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.

10376–10400 of 21617

  • ModerateFDA (Drugs)·D-0845-2018·2018-06-20

    RIJ Pharmaceutical Recalls Children's Acetaminophen Elixir Due to Microbial Count

    RIJ Pharmaceutical LLC is recalling 1,272 bottles of RPC Children's Non-Aspirin Elixir due to out-of-specification microbial counts in a water sample.

    Product
    RPC Children's Non-Aspirin (Acetaminophen 160 mg) Elixir, packaged in 4 FL. OZ. (118 mL), RIJ PHARMACETUICAL CORPORATION, 40 COMMERCIAL AVENUE, MIDDLETOWN, NY 10941, NDC 53807-129-04, UPC 353807129048
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0874-2018·2018-06-20

    BioDiagnostic International Recalls Monsel's Solution for CGMP Deviations

    BioDiagnostic International is recalling 1,000 boxes of Monsel's Solution (Ferric Subsulfate) 20% because the product was not manufactured under current good manufacturing practices.

    Product
    Monsel's Solution (Ferric Subsulfate), 20%, packaged as 12 single application vials and 12 applicators, 8 mL per box, Manufactured For: MedGyn Products, Inc., 100 W. Industrial Rd., Addison, IL 60101 USA; Manufactured By: BioDiagnostics Intl, 555 West Lambert Road Unit-C, Brea,
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0847-2018·2018-06-20

    RIJ Pharmaceutical Recalls Acetaminophen Elixir Due to Microbial Count

    RIJ Pharmaceutical is recalling 228 bottles of RPC APAP Elixir due to out-of-specification microbial counts in a water sample.

    Product
    RPC APAP Elixir (Acetaminophen 160mg), Packaged in 16 FL. OZ. (473 mL) bottles, RIJ PHARMACEUTICAL CORPORATION, 40 COMMERCIAL AVENUE, MIDDLETOWN, NY, NDC 53807-129-16, UPC 353807129161
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0870-2018·2018-06-20

    MBi Nutraceuticals Recalls Stomach Calm and Other Homeopathic Products

    MBi Nutraceuticals is voluntarily recalling Stomach Calm and other homeopathic products due to inadequate manufacturing controls.

    Product
    Stomach Calm, Calms Upset Stomach and Aids in Treatment of Simple Diarrhea, 8 fl. oz., liquid 8 ounce amber PET bottle with Black CRC Cap, MBi Nutraceuticals Lindon, UT 84042. Bar Code: 3 58301 38414 2
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2170-2018·2018-06-20

    BioMérieux PREVI Color Gram Reagents Recalled Due to Temperature Excursion

    BioMérieux is recalling PREVI Color Gram reagents shipped to Guadeloupe that experienced a temperature excursion exceeding acceptable limits.

    Product
    The PREVI¿ Color Gram dyes are used with the PREVI¿ Color Gram instrument to stain bacterial and fungal microorganisms for direct examination, according to Gram s method. The PREVI¿ Color Gram instrument sprays the PREVI¿ Color Gram reagents onto microscope slides which have b
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Food)·F-1578-2018·2018-06-20

    Yukon Jackson Coffee Toffee Recalled for Missing Pecan Allergen Labeling

    Yukon Jackson is recalling Coffee Toffee because pecans are listed in the ingredients but not in the 'Contains' statement.

    Product
    Coffee Toffee - 4 oz. packages. UPC 6 55974 89001 2. The label is read in parts: "***Ingredients: butter (milk), sugar, bittersweet chocolate 60% (cocoa liquor, emulsifier, soya lecithin, vanilla), coffee, pecans *** Contains: milk & soya ***".
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2183-2018·2018-06-20

    Zimmer Biomet Recalls Vanguard Knee System Tibial Bearings Due to Labeling Error

    Zimmer Biomet is recalling 169 Vanguard Knee System PS Tibial Bearings because the label master file was incorrectly set up, though the physical product is correctly marked.

    Product
    Vanguard Knee System PS Tibial Bearing, Part Number 183621 Intended for use in knee joint replacement procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0873-2018·2018-06-20

    MBi Nutraceuticals Recalls Homeopathic Teething and Nausea Drops

    MBi Nutraceuticals is voluntarily recalling several homeopathic products, including teething and nausea drops, due to a lack of adequate manufacturing controls.

    Product
    Silver-Zinc Throat Spray, HOMEOPATHIC IMMUNE DEFENSE, 50PPM, 4oz/50 ppm/ 120ml,amber PET bottle with white sprayer. MBi Nutraceuticals Lindon, Utah 84042 USA. Bar Code: 3 58301 18118 9
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0851-2018·2018-06-20

    RIJ Pharmaceutical Recalls Senna Syrup Due to Microbial Count Deviation

    RIJ Pharmaceutical LLC is recalling Senna Syrup (Sennosides A and B) due to an out-of-specification total aerobic microbial count in a water sample.

    Product
    SENNA SYRUP — SENNA SYRUP (SENNOSIDES A AND B)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0853-2018·2018-06-20

    RIJ Recalls Gericare Iron Supplement Elixir Due to Microbial Count

    RIJ Pharmaceutical LLC is recalling Gericare Iron Supplement Elixir due to out-of-specification microbial counts in a water sample.

    Product
    Gericare Iron Supplement Elixir Ferrous Sulfate 220 mg, packaged in 16 fl oz. (473 mL) bottles, Dist by: Gericare Pharmaceuticals Corp. 1650 63rd Street Brooklyn, NY 11204, NDC 57896-709-16, UPC 57896709167
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2163-2018·2018-06-20

    Smith & Nephew Recalls GENESIS II Tibial Punches Due to Size Defect

    Smith & Nephew is recalling 5 units of GENESIS II 13 mm tibial punches because they are 2 mm smaller than the specified size.

    Product
    smith&nephew GENESIS(R) II TIBIAL Punch, 13 MM, REF 71440408, QTY: (1)
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2144-2018·2018-06-20

    Philips IntelliVue MX40 Patient Monitor Recall for Missing Warning Statements

    Philips is recalling 94 IntelliVue MX40 Patient Monitors because five warning statements are missing from the instructions for use.

    Product
    IntelliVue MX40 Patient Monitor, Software Versions B.05, B.06, B.06.5X, Model 867146
    Category
    Medical Device
    Distribution
    53 states
  • ModerateFDA (Drugs)·D-0852-2018·2018-06-20

    RIJ Recalls Gericare Diocto Liquid Due to Microbial Count Deviation

    RIJ Pharmaceutical LLC is recalling Gericare Diocto Liquid because a water sample showed an out-of-specification total aerobic microbial count.

    Product
    Gericare Diocto Liquid (Docusate Sodium 50mg), 50 mg/5 mL, packaged in 16 FL OZ (473 mL) bottles, Dist by: Gericare Pharmaceuticals Corp. 1650 63rd Street, Brooklyn, NY 11204, NDC 57896-403-16, UPC 357896-403164,
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0844-2018·2018-06-20

    RIJ Pharmaceutical Recalls Senna Syrup Due to Microbial Contamination

    RIJ Pharmaceutical LLC is recalling RPC Senna Syrup due to out-of-specification microbial counts in a water sample.

    Product
    RPC Senna Syrup (Sennosides 8.8mg), packaged in 8 fl oz (237 mL) bottles, RIJ Pharmaceuticals Corporation 40 Commercial Avenue, Middletown, NJ 10941, NDC 5380755608, UPC 353807556080
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2137-2018·2018-06-20

    Thermo Fisher Recalls Remel SUPERPACK CS/ 500 SEG/FLASK Due to Performance Failure

    Thermo Fisher is recalling 67 units of Remel SUPERPACK CS/ 500 SEG/FLASK because the product may fail performance testing for Staphylococcus aureus.

    Product
    remel SUPERPACK CS/ 500 SEG/FLASK, REF R01626, Qty:50, plate label: REMEL MH W/OXACILLIN Product Usage: Recommended for the use in qualitative procedures to screen Staphylococcus aureus for resistance to penicillinase- resistance penicillins (e.g., methicillin, nafcillin, and
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2141-2018·2018-06-20

    Philips IntelliVue MX40 Patient Monitor Recall for Missing Warning Statements

    Philips is recalling IntelliVue MX40 Patient Monitors because five warning statements are missing from the instructions for use.

    Product
    IntelliVue MX40 Patient Monitor, Software Versions B.05, B.06, B.06.5X, Model 865350
    Category
    Medical Device
    Distribution
    53 states
  • ModerateFDA (Food)·F-1576-2018·2018-06-20

    Yukon Jackson Recalls Herd of Turtles Milk Chocolate for Allergen Labeling Error

    Yukon Jackson is recalling Herd of Turtles milk chocolate because pecans are listed in the ingredients but missing from the 'Contains' statement.

    Product
    Herd of Turtles confection milk chocolate, 4 oz. and 8 oz. packages. UPC of 4 oz: 6 55974 89004 3. UPC of 8 oz: 6 55974 89008 1. The label is read in parts: "***INGREDIENTS: MILK CHOCOLATE 35% (SUGAR, COCOA BUTTER, WHOLE MILK POWDER, EMULSIFIER, SOYA LECITHIN, VANILLA), C
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0872-2018·2018-06-20

    MBi Recalls Homeopathic Products Due to Manufacturing Control Deficiencies

    MBi Distributing Inc. is voluntarily recalling several homeopathic products, including Argentum Elixir, due to a lack of adequate manufacturing controls.

    Product
    Argentum Elixir Colloidal Silver, 50 PPM Homeopathic Infection Fighter, 8 fl oz. amber PET bottle with white sprayer. MBi nutraceuticals Lindon UT, 84042. Bar COde: 3 58301 18114 1
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0848-2018·2018-06-20

    GeriCare Senna Syrup Recalled for Microbial Contamination

    RIJ Pharmaceutical LLC is recalling GeriCare Senna Syrup due to out-of-specification microbial counts in a water sample.

    Product
    GeriCare Senna Syrup (Sennosides 8.8 mg), 8 fl oz (237 mL) bottles, Dist, by Gericare Pharmaceuticals 1650 63rd Street Brooklyn, NY 11204, NDC 57696-452-08, UPC 357896452087
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2168-2018·2018-06-20

    BioMérieux Recalls VITEK 2 Gram Negative Susceptibility Cards Due to Temperature Excursion

    BioMérieux is recalling VITEK 2 Gram Negative Susceptibility Cards shipped to Guadeloupe that experienced a temperature excursion exceeding acceptable limits.

    Product
    The VITEK 2 Gram Negative Susceptibility Card is intended for use with the VITEK 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of clinically significant aerobic gram negative bacilli to antimicrobial agents. Fully automated short-term
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2167-2018·2018-06-20

    BioMérieux Recalls VITEK 2 Gram Positive Susceptibility Cards Due to Temperature Excursion

    BioMérieux is recalling VITEK 2 Gram Positive Susceptibility Cards in Guadeloupe because a shipment experienced a temperature excursion up to 47.8°C, exceeding acceptable limits.

    Product
    The VITEK¿ 2 Gram Positive Susceptibility Card is intended for use with the VITEK 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of Staphylococcus spp., Enterococcus spp., and S. agalactiae to antimicrobial agents. Fully automated short
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0842-2018·2018-06-20

    RIJ Pharmaceutical Recalls Antacid Due to Microbial Count Deviation

    RIJ Pharmaceutical LLC is recalling Preferred Plus Pharmacy Antacid Extra Strength due to out-of-specification microbial counts in a water sample.

    Product
    Preferred Plus Pharmacy Antacid Extra Strength (Aluminum Hydroxide 400mg, Magnesium Hydroxide 400mg, Simethicone 40 mg), packaged in 12 FL. OZ. (355 mL), Manufactured By: RIJ Pharmaceutical Corp.40 Commercial Avenue, Middletown, NY 10941, Distributed by: Kinray Inc. Whitestone,
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2171-2018·2018-06-20

    BioMérieux Recalls Color Gram 2 Stains Due to Temperature Excursion

    BioMérieux is recalling Color Gram 2 stains in Guadeloupe after a shipment experienced a temperature excursion exceeding acceptable limits.

    Product
    Color Gram 2 (COLOR GRAM 2 - F), these stains are used to stain bacterial and fungal microorganisms for direct examination, according to the Gram method. Dye and chemical solution stains for medical purposes are mixtures of synthetic or natural dyes or nondye chemicals in sol
    Category
    Medical Device
    Distribution
    0 states