oz. (473 mL) UPC 8 91857 00055 4; c) Rubbing Alcohol 10 fl. oz. (296 mL) UPC 8 91857 00044 8, Manufactured by Frenda Corporation Trujillo Alto, PR 00976
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0255-2023·2023-02-08

    FDA Recalls Easy Clean Alcohol Surface Disinfectant Due to Manufacturing Deviations

    Frenda Corporation recalls Easy Clean Alcohol Surface Disinfectant Cleaner due to cGMP deviations. The recall affects 8,475 bottles distributed in Puerto Rico.

    Product
    Easy Clean Alcohol Mult Surface Disinfecting Cleaner 75% Ethyl Alcohol, 32 FL. OZ. (946 mL.), Manufactured by: Frenda Corporation Trujilio Alto, PR 00976, UPC 8 91857 00052 3
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0260-2023·2023-02-08

    Global Care 70% rubbing alcohol products recalled for cGMP manufacturing violations

    Global Care 70% Alcohol Ethyl Rubbing Alcohol, distributed in Puerto Rico, has been voluntarily recalled by Frenda Corporation due to manufacturing compliance deviations. The recall affects 12,130 bottles in multiple package sizes.

    Product
    Global Care 70% Alcohol Ethyl Rubbing Alcohol, packaged in a) 32 FL OZ (946 mL) UPC 8 70373 01323 1; b) 16 FL OZ (473 mL) UPC 8 70373 01332 3; c) 1 Gallon (128 FL OZ) 3785.41 mL UPC 8 70373 01330 4, Dist. By Target Price, Inc. Catano, PR
    Category
    Drug
    Distribution
    0 states
  • HighFDA (Drugs)·D-0177-2023·2023-02-01

    Sodium Chloride Injection Recalled for Manufacturing Control Deviations

    Nephron Pharmaceuticals is recalling 378 bags of 0.9% Sodium Chloride Injection nationwide due to manufacturing deviations that could create product carryover.

    Product
    SODIUM CHLORIDE — SODIUM CHLORIDE (SODIUM CHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0156-2023·2023-01-25

    Eye-drop drug recall: Timolol solution due to manufacturing deviations

    Akorn is recalling over 1.3 million bottles of Timolol Maleate eye drops distributed nationwide due to manufacturing process violations. The voluntary recall addresses risks from Current Good Manufacturing Practice deviations.

    Product
    Timolol Maleate Ophthalmic Solution, USP, 0.5%, Packaged in (a) 5 mL dropper bottle, NDC 17478-288-10; (b) 10 mL dropper bottles: NDC 17478-288-11; (c) 15 mL dropper bottles, NDC 17478-288-12; Rx Only, Sterile, Manufactured by: Akorn, Inc., Lake Forest, IL 60045.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0158-2023·2023-01-25

    FDA Recalls Tobramycin Ophthalmic Solution for Manufacturing Compliance Issues

    Akorn, Inc. is recalling 91,692 bottles of Tobramycin Ophthalmic Solution (0.3%) nationwide due to Current Good Manufacturing Practice deviations. The voluntary recall was initiated on October 13, 2022.

    Product
    Tobramycin Ophthalmic Solution, USP, 0.3%, 5 mL per bottle, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045; Distributed by: MWI, Boise, ID 83705. NDC 13985-604-05
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0149-2023·2023-01-25

    Olopatadine HCl ophthalmic solution recalled for manufacturing deviations

    Olopatadine HCl Ophthalmic Solution 0.2% manufactured by Akorn, Inc. is being recalled nationwide due to Current Good Manufacturing Practice (CGMP) deviations affecting 173,928 bottles.

    Product
    Olopatadine HCl Ophthalmic Solution, USP 0.2%, 2.5 mL per bottle, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-305-12
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0136-2023·2023-01-25

    Ciprofloxacin ophthalmic solution recalled for manufacturing practice deviations

    Akorn, Inc. is recalling 1,584 bottles of Ciprofloxacin Ophthalmic Solution nationwide due to Current Good Manufacturing Practice (CGMP) deviations. This is a voluntary recall.

    Product
    Ciprofloxacin Ophthalmic Solution, USP 0.3% (Ciprofloxacin HCl), 2.5mL per bottle, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-714-25
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0138-2023·2023-01-25

    Drug Recall: Erythromycin Ophthalmic Ointment Due to Manufacturing Deviations

    Akorn, Inc. recalls 1.1 million tubes of Erythromycin Ophthalmic Ointment nationwide due to manufacturing deviations. The voluntary, Class II recall was initiated by the firm.

    Product
    ERYTHROMYCIN OPHTHALMIC OINTMENT USP 0.5%, Net Weight: 3.5g (1/8 oz) per tube, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-070-35
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0083-2023·2022-12-21

    Drug Recall: ProSirona Homeopathic Calendula Oil Manufacturing Deviations

    ProSirona Homeopathic Calendula Oil (Lot B-02) is being recalled because the manufacturer failed to follow Current Good Manufacturing Practice standards. The voluntary recall affects products distributed nationwide and in Australia.

    Product
    ProSirona, A Homeopathic Formula, Calendula Oil packaged in 1/8 Fl. oz. (3.5 g) bottles, Dist. by: Endometriosis Assoc. Inc. (International), Mfg. by Claire Ellen Topicals, P.O. Box 901 Westborough, MA 01581, USA, NDC# 66233-712-01.
    Category
    Drug
    Distribution
    Distributed nationwide