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.

1201–1225 of 21588

  • ModerateFDA (Devices)·Z-0547-2026·2025-11-26

    Clot activator microtubes recalled over an inadequate quality system

    ASP Global is recalling 27,950 SAFE-T-FILL micro capillary blood collection tubes, 200 microlitres with clot activator, over an inadequate quality system.

    Product
    SAFE-T-FILL Micro Capillary Blood Collection, 200 ¿L; Prepared with Clot Activator; Red Model/Catalog Number: 07 7150 Product Description: The SAFE-T-FILL Capillary Blood Collection System is a collection device used to draw capillary blood from the finger or heelstick.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0163-2026·2025-11-26

    Antiseptic lotion soap recalled over contamination found at the manufacturing facility

    DermaRite Industries is recalling 7,736 tubes of DermaKleen antiseptic lotion soap because it was made at the same facility where other products were found contaminated.

    Product
    DermaKleen, Health Care Antiseptic Lotion Soap with Vitamin E, Chloroxylenol 0.2%, packaged in a) 222 mL (7.5 fl. oz.) per tube (NDC 61924-092-08), b) 800 mL (27 fl. oz.) per bag (NDC 61924-092-27), and c 1000 mL (34 fl. oz.) per bag (NDC 61924-092-34), DermaRite Industries LLC,
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0159-2026·2025-11-26

    Bromocriptine capsules recalled after an out of specification impurity result

    Zydus Pharmaceuticals is recalling 36,624 bottles of Bromocriptine Mesylate Capsules USP 5 mg after an out of specification result for the 2-Bromoergine impurity.

    Product
    BROMOCRIPTINE MESYLATE — BROMOCRIPTINE MESYLATE (BROMOCRIPTINE MESYLATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0561-2026·2025-11-26

    Larger sodium heparin capillary tubes recalled over unvalidated manufacturing processes

    ASP Global is recalling 947,100 SAFE-T-FILL plastic blood gas capillary tubes, 150 microlitres with sodium heparin, over an inadequate quality system.

    Product
    SAFE-T-FILL Plastic Blood Gas Capillary Tubes, 150 ¿L; Prepared with Sodium Heparin Model/Catalog Number: 06 0007 Product Description: A clear, plastic capillary blood collection tube
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0539-2026·2025-11-26

    Clotting time cartridges recalled over dried blood on carton labels

    Medtronic is recalling 3,850 HR-ACT clotting time cartridges after trace amounts of dry blood were observed on the external carton label and instructions in five boxes.

    Product
    Medtronic HR-ACT (High Range Activated Clotting Time Cartridges), REF 402-03
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0177-2026·2025-11-26

    Antiperspirant spray recalled over contamination found elsewhere at the facility

    DermaRite Industries is recalling 37,379 spray bottles of UltraSure Anti-Perspirant & Deodorant because it was made at the same facility where other products were found contaminated.

    Product
    UltraSure Anti-Perspirant & Deodorant, Aluminum Sesquichlorohydrate 15%, 118 mL (4 fl. oz.), DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. NDC 61924-266-04
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0559-2026·2025-11-26

    Untreated blood gas tubes recalled over an inadequate quality system

    ASP Global is recalling 77,500 SAFE-T-FILL plastic blood gas capillary tubes, 150 microlitres untreated, over an inadequate quality system.

    Product
    SAFE-T-FILL Plastic Blood Gas Capillary Tubes, 150 ¿L; Untreated. Model 06 0199 Product Description: A clear, plastic capillary blood collection tube
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0566-2026·2025-11-26

    Capillary mixing fleas recalled over an inadequate quality system

    ASP Global is recalling 50,250 mixing fleas for SAFE-T-FILL blood gas capillaries over an inadequate quality system with unvalidated processes.

    Product
    Mixing Fleas for SAFE-T-FILL Blood Gas Capillaries, Model 07 9503
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0535-2026·2025-11-26

    Shoulder reamers recalled after release without completed performance testing

    Exactech is recalling one Equinoxe Ergo Adjustable Angle rTSA Reamer, 42mm, because it was released before design updates and performance testing were completed.

    Product
    Brand Name: Equinoxe Ergo Product Name: Adjustable Angle rTSA Reamer, 42mm Model/Catalog Number: 321-59-42 Software Version: N/A Product Description: rTSA Reamer, 42mm Component: Not a component
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0178-2026·2025-11-26

    Compounded fentanyl infusion bags recalled over revised quality level interpretation

    Park Avenue Compounding is recalling 189 bags of compounded fentanyl citrate and ropivacaine in sodium chloride for CGMP deviations involving a revised interpretation of AQL results.

    Product
    Fentanyl citrate, 2 mcg / ml / Ropivacaine, 0.2% in NS 150 mL, CII, 150 mL bag, Rx Only, Park Avenue Compounding, 3662 Park Ave, Saint Louis, MO, 63110, NDC 83863-4272-1.
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0157-2026·2025-11-26

    Cyclosporine eye drops recalled as subpotent across many compounded lots

    Imprimis NJOF is recalling 67,091 bottles of compounded Klarity-C Drops (Cyclosporine) 0.1% preservative-free ophthalmic emulsion as a subpotent drug.

    Product
    Klarity-C Drops (Cyclosporine) 0.1%, Preservative-Free Sterile Ophthalmic Emulsion, This is a compounded drug, Office Use Only, 5.5 mL bottle, Rx only, Mfg by: Imprimis NJOF, LLC, 1705 Route 46 West, Ledgewood, NJ 07852, NDC 71384-514-05
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0175-2026·2025-11-26

    Skin repair cream recalled over contamination found at the manufacturing facility

    DermaRite Industries is recalling 57,041 units of Renew Skin Repair Cream because it was made at the same facility where other products and lots were found to be contaminated.

    Product
    Renew Skin Repair Cream, Dimethicone 1.5%, packaged in a) 5g tube (NDC 61924-405-05), b) 4 oz tube (NDC 61924-405-04), and c) 800 mL (NDC 61924-405-27), DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0560-2026·2025-11-26

    Sodium heparin capillary tubes recalled over an inadequate quality system

    ASP Global is recalling 1,000 SAFE-T-FILL plastic blood gas capillary tubes, 115 microlitres with sodium heparin, over an inadequate quality system.

    Product
    SAFE-T-FILL Plastic Blood Gas Capillary Tubes, 115 ¿L; Prepared with Sodium Heparin Model/Catalog Number: 06 0005 Product Description: A clear, plastic capillary blood collection tube
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0165-2026·2025-11-26

    External analgesic lotion recalled over contamination found at the same facility

    DermaRite Industries is recalling 2,389 bottles of DermaSarra external analgesic because it was made at the same facility where other products and lots were found to be contaminated.

    Product
    DermaSarra, Camphor 0.5%, External Analgesic, 222 mL (7.5 fl. oz.) per bottle, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. NDC 61924-189-08
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0564-2026·2025-11-26

    Capillary end caps recalled over an inadequate quality system

    ASP Global is recalling 620,502 SAFE-T-FILL end caps for blood gas capillaries over an inadequate quality system with unvalidated manufacturing processes.

    Product
    SAFE-T-FILL End Caps for SAFE-T-FILL Blood Gas Capillaries; Fits outer diameter 1.6 - 2.1mm, Model 06 0402 Product Description: A clear, plastic capillary blood collection tube
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0552-2026·2025-11-26

    Three hundred microlitre heparin tubes recalled over unvalidated manufacturing processes

    ASP Global is recalling 6,050 SAFE-T-FILL micro capillary blood collection tubes, 300 microlitres with lithium heparin, over an inadequate quality system.

    Product
    SAFE-T-FILL Micro Capillary Blood Collection, 300 ¿L; Prepared with Lithium Heparin; Green Model/Catalog Number: 07 7251 Product Description: The SAFE-T-FILL Capillary Blood Collection System is a collection device used to draw capillary blood from the finger or heelstick.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0550-2026·2025-11-26

    Plasma separator tubes recalled over unvalidated manufacturing processes

    ASP Global is recalling 9,150 SAFE-T-FILL micro capillary blood collection tubes, 300 microlitres with lithium heparin and plasma separator gel, over an inadequate quality system.

    Product
    SAFE-T-FILL Micro Capillary Blood Collection, 300 ¿L; Prepared with Lithium Heparin and Plasma Separator Gel; Green Model/Catalog Number: 07 7221 Product Description: The SAFE-T-FILL Capillary Blood Collection System is a collection device used to draw capillary blood from t
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0553-2026·2025-11-26

    Sodium fluoride microtubes recalled over an inadequate quality system

    ASP Global is recalling 2,100 SAFE-T-FILL micro capillary blood collection tubes, 200 microlitres with sodium fluoride, over an inadequate quality system.

    Product
    SAFE-T-FILL Micro Capillary Blood Collection, 200 ¿L; Prepared with Sodium Fluoride; Gray Model/Catalog Number: 07 7340 Product Description: The SAFE-T-FILL Capillary Blood Collection System is a collection device used to draw capillary blood from the finger or heelstick.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0168-2026·2025-11-26

    Antimicrobial foam soap recalled over contamination found at the manufacturing facility

    DermaRite Industries is recalling 15,267 cartridges of KleenFoam Antimicrobial Foam Soap because it was made at the same facility where other products were found contaminated.

    Product
    KleenFoam Antimicrobial Foam Soap, Chloroxylenol 0.5%, 34 FL OZ (1000 mL) per cartridge, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. NDC 61924-093-34
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0536-2026·2025-11-26

    Shoulder reamer 46mm recalled after release without completed performance testing

    Exactech is recalling one Equinoxe Ergo Adjustable Angle rTSA Reamer, 46mm, because it was released before design updates and performance testing were completed.

    Product
    Brand Name: Equinoxe Ergo Product Name: Adjustable Angle rTSA Reamer, 46mm Model/Catalog Number: 321-59-46 Software Version: N/A Product Description: rTSA Reamer, 46mm Component: Not a component
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0174-2026·2025-11-26

    Zinc oxide barrier cream recalled over contamination found at the facility

    DermaRite Industries is recalling 37,272 tubes of Renew PeriProtect because it was made at the same facility where other products and lots were found to be contaminated.

    Product
    Renew PeriProtect, Zinc Oxide 12%, Dimethicone 1%, 113g (4 oz.) per tube, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. NDC 61924-435-04
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0169-2026·2025-11-26

    Dry skin therapy cream recalled over contamination found at the facility

    DermaRite Industries is recalling 8,378 containers of Lantiseptic Dry Skin Therapy because it was made at the same facility where other products were found contaminated.

    Product
    Lantiseptic, Dry Skin Therapy, Lanolin USP 30%, packaged in a) 5 g (0.17 oz) (NDC 61924-504-05), b) 4 oz (NDC 61924-504-04), and c)14 oz (NDC 61924-710-14) tubes, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0176-2026·2025-11-26

    Alcohol hand foam recalled over contamination found at the manufacturing facility

    DermaRite Industries is recalling 15,465 cartridges of San-E-Foam alcohol hand sanitiser because it was made at the same facility where other products were found contaminated.

    Product
    San-E-Foam, Alcohol 67%, 1000 mL (34 fl. oz.) per cartridge, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. NDC 61924-107-34
    Category
    Drug
    Distribution
    Distributed nationwide