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.

Which agencies issued them

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.

451–475 of 1552

  • ModerateFDA (Drugs)·D-0325-2023·2023-02-22

    FDA recalls Techni-Care Chloroxylenol antiseptic due to manufacturing deviations

    Consolidated Chemical is recalling Techni-Care Chloroxylenol 3% in 4 oz and 8 oz bottles nationwide due to manufacturing practice violations. No illnesses have been reported.

    Product
    Techni-Care Chloroxylenold 3%, [4 fl oz /118 mL or 8 fl oz/236 mL] per bottle, Care-Tech Laboratories, Inc., Saint Louis, Missouri 63139. NDC 4 oz bottle: 46706-222-01; NDC 8 oz: 46706-222-02
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0153-2023·2023-01-25

    Proparacaine Ophthalmic Solution Recalled for Manufacturing Quality Deviations

    Akorn is voluntarily recalling Proparacaine Ophthalmic Solution nationwide due to Current Good Manufacturing Practice deviations.

    Product
    Proparacaine Hydrochloride Ophthalmic Solution, USP 0.5%, 15 mL per dropper bottle, Rx only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031 NDC: 17478-263-12
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0151-2023·2023-01-25

    Prescription eye drop recall due to manufacturing compliance issues

    Akorn, Inc. is recalling Olopatadine HCl Ophthalmic Solution due to manufacturing process deviations. The nationwide voluntary recall involves 121,176 bottles distributed across the United States.

    Product
    Olopatadine HCl Ophthalmic Solution, USP 0.1%, 5 mL per bottle, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. Marketed by: GSMS, Incorporated, Camarillo, CA 93012. NDC: 60429-957-05
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0146-2023·2023-01-25

    Ofloxacin Ophthalmic Solution Recalled Nationwide for Manufacturing Quality Issues

    Akorn, Inc. is recalling Ofloxacin Ophthalmic Solution 0.3% due to manufacturing quality deviations. The recall affects 65,006 bottles distributed nationwide.

    Product
    Ofloxacin 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: 13985-602-05
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0163-2023·2023-01-25

    Hand Sanitizer Recalled for Manufacturing Practice Deviations

    Fisher Scientific voluntarily recalls HSANI500ML hand sanitizer (75% isopropyl alcohol) due to manufacturing practice deviations. The product was made under expired temporary FDA approval.

    Product
    Hand Sanitizer, HSANI500ML, (Isopropyl Alcohol), 75% v/v, packaged in a) 500 mL bottle and b) 6 x 500 mL bottles per case, Thermo Fisher Scientific: Janssen Pharmaceuticalaan 3a, 2440 Geel - Belgium, 1 Reagent Lane, Fair Lawn, NJ 07410.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0148-2023·2023-01-25

    Ophthalmic solution recalled due to manufacturing quality control deviations

    Akorn, Inc. is recalling 1,752 bottles of Olopatadine HCL Ophthalmic Solution, USP 0.1% nationwide due to manufacturing quality control deviations. Lot 1L03A with expiration 10/31/2023 is affected.

    Product
    Olopatadine HCL Ophthalmic Solution, USP 0.1%, Antihistamine and Redness Reliever, 5 mL (0.17 FL OZ) per bottle, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-308-05
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0152-2023·2023-01-25

    FDA Recalls Akorn PAREMYD Eye Medication for Manufacturing Quality Deviations

    Akorn, Inc. is voluntarily recalling 51,601 bottles of PAREMYD eye medication nationwide due to manufacturing process deviations. The firm initiated the recall in October 2022.

    Product
    PAREMYD (hydroxyamphetamine hydrobromide/ tropicamide ophthalmic solution) 1%/0.25%, 15 mL per dropper bottle, Rx only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-704-12
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0134-2023·2023-01-25

    Akorn Artificial Tears Eye Drops Recalled for Manufacturing Quality Deviations

    Akorn, Inc. is voluntarily recalling 967,075 bottles of Artificial Tears Solution eye drops nationwide due to manufacturing process deviations identified during quality inspections.

    Product
    Artificial Tears Solution, Lubricant Eye Drops, Polyvinyl Alcohol 1.4%, 15 mL (0.5 fl. oz.) per bottle, Sterile, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-060-12
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0140-2023·2023-01-25

    FDA recalls GONAK ophthalmic drug solution for manufacturing deviations

    Akorn voluntarily recalled 196,254 bottles of GONAK ophthalmic solution nationwide due to CGMP manufacturing practice deviations. This professional-use eye solution is employed in gonioscopic examinations.

    Product
    GONAK Hypromellose Ophthalmic Demulcent Solution, (25 mg) 2.5%, 15 mL per dropper bottle, For Professional Use in Goinoscopic Examinations, Mfd. by: Akorn, INc., Lake Forest, IL 60045. NDC: 17478-064-12
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0144-2023·2023-01-25

    Akorn Recalls Moxifloxacin Ophthalmic Solution for CGMP Deviations

    Akorn, Inc. is recalling 2,563 bottles of Moxifloxacin Ophthalmic Solution nationwide due to manufacturing deviations. The recall is voluntary and affects lot 1E28A with expiration date 4/30/2023.

    Product
    Moxifloxacin Ophthalmic Solution, USP, 0.5%, 3 mL per dropper bottle, Rx only, Manufactured by: Akorn, Lake Forest, IL 60045. NDC: 17478-519-19
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0142-2023·2023-01-25

    Akorn recalls Levofloxacin eye drops due to manufacturing compliance issues

    Akorn, Inc. is recalling Levofloxacin Ophthalmic Solution due to manufacturing process deviations. The voluntary recall affects 3,108 bottles distributed nationwide.

    Product
    Levofloxacin Ophthalmic Solution 0.5%, 5 mL per bottle, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, Il 60045. NDC: 17478-106-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0145-2023·2023-01-25

    FDA recalls Akorn ophthalmic ointment for manufacturing process deviations

    Akorn, Inc. is recalling 2,082 tubes of Neomycin and Polymyxin B Sulfates, and Bacitracin Zinc Ophthalmic Ointment nationwide due to manufacturing process deviations. The recall is voluntary and initiated by the manufacturer.

    Product
    Neomycin and Polymyxin B Sulfates, and Bacitracin Zinc Ophthalmic Ointment, USP, Net Wt. 3.5 g (1/8 oz.), Rx Only, Manufactured by: Akorn, INC., Lake Forest, IL 60045. NDC: 17478-235-35
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0155-2023·2023-01-25

    Sodium Chloride Ophthalmic Ointment Recalled for Manufacturing Deviations

    Akorn, Inc. has voluntarily recalled 524,506 tubes of Sodium Chloride Ophthalmic Ointment, USP 5%, nationwide due to Current Good Manufacturing Practice deviations.

    Product
    Sodium Chloride Ophthalmic Ointment, USP, 5%, Net Wt. 3.5 g (1/8 oz.) per tube, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-622-35
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0101-2023·2023-01-18

    Moxifloxacin Ophthalmic Solution Recalled Due to Manufacturing Quality Deviation

    Direct Rx recalled 11 bottles of Moxifloxacin Ophthalmic Solution (0.5%, 3 mL) due to a cGMP deviation and discontinued stability support.

    Product
    Moxifloxacin Ophthalmic Solution, 0.5%, 3 mL, Rx Only, Packaged and Distributed By: Direct Rx, LLC 94 Worldwide Drive, Dawsonville, GA 30534, NDC 72189-0334-05
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-1511-2022·2022-09-21

    OTC Magnesium Citrate Laxative Recalled for Manufacturing Process Deviations

    Magnesium citrate saline laxative products branded as CITROMA and multiple retail equivalents are subject to a Class II recall due to manufacturing process deviations. The voluntary recall affects millions of bottles distributed nationwide and internationally.

    Product
    CITROMA — CITROMA (MAGNESIUM CITRATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1512-2022·2022-09-21

    FDA Recalls Citroma Magnesium Citrate Laxative for Manufacturing Deviations

    Vi-Jon is recalling Citroma magnesium citrate oral laxative due to Current Good Manufacturing Practice (CGMP) deviations. The recall affects units distributed nationwide and internationally.

    Product
    CITROMA — CITROMA (MAGNESIUM CITRATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1487-2022·2022-09-14

    Calcium Carbonate Oral Suspension Recalled Due to Manufacturing Control Deviations

    Plastikon Healthcare recalls 49,280 cups of Calcium Carbonate Oral Suspension (1250 mg/5 mL) distributed nationwide due to manufacturing process control failures during production.

    Product
    CALCIUM CARBONATE ORAL SUSPENSION, 1250 mg/5 mL, 5 mL cup, packaged in 10 cups per tray, 4 trays per carton, For Institutional Use Only, Major Pharmaceuticals, 17177 N Laurel Park Dr. Suite 233, Livonia, MI 48152, NDC 0904-7098-94
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1490-2022·2022-09-14

    Guaifenesin and dextromethorphan liquid medication recalled for manufacturing control issues

    Plastikon Healthcare LLC is recalling guaifenesin and dextromethorphan liquid medication (280,500 cups) distributed nationwide due to manufacturing control deviations in production.

    Product
    GUAIFENESIN AND DEXTROMETHORPHAN 100 mg-10 mg/5 mL, 5 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only, Major Pharmaceuticals, 17177 N Laurel Park Dr. Suite 233, Livonia, MI 48152. NDC 0904-6844-70
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1367-2022·2022-08-31

    Multiple Toothpaste and Dental Care Products Recalled for Improper Storage

    Family Dollar Stores is recalling multiple toothpaste and dental care products that were stored outside appropriate temperature conditions, distributed April 30–June 10, 2022.

    Product
    COLGATE MAX FRESH CLEAN MINT 1.9OZ SKU 900596 COLGATE CAVITY PROTECTION 6OZ 3PK SKU 900734 SENSODYNE REPAIR AND PROTCT WHITNG 3.4 OZ SKU 901003 COLGATE BSPW PASTE BRISK MINT 6 OZ 2PK SKU 901658 COLGATE MAX FRESH COOL MINT 6OZ 2PK SKU 901785 COLGATE BSPW PASTE 6 OZ 3PK SKU 9
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1401-2022·2022-08-31

    Jet Alert Tablets Recalled for Improper Storage Temperature Conditions

    Jet Alert stimulant tablets distributed nationwide from April to June 2022 are being recalled due to improper storage temperature conditions that may affect product safety and efficacy.

    Product
    JET ALERT TABLET 30 CT distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1408-2022·2022-08-31

    Witch hazel product recalled for improper storage temperature conditions

    Witch hazel product distributed to Family Dollar Stores from April through June 2022 was stored at improper temperatures. The FDA issued a Class II recall due to manufacturing and quality control (CGMP) deviations.

    Product
    TN DICKINSON WITCH HAZEL 16 FL OZ distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1391-2022·2022-08-31

    FDA Recalls BC and Goody's Powders Due to Improper Storage Conditions

    Family Dollar Stores is recalling BC Powder and Goody's Powder products due to improper storage temperature conditions. The affected products were distributed nationwide from April 30 through June 10, 2022.

    Product
    BC POWDER 50 CT SKU 901588 BC POWDER 18 CT SKU 913228 GOODYS POWDER 50 CT SKU 901589 distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1387-2022·2022-08-31

    Topical ointment recall due to improper storage temperature conditions

    Family Dollar Stores is recalling AD PREV OINT ORIG 4 OZ due to improper storage conditions that may affect product quality. Products distributed nationwide from April 30 through June 10, 2022 are affected.

    Product
    AD PREV OINT ORIG 4 OZ distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1460-2022·2022-08-31

    Mucinex SE Max Strength recalled for improper storage conditions

    Family Dollar Stores is recalling Mucinex SE Max Strength 7CT distributed from April through June 2022 due to CGMP deviations involving improper storage temperature.

    Product
    MUCINEX SE MAX STRENGTH 7CT distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.
    Category
    Drug
    Distribution
    Distributed nationwide