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.

1351–1375 of 3531

  • ModerateFDA (Drugs)·D-0942-2023·2023-08-02

    Safe Tussin DM Cough Suppressant Recalled for Manufacturing Deviation

    Kramer Laboratories is recalling Safe Tussin DM Cough + Chest Congestion due to a manufacturing deviation involving non-food grade lubricant in the mixing vessel. Affected lots 8753, 8753A, and 8659 were distributed nationwide.

    Product
    Safe Tussin DM Cough + Chest Congestion (Dextromethorphan HBr/ Cough Suppressant Guaifenesin/Expectorant), packaged in 4.0 FL OZ(118mL), 2020 Kramer Laboratories, Inc. Bridgewater, NJ 08807
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1294-2023·2023-08-02

    Trader Joe's Unexpected Broccoli Cheddar Soup recalled for insect contamination

    Winter Gardens Quality Foods is recalling Trader Joe's Unexpected Broccoli Cheddar Soup due to insects found in frozen broccoli florets. The recall affects 10,889 cases distributed to FL, IL, CA, TX, WA, PA, and CT.

    Product
    Trader Joes Unexpected Broccoli Cheddar Soup ( Sharp Cheddar Cheese & Unexpected Cheddar Cheese )Keep Refrigerated, NET WT. 20 OZ (1 LB 4 OZ ) 567g, 12 in a Case
    Category
    Food
    Distribution
    7 states
  • ModerateFDA (Food)·F-1295-2023·2023-08-02

    Natural Systems Multi Vitamin Recalled for Low Magnesium Content

    FDA analysis found Natural Systems Naturasys Multi Vitamin contains magnesium at only 33.5% of the labeled amount. The recall affects 554 bottles with lot 38883 (expires 07/2024).

    Product
    Natural Systems, Naturasys MULTI VITAMIN HIGH POTENCY AND FORMULATION, Dietary Supplement 60 Tablets
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2226-2023·2023-08-02

    A901 Communication Manager Software Update Not Available for Intellis System

    The A901 Communication Manager application did not receive a timely update to match the A710 Clinician Programmer software release for Intellis Neurostimulation Systems, creating a version mismatch.

    Product
    A901 Communication Manager Application, used in conjunction with the A710 Clinician Programmer application..
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2225-2023·2023-08-02

    Diagnostic Verification Product May Not Meet Shelf Life Stability Specifications

    Ortho-Clinical Diagnostics is recalling VITROS NT-proBNP II Range Verifiers Lot 0090 because the product may not meet shelf life stability specifications. Used for diagnostic system calibration verification.

    Product
    VITROS Immunodiagnostic Products NT-proBNP II Range Verifiers-For in vitro diagnostic use only. For use in verifying the calibration range of the VITROS ECi/ECiQ/3600 Immunodiagnostic Systems and the VITROS 5600/XT 7600 Integrated Systems when used for the quantitative measuremen
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0925-2023·2023-07-26

    Prescription drug recall: Fingolimod capsules fail dissolution specifications

    Ascend Laboratories is recalling 2,652 bottles of Fingolimod capsules nationwide because they failed to meet dissolution specifications, potentially affecting medication effectiveness.

    Product
    FINGOLIMOD — FINGOLIMOD (FINGOLIMOD HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2214-2023·2023-07-26

    Ultrasound reporting software recalled by manufacturer for software issue

    Digisonics has voluntarily recalled OBView ultrasound reporting software versions 4.8.2 SP6 through 4.8.3 due to a software issue. The recall affects 32 units distributed across multiple U.S. states and Aruba.

    Product
    Digisonics OBView Versions 4.8.2 SP6 - 4.8.3, Ultrasound reporting software
    Category
    Medical Device
    Distribution
    19 states
  • ModerateFDA (Drugs)·D-0927-2023·2023-07-26

    FDA Recalls Phenylephrine HCl IV Solution Over Manufacturing Contamination

    Advanced Compounding Solutions is recalling 82 bags of phenylephrine HCl intravenous solution due to potential contamination from manufacturing facility violations. No illnesses have been reported.

    Product
    PHENYLephrine HCl 10mg added to 0.9% Sodium Chloride 250mL, 250 mL IV Bag @60 Total volume), RX only, Advanced Compounding Solutions, 4 Constitution Way Ste L Woburn, MA 01801-1042, NDC: 71546-450-25;
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0924-2023·2023-07-26

    Loteprednol Etabonate Eye Drops Recalled for Out-of-Specification Potency

    Sun Pharmaceutical recalls Loteprednol Etabonate eye drops due to out-of-specification unit dose content in certain lots. Affected bottles may contain incorrect potency levels.

    Product
    LOTEPREDNOL ETABONATE — LOTEPREDNOL ETABONATE (LOTEPREDNOL ETABONATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0939-2023·2023-07-26

    Famotidine tablets recalled for carton labeling error on strength

    Glenmark Therapeutics is recalling famotidine 20 mg tablets after some cartons were labeled with a side label indicating 10 mg instead. The medication inside is correct; only the external carton label is mislabeled.

    Product
    FAMOTIDINE — FAMOTIDINE (FAMOTIDINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2146-2023·2023-07-26

    Aesculap Surgical Needle Recalled for Incorrect Product Code Marking

    Aesculap Implant Systems is recalling Aesculap Surgical Needles (MD610) because they are etched with an incorrect product code. The needles are marked MD611 when they should be marked MD610.

    Product
    Aesculap Surgical Needle, straight, 3 1/2", (90 mm), 13GA, width: 2,400 mm, non-sterile, reusable Article Number: MD610
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateCPSC·23775·2023-07-20

    Pottery Barn Kids Penny Convertible Cribs Recalled for Laceration Hazard

    Williams-Sonoma Inc., operating as Pottery Barn Kids, is recalling about 310 Penny Convertible Cribs because the end panel can become loose and expose sharp edges, creating a laceration hazard to children. No injuries have been reported.

    Product
    Pottery Barn Kids Penny Convertible Cribs
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0899-2023·2023-07-19

    Amlodipine Besylate 10 mg Tablets Recalled for Failing Potency Tests

    Lupin Pharmaceuticals recalls Amlodipine Besylate 10 mg tablets (Lot A102887) after stability testing revealed the tablets failed potency specifications, containing less active ingredient than labeled. Patients should contact their pharmacist or doctor.

    Product
    AMLODIPINE BESYLATE — AMLODIPINE BESYLATE (AMLODIPINE BESYLATE)
    Category
    Drug
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-2132-2023·2023-07-19

    Medline Non-Sterile PVP Solution Mislabeled as Sterile Product

    Medline Industries recalled 15 units of non-sterile PVP solution in EAR CDS kits that were mislabeled as 'Sterile PVP SLN' instead of 'Non-Sterile PVP Solution, Sterile Packaging.' The mislabeling could result in inappropriate use in sterile medical applications.

    Product
    MEDLINE NON-STERILE PVP SOLUTION, packaged in kits as follows: EAR CDS, Model Number CDS980089O
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0912-2023·2023-07-19

    OTC Allergy Relief Tablets Recalled for Failed Manufacturing Specifications

    Topcare Allergy Relief 180 mg tablets recalled for failed impurity and degradation specifications. The recall affects 44,280 cartons distributed nationwide.

    Product
    TOPCARE ALLERGY RELIEF — TOPCARE ALLERGY RELIEF (FEXOFENADINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1249-2023·2023-07-19

    Ranch Salad Dressing Recalled for Product Spoilage

    SCREAMING EAGLE CO PACK LLC is recalling Tony Charchere's Ranch Salad Dressing due to bubbling and sour taste indicating spoilage. No illnesses have been reported.

    Product
    Tony Charchere's Ranch Salad Dressing packaged in 12oz PET bottle - 6 bottles per case
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0904-2023·2023-07-19

    OTC Antihistamine Tablets Recalled for Failed Quality Specifications

    L. Perrigo Company is recalling 1,920 cartons of Exchange Select Aller Ease (Fexofenadine Hydrochloride) 180 mg tablets nationwide due to failed impurity and degradation specifications.

    Product
    EXCHANGE SELECT ALLER EASE — EXCHANGE SELECT ALLER EASE (FEXOFENADINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0906-2023·2023-07-19

    OTC Allergy Relief Medication Recalled for Failed Quality Specifications

    L. Perrigo Company is recalling approximately 59,688 cartons of Fexofenadine Hydrochloride 180 mg allergy relief tablets nationwide because the product failed to meet FDA specifications for impurities and degradation.

    Product
    ALLERGY RELIEF — ALLERGY RELIEF (FEXOFENADINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0896-2023·2023-07-19

    Vivus Pancreaze prescription drug recall for failed stability specifications

    Vivus, Inc. is recalling Pancreaze delayed-release capsules nationwide due to failed stability specifications. The affected lot may not maintain product strength through the stated expiration date.

    Product
    PANCREAZE — PANCREAZE (PANCRELIPASE LIPASE, PANCRELIPASE AMYLASE, AND PANCRELIPASE PROTEASE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0905-2023·2023-07-19

    Kirkland Signature Aller Fex Allergy Tablets Recalled for Failed Impurities Specifications

    L. Perrigo Company recalls Kirkland Signature Aller Fex allergy tablets nationwide due to certain lots failing impurities and degradation quality specifications. Consumers with affected lots should contact their healthcare provider.

    Product
    KIRKLAND SIGNATURE ALLER FEX — KIRKLAND SIGNATURE ALLER FEX (FEXOFENADINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1237-2023·2023-07-19

    Coca-Cola bottler recalls incorrectly labeled zero-sugar beverages in Georgia

    Coca Cola Bottling Group United is recalling 177 cases of Coca-Cola Ultimate in Georgia because products labeled as 'Zero Sugar' actually contain regular sugar. The mislabeling affects consumers monitoring their sugar intake.

    Product
    Coca Cola Ultimate; packaged in 20oz PET bottles, 24 loose bottles per case *Product incorrectly labeled as Coca Cola Ultimate Zero Sugar
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0898-2023·2023-07-19

    Eye drops Equate and private-label brands recalled for manufacturing documentation deficiency

    K.C. Pharmaceuticals is recalling 397,430 bottles of Equate and private-label dry eye relief drops nationwide due to Current Good Manufacturing Practice deficiencies related to fill line documentation.

    Product
    EQUATE EYE DROPS DRY EYE RELIEF — EQUATE EYE DROPS DRY EYE RELIEF (GLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0910-2023·2023-07-19

    FDA Recalls Fexofenadine Allergy Relief Tablets Due to Impurity and Degradation Issues

    Target's store-brand fexofenadine allergy relief tablets are being recalled nationwide due to failed quality specifications for impurities and degradation. Consumers should stop using affected lots and contact Target or their healthcare provider.

    Product
    allergy relief, Fexofenadine Hydrochloride Tablets, 180 mg, packaged in a)15-count cartons (NDC 11673-617-22), b)30-count cartons (NDC 11673-617-39), c)70-count cartons (NDC 11673-617-01), and d)150-count cartons (11673-617-47), Distributed by: Target Corporation, Minneapolis, MN
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0894-2023·2023-07-12

    Tizanidine tablets recalled nationwide for failed stability specifications

    Preferred Pharmaceuticals is recalling 541 bottles of Tizanidine 4mg tablets nationwide due to failed stability specifications. Consumers with affected lot numbers should contact their pharmacist or healthcare provider.

    Product
    TIZANIDINE — TIZANIDINE (TIZANIDINE)
    Category
    Drug
    Distribution
    Distributed nationwide