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.

2276–2300 of 3531

  • ModerateFDA (Devices)·Z-1537-2022·2022-08-24

    First Response 2-Count Pregnancy Test Recalled for Improper Storage

    Family Dollar Stores is recalling First Response 2 CT pregnancy tests due to improper storage outside temperature-controlled areas. Affected products were sold nationwide between May 1 and June 10, 2022.

    Product
    FIRST RESPONSE 2 CT, SKU 902343
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1535-2022·2022-08-24

    Travel Kit Toothbrush and Toothpaste Recalled Due to Improper Storage

    Family Dollar is recalling approximately 1,555 travel kit toothbrush and toothpaste pouches that were stored in non-temperature-controlled areas. Products sold between May 1 and June 10, 2022 are affected.

    Product
    TRVL KIT TOTHBRSH CAP PASTE IN POUCH 1CT, SKU 900737
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1540-2022·2022-08-24

    Contact Lens Solution Recalled for Improper Temperature Storage

    OPTI FREE REPLENISH contact lens solution sold at Family Dollar stores (May 1–June 10, 2022) was not stored in temperature-controlled areas and is being recalled.

    Product
    OPTI FREE REPLENISH MULTI PURPOSE 2 OZ
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1558-2022·2022-08-24

    Sensis Signal Input Box recall for patient electrical leakage hazard with improper mounting

    Siemens recalls 399 units of AXIOM Sensis systems due to risk of patient electrical shock if the Signal Input Box mounting deviates from its default position.

    Product
    AXIOM Sensis or Sensis Vibe Combo systems as follows: System Material # AXIOM Sensis, Combo 64 6623974; AXIOM Sensis, Hemo LOW 6634633; AXIOM Sensis, Combo 32 6634641; AXIOM Sensis, EP 129 6634658; Sensis 10764561
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1319-2022·2022-08-17

    FDA Recalls Miralax Osmotic Laxative Powder for Storage Deviations

    The FDA recalled 67 bottles of Miralax laxative powder due to storage conditions that violated drug label specifications. The precautionary recall is due to potential product quality concerns from improper storage conditions.

    Product
    MIRALAX — MIRALAX (POLYETHYLENE GLYCOL 3350)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1322-2022·2022-08-17

    FDA Recalls A&D Original Ointment due to improper storage conditions

    A&D Original Ointment 16 oz jars are being recalled nationwide because products were stored outside manufacturer specifications. The recall affects all NDC 11523-0096-3 units distributed in the USA.

    Product
    A&D Original Ointment, Diaper Rash Ointment & Skin Protectant, 16 oz. Jar, Bayer Healthcare Pharmaceutica, NDC 11523-0096-3.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1323-2022·2022-08-17

    FDA Recalls Dakin's Solution Due to Storage Condition Deviations

    McKesson Medical-Surgical recalled 113 bottles of Dakin's Solution (sodium hypochlorite) nationwide due to improper storage outside label specifications. Products may have compromised stability.

    Product
    DAKINS QUARTER — DAKINS QUARTER (SODIUM HYPOCHLORITE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1312-2022·2022-08-17

    Bisacodyl suppositories recalled nationwide due to improper storage

    McKesson Medical-Surgical is recalling Bisacodyl suppositories stored outside label specifications. The FDA Class II recall affects 45 boxes distributed nationwide.

    Product
    BISACODYL — BISACODYL (BISACODYL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1305-2022·2022-08-17

    Prescription Drug Recall: Telmisartan-Hydrochlorothiazide Tablets Due to Defective Packaging

    Glenmark Pharmaceuticals recalls 72,288 units of Telmisartan-Hydrochlorothiazide 80/25 mg tablets nationwide due to defective blister packaging that is difficult to open and causes tablets to break.

    Product
    TELMISARTAN AND HYDROCHLOROTHIAZIDE — TELMISARTAN AND HYDROCHLOROTHIAZIDE (TELMISARTAN AND HYDROCHLOROTHIAZIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1318-2022·2022-08-17

    Earwax Removal Aid Debrox Recalled Nationwide for Improper Storage Conditions

    Debrox earwax removal aid is recalled nationwide because 131 boxes of the product were stored outside label-specified conditions. Consumers should discontinue use and consult a healthcare provider if needed.

    Product
    DEBROX — DEBROX (CARBAMIDE PEROXIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1321-2022·2022-08-17

    FDA Recalls Pataday Eye Allergy Drops Due to Storage Deviations

    Mckesson Medical-Surgical is recalling Pataday Once Daily Relief eye drops nationwide because the products were stored outside label specifications. No illnesses have been reported.

    Product
    PATADAY ONCE DAILY RELIEF — PATADAY ONCE DAILY RELIEF (OLOPATADINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1329-2022·2022-08-17

    Lamotrigine Tablets Recalled for Label Strength Error

    AVKARE Inc. is recalling 8,328 bottles of Lamotrigine Tablets, USP 100 mg nationwide due to a labeling error in the declared strength.

    Product
    LAMOTRIGINE — LAMOTRIGINE (LAMOTRIGINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1314-2022·2022-08-17

    FDA Recalls SYSTANE Lubricant Eye Drops Due to Improper Storage

    McKesson Medical-Surgical Inc. is recalling 47 bottles of SYSTANE Lubricant Eye Drops nationwide. The products were stored outside label specifications, violating manufacturing practices.

    Product
    SYSTANE LUBRICANT — SYSTANE LUBRICANT (POLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1316-2022·2022-08-17

    Eye Drops Recalled for Improper Storage Outside Specifications

    SYSTANE BALANCE lubricant eye drops (12 boxes, nationwide) are being recalled because they were stored outside the manufacturer's label specifications. The FDA classified this as a Class II recall.

    Product
    SYSTANE BALANCE — SYSTANE BALANCE (PROPYLENE GLYCOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1508-2022·2022-08-17

    Cholestech LDX cholesterol test cassettes require bilirubin interference label update

    Alere is updating the package insert for Cholestech LDX cholesterol test cassettes to disclose that samples with elevated bilirubin can produce inaccurate triglyceride and HDL results. Approximately 436,990 units are affected.

    Product
    The Cholestech LDX¿ System combines enzymatic methodology and solidphase technology to measure total cholesterol, HDL cholesterol, triglycerides and glucose. Samples used for testing can be whole blood from a fingerstick (collected in a lithium heparin-coated capillary tube) or
    Category
    Medical Device
    Distribution
    31 states
  • ModerateFDA (Drugs)·D-1306-2022·2022-08-17

    Glenmark Pharmaceuticals Recalls Telmisartan/Hydrochlorothiazide Due to Defective Blister Packs

    Glenmark Pharmaceuticals Inc., USA is recalling specific lots of Telmisartan and Hydrochlorothiazide tablets due to complaints of defective blister packs that are difficult to open and cause tablets to break during removal.

    Product
    TELMISARTAN AND HYDROCHLOROTHIAZIDE — TELMISARTAN AND HYDROCHLOROTHIAZIDE (TELMISARTAN AND HYDROCHLOROTHIAZIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1325-2022·2022-08-17

    Racepinephrine Inhalation Solution Recalled for Improper Storage Conditions

    Mckesson Medical-Surgical is recalling S2 Racepinephrine Inhalation Solution due to storage that deviated from label specifications. This Class II recall affects 23 cartons distributed nationwide.

    Product
    S2 — S2 (RACEPINEPHRINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1324-2022·2022-08-17

    Asthmanefrin Racephinephrine Inhalation Solution Recalled Due to Improper Storage

    Asthmanefrin Racephinephrine Inhalation Solution is being recalled because batches were stored outside the conditions specified on the drug label. The recall affects products distributed nationwide.

    Product
    Asthmanefrin Racephinephrine Inhalation Solution Bronchodilator, For temporary relief of mild symptoms of intermittent asthma, Preservative Free, Sterile, For Oral Inhalation Only, 30 vials per box, Nephron Pharmaceuticals Corporation, NDC 0487-2784-01.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1522-2022·2022-08-10

    Frozen Foods Recalled Due to Temperature Abuse During Delivery

    United Natural Foods, Inc. is recalling multiple frozen food products that were exposed to temperature abuse during delivery to retailers in Alabama and Mississippi.

    Product
    1. TFM ORG BLUEBERRIES UPC 73709422933 32OZ BC FROZEN FOODS LTD 2. TRU FRU BANANAS IN PB AND DK CHOC UPC 85001211717 8OZ TRU FRU LLC 3. LANTMANNE APPLE CROWN 3.5 OZ UPC 70099806097 3.5 OZ LANTMANNEN UNIBAKE U
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-1491-2022·2022-08-10

    Boston Scientific Recalls EkoSonic Endovascular Device Kit for Mislabeling

    Boston Scientific is recalling 10 EkoSonic Endovascular Device Kits due to mislabeling. The affected kits were distributed to healthcare facilities in 10 U.S. states.

    Product
    EkoSonic Kit 135cm, 12cm TZ The EkoSonic Endovascular Device is packaged as a kit that includes both the USC and IC components. They are placed into the respective trays and sealed in a Tyvek pouch. The sealed pouches are placed inside the kit carton (box) and the product la
    Category
    Medical Device
    Distribution
    10 states