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.

16401–16425 of 21645

  • ModerateFDA (Devices)·Z-1615-2015·2015-05-20

    Siemens Dimension Chemistry Systems Recalled for Non-Standard Power Plugs

    Siemens Healthcare Diagnostics is recalling certain Dimension Integrated Chemistry Systems installed with non-standard power plugs due to a potential electrical hazard.

    Product
    Dimension EXL with LM, Dimension EXL 200, Dimension RxL, Dimension RxL HM, Dimension RxL Max, Dimension RxL Max HM, Dimension Xpand, Dimension Xpand HM, Dimension Xpand Plus, Dimension Xpand Plus HM. The Dimension EXL clinical chemistry system is a discrete…
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Food)·F-2287-2015·2015-05-20

    Magic Valley Fresh Frozen Recalls Chopped Spinach Due to Pesticide Residue

    Magic Valley Fresh Frozen, Inc. is recalling various brands of chopped and cut leaf spinach because unapproved pesticide Lambda-Cyhalothrin was found at levels higher than 0.01 ppm.

    Product
    Bountiful Harvest Chopped Spinach, KEEP FROZEN, Net Wt. 3 LBS. (1.36kg), Case with 12; Chopped Spinach (Cheney Brothers) 3 pounds, 12 per case; Essential Everyday Chopped Spinach Net Wt. 10 oz. (283g), 24 per case; Essential Everyday Chopped Spinach Net wt. 16 oz. (1 LB)…
    Category
    Food
    Distribution
    6 states
  • ModerateFDA (Food)·F-2252-2015·2015-05-20

    Poco Dolce Chocolate Tiles Recalled for Missing Milk Labeling

    Poco Dolce Confections is recalling bittersweet chocolate tiles because milk was not listed as an ingredient on the label.

    Product
    Poco Dolce Bittersweet Chocolate: Almond Coconut Tile, sea salt topped; 0.6 oz (17 grams) San Francisco CA. Ingredients: Bittersweet Chocolate (Chocolate Liquor, Sugar, Cocoa Butter, Butter, Soy Lecithin, Pure Vanilla) Almonds, Coconut, Grey Sea Salt. May contain traces of…
    Category
    Food
    Distribution
    18 states
  • ModerateFDA (Food)·F-2257-2015·2015-05-20

    Purely Elizabeth Muesli Recalled for Undeclared Sulfur Dioxide

    Natural Foodworks Group is recalling Purely Elizabeth Cranberry Cashew Ancient Grain Muesli because it contains undeclared sulfur dioxide.

    Product
    Purely Elizabeth Cranberry Cashew Ancient Grain Muesli, 10 ounces, packaged in plastic bag sealed into paper cartons, 6 packages per case, Manufactured by Natural Foodworks Group, LLC. Denver, CO
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1082-2015·2015-05-20

    Alvogen Recalls Nitrofurantoin Capsules Due to Failed Dissolution Test

    Alvogen, Inc. is recalling Nitrofurantoin Monohydrate/Macrocrystalline capsules because they failed a dissolution specification test.

    Product
    NITROFURANTOIN MONOHYDRATE/ MACROCRYSTALLINE — NITROFURANTOIN MONOHYDRATE/ MACROCRYSTALLINE (NITROFURANTOIN MONOHYDRATE/MACROCRYSTALLINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1603-2015·2015-05-20

    Biomerieux Recalls Vitek 2 Fungal Susceptibility Cards Due to QC Errors

    Biomerieux Inc is recalling Vitek 2 Fungal Susceptibility Cards because they produce Out-of-Range-Low Flucytosine QC results for Candida krusei. The affected products were distributed to foreign subsidiaries and distributors.

    Product
    Vitek 2 AST-YS01 REF 22 108, Fungal Susceptibility Card, 20 cards per carton, IVD. Intended for use with the Vitek 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of clinically significant yeasts to antifungal agents when used as…
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0995-2015·2015-05-20

    Akorn Recalls Sulfamethoxazole and Trimethoprim Oral Suspension for Dissolution Failure

    Akorn, Inc. is recalling specific lots of Sulfamethoxazole and Trimethoprim Oral Suspension because the sulfamethoxazole failed to meet dissolution specifications.

    Product
    SULFAMETHOXAZOLE AND TRIMETHOPRIM ORAL SUSPENSION, USP,200 mg/ 40 mg per 5mL, CHERRY FLAVOR, 16 fl oz (473 mL) bottles (NDC 50383-0823-16), Rx only, HI-TECH PHARMACAL CO. INC, Amityville, NY 11701
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1600-2015·2015-05-20

    Synthes Recalls TFNA Proximal Femoral Nails Due to Locking Mechanism Defect

    Synthes, Inc. is recalling 8,175 TFNA Proximal Femoral Nails because the locking mechanism was assembled too close to the top, potentially causing surgical delays.

    Product
    TFN-ADVANCED Proximal Femoral Nailing System (TFNA); for treatment of fractures in orthopedics and trauma.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1032-2015·2015-05-20

    Carvedilol 1.25 mg/mL Recalled for Sterility and Stability Concerns

    Health Innovations Pharmacy is recalling Carvedilol 1.25 mg/mL due to quality control issues affecting sterility and stability data.

    Product
    Carvedilol 1.25 mg/mL, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0996-2015·2015-05-20

    Akorn Recalls Sulfamethoxazole and Trimethoprim Oral Suspension for Dissolution Failure

    Akorn, Inc. is recalling specific lots of Sulfamethoxazole and Trimethoprim Oral Suspension because the sulfamethoxazole component failed to meet dissolution specifications.

    Product
    SULFAMETHOXAZOLE AND TRIMETHOPRIM ORAL SUSPENSION, USP,200 mg/ 40 mg per 5mL, GRAPE FLAVOR, 16 fl oz (473 mL) bottles (NDC 50383-0824-16), Rx only, HI-TECH PHARMACAL CO. INC, Amityville, NY 11701
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1605-2015·2015-05-20

    BioHorizons Recalls Tapered HD Upgrade Set Due to Incorrect Drill Component

    BioHorizons is recalling 48 units of the Tapered HD Upgrade Set because they were packaged with a stainless steel drill instead of the correct titanium component.

    Product
    Tapered HD Upgrade Set, REF TSKHDUS, Non-Sterile, Rx Only, Product Usage Usage: Surgical instruments used in preparation for dental implant placement
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1080-2015·2015-05-20

    Apotex Recalls Subpotent Olanzapine Orally Disintegrating Tablets

    Apotex Inc. is voluntarily recalling 6,467 units of Olanzapine 10 mg orally disintegrating tablets because the drug is subpotent.

    Product
    Olanzapine, Orally Disintegrating Tablets, 10 mg, a) 30-count bottle (NDC 60505-3276-03), b) 100-count blister (NDC 60505-3276-00), Rx only, Manufactured by Apotex Inc. Toronto, Ontario Canada, M9L 1T9
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1601-2015·2015-05-20

    Biomerieux Recalls Vitek 2 Fungal Susceptibility Cards Due to QC Errors

    Biomerieux Inc is recalling Vitek 2 Fungal Susceptibility Cards because they produced Out-of-Range-Low Flucytosine QC results for Candida krusei.

    Product
    Vitek 2 AST-YS06 REF 412 610, Fungal Susceptibility Card, 20 cards per carton, IVD. Intended for use with the Vitek 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of clinically significant yeasts to antifungal agents when used as…
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Food)·F-2251-2015·2015-05-20

    Poco Dolce Bittersweet Chocolate Recalled for Missing Milk Labeling

    Poco Dolce Confections is recalling bittersweet chocolate tiles because the label failed to list milk as an ingredient from butter.

    Product
    Poco Dolce Bittersweet Chocolate: Almond Tile, sea salt topped; 0.6 oz (17 grams) San Francisco CA. Ingredients: Bittersweet Chocolate (Chocolate Liquor, Sugar, Cocoa Butter, Butter, Soy Lecithin, Pure Vanilla) Almonds, Grey Sea Salt. May contain traces of peanuts, tree…
    Category
    Food
    Distribution
    18 states
  • ModerateFDA (Devices)·Z-1607-2015·2015-05-20

    Philips Recalls Nuclear Gamma Cameras Due to Collimator Misalignment

    Philips Medical Systems is recalling 975 nuclear gamma cameras because the collimator exchange carriage and storage cabinet were misaligned.

    Product
    Nuclear gamma cameras (ADAC VERTEX PLUS/SOLUS/CARDIO, ADAC VERTEX V60 & ADAC CARDIO C60) Nuclear gamma cameras intended to produce images depicting the anatomical distribution of single photon and positron emitting radioisotopes with the human body for interpretation by…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1057-2015·2015-05-20

    Health Innovations Pharmacy Recalls Colchicine Capsules Due to Sterility Concerns

    Health Innovations Pharmacy is recalling Colchicine 0.6 mg capsules because inspection observations indicate a lack of assurance regarding sterility and stability data.

    Product
    Colchicine 0.6 mg Caps, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Food)·F-2206-2015·2015-05-20

    Tastefully Simple Recalls Blackberry Syrup Due to Suspected Mold

    Tastefully Simple is recalling specific lots of Blackberry Syrup because of suspected mold presence in some units.

    Product
    Tastefully Simple, Blackberry Syrup, 12 FL oz ( 360 ml), Item 763905. Ingredients: Corn syrup, blackberries, cane sugar, lemon juice, natural flavor. Container consists of Glass, flask bottle with black boot seal over cap/neck of bottle. These multi-product items also…
    Category
    Food
    Distribution
    24 states
  • ModerateFDA (Drugs)·D-1045-2015·2015-05-20

    Health Innovations Pharmacy Recalls Nifedipine and Lidocaine Jelly

    Health Innovations Pharmacy is recalling Nifedipine 0.2% - Lidocaine 2% Jelly due to sterility and stability concerns. The recall covers all lots distributed in North Carolina.

    Product
    Nifedipine 0.2% - Lidocaine 2% Jelly, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0997-2015·2015-05-20

    Akorn Recalls Sulfamethoxazole and Trimethoprim Oral Suspension for Dissolution Failure

    Akorn, Inc. is recalling 8,400 cups of Sulfamethoxazole and Trimethoprim oral suspension because the sulfamethoxazole failed to meet dissolution specifications.

    Product
    SULFAMETHOXAZOLE AND TRIMETHOPRIM ORAL SUSPENSION, USP 800 mg/ 160 mg per 5mL, GRAPE FLAVOR, 20 mL unit dose cup (NDC 50383-0824-20), Rx only, HI-TECH PHARMACAL CO. INC, Amityville, NY 11701
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1065-2015·2015-05-20

    Mission Pharmacal Recalls Sodium Sulfacetamide and Sulfur Wash Kits

    Mission Pharmacal is recalling 1,992 kits of Sodium Sulfacetamide 9% and Sulfur 4.5% Wash due to microbial contamination.

    Product
    Sodium Sulfacetamide 9% and Sulfur 4.5% Wash Kit with Sunscreen, Rx Only, Sunscreen Broad Spectrum SPF 25, Net Wt. 3 oz (85 g), Sodium Sulfacetamide 9% and Sulfur 4.5% Wash Net Wt. 16 oz (454 g), Manufactured for: BioComp Pharma Inc., San Antonio TX, 78230, NDC 44523-616-23
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1612-2015·2015-05-20

    Fujifilm Synapse Cardiovascular Software Recall for Patient Demographic Mismatch

    Fujifilm Medical Systems is recalling Synapse Cardiovascular software versions v4.0.8 and v4.0.8 SR1 because patient demographics in exported reports may not match the clinical reports.

    Product
    Fujifilm Synapse Cardiovascular I ProSolv CardioVascular Synapse Cardiovascular v4.0.8 Synapse Cardiovascular v4.0.8 SR1 Intended Use: Picture Archiving and Communication System Computer, Diagnostic, Programmable
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1019-2015·2015-05-20

    Health Innovations Pharmacy Recalls DHEA Capsules Due to Sterility Concerns

    Health Innovations Pharmacy is recalling DHEA 10 mg SR Capsules because inspection findings indicate a lack of assurance regarding sterility and stability data.

    Product
    DHEA 10 mg SR Caps, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1614-2015·2015-05-20

    Stryker Recalls 80 mm Kinemax Stem Extenders Due to Mislabeling

    Stryker Howmedica Osteonics is recalling four 80 mm Kinemax Stem Extenders because they were shipped in boxes labeled for the 80 mm part but contained 40 mm extenders.

    Product
    Kinemax Stem Extenders, 80 mm, Product Usage: Kinemax Cemented Stem Extenders are modular components designed to be mated with tibial baseplates or femoral components of the Modular Rotating Hinge (MRH), Scorpio Total Stabilizer (TS) or Duracon TS knee replacement systems.…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1048-2015·2015-05-20

    Health Innovations Pharmacy Recalls Phenylephrine Solution Due to Sterility Concerns

    Health Innovations Pharmacy is recalling Phenylephrine 0.5% Solution due to quality control issues that present a risk to sterility and stability.

    Product
    Phenylephrine 0.5% Solution (Bottle), Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155
    Category
    Drug
    Distribution
    1 state
  • ModerateUSDA FSIS·079-2015·2015-05-14

    AA Poultry Recalls Chicken and Turkey Due to Unapproved Substance

    AA Poultry Processing is recalling chicken and turkey products contaminated with trichloro-s-triazinetrione, an unapproved substance.

    Product
    Pine Creek Processing LLC — AA Poultry Processing, LLC Recalls Chicken and Turkey Products Due to Use of Unapproved Substance
    Category
    Food
    Distribution
    Distributed nationwide