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.

15551–15575 of 21645

  • ModerateFDA (Drugs)·D-0512-2016·2015-12-16

    RemedyRepack Recalls Bicillin L-A Due to Incorrect Storage Instructions

    RemedyRepack, Inc. is recalling 60 vials of Bicillin L-A 600,000 Units/mL injection because the product labels contain incorrect storage instructions.

    Product
    Bicillin L-A 600000 Units/mL Inj., Qty: 20 mL Syringe, MFG by: King Pharma Inc., Bristol, TN 37620, Repackaged by: RemedyRepack, Inc., 625 Kolter Dr., Indiana, PA 15701, NDC 61786-0253-03
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0513-2016·2015-12-16

    RemedyRepack Recalls Vitamin B-Complex Injections Due to Labeling Error

    RemedyRepack Inc. is recalling Vitamin B-Complex 100 injections because the vials contain incorrect storage instructions.

    Product
    Vitamin B-Complex 100, Multi MG Inj, Qty: 30 mL Vial, MFG by: Mylan Institutional, Rockford, IL 61103, Repackaged by: RemedyRepack Inc., 625 Kolter Dr., Indiana, PA 15701, NDC 52125-0873-02
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0373-2016·2015-12-16

    Thrive Foods Recalls Organic Blenditup Smoothie Mix Due to Foreign Object

    Thrive Foods LLC is recalling 5,305 canisters of Organic Blenditup Smoothie Mix because a wingnut was found inside a canister.

    Product
    Organic blenditup Protein + Plant Based Smoothie Mix, No Dairy, Vitamin Fortified, 100% Vegan, Mild Natural Flavor with a Hint of Sweetness, Net Wt. 24 oz (682g), packaged in plastic canister, 12 packages per case. Distributed by: Blenditup, 504 W. Buena Vista, Suite 1…
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0377-2016·2015-12-16

    Windstone AMS 4675 Angio Pack Recalled Due to Component Issue

    Windstone Medical Packaging is recalling 40 kits of the AMS 4675 Angio Pack because they contain a recalled Seldinger Needle.

    Product
    AMS 4675 Angio Pack. For use in a general clinical procedure.
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-0386-2016·2015-12-16

    LeMaitre Embolectomy Catheter Recalled for Packaging Sterility Risk

    LeMaitre Vascular is recalling specific embolectomy catheters because a manufacturing defect could compromise sterility.

    Product
    LeMaitre Single Lumen Embolectomy Catheter 3F, 80 cm, Model 1601-38 and e1601-38. Indicated for the removal of arterial emboli and thrombi.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0518-2016·2015-12-16

    Steris Recalls Kindest Kare Antimicrobial Foaming Handwash Due to Labeling Error

    Steris is recalling 54 bottles of Kindest Kare Antimicrobial Foaming Handwash because an outdated label incorrectly lists an inactive ingredient.

    Product
    Kindest Kare Antimicrobial Foaming Handwash, Hand Soap, 0.75% Triclosan, 444 ml (15 fl oz) bottles, STERIS Corporation, 7501 Page Avenue, St. Louis, MO 63133, Reorder # 1452-RF, NDC 0519-1452-13, UPC (01)00724995 086251.
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0515-2016·2015-12-16

    RemedyRepack Recalls Lorazepam Injections Due to Incorrect Storage Instructions

    RemedyRepack Inc. is recalling 1,625 vials of Lorazepam 2 mg/mL injection because the product labels contain incorrect storage instructions.

    Product
    Lorazepam 2 mg/mL Inj., Qty: 1 mL Vial, MFG by: West-Ward Pharma, Eatontown, NJ 07724, Repackaged by: RemedyRepack Inc., 625 Kolter Dr., Indiana, PA 15701, NDC 61786-0316-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0383-2016·2015-12-16

    LeMaitre Embolectomy Catheter Recalled for Packaging Sterility Risk

    LeMaitre Vascular is recalling Over-the-Wire Embolectomy Catheters due to a manufacturing issue that may compromise packaging sterility.

    Product
    LeMaitre Over-the-Wire Embolectomy Catheter 5F Plus, 40 cm, Model e1651-84. Indicated for the removal of arterial emboli and thrombi.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0516-2016·2015-12-16

    RemedyRepack Recalls Novolin 70/30 Vials Due to Incorrect Storage Instructions

    RemedyRepack Inc. is recalling 106 vials of Novolin 70/30 insulin because the packaging contains incorrect storage instructions.

    Product
    Novolin 70/30, 100 Units/mL Solu., Qty: 1 Vial, MFG by: Novo Nordisk, A/S, Bagsvaerd, Denmark DK-2880, Repackaged by: RemedyRepack Inc., 625 Kolter Dr., Indiana, PA 15701, NDC 52125-0414-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0517-2016·2015-12-16

    RemedyRepack Recalls Rocuronium Bromide Vials Due to Incorrect Storage Instructions

    RemedyRepack Inc. is recalling Rocuronium Bromide 50 mg/5 mL vials because the product labels contain incorrect storage instructions.

    Product
    Rocuronium Bromide 50 MG/5ML INJ., Qty: 5 mL Vial, MFG by: Mylan Institutional, Rockford, IL 61103, Repackaged by: RemedyRepack Inc., 625 Kolter Dr., Indiana, PA 15701, NDC 61786-0222-57
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0348-2016·2015-12-16

    Durrset Amigos Recalls Texas Style Borracho Beans Due to Foreign Material

    Durrset Amigos Ltd. is recalling specific cans of Texas Style HEB Borracho Beans because they may contain rocks.

    Product
    Texas Style HEB Borracho Beans Made with Shiner Rock NET WT. 15 OZ (425g) in metal cans; Texas Style HEB Borracho Beans Made with Shiner Rock NET WT. 31 OZ (1.94 LB) 879g in metal cans.
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0387-2016·2015-12-16

    LeMaitre Embolectomy Catheter Recalled for Packaging Sterility Risk

    LeMaitre Vascular is recalling Single Lumen Embolectomy Catheters due to a manufacturing defect that may compromise packaging sterility.

    Product
    LeMaitre Single Lumen Embolectomy Catheter 4F, 80 cm, Model 1601-48 and e1601-48. Indicated for the removal of arterial emboli and thrombi.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0509-2016·2015-12-16

    Golden State Medical Supply Recalls Meclizine Hydrochloride Tablets Due to Impurities

    Golden State Medical Supply Inc. is recalling 1,136 bottles of Meclizine Hydrochloride tablets because they failed impurity specifications.

    Product
    MECLIZINE HYDROCHLORIDE TABLETS, 12.5 mg, Packaged in 1000 ct Bottles, Rx Only. Manufactured by: Par Pharmaceuticals Companies Inc., Spring Valley, NY 10977. Packaged by: GSMS Incorporated, Carmarillo, CA 93012. NDC: 60429-204-10.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0393-2016·2015-12-09

    Geritrex Recalls Unapproved Polyethylene Glycol 3350 Powder Jars

    Geritrex Corporation is recalling Polyethylene Glycol 3350-GRX Powder 100% jars because the FDA determined they are unapproved new drugs and misbranded.

    Product
    Polyethylene Glycol 3350-GRX Powder 100% jars a) 8.4 oz (250 g) (NDC 54162-335-02), b) Net wt. 16.9 oz (500 g) (NDC 54162-335-05), Distributed by: Geritrex Corporation, Mount Vernon, NY 10550
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0359-2016·2015-12-09

    ConMed Recalls Altrus Thermal Tissue Fusion Energy Sources

    ConMed is recalling nine Altrus Thermal Tissue Fusion Energy Sources due to a miscalibration issue that may cause false alarms and stop heating cycles.

    Product
    Altrus Thermal Tissue Fusion Energy Sources, Catalog Numbers: 1) 60-9500-120 & 2) 60-9500-INT. Thermal Ligation and Cutting Energy Source.
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-0362-2016·2015-12-09

    Stryker Duracon Tibial Wedge Implants Recalled for Packaging Integrity Issues

    Stryker is recalling 2,577 Duracon Tibial Wedge implants because they punctured the packaging's Tyvek lids, potentially compromising sterility.

    Product
    Stryker Orthopaedics Duracon Flat Tibial Wedge Cemented use only Sterile. Tibial Wedge is a component of Total Stabilizer Knee which consists of femoral component, tibial insert, modular offset adaptor, femoral/tibial stem extenders and tibial wedges. Tibial wedges are intended…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0366-2016·2015-12-09

    Merz Recalls Radiesse Injectable Implant Due to Incorrect Expiration Date

    Merz North America is recalling 1,616 units of Radiesse (+) Lidocaine Injectable Implant because the expiration date on the packaging is incorrect.

    Product
    Radiesse (+) Lidocaine Injectable Implant 1.5cc, P/N: 8063M0K1. Indicated for subdermal implantation for the correction of moderate to severe facial wrinkles and folds.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0367-2016·2015-12-09

    Merz Recalls Prolaryn Injectable Implant Due to Incorrect Expiration Date

    Merz North America is recalling Prolaryn Injectable Implant 1.0 cc Gel because the expiration date on the label is incorrect.

    Product
    PROLARYN Injectable Implant 1.0 cc Gel, Model No. 8602M0K5. A restorable implant material to aid in surgical reconstructions as a space occupying material in laryngeal surgical procedures for vocal fold medialization and augmentation.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0390-2016·2015-12-09

    Geritrex Recalls Unapproved Carbo-O-Philic 40 Cream Tubes Nationwide

    Geritrex Corporation is recalling Carbo-O-Philic 40 Cream tubes because the FDA determined the product is an unapproved new drug and misbranded.

    Product
    Carbo-O-Philic 40 Cream 40% (Urea) tubes, a) 3 oz (85 g) (NDC 54162-640-03) , b) 7 oz (200 g) (NDC 54162-640-07), Rx Only For topical use only, Distributed by Geritrex Corporation, East Mount Vernon, NY 10550
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0389-2016·2015-12-09

    Nephron Recalls Asthmanefrin Racepinephrine Inhalation Solution Due to Discoloration

    Nephron Pharmaceuticals is recalling 32,490 cartons of Asthmanefrin Racepinephrine Inhalation Solution due to discoloration. The FDA classifies this as a Class II recall.

    Product
    Asthmanefrin Racepinephrine Inhalation Solution Bronchodilator Refills (Racepinephrine USP 11.25 mg), 30 individual foil wrapped vials per carton, Manufactured By: nephron pharmaceuticals corporation, Orlando, FL --- NDC 0487-2784-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0343-2016·2015-12-09

    Ormco Recalls Copper NiTi Preformed Archwires Due to Incorrect Labeling

    Ormco is recalling Copper NiTi Preformed Archwires because the transformation temperature listed on the label is incorrect.

    Product
    Copper NiTi Preformed Archwires; Copper NiTi 40 BAF .016X.022 LO Pk10, Part No. 211-0952. Intended to provide tooth movement.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0355-2016·2015-12-09

    Procedure Products Recalls Ultra Modified Seldinger Needles Due to Insertion Difficulty

    Procedure Products, Inc. is recalling 1,100 non-sterile Seldinger needles because a medical professional reported difficulty inserting a guide wire.

    Product
    U-SDN 2 Part Ultra Modified Seldinger Needles, NS/37-0387. All needles were sold in bulk, non-sterile, and intended for further processing. Needles are packaged in zipper-bags, 300 pieces per bag, with shipment occurring in a corrugated cardboard box. Needles consist of a…
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-0368-2016·2015-12-09

    Merz Recalls Prolaryn Plus Injectable Implant Due to Incorrect Expiration Date

    Merz North America is recalling Prolaryn Plus Injectable Implants because the expiration date on the labels is incorrect. The recall covers 9,439 units distributed in the US and South Africa.

    Product
    PROLARYN PLUS Injectable Implant 1.0 cc Plus Calcium Hydroxlyapatite (CaHA) Injectable Implant, Model No. 8044M0K5. An injectable implant used to treat vocal fold insufficiency.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0391-2016·2015-12-09

    Geritrex Recalls Unapproved Carbo-O-Philic 40 Gel Topical Urea Product

    Geritrex Corp is recalling Carbo-O-Philic 40 Gel because the FDA determined it is an unapproved new drug and misbranded.

    Product
    Carbo-O-Philic 40 Gel 40% (Urea) NET WT tube, .5 oz (15 g), Rx Only For topical use only, Distributed byGeritrex Corporation 144, Mount Vernon, NY 10550, NDC 54162-016-15
    Category
    Drug
    Distribution
    Distributed nationwide