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.

20801–20825 of 21633

  • ModerateFDA (Food)·F-0980-2013·2013-02-13

    MET-Rx Extreme Thermo Rage Watermelon Supplement Recalled for Spoilage

    NBTY Inc. is recalling MET-Rx Extreme Thermo Rage Watermelon dietary supplements because Acetobacter lovaniensis was detected in a sample. This is a commercial spoilage issue.

    Product
    MET-Rx EXTREME THERMO RAGE WATERMELON DIETARY SUPPLEMENT, 8 FL. OZ. (240 mL) , Product Number 50390 (Bulk number 50389), UPC 7 86560 50389 1, Label Revision 00B --- Manufactured in the USA by MET-RX Nutrition, Inc. Boca Raton, FL 33487
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-145-2013·2013-02-13

    Watson Pharmaceuticals Recalls Taztia XT Due to Dissolution Failure

    Watson Pharmaceuticals is recalling Taztia XT (diltiazem HCI) capsules because stability testing revealed a failed dissolution specification.

    Product
    Taztia XT(diltiazem HCI extended release capsules, USP, Once-A-Day Dosage, 360 mg, 90 Capsules per bottle, Rx only, Manufactured by: Watson Laboratories, Inc., Corona, CA 92880, Distributed by: Watson Pharma, NDC 62037-700-90.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0788-2013·2013-02-13

    Exactech Recalls Hip Replacement Liners Due to Labeling Error

    Exactech is recalling 26 hip replacement liners because the device labeling was inadvertently transposed. The units were distributed in five states.

    Product
    Exactech NOVATION CROWN CUP +5mm LATERALIZED LINER, Use with Crown Cup Only, GXL UHMWPE, SN 0123456, REF 136-32-53. Exactech Hip Systems are indicated for use in surgery for hip replacement.
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-0767-2013·2013-02-13

    Philips Easy Diagnost Eleva DRF Recalled for Image Marker Misinterpretation

    Philips Healthcare is recalling 14 Easy Diagnost Eleva DRF units because a mirror icon on images could be misinterpreted as a right lead marker in PACS systems.

    Product
    Phillips Easy Diagnost Eleva DRF. Model Number: 706034 Product Usage: Universal Fluoroscopic Applications
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0787-2013·2013-02-13

    Exactech Recalls Novation Crown Cup Hip Liners Due to Labeling Error

    Exactech is recalling 26 units of Novation Crown Cup hip replacement liners because device labeling was inadvertently transposed.

    Product
    Exactech NOVATION CROWN CUP, NEUTRAL LINER, Use with Crown Cup Only, GXL UHMWPE, SN 0123456, REF 130-32-53. Exactech Hip Systems are indicated for use in surgery for hip replacement.
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-0793-2013·2013-02-13

    OPTIGEN Food 30 Allergen Testing Kits Recalled for Potential False Negatives

    Hitachi Chemical Diagnostics is recalling 20 kits of OPTIGEN Food 30 allergen testing products due to a potential low fill volume that could cause false negative results.

    Product
    OPTIGEN Food 30; Catalog number: 85035. For allergen testing. Manufactured by Hitachi Chemical Diagnostics, Mountain View, CA. Distributed by Theridiag, Cedex, France
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-149-2013·2013-02-13

    West-ward Recalls Prednisone Tablets Due to Gray Defects

    West-ward Pharmaceutical Corp. is recalling specific lots of PredniSONE Tablets, USP, 10 mg, due to the presence of gray defects in the tablets.

    Product
    PredniSONE Tablets, USP, 10 mg, packaged in a) 100-count tablets per bottle (NDC 0143-1473-01), b) 1000-count tablets per bottle (NDC 0143-1473-10), Rx only, Manufactured by: West-ward Pharmaceutical Corp., Eatowntown, NJ 07724.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0790-2013·2013-02-13

    Remel Recalls Oxoid Aztreonam Antimicrobial Susceptibility Test Discs

    Remel Inc is recalling Oxoid Aztreonam test discs because some may lack antibiotic impregnation, potentially affecting test accuracy.

    Product
    Oxoid Antimicrobial Susceptibility Test Discs, Aztreonam 30 ug, IVD, REF CT0264B, Oxoid Ltd., UK, [email protected] (Both Remel & Oxoid, Ltd are a part of Thermo Fisher Scientific) An antimicrobial susceptibility test disc is a device that consists…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0977-2013·2013-02-13

    Mama Tere Barley Flour Recalled for Undeclared Food Dyes

    Family Food Distributor, Inc. is recalling Mama Tere Cebada Natural Barley Flour because it contains undeclared food dyes Red #3 and Red #40.

    Product
    Mama Tere Cebada Natural Barley Flour Net Weight /Peso Neto: 12 oz (340g) Family Food Distributors Bergen Avenue Kearny, NY 07032 UPC 7412003000259
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Food)·F-0969-2013·2013-02-13

    Acme Recalls Canned Mandarin Oranges Due to Unidentified Chemical Contaminant

    Acme Food Sales is recalling 8,707 cases of Western Family canned mandarin oranges after consumer complaints of chemical taste and preliminary testing confirmed a contaminant.

    Product
    Canned mandarin oranges labeled in part: "WESTERN FAMILY Choice Selections Mandarin Oranges Naturally Sweet in Mandarin Orange Juice NET WT 10.5OZ (297g)***Ingredients: Mandarin Oranges, Mandarin Orange Juice. Proudly Distributed by Western Family P.O. Box 4057, Portland, OR…
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0738-2013·2013-02-06

    bioMerieux Recalls BacT/ALERT SA Blood Culture Bottles with Uncured Sensors

    bioMerieux, Inc. is recalling BacT/ALERT SA Blood Culture Bottles because some units may contain uncured sensors, potentially affecting the detection of microorganisms.

    Product
    BacT/ALERT SA Blood Culture Bottle. The BacT/ALERT SA reagent bottle is intended to be recover and detect aerobic microorganisms (bacteria and fungi) from blood and other normally sterile body fluids.
    Category
    Medical Device
    Distribution
    29 states
  • ModerateFDA (Food)·F-0952-2013·2013-02-06

    Gordon Food Service Recalls Pasteurized Crab Meat Due to Temperature Abuse

    Gordon Food Service is recalling 10 cases of 16-ounce pasteurized crab meat sold in Florida due to time and temperature abuse during transit.

    Product
    ***GFS***CLAW MEAT***Wild-Caught and Hand-Picked***PASTEURIZED CRAB***Carne de mano de jaiba*** NET WT/PESO NETO***16 OZ (1 LB) 453g***Reorder #536030***PRODUCT OF THAILAND***.
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0750-2013·2013-02-06

    Envoy Medical Recalls Esteem Programmers for Noise Interference

    Envoy Medical is voluntarily correcting 44 Esteem Programmers to reduce susceptibility to noise interference.

    Product
    Esteem Programmer Model 6001, US and ISA, Model 3001 Dell E54XX, part of the Esteem Totally Implantable Hearing System. The ISA and Commander are software packages that run on a laptop personal computer.
    Category
    Medical Device
    Distribution
    14 states
  • ModerateFDA (Food)·F-0951-2013·2013-02-06

    JFC International Recalls Saki Ika Cuttlefish Due to Mold Contamination

    JFC International is recalling specific lots of WelPac Saki Ika Cuttlefish because of mold. Consumers should check their products and stop using them if they match the listed codes.

    Product
    WP Saki Ika Cuttlefish Hot JFC# 15606, 4/24/0.75 oz; JFC# 06318, 8/12/2 oz; JFC# 07269, 5/12/4 oz; JFC# 06360, 3/12/8 oz.
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-137-2013·2013-02-06

    Mylan Recalls Carvedilol Tablets for Weight and Thickness Failures

    Mylan Pharmaceuticals is recalling 11,580 bottles of Carvedilol 12.5 mg tablets because they failed specifications for weight and thickness.

    Product
    Carvedilol Tablets, USP, 12.5 mg, 500-count tablets per bottle, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A., NDC 0378-3633-05, UPC 3 0378-3633-05 3.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0753-2013·2013-02-06

    Biomet TUNNELOC Round Head Interference Screw Recalled for Undersized Tip Hole

    Biomet is recalling 44 TUNNELOC Round Head Interference Screws because the hole at the tip is undersized. The defect may affect the device's performance during orthopedic procedures.

    Product
    TUNNELOC ROUND HEAD INTERFERENCE SCREW 8MMX25MM Biomet Sports Medicine manufactures a variety of internal fixation devices intended to aid in arthroscopic and orthopedic reconstructive procedures requiring soft tissue fixation, due to injury or degenerative disease. Implants…
    Category
    Medical Device
    Distribution
    7 states
  • ModerateFDA (Food)·F-0936-2013·2013-02-06

    General Mills Recalls Betty Crocker Cake Mix for Undeclared Colors

    General Mills is recalling a limited quantity of Betty Crocker SuperMoist Golden Vanilla cake mix due to a labeling error involving undeclared FD&C color ingredients.

    Product
    Betty Croker, Super Moist Cake Mix, Golden Vanilla, NET WT 15.25 oz (432 g), UPC 0 16000 40993 4, Dist by General Mills Sales, Inc., Minneapolis, MN 55440. Case UPC code 1600040993000
    Category
    Food
    Distribution
    10 states
  • ModerateFDA (Devices)·Z-0739-2013·2013-02-06

    Becton Dickinson Recalls BBL Fildes Enrichment Tubes for Growth Failure

    Becton Dickinson is recalling BBL Fildes Enrichment tubes because they may fail to support the growth of Haemophilus species, potentially affecting laboratory test results.

    Product
    BBL(TM) Fildes Enrichment, catalog number 211866, 10 tubes/pack, labeled in part ***Becton Dickinson and Company, Sparks, MD 21152 USA*** Intended Use: Fildes Enrichment may be used to enrich a variety of media for the cultivation of various microorganisms. Fildes Enrichment…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-141-12013·2013-02-06

    Femtrace Tablets Recalled for Moisture Ingress and Impurity Failures

    Warner Chilcott is recalling 5,439 bottles of Femtrace 0.9 mg tablets nationwide due to moisture ingress causing failed impurity specifications.

    Product
    Femtrace 0.9 mg (Estradiol Acetate) Tablets, Rx Only, 100 tablets, Manufactured by Pharmaceutics International Inc, Hunt Valley, MD 21031 for Warner Chilcott Company LLC, Fajardo, PR 00738
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0764-2013·2013-02-06

    MOOG Infinity Enteralite Feeding Pumps Recall for Manual Addendum

    MOOG Medical Devices Group is recalling 92,488 Infinity Enteralite Ambulatory Feeding Pumps to add an operator's manual addendum regarding the Infinite Dose mode and air-in-line detection limitations.

    Product
    Infinity Enteralite Ambulatory Feeding Pumps, List number: INFKIT2 - Addendum to Operator's Manual Product usage: provide a means for the volumetric delivery of fluids used in Enteral applications.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0743-2013·2013-02-06

    Alfa Wassermann System Diluent Recalled for Inaccurate Calibration Results

    Alfa Wassermann is recalling 4,104 kits of System Diluent because inorganic phosphorus assays may not produce acceptable calibration results.

    Product
    Alfa Wassermann System Diluent 750 mL Manufactured for Alfa Wassermann Diagnostic Technologies LLC 4 Henderson Drive West Caldwell, NJ 07006 Alfa Wassermann B.V. Pompmolenlaan 24 3447 GK, Woerden The Netherlands Common name is water solution. Intended to dilute…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0950-2013·2013-02-06

    JFC International Recalls Saki Ika Cuttlefish Due to Mold Contamination

    JFC International is recalling specific lots of Saki Ika Cuttlefish nationwide because of mold. Consumers should check their products and discard any affected items.

    Product
    WP Saki Ika Cuttlefish JFC# 15603, 4/24/0.75oz; JFC# 06315, 8/12/2oz; JFC# 07266, 5/12/4oz; JFC# 06375, 3/12/8oz.
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0938-2013·2013-02-06

    The Father's Table Vanilla Rolls Recalled for Missing Allergen Labeling

    The Father's Table LLC is recalling Vanilla Rolls because the labels fail to list strawberries and color additives. The FDA classified this as a Class III recall.

    Product
    Individual packages labeled in part: ***The Father's Table***Vanilla Roll***8oz**** and Master carton labeled in part: "The Father's Table***Shelf Stable*** Mini Vanilla Roll***Contains 12/8oz.***
    Category
    Food
    Distribution
    11 states
  • ModerateFDA (Food)·F-0939-2013·2013-02-06

    The Father's Table Recalls Vanilla Mini Cake Rolls for Labeling Errors

    The Father's Table, LLC is recalling Vanilla Mini Cake Rolls because the labels fail to list strawberries and specific color additives.

    Product
    Individual packages labeled in part: ***The Bakery baked with pride***Vanilla Mini Cake Roll***8oz**** with strawberry filling*** NETWT 8oz (226g)
    Category
    Food
    Distribution
    11 states
  • ModerateFDA (Devices)·Z-0751-2013·2013-02-06

    Greatbatch Medical Recalls 45 Degree Angle Drivers for Noisy Operation

    Greatbatch Medical is voluntarily recalling 913 Small Angled Driver 45 units worldwide due to reports of noisy or rough operation.

    Product
    45¿ Angle Driver / Z-H, Greatbatch Medical 10 000 Wahrie Drive, Clarance, NY 14031. Model #: P2661, P2662, T3635, T5586,T6031, T6164,T10161, T12628,T14879, T16422,T2487,T2713,T116057, T13635, MPU260045AO01, MPU260045ZH01. The Driver is intended to act as an interface…
    Category
    Medical Device
    Distribution
    8 states