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.

13526–13550 of 21617

  • ModerateFDA (Drugs)·D-0161-2017·2016-12-07

    Burel Pharmaceuticals Recalls Phenazopyridine Hydrochloride Tablets Due to CGMP Deviations

    Burel Pharmaceuticals is recalling 17,788 bottles of Phenazopyridine Hydrochloride Tablets due to manufacturing deviations that may cause assay or content uniformity failures.

    Product
    Phenazopyridine Hydrochloride Tablets, USP, 100 mg, 100 count bottles, Rx only, Manufactured for: Burel Pharmaceuticals, Inc., Richland, MS --- NDC 35573-304-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0545-2017·2016-12-07

    Mel-O Cream Fried Danish Recalled Due to Foreign Object Contamination

    Mel-O Cream Donuts International is recalling specific batches of Fried Danish because a human fingertip was found in the product filling line.

    Product
    Fried Danish; Best If Used By 02/25/2017; Batch 162724711; NET WT 11.25 Pounds; Approximate Unit Count: 89 pcs.
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-0670-2017·2016-12-07

    Baxter Recalls Sigma Spectrum Infusion Pumps Due to Speaker Failure Risk

    Baxter Healthcare is recalling 5,976 Sigma Spectrum Infusion Pumps because some speakers may fail prematurely, potentially affecting audible alarms.

    Product
    sigma spectrum VOLUMETRIC INFUSION PUMP with Master Drug Library, V6 Spectrum Infusion Pump, Product Code 35700BAX and 35700BAXR, Unique Device Identifier GTIN 00085412091570, Rx ONLY -- Sigma, LLC Medina, NY 14103 --- NOTE: The speakers are a part of the rear case assembly…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0160-2017·2016-12-07

    Burel Pharmaceuticals Recalls Indiomin MB Capsules Due to Manufacturing Deficiencies

    Burel Pharmaceuticals is recalling 795 bottles of Indiomin MB capsules due to manufacturing deviations that may cause assay or content uniformity failures.

    Product
    Indiomin MB URINARY ANTISEPTIC, ANTISPASMODIC Capsules, Each capsule contains: Methenamine 120 mg, Monobasic Sodium Phosphate 40.8 mg, Methylene Blue, 10 mg; Hyoscyamine Sulfate, 0.12 mg, 100 count, Rx only, Manufactured for: BUREL PHARMACEUTICALS, NDC 35573-315-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0499-2017·2016-11-30

    Infiniti Creations Recalls Amino Complex Formula Due to Misbranding

    Infiniti Creations, LLC is voluntarily recalling Amino Complex Formula HCG Drops due to misbranding and potential undeclared HCG.

    Product
    Amino Complex Formula. 2oz HCG Drops. Blue Glass.
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0629-2017·2016-11-30

    DePuy Spine Recalls SKYLINE Anterior Cervical Plate System Screws

    DePuy Spine is recalling 21 units of SKYLINE Anterior Cervical Plate System Constrained Self-Tapping Screws because Variable Ti screws may have been incorrectly packaged with them.

    Product
    DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM CONSTRAINED SELF-TAPPING SCREW 4 x 18mm Item Code: 186862018 The SKYLINE¿ Anterior Cervical Plate System is indicated for stabilization from C2 to C7 for degenerative disc disease (DDD) (defined as back pain of discogenic…
    Category
    Medical Device
    Distribution
    15 states
  • ModerateFDA (Food)·F-0493-2017·2016-11-30

    Infiniti Creations Recalls HCG Complex Drops for Misbranding

    Infiniti Creations, LLC is voluntarily recalling HCG Complex drops due to misbranding and potential undeclared HCG content.

    Product
    HCG Complex. 2oz HCG Drops. Blue Plastic.
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0648-2017·2016-11-30

    Beckman Coulter Recalls AQUIOS Lyse Reagent Kit for Increased Flags

    Beckman Coulter is recalling the AQUIOS Lyse Reagent Kit because it may cause increased notifications and flags on AQUIOS CL systems, potentially delaying test results.

    Product
    AQUIOS Lyse Reagent Kit, Catalog No. B23538 Product Usage: AQUIOS Lysing Reagent Kit is used as part of the AQUIOS flow cytometer system. The kit consists of two reagents used by AQUIOS flow cytometers to prepare whole blood samples for analysis of white blood cells.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0504-2017·2016-11-30

    Westby Coop Creamery Recalls 4% Cottage Cheese for Phosphatase Residue

    Westby Coop Creamery is recalling 4% cottage cheese sold in Wisconsin and Illinois because the product tested positive for residue phosphatase.

    Product
    4% cottage cheese packaged in 16-ounce, 22-ounce, and 24-ounce plastic containers; under the Westby, Food Club, Oberweis, and Shurfine brand names.
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Drugs)·D-0152-2017·2016-11-30

    Akorn Recalls Desoximetasone Ointment for Stability Failures

    Akorn Inc. is recalling Desoximetasone Ointment USP, 0.25%, due to failed stability specifications and phase separation.

    Product
    Desoximetasone Ointment USP, 0.25%, a) 15 g tubes (NDC 61748-206-15 and b) 60 g tubes (NDC 61748-206-60, Marketed by Versapharm Inc., An Akorn Company, Lake Forest, IL, Manufactured by Hi-Tech, Pharmacal Co, Inc., Amityville, NY
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0644-2017·2016-11-30

    Synthes 2.5 mm Reaming Rods Recalled for Delaminating Peel Pouches

    Synthes (USA) Products LLC is recalling 2,157 sterile 2.5 mm reaming rods because their peel pouches are delaminating.

    Product
    2.5 mm Reaming Rod W/Ball Tip 650 mm, Sterile
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0630-2017·2016-11-30

    DePuy Spine Recalls SKYLINE Anterior Cervical Plate Screws

    DePuy Spine is recalling 12 SKYLINE Anterior Cervical Plate System screws because they may have been packaged with the wrong screw type.

    Product
    DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM CONSTRAINED OVERSIZED SCREW 4.5 x 18mm Item Code: 186864018 The SKYLINE¿ Anterior Cervical Plate System is indicated for stabilization from C2 to C7 for degenerative disc disease (DDD) (defined as back pain of discogenic…
    Category
    Medical Device
    Distribution
    15 states
  • ModerateFDA (Food)·F-0491-2017·2016-11-30

    Infiniti Creations Recalls Believe HCG Drops Due to Misbranding

    Infiniti Creations is voluntarily recalling Believe HCG Drops due to misbranding and potential undeclared HCG content.

    Product
    Believe HCG. 2oz HCG Drops. Blue Glass.
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0626-2017·2016-11-30

    DePuy Spine Recalls SKYLINE Anterior Cervical Plate System Screws

    DePuy Spine is recalling SKYLINE Variable Self-Tapping Screws because the packaging may contain Constrained Ti screws instead.

    Product
    DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM VARIABLE SELF-TAPPING SCREW 4.0 x 20mm Item Code: 186852020 The SKYLINE¿ Anterior Cervical Plate System is indicated for stabilization from C2 to C7 for degenerative disc disease (DDD) (defined as back pain of discogenic…
    Category
    Medical Device
    Distribution
    15 states
  • ModerateFDA (Devices)·Z-0642-2017·2016-11-30

    Synthes Extraction Hook Recall Due to Peel Pouch Delamination

    Synthes (USA) Products LLC is recalling 114 sterile extraction hooks because their peel pouches are delaminating, potentially compromising sterility.

    Product
    Extraction Hook - Sterile for TI Cannulated Nails
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0627-2017·2016-11-30

    DePuy Spine Recalls SKYLINE Anterior Cervical Plate System Screws

    DePuy Spine is recalling SKYLINE Variable Self-Tapping Screws because the packaging may contain Constrained Ti screws instead.

    Product
    DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM VARIABLE SELF-TAPPING SCREW 4.0 x 26mm Item Code: 186852026 The SKYLINE¿ Anterior Cervical Plate System is indicated for stabilization from C2 to C7 for degenerative disc disease (DDD) (defined as back pain of discogenic…
    Category
    Medical Device
    Distribution
    15 states
  • ModerateFDA (Food)·F-0494-2017·2016-11-30

    Infiniti Creations Recalls HCG Diet Plan Drops Due to Misbranding

    Infiniti Creations, LLC is voluntarily recalling HCG Diet Plan drops due to misbranding and potential undeclared HCG content.

    Product
    Official HCG Diet Plan. 1oz, 2oz & 4oz HCG Drops. Amber Plastic and Glass.
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0656-2017·2016-11-30

    Synthes Flexible Shaft Orthopedic Surgical Instrument Recalled for Non-Conforming Material

    Synthes (USA) Products LLC is recalling 198 units of Flexible Shaft orthopedic surgical instruments because non-conforming material was used in their manufacture.

    Product
    Synthes Flexible Shaft, Orthopedic manual surgical instrument The Flexible shafts are intended for use as an optional reaming step in intramedullary nailing systems.
    Category
    Medical Device
    Distribution
    Distributed nationwide