The Recall Desk

Severity 2 of 5

Moderate recalls

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

What “moderate” means here

Severity 2 (Moderate) recalls cover minor labeling errors, low-risk contamination, and voluntary precautionary recalls. The agency's own classification is typically FDA Class III, or the issue is something like incomplete instructions or a small UPC mismatch where the product itself is safe but doesn't meet documentation requirements. Use the same brand-name product safely; follow the manufacturer's instructions for return or exchange if you want a refund.

The full rubric is on the methodology page. Severity is computed deterministically from the agency’s own classification plus the source text — no editorial vibes.

1676–1700 of 3531

  • ModerateFDA (Food)·F-0388-2023·2023-03-08

    Hot chocolate and cappuccino products recalled for undeclared peanut allergen

    Corim Industries is recalling Agglomerated Peanut Butter Hot Chocolate and Peanut Butter Cappuccino products in multiple formats due to undeclared peanut allergen on the label.

    Product
    Smart Sips, 24 ct single serve coffee pods (12.7 oz carton)
    Category
    Food
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-0385-2023·2023-03-08

    FDA Recalls Dofetilide Antiarrhythmic Drug for Manufacturing Deviations

    Accord Healthcare is recalling Dofetilide antiarrhythmic capsules due to manufacturing compliance deviations identified during FDA inspection. The recall affects approximately 113,003 bottles distributed in the U.S., Puerto Rico, and Canada.

    Product
    DOFETILIDE — DOFETILIDE (DOFETILIDE)
    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-0352-2023·2023-03-08

    Microcrystalline Cellulose Pharmaceutical Excipient Recalled for Specification Failure

    DuPont Nutrition USA is recalling BD-102 NF Microcrystalline Cellulose, a pharmaceutical excipient, due to failed conductivity specifications. Affected batches were distributed nationwide and internationally for use in drug manufacturing.

    Product
    BD-102 NF, Microcrystalline Cellulose, NF, Ph. Eur., Jp., Net Content/Gross Weight 20.0 KG / 21.1 KG bulk container, Manufactured by: DuPont Nutrition USA, Inc., 1301 Ogletown Road, Newark, DE 19711, USA. Headquarters: DuPont Nutrition Biosciences ApS, Langebrogade 1, Copenhagen,
    Category
    Drug
    Distribution
    Distributed nationwide
  • 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-0418-2023·2023-03-08

    Vigabatrin Oral Solution Recalled for Manufacturing Quality Deviations

    Accord Healthcare is recalling 821 cartons of Vigabatrin for Oral Solution due to manufacturing quality deviations found during an FDA inspection. The product was distributed in the United States, Puerto Rico, and Canada.

    Product
    Vigabatrin for Oral Solution, USP, 500 mg, Rx Only, 50-packets/carton, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA. Packet NDC 16729-521-63, UPC 3 16729 52163 5; Carton NDC 16729-52
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0430-2023·2023-03-08

    Ropinirole Tablets Recalled Due to Manufacturing Practice Deviations

    Accord Healthcare is recalling 8,184 bottles of Ropinirole 4 mg tablets due to manufacturing practice deviations found during an FDA inspection. The recalled batches were distributed in the United States, Puerto Rico, and Canada.

    Product
    ROPINIROLE — ROPINIROLE (ROPINIROLE)
    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-0363-2023·2023-03-08

    Fentanyl Injection Syringes Recalled for Subpotent Active Ingredient

    SCA Pharmaceuticals is recalling 2,125 fentanyl injection syringes nationwide due to subpotency—the product contains less active ingredient than labeled. The firm voluntarily initiated this Class III recall in February 2023.

    Product
    Fentanyl 1,500 mcg/30 mL syringe, Injection for Intravenous Use, Concentration = 50 mcg/mL, Preservative Free, Rx Only, Single Dose Container, SCA Pharmaceuticals, Windsor CT 06095, NDC# 70004-0200-16.
    Category
    Drug
    Distribution
    Distributed nationwide
  • 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
    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-0398-2023·2023-03-08

    Glycopyrrolate injection recalled due to manufacturing practice deviations

    Accord Healthcare recalls Glycopyrrolate injection due to manufacturing practice deviations found during FDA inspection. The recall affects 3,164 vials distributed in the US, Puerto Rico, and Canada.

    Product
    GLYCOPYRROLATE — GLYCOPYRROLATE (GLYCOPYRROLATE)
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0390-2023·2023-03-08

    Finasteride tablets recalled for manufacturing practice deviations

    Accord Healthcare recalls 325,356 bottles of Finasteride 1 mg tablets due to manufacturing practice deviations identified during an FDA inspection. Affected batches were distributed in the United States, Puerto Rico, and Canada.

    Product
    FINASTERIDE — FINASTERIDE (FINASTERIDE)
    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-0420-2023·2023-03-08

    Pirfenidone Tablets Recalled Due to Manufacturing Compliance Deviations

    Accord Healthcare is recalling Pirfenidone 801 mg tablets due to Current Good Manufacturing Practice deviations identified during an FDA inspection. Affected batches P2202519 and P2202513 were distributed in the United States, Puerto Rico, and Canada.

    Product
    PIRFENIDONE — PIRFENIDONE (PIRFENIDONE)
    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-0353-2023·2023-03-08

    Prescription Levothyroxine Sodium Tablets Recalled Due to Sub-Potency

    Alvogen is recalling 21,276 bottles of Levothyroxine Sodium Tablets (Lot HE02221, expiration 05/2023) distributed nationwide and in Puerto Rico due to sub-potency.

    Product
    LEVOTHYROXINE SODIUM — LEVOTHYROXINE SODIUM (LEVOTHYROXINE SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • 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-0414-2023·2023-03-08

    Tadalafil tablets recalled due to manufacturing process deviations

    Accord Healthcare is recalling Tadalafil 2.5 mg tablets following discovery of manufacturing deviations during an FDA inspection. Approximately 36,773 bottles were distributed in the United States, Puerto Rico, and Canada.

    Product
    TADALAFIL — TADALAFIL (TADALAFIL)
    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-0382-2023·2023-03-08

    Daptomycin Injectable Recalled Due to Manufacturing Deviations

    Accord Healthcare is recalling Daptomycin for Injection due to manufacturing practice deviations discovered during FDA inspection. No illnesses or injuries have been reported.

    Product
    DAPTOMYCIN — DAPTOMYCIN (DAPTOMYCIN)
    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-0350-2023·2023-03-08

    DuPont Avicel PH-102 Microcrystalline Cellulose Recalled for Conductivity Specification Failure

    DuPont Nutrition USA is recalling Avicel PH-102 NF microcrystalline cellulose excipient due to failed conductivity specifications indicating potential impurities. The product was distributed nationwide and internationally.

    Product
    Avicel PH- 102 NF, Microcrystalline Cellulose, NF, Ph. Eur., Jp, Net Content/Gross Weight 20.0 KG / 21.1 KG bulk container, Manufactured by: DuPont Nutrition USA, Inc., 1301 Ogletown Road, Newark, DE 19711, USA. Headquarters: DuPont Nutrition Biosciences ApS, Langebrogade 1, Cope
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateCPSC·23732·2023-03-02

    DR Power PRO XL501 Chipper Shredders Recalled for Laceration Hazard

    DR Power is recalling about 2,100 PRO XL501 Chipper Shredders because the fin scroll can fail and eject metal pieces from the hopper during operation. No injuries have been reported, but the company has received six reports of metal ejection.

    Product
    DR®Power PRO XL501 Chipper Shredders
    Category
    Consumer Product
    Distribution
    Distributed nationwide