The Recall Desk

Hazard

Cgmp Violation recalls

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

What the numbers show

Total
108
Critical
0
Severe
3
Most recent
2026-07-08

Of the 108 cgmp violation recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 3 (3%) 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 violation 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.

26–50 of 108

  • HighFDA (Drugs)·D-0775-2023·2023-06-07

    Cough Relief Medication Recalled for Non-Food Grade Lubricant Manufacturing Defect

    Denison Pharmaceuticals is recalling Safe tussin PM nighttime cough relief due to use of non-food grade lubricant during manufacturing. Consumers should stop use and consult a pharmacist.

    Product
    Safe tussin PM, NIGHT TIME Cough Relief, (Dextromethorphan HBr, USP 7.5mg, Doxylamine Succinate 3.125mg), 4.0 FL OZ (118mL) bottle, Kramer Laboratories , Inc. Bridgewater, NJ 08807.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0795-2023·2023-06-07

    Clobetasol Propionate Ointment recalled due to manufacturing compliance failures

    Akorn, Inc. is recalling all lots of Clobetasol Propionate Ointment 0.05% due to manufacturing practice violations and inability to complete required stability studies. Product was distributed nationwide in the USA and Puerto Rico.

    Product
    Clobetasol Propionate Ointment, USP, 0.05%, 15 g tubes, Rx Only, Distributed by: Akorn Operating Company, LLC., Gurnee, IL 60031. ALL NDCs
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0846-2023·2023-06-07

    Akorn Recalls All Lots of Sodium DIURIL Injectable Due to CGMP Deviations

    Akorn Operating Company recalls all lots of Sodium DIURIL (chlorothiazide sodium) 0.5g/vial due to Current Good Manufacturing Practice deviations. The manufacturer was unable to complete required stability studies after the firm ceased operations.

    Product
    Sodium DIURIL (chlorothiazide sodium), 0.5g/vial, Single-dose vial Rx only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0784-2023·2023-06-07

    FDA Recalls Apraclonidine Ophthalmic Solution Due to Manufacturing Compliance Failures

    Akorn Inc. is recalling all lots of Apraclonidine Ophthalmic Solution 0.5% due to manufacturing compliance deviations. The firm went out of business and could not complete required stability studies.

    Product
    Apraclonidine Ophthalmic Solution 0.5%, packaged in a) 5mL and b) 10 mL bottles, Rx only, Sterile, For Topical Ophthalmic Use Only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0851-2023·2023-06-07

    Tobramycin Ophthalmic Solution Recalled Due to Incomplete Stability Studies

    Akorn, Inc. is recalling all lots of Tobramycin Ophthalmic Solution 0.3% because the manufacturer went out of business and could not complete required stability studies, a violation of manufacturing regulations.

    Product
    Tobramycin Ophthalmic Solution, USP 0.3%, 5mL bottles, Rx only, Manufactured by: Akorn , Inc, Lake Forest, IL 60045. ALL NDCs
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0823-2023·2023-06-07

    Lidocaine HCl Jelly 2% recalled nationwide for manufacturing compliance deviations

    Akorn, Inc. is recalling all lots of Lidocaine HCl Jelly USP 2% in 5mL tubes nationwide due to manufacturing quality control violations. The company ceased operations and could not complete required stability testing.

    Product
    Lidocaine HCl Jelly USP, 2%, 5mL tubes, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0863-2023·2023-06-07

    Ropivacaine Hydrochloride Injection recalled; manufacturer unable to complete stability studies

    Akorn, Inc. recalls all lots of Ropivacaine Hydrochloride Injection nationwide because the manufacturer went out of business and cannot complete required stability studies.

    Product
    Ropivacaine Hydrochloride Injection USP, 0.2%, 200mg/100 mL (2 mg/mL), 100 mL Vial, Rx Only, Manufactured by: Akorn Inc., Lake Forest, IL 60045. ALL NDCs
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0816-2023·2023-06-07

    Levetiracetam Oral Solution Recalled Nationwide for Incomplete Stability Testing

    Akorn, Inc. is recalling Levetiracetam Oral Solution nationwide after closing and failing to complete required FDA stability studies. The Class II recall affects all lots distributed in the United States and Puerto Rico.

    Product
    Levetiracetam Oral Solution 100 mg/mL (100 mg/mL), 473 mL, Rx Only, Distributed by: Akorn, Inc., Gurnee, IL 60031. ALL NDCs
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0790-2023·2023-06-07

    FDA Recalls Calcitriol Injection Due to Manufacturing Practice Violations

    FDA is recalling all lots of Calcitriol Injection 1 mcg/mL due to current good manufacturing practice (CGMP) violations. The manufacturer went out of business and could not complete required stability studies.

    Product
    Calcitriol Injection 1 mcg/mL, 1 mL ampules Rx Only, Distributed by: Akorn Operating Company, LLC., Gurnee, IL 60031. ALL NDCs
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0801-2023·2023-06-07

    Docusate Liquid Drug Recalled Over Incomplete Stability Testing

    Akorn, Inc. is recalling all lots of DOCU LIQUID (docusate sodium) after the company ceased operations and could not complete mandatory stability testing required for FDA compliance.

    Product
    DOCU LIQUID (docusate sodium, 50 mg/5 mL), packaged in 473mL bottles and b)10mL Unit Dose cups, Distributed by: Akorn Operating Company, LLC., Gurnee, IL 60031. ALL NDCs
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0526-2023·2023-04-12

    Prescription Tadalafil tablets recalled for manufacturing process deviations

    Preferred Pharmaceuticals is recalling 32 bottles of Tadalafil 20 mg tablets due to manufacturing process deviations identified during FDA inspection. The recalled lots expire January 31, 2024.

    Product
    TADALAFIL — TADALAFIL (TADALAFIL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0423-2023·2023-03-08

    FDA Recalls Pravastatin Sodium Tablets Due to Manufacturing Deviations

    Accord Healthcare is recalling Pravastatin Sodium Tablets USP 40 mg due to manufacturing compliance deviations identified during an FDA inspection. The recall affects 120 bottles distributed in the United States, Puerto Rico, and Canada.

    Product
    PRAVASTATIN SODIUM — PRAVASTATIN SODIUM (PRAVASTATIN SODIUM)
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0431-2023·2023-03-08

    Ropinirole Tablets Recalled Due to Manufacturing Quality Violations

    Accord Healthcare is recalling Ropinirole 5mg tablets due to Current Good Manufacturing Practice (CGMP) deviations identified during an FDA inspection. The recall affects 5,112 bottles distributed in the United States, Puerto Rico, and Canada.

    Product
    ROPINIROLE — ROPINIROLE (ROPINIROLE)
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0381-2023·2023-03-08

    Daptomycin injection recalled due to manufacturing compliance deviations

    Accord Healthcare recalls Daptomycin for Injection in the US, Puerto Rico, and Canada affecting 65,233 vials due to Current Good Manufacturing Practice (CGMP) deviations found during FDA inspection.

    Product
    DAPTOMYCIN — DAPTOMYCIN (DAPTOMYCIN)
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0256-2023·2023-02-08

    Easy Clean Isopropyl Alcohol Recalled for Manufacturing Deviations

    Frenda Corporation is voluntarily recalling Easy Clean Isopropyl Alcohol 99%, 1-gallon bottles (164 units) due to current Good Manufacturing Practice deviations. The product was distributed in Puerto Rico, lot C030121.

    Product
    Easy Clean Isopropyl Alcohol 99%, 1 Gallon (128 fl. oz.), Manufactured by: Frenda Corporation Trujillo Alto, PR 00976, UPC 8 91857 00054 7
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0164-2023·2023-01-25

    Hand Sanitizer Recalled Due to Manufacturing Practice Deviations

    Fisher Scientific voluntarily recalls hand sanitizer due to manufacturing deviations. The recall affects products distributed after March 31, 2022.

    Product
    Hand Sanitizer, HSANI4LI, (Isopropyl Alcohol), 75% Topical Solution, packaged in 4 L bottles, Thermo Fisher Scientific: Janssen Pharmaceuticalaan 3a, 2440 Geel - Belgium, 1 Reagent Lane, Fair Lawn, NJ 07410.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1398-2022·2022-08-31

    AZO YEAST PLUS 20 CT Recalled Due to Improper Storage Conditions

    AZO YEAST PLUS 20 CT has been recalled by Family Dollar Stores due to improper storage temperature conditions that violate CGMP requirements. The product was distributed nationwide from April through June 2022.

    Product
    AZO YEAST PLUS 20 CT distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1455-2022·2022-08-31

    QP Sudfedrine PE Max Strength tablets recalled for improper storage

    Family Dollar Stores is recalling QP Sudfedrine PE Max Strength tablets nationwide due to storage temperature deviations that may have compromised product quality.

    Product
    QP SUDFEDRINE PE MAX STRENGTH TBLT 24 CT distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1375-2022·2022-08-31

    Antifungal spray and powder recalled for improper storage temperature conditions

    Family Dollar Stores recalled two antifungal products due to storage temperature deviations. The products may have been compromised in effectiveness due to failure to maintain proper storage conditions.

    Product
    DR SCHOLLS ANTI FUNGAL SPRAY PWDER 4.7 OZ SKU 998250 PREMIER ANTFGL TLNFTT LQ SPRY 5.3 FL OZ SKU 911077 distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1394-2022·2022-08-31

    Medicated chest rubs recalled for improper storage temperature conditions

    Vicks VapoRub and Swan Medicated Chest Rub products from Family Dollar Stores are being recalled due to improper storage temperature conditions during their distribution.

    Product
    VICKS VAPORUB 1.76 OZ SKU 919667 VICKS VAPOR RUB LAVENDER 1.76 OZ 999813 SWAN MEDICATED CHEST RUB 3.53 OZ SKU 920611 distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1366-2022·2022-08-31

    Personal Care Lotions Recalled Due to Improper Storage Temperature

    Family Dollar Stores is recalling multiple lotion products that were held outside appropriate storage temperatures. The affected brands include Dermasil, Aveeno, and Vaseline products distributed from April 30 through June 10, 2022.

    Product
    Dermasil Dry Skin Treatment 10 OZ SKU 2098068 Aveeno Daily Moisturizing Lotion 5 OZ SKU 2005444 Aveeno Baby Daily Moistue Lotion 8 OZ SKU 900016 Vaseline Mens Extra Strength Body and Face Lotion 10 OZ SKU 2003674 distributed to specific Family Dollar Stores 04/30/2022 thro
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1440-2022·2022-08-31

    NPX Enema 4.5 FL OZ Two-Pack Recalled for Improper Storage

    Family Dollar Stores is recalling NPX Enema 4.5 FL OZ 2-packs due to improper storage conditions that violate manufacturing standards. The product was held outside appropriate temperature conditions at select Family Dollar stores between April 30 and June 10, 2022.

    Product
    NPX ENEMA 4.5 FL OZ 2 PK distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1397-2022·2022-08-31

    FDA Recalls MICON Antifungal Drugs for Improper Storage Conditions

    Family Dollar Stores is recalling READY IN CASE MICON 7 DAY and 3 DAY COMBO PACK products distributed April 30 through June 10, 2022, because they were stored outside appropriate temperature conditions. Consumers should stop using these products and return them to Family Dollar.

    Product
    READY IN CASE MICON 7 DAY 1.59 OZ SKU 939212 READY IN CASE MICON 3 DAY COMBO PACK SKU 902373 distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1447-2022·2022-08-31

    Johnson's Baby First Touch Gift Set Recalled for Storage Temperature Deviations

    Johnson's Baby First Touch Gift Set 4PC is being recalled due to CGMP deviations related to improper storage temperature. The recalled products were distributed nationwide to Family Dollar Store locations between April 30, 2022 and June 10, 2022.

    Product
    JOHNSONS BABY FIRST TOUCH GIFT SET 4PC distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1371-2022·2022-08-31

    Liquid Hand Soaps and Cleaning Products Recalled for Storage Temperature Deviations

    Family Dollar is recalling multiple liquid hand soaps and cleaning products that were stored at improper temperatures during distribution.

    Product
    SOFTSOAP ANTI BACTRIAL LQ SOAP 11.25 FLOZ SKU 2005090 DIAL LHS WHITE TEA AND VITAMIN E 7.5FLOZ SKU 2007700 SOFTSOAP LHS CC ANTIBAC ORANGE 50 FL OZ SKU 2007708 SPA SOAP ANTIBAC GLD LHS PUMP 20.2 FL OZ SKU 2097440 DIAL FOAMING LHS POWER BERRIES 7.5 FL OZ SKU 2044098 SOFTS
    Category
    Drug
    Distribution
    Distributed nationwide