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.

19626–19650 of 21751

  • ModerateFDA (Food)·F-0806-2014·2013-12-25

    National Enzyme Co Recalls Dietary Supplements Due to Chloramphenicol Contamination

    National Enzyme Co is recalling specific dietary supplements because they may contain chloramphenicol levels exceeding 0.3 ppb.

    Product
    Dietary Supplements packaged in the following configurations: (1) No-Fenol Chewable, Multi-Enzyme Product for Digestion of Phenolic Foods and Fibers, packaged 180-chewable tablets bottles (SKU 54651). Firm name on the label is Houston Nutraceutical Inc. (HNI), Siloam, AR; (2)…
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-343-2014·2013-12-18

    Oxcarbazepine Tablets Recalled for Potential Subpotency

    Boehringer Ingelheim Roxane Inc. is recalling Oxcarbazepine Tablets, 150 mg, due to out-of-specification assay results and potential lower weight tablets.

    Product
    Oxcarbazepine Tablets, 150 mg, packaged in a) 10 x 10 count Unit-Dose Tablets in blisters packaged in a carton (NDC 0054-0097-20) and b) 100-count bottle (NDC 0054-0097-25), Rx only, Roxane Laboratories, Inc., Columbus, Ohio 43216
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0465-2014·2013-12-18

    Karl Storz Recalls Misidentified Axillent Debakey Grasping Forceps

    Karl Storz is recalling 7 units of Axillent Debakey Grasping Forceps because they were mislabeled as a different model.

    Product
    Axillent Debakey Grasping Forceps, Part No. 33821DYD In general the surgeons use 33821DYD Debakey forceps to grasp tissue.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-329-2014·2013-12-18

    Novartis Recalls Exforge Physician Samples Due to Chemical Contamination

    Novartis is recalling Exforge physician sample bottles due to contamination with Darocur 1173, a photocuring agent used in ink.

    Product
    Exforge (amlodipine and valsartan Tablets) 5/320 mg, Rx only 7 tablets per bottle, Physician Sample - Not For Sale. Manufactured by: Novartis Pharma Stein AG Stein, Switzerland. Distributed by: Novartis Pharmaceuticals Corp. East Hanover, New Jersey 07936 - NDC # 0078-9490-07
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-331-2014·2013-12-18

    Novartis Recalls Multiple Prescription Medications Due to Chemical Contamination

    Novartis is recalling physician sample bottles of several prescription medications due to contamination with a photocuring agent found in ink.

    Product
    Exforge HCT (amlodipine, valsartan, hydrochlorothiazide) 5/160/12.5 mg, Rx only, 7 tablets per bottle, Physician Sample - Not For Sale. Manufactured by: Novartis Pharma Stein AG Stein, Switzerland. Distributed by: Novartis Pharmaceuticals Corp. East Hanover, New Jersey 07936…
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0469-2014·2013-12-18

    Omnyx Digital Pathology Software Recalled for Incorrect Measurement Display

    Omnyx LLC is recalling Digital Pathology System (DPS) Software version 1.1 because its annotation tools may display incorrect measurements and area calculations for regions of interest on scanned slides.

    Product
    Digital Pathology System (DPS) Software version 1.1 The Omnyx" Integrated Digital Pathology system, which consists of a whole slide scanner and associated software applications, is a scanning, receiving, storing, managing, annotating and computer monitor viewing system for…
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-337-2014·2013-12-18

    Novartis Recalls Physician Sample Tablets Due to Chemical Contamination

    Novartis is recalling physician sample bottles of several prescription medications, including Tekturna, due to contamination with a photocuring agent.

    Product
    Tekturna (aliskiren) Tablets 150 mg, 7 tablets per bottle, Physician Sample-Not For Sale, Rx only. Manufactured by: Novartis Pharma Productions GmbH Wehr, Germany. Distributed by: Novartis Pharmaceuticals Corp. East Hanover, New Jersey 07936, NDC # 0078-9485-07
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-327-2014·2013-12-18

    Novartis Recalls Diovan and Other Tablets Due to Chemical Contamination

    Novartis is recalling physician sample bottles of Diovan and other tablets because they were contaminated with Darocur 1173, a photocuring agent used in inks.

    Product
    Diovan (valsartan) 320 mg per tablet, 7 Tablets per bottle, Rx only Physician Sample Not For Sale, Manufactured by: Novartis Pharmaceuticals Corporation Suffern, NY 10901 for Novartis Pharmaceuticals Corporation East Hanover, NJ 07936, NDC # 0078-9360-07
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-328-2014·2013-12-18

    Novartis Recalls Exforge Physician Samples Due to Chemical Contamination

    Novartis is recalling Exforge physician sample bottles due to contamination with Darocur 1173, a photocuring agent found in ink.

    Product
    Exforge (amlodipine and valsartan Tablets) 5/160 mg, Rx only 7 tablets per bottle, Physician Sample - Not For Sale. Manufactured by: Novartis Pharma Stein AG Stein, Switzerland. Distributed by: Novartis Pharmaceuticals Corp. East Hanover, New Jersey 07936 - NDC # 0078-9488-07
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0482-2014·2013-12-18

    Accumetrics Recalls VerifyNow IIb/IIIa Test Kits Due to Incorrect Instructions

    Accumetrics is recalling VerifyNow IIb/IIIa Test Kits because they contain incorrect instructions regarding the time limit for performing the test after sample collection.

    Product
    VerifyNow IIb/IIIa Test, 10-Test Kit, Catalog No. 85310, 10 tests/box; 690 total tests. The VerifyNow IIb/IlIa Test is a semi-quantitative, whole blood platelet function test used to measure glycoprotein (GP) lIb/IlIa receptor blockade in patients treated with abciximab or…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0817-2014·2013-12-18

    Sugar-Free Carrot Cake Recalled for Missing Phenylketonuria Warning

    Cakes & More Delight's is recalling sugar-free carrot cakes because they contain aspartame but lack the required phenylketonuria warning.

    Product
    Sugar free cake: Carrot flavor, Package size: 4 oz, 12 oz.
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Food)·F-0822-2014·2013-12-18

    Sugar-Free Almond Cake Recalled for Missing Phenylketonuria Warning

    Cakes & More Delight's is recalling sugar-free almond cakes because the packaging lacks a required warning for individuals with phenylketonuria (PKU).

    Product
    Sugar free cake: Almond flavor. Package size:12 oz
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0467-2014·2013-12-18

    Stryker Recalls Accolade II Hip Stems Due to Packaging Error

    Stryker is recalling 20 Accolade II Hip Stems because a Size #3 was found packaged with a Size #5. The error poses a risk of incorrect implant selection.

    Product
    1) Accolade II 127 Neck Angle Hip Stem, Size # 3 2) Accolade II 127 Neck Angle Hip Stem, Size #5 Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430 USA Telephone # +1 201-831-5000 Stryker France ZAC Satolas Green Pusignan Av de Satolas Green 69881…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0471-2014·2013-12-18

    Beckman Coulter Recalls LH 750 and LH 780 Hematology Systems

    Beckman Coulter is recalling LH 750 and LH 780 Hematology Systems because optical degradation may delay reporting results for specific blood cell counts.

    Product
    Coulter LH 780 Hematology Analyzer, Part No. 723585, A90728 Product Usage: Coulter LH 780 Hematology Analyzer is a is a quantitative, automated hematology analyzer and leukocyte differential counter For In Vitro Diagnostic Use in clinical laboratories. The Coulter¿ LH 780…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0474-2014·2013-12-18

    Synthes Trochanteric Fixation Nail Recalled for Incorrect Packaging Labeling

    Synthes USA is recalling 12 Trochanteric Fixation Nails because the packaging incorrectly lists the nail's length and diameter.

    Product
    Synthes Trochanteric Fixation Nail As part of the Synthes Trochanteric Fixation Nail (TFN) System, the TFN Nail is intended to treat stable and unstable fractures of the proximal femur.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0475-2014·2013-12-18

    Zimmer Trabecular Metal Total Ankle Talar Component Recall for Residue

    Zimmer, Inc. is recalling specific Total Ankle Talar Components because routine monitoring found potential elevated levels of manufacturing residue on the implants.

    Product
    Zimmer Trabecular Metal Total Ankle Talar Component Left Sizes 1-6 Total ankle arthroplasty is intended to provide a patient with limited mobility by restoring alignment, reducing pain and preserving the flexion/extension movement within the ankle joint.The Zimmer Trabecular…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-346-2014·2013-12-18

    Lupin Recalls Ethambutol Hydrochloride Tablets Due to Impurity

    Lupin Pharmaceuticals is recalling 4,896 bottles of Ethambutol Hydrochloride 400 mg tablets because of an out-of-specification impurity result.

    Product
    ETHAMBUTOL HYDROCHLORIDE — ETHAMBUTOL HYDROCHLORIDE (ETHAMBUTOL HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-338-2014·2013-12-18

    Novartis Recalls Tekturna Tablets Due to Chemical Contamination

    Novartis is recalling Tekturna physician sample bottles contaminated with Darocur 1173, a photocuring agent found in ink.

    Product
    Tekturna (aliskiren) Tablets 300 mg, 7 tablets per bottle, Physician Sample-Not For Sale, Rx only. Manufactured by: Novartis Pharma Produktions GmbH Wehr, Germany. Distributed by: Novartis Pharmaceuticals Corp. East Hanover, New Jersey 07936, NDC # 0078-9486-07
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-334-2014·2013-12-18

    Novartis Recalls Exforge Physician Samples Due to Chemical Contamination

    Novartis is recalling Exforge physician sample bottles due to contamination with Darocur 1173, a photocuring agent found in ink.

    Product
    Exforge (amlodipine and valsartan, Tablets) 10/320 mg, Rx only, 7 tablets per bottle, Physician Sample - Not For Sale. Manufactured by: Novartis Pharma Stein AG Stein, Switzerland. Distributed by: Novartis Pharmaceuticals Corp. East Hanover, New Jersey 07936, NDC # 0078-9491-07
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0473-2014·2013-12-18

    Synthes TomoFix Osteotomy System Recalled for Surgical Technique Guide Labeling Error

    Synthes USA HQ, Inc. is recalling the TomoFix Osteotomy System due to a labeling error in the Surgical Technique Guide that may cause surgical delays.

    Product
    Synthes TomoFix Plates The Synthes J5606-C TomoFix Osteotomy System is used for open and closed wedge osteotomies of the medial proximal tibia, lateral proximal tibia, medial and lateral distal femur, treatment of bone and joint deformities, fractures, and malalignment caused…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0483-2014·2013-12-18

    Stryker Recalls Cancellous Bone Screws Due to Packaging Error

    Stryker is recalling specific Cancellous Bone Screws because a 5.5 mm screw was found in packaging labeled for a 6.5 mm screw.

    Product
    Stryker Orthopaedics Cancellous Bone Screw Howmedica Osteonics Corp. Stryker France Both the 6.4 mm diameter, 25mm length, Cancellous Bone Screws (Cat no 2030-6525-1) and the 5.5mm diameter, 40 mm length Cancellous Bone Screws (Cat no 2029-5540-1) are cleared for use in…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0821-2014·2013-12-18

    Sugar-Free Corn Cake Recalled for Missing Phenylketonuria Warning

    Cakes & More Delight's is recalling sugar-free corn cakes because the packaging lacks a warning for individuals with phenylketonuria (PKU). The product contains aspartame.

    Product
    Sugar free cake: Corn. Package size: 4 oz, 12 oz
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-330-2014·2013-12-18

    Novartis Recalls Physician Sample Blood Pressure Medications Due to Chemical Contamination

    Novartis is recalling physician sample bottles of several blood pressure and cholesterol medications due to contamination with a photocuring agent used in packaging inks.

    Product
    Exforge HCT (amlodipine, valsartan, hydrochlorothiazide) 10/320/25 mg, Rx only, 7 tablets per bottle, Physician Sample - Not For Sale. Manufactured by: Novartis Pharma Stein AG Stein, Switzerland. Distributed by: Novartis Pharmaceuticals Corp. East Hanover, New Jersey 07936…
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-339-2014·2013-12-18

    Novartis Recalls Tekturna HCT Physician Samples Due to Chemical Contamination

    Novartis is recalling physician sample bottles of Tekturna HCT and other medications due to contamination with Darocur 1173, a photo-curing agent.

    Product
    Tekturna HCT (aliskiren and hydrochlorothiazide) Tablets 150/12.5 mg, 7 tablets per bottle, Physician Sample-Not For Sale, Rx only, Manufactured by: Novartis Pharma Productions GmbH Wehr, Germany. Distributed by: Novartis Pharmaceuticals Corp. East Hanover, New Jersey 07936…
    Category
    Drug
    Distribution
    Distributed nationwide