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.

12176–12200 of 21617

  • ModerateFDA (Drugs)·D-1050-2017·2017-08-09

    Bayer Recalls Alka-Seltzer Extra Strength Tablets Due to Defective Packaging

    Bayer is recalling Alka-Seltzer Extra Strength effervescent tablets because customer complaints confirmed small holes or cracks in the foil blister packs.

    Product
    Alka-Seltzer Extra Strength (500 mg Aspirin (NSAID), 1985 mg Analgesic Sodium bicarbonate/Antacid, 1000 mg Anhydrous Citric Acid) Effervescent Tablets, 24-count carton, Made in Germany, Distributed by Bayer HealthCare, LLC Whippany, NJ 07981, UPC 016500044048
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2801-2017·2017-08-09

    Stryker Stroke Fast Pack Recall Due to Mismatched Carton Sleeve Labeling

    Stryker Neurovascular is recalling 139 Stroke Fast Packs because the pre-printed contents on the carton sleeve did not match the physical contents of the pack.

    Product
    Stroke Fast Pack(TM) Trevo XP ProVue Retriever 4 x 30, Trevo Pro 18 Microcatheter, AXS Catalyst 060x132CM - US, UPN M0033PK43022001
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2800-2017·2017-08-09

    Stryker Neurovascular Recalls Stroke Fast Packs Due to Labeling Mismatch

    Stryker Neurovascular is recalling 63 Stroke Fast Packs because the printed carton contents did not match the physical items inside.

    Product
    Stroke Fast Pack(TM) Trevo XP ProVue Retriever 4 x 20, Trevo Pro 18 Microcatheter, AXS Catalyst 060x132CM - US, UPN M0033PK42022001
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-3349-2017·2017-08-09

    Whole Foods Thai Shrimp Salad Recalled for Incorrect Back Label

    Cafe Spice GCT is recalling Whole Foods Market Thai Shrimp Salad because the back label displays information for a different product.

    Product
    Whole Foods Market Thai Shrimp Salad, Net Wt. 14 oz.. packaged in a clear clamshell container (refrigerated)
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-1041-2017·2017-08-09

    Zydus Recalls Divalproex Sodium Tablets for Failed Dissolution Specifications

    Zydus Pharmaceuticals is recalling Divalproex Sodium Delayed Release Tablets because they failed to meet dissolution specifications.

    Product
    Divalproex Sodium Delayed Release Tablets, USP, 125 mg, 100-count bottle Rx only, Manufactured by Cadila Healthcare Ltd, Ahmedabad, India, Distributed by: Zydus Pharmaceuticals, Pennington, NJ 07054, NDC 68382-031-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1043-2017·2017-08-09

    Zydus Recalls Divalproex Sodium Tablets for Failed Dissolution Specifications

    Zydus Pharmaceuticals is recalling Divalproex Sodium Delayed Release Tablets because they failed to meet dissolution specifications.

    Product
    Divalproex Sodium Delayed Release Tablets, USP, 500 mg, a.) 100-count bottle (NDC 68382-033-01) b.) 500-count bottle (NDC 68382-033-05), Rx only, manufactured by Cadila Healthcare Ltd, Ahmedabad, India, Distributed by: Zydus Pharmaceuticals, Pennington, NJ 07054
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1057-2017·2017-08-09

    PD-Rx Pharmaceuticals Recalls Famotidine 20 mg Tablets for Weight Issues

    PD-Rx Pharmaceuticals is recalling 100 bottles of Famotidine USP 20 mg tablets because they failed to meet tablet weight specifications.

    Product
    Famotidine USP 20 mg, 30 tablets bottle, Rx, PKG By; PD Rx Pharmaceuticals Incorporated Oklahoma City, OK 73127 --- NDC 55289-765-30
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1037-2017·2017-08-09

    Precision Dose Recalls Carbamazepine Oral Suspension Due to Carton Labeling Error

    Precision Dose Inc. is recalling Carbamazepine Oral Suspension because the product cartons list incorrect volume and NDC numbers, although the individual unit dose cups are correctly labeled.

    Product
    Carbamazepine Oral Suspension, USP. 100 mg/5 mL, 5 mL Unit Dose Cups, Rx Only, Pkg: Precision Dose, Inc., S. Beloit, IL 61080, NDC 68094-301-59.
    Category
    Drug
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-2780-2017·2017-08-09

    Ortho Solutions Recalls Mislabelled Oxford AFN End Caps

    Ortho Solutions Inc is recalling 277 units of Oxford/Oxbridge AFN End Caps due to material mislabeling. The affected devices were distributed to Maryland, New York, and Pennsylvania.

    Product
    Oxford/Oxbridge AFN End Cap 10 mm x 5 mm tp 12 mm x10 mm The end caps are a circular disk with a small threaded shaft to be screwed to the distal end of the Nail.
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-2777-2017·2017-08-09

    GE Blade|line Industrial Cabinet X-ray System Recalled for Emission Violations

    GE Inspection Technologies is recalling 13 Blade|line Industrial Cabinet X-ray systems because they exceed federal emission limits in an inaccessible crawl space.

    Product
    GE Inspection Technologies Blade|line Industrial Cabinet X-ray system
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Drugs)·D-1040-2017·2017-08-09

    Axia Pharmaceutical Recalls Compounded Testosterone Cypionate and Progesterone Vials

    Axia Pharmaceutical is recalling 120 vials of compounded Testosterone Cypionate and Progesterone due to CGMP deviations. The product was distributed to one customer in California.

    Product
    Testosterone Cypionate + Progesterone, 200 mg/ 2.5 mg/mL ,10 mL amber glass vials, Rx Only, Compounded by AXIA Pharmaceutical, Los Angeles, CA 90025
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-1053-2017·2017-08-09

    VistaPharm Recalls Lactulose Solution Due to Microbial Contamination

    VistaPharm is recalling Lactulose Solution, USP, because the product failed microbial testing for yeast and mold counts.

    Product
    Lactulose Solution, USP, 20 g/30 mL, dose cups delivers 30 mL packaged 50-unit dose cups per case, Manufactured by VistaPharm, Inc., Largo, FL 33771, NDC 66689-038-01
    Category
    Drug
    Distribution
    7 states
  • ModerateFDA (Devices)·Z-2782-2017·2017-08-09

    Biosense Webster MobiCath Guiding Sheath Recalled for Unsealed Pouch

    Greatbatch Medical is recalling 11,360 MobiCath Bi-Directional Guiding Sheaths because one side of the pouch may not be sealed.

    Product
    Biosense Webster MobiCath Bi-Directional Guiding Sheath, Model D140010 (small curve) and D140011 (large curve). The MobiCath Bi-Directional Guiding Sheath is a flexible tipped percutaneous catheter introducer (or guiding sheath) designed for gaining access to the coronary…
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-1044-2017·2017-08-09

    Bayer Recalls Alka-Seltzer Tablets Due to Defective Blister Pack Foil

    Bayer HealthCare is recalling Alka-Seltzer Original effervescent tablets because customer complaints confirmed small holes or cracks in the foil of the blister packs.

    Product
    Alka-Seltzer Original ( 325 mg Aspirin (NSAID), 1916 mg Analgesic, Sodium bicarbonate/Antacid, 1000 mg Anhydrous Citric Acid) Effervescent Tablets, 12-count carton, Made in Germany, Distributed by Bayer HealthCare, LLC Whippany, NJ 07981, UPC 016500040194
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-2920-2017·2017-08-02

    Channel Brand Raw Breaded Pollock Squares Recalled for Undeclared Milk

    Channel Fish Processing Co. Inc. is recalling Channel Brand Raw Breaded Pollock Squares due to undeclared milk. The product was distributed to 14 states.

    Product
    Channel Brand - 4OZ Raw Breaded Pollock Squares - Net wt.10 lbs. (4.54 kg) Channel Brand- 4 oz. Raw Breaded Pollock Squared Net Wt. 10 lb. (4.54 KG)
    Category
    Food
    Distribution
    14 states
  • ModerateFDA (Devices)·Z-2765-2017·2017-08-02

    Medtronic DLP Antegrade/Retrograde Adapter Recalled for Packaging Pinholes

    Medtronic is recalling DLP Antegrade/Retrograde Adapters because small pinholes were found in a single packaging configuration of sterile pouches.

    Product
    DLP Antegrade/Retrograde Adapter Method for perfusion of cardioplegia alternately in either an antegrade or retrograde fashion. It is fitted with flexible lines and standard luer sites to facilitate direct connections to the cannulae
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-2927-2017·2017-08-02

    Channel Fish Processing Recalls Raw Breaded Whiting Squares for Undeclared Milk

    Channel Fish Processing Co. Inc. is recalling raw breaded whiting squares because the product contains milk, which is not declared on the label.

    Product
    PRIMA - 3 OZ Raw Breaded Whiting Squares - NET WT 10 LBS. (4.54 KG.) PRIMA - 4 OZ Raw Breaded Whiting Squares - NET WT 10 LBS. (4.54 KG.)
    Category
    Food
    Distribution
    14 states
  • ModerateFDA (Food)·F-2898-2017·2017-08-02

    Channel Fish Processing Recalls Raw Breaded Fish Portions for Undeclared Milk

    Channel Fish Processing Co. Inc. is recalling raw Oriental Breaded Fish Portions due to undeclared milk. The product was distributed to 14 states.

    Product
    Winsor Bay- Raw Oriental Breaded Fish Portions - 4 oz. Haddock Tails - Net wt. 10 lbs (4.54.KG)
    Category
    Food
    Distribution
    14 states
  • ModerateFDA (Devices)·Z-2768-2017·2017-08-02

    Medtronic Recalls DLP Pressure Display Sets Due to Packaging Pinholes

    Medtronic Perfusion Systems is recalling DLP Pressure Disposable Pressure Display Sets because small pinholes were found in the sterile packaging.

    Product
    DLP Pressure Disposable Pressure Display Sets Extends the pressure line in order to reach the pressure monitoring unit during cardiopulmonary bypass surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2761-2017·2017-08-02

    Atrium iCAST and Advanta V12 Stents Recalled for Incorrect Hub Labeling

    Atrium Medical Corporation is recalling specific iCAST and Advanta V12 covered stents because the catheter hub was printed with incorrect dimensional information.

    Product
    Atrium iCAST Balloon Expandable Covered Stent; 7mm x 22mm x 120cm; Model/Part Number 85455 (Marketed in U.S. only) Atrium Advanta V12 Balloon Expandable Covered Stent; 7mm x 22mm x 120cm; Model/Part Number 85355 (Marketed OUTSIDE U.S. only) The iCAST Covered Stent is…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-2874-2017·2017-08-02

    Beatrice Bakery Recalls Key Lime Cakes Due to Mislabeling

    Beatrice Bakery Co is recalling Key Lime Dessert Cakes because certified colors were incorrectly declared as vegetable and turmeric.

    Product
    1) Key Lime Dessert Cake, Grandma's Bake Shoppe, NET WT. 14 OZ. (400 g), UPC 8 24153 02582 2
    Category
    Food
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-2766-2017·2017-08-02

    Medtronic Recalls DLP Cardioplegia Adapters Due to Packaging Pinholes

    Medtronic Perfusion Systems is recalling DLP Cardioplegia Adapters with Pressure Port because small pinholes were identified in a single packaging configuration of sterile pouches.

    Product
    DLP Cardioplegia Adapter with Pressure Port Provides access for a pressure monitoring needle near the connection to the cardioplegia cannula. These adapters are intended for use in conjunction with the delivery of cardioplegia solution and to provide access for pressure…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2757-2017·2017-08-02

    Cardinal Health Recalls Mislabeled Sterile Surgical Drapes

    Cardinal Health is recalling specific lots of sterile surgical drapes because the outer labels do not match the packaged product inside.

    Product
    Converters(R) Under Buttocks Drape with Fluid Control Pouch II, REF 8482, STERILE R, Qty. 1, Cardinal Health, Waukegan, IL A surgical drape and drape accessories is a device made of natural or synthetic materials intended to be used as a protective patient covering, such as…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2758-2017·2017-08-02

    Cardinal Health Recalls Tiburon Arthroscopy Drapes Due to Labeling Mismatch

    Cardinal Health is recalling specific lots of Tiburon Arthroscopy Drapes because the outer labels do not match the packaged product.

    Product
    Converters(R) Tiburon(R) Arthroscopy Drape, REF 9414, STERILE EO, Qty. 1, Cardinal Health, Waukegan, IL A surgical drape and drape accessories is a device made of natural or synthetic materials intended to be used as a protective patient covering, such as to isolate a site of…
    Category
    Medical Device
    Distribution
    Distributed nationwide