The Recall Desk

State

Pennsylvania product recalls

72,986 recalls have nationwide distribution and so reach Pennsylvania. 11,919 additional recalls listed Pennsylvania specifically in their distribution scope.

What the numbers show

Total
11,919
Critical
1,922
Severe
2,866
Most recent
2026-09-16

Of the 11,919 recalls naming Pennsylvania we have scored against our rubric, 1,922 (16%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 2,866 (24%) are Severe.

These figures cover only the 11,919 recalls whose distribution notice names Pennsylvania specifically. The 72,986 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

6151–6175 of 84905

  • HighFDA (Drugs)·D-0552-2025·2025-08-13

    Duloxetine 60 mg capsules exceed the safety assessment limit for nitrosamine

    Duloxetine Delayed-Release Capsules USP 60 mg distributed by Breckenridge are being recalled because N-nitroso-duloxetine was present above the safety assessment limit. 1,829 bottles affected.

    Product
    DULOXETINE — DULOXETINE (DULOXETINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0567-2025·2025-08-13

    Duloxetine delayed-release capsules exceed the interim nitrosamine impurity limit

    Duloxetine Delayed-Release 20 mg capsules packaged by Direct Rx are being recalled because a nitrosamine drug substance related impurity was present above the proposed interim limit. 16 bottles affected.

    Product
    Duloxetine D/R, 20 mg, 30 Caps, 30-count bottle, RX Only, Packaged & Distributed by: Direct Rx, Dist. By Breckenridge Pharm., Inc., Berlin, CT 06037, NDC 61919-422-30
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2272-2025·2025-08-13

    epoc BUN test cards may show a negative sodium bias

    epoc BGEM BUN Test Cards are being recalled because a negative sodium bias may exist in some lots, with an observed average bias of -4.4 mmol/L. 37,554 units are affected.

    Product
    epoc BGEM BUN Test Card [25pk]. Material Number: 10736515.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0566-2025·2025-08-13

    Doxepin hydrochloride capsules exceed the interim nitrosamine impurity limit

    Doxepin Hydrochloride Capsules USP 10 mg from Alembic are being recalled because a nitrosamine drug substance related impurity was present above the proposed interim limit. 9,492 bottles affected.

    Product
    DOXEPIN HYDROCHLORIDE — DOXEPIN HYDROCHLORIDE (DOXEPIN HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0382-2025·2025-08-13

    Queen Bee Gardens raspberry whipped honey may contain stainless steel flakes

    Queen Bee Gardens Whipped Honey Raspberry in 11 oz jars is being recalled because the product may have small flakes of stainless steel in it. 129 jars are affected.

    Product
    Brand Name: Queen Bee Gardens Whipped Honey Raspberry. Intended use: spread. Item is shelf stable. Packaging type: Jar. Net wt., 11oz. UPC: 788394182358. Firm Name: Queen Bee Gardens Firm Address: 262 East Main Street, Lovell, WY 82431
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2277-2025·2025-08-13

    Stryker SmartPump tourniquet cuff flanges may detach from the bladder

    Stryker SmartPump Tourniquet disposable cuffs are being recalled because the cuff flange may become detached from the bladder, which the manufacturer links to a risk of hemorrhage if a leak occurs during a procedure.

    Product
    Stryker SmartPump Tourniquet, disposable sterile (single use) DISP 18X3,1BLA,1PRT QUICK / 5921-018-135; DISP 18X3,1BLA,2PRT QUICK / 5921-018-235; DISP 24X4,1BLA, 2PRT QUICK / 5921-024-235
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0384-2025·2025-08-13

    Queen Bee Gardens whipped honey may contain stainless steel flakes

    Queen Bee Gardens Whipped Honey Huckleberry in 11 oz jars is being recalled because the product may have small flakes of stainless steel in it. 24 jars are affected.

    Product
    Brand Name: Queen Bee Gardens Whipped Honey Huckleberry Intended use: spread. Item is shelf stable. Packaging type: Jar. Net wt., 11oz. UPC: 788394182259. Firm Name: Queen Bee Gardens Firm Address: 262 East Main Street, Lovell, WY 82431
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0568-2025·2025-08-13

    Direct Rx duloxetine 30 mg capsules exceed the interim nitrosamine limit

    Duloxetine Delayed-Release 30 mg capsules packaged by Direct Rx are being recalled because a nitrosamine drug substance related impurity was present above the proposed interim limit. 875 bottles affected.

    Product
    Duloxetine D/R, 30 mg, 30 Caps, RX Only, Packaged as a) 30-count bottle NDC 61919-0482-30, b) 60-count bottle, NDC 61919-0482-60, c) 90-count bottle, NDC 61919-0482-90; Packaged & Distributed by: Direct Rx, Dist. By Breckenridge Pharm., Inc., Berlin, CT 06037,
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0574-2025·2025-08-13

    Spironolactone 25 mg tablets recalled after aluminum was found in product

    Spironolactone Tablets USP 25 mg are being recalled because of the presence of a foreign substance identified as aluminum. 11,328 bottles are affected.

    Product
    SPIRONOLACTONE — SPIRONOLACTONE (SPIRONOLACTONE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2239-2025·2025-08-13

    Pinnacle 3 radiation planning software may miscalculate stopping power ratio

    Pinnacle 3 with TumorLOC Radiation Therapy Planning System software is being recalled because a software issue may provide incorrect dataset calculations when performing the Stopping Power Ratio. 149 serial numbers affected.

    Product
    Pinnacle 3 with TumorLOC, (870258) Radiation Therapy Planning System Software
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0385-2025·2025-08-13

    Favorite Day frosted sugar cookies may contain wood foreign material

    Favorite Day Bakery Frosted Sugar Cookies, 10 count, are being recalled because of foreign material, specifically wood. 803 cases are affected.

    Product
    Favorite Day Bakery Frosted Sugar Cookies, 10 count, Net Wt 13.5 oz (383g). UPC - 85239-41250 3. Dist. By Target Corporation, Minneapolis, MN 55403. Product of Canada.
    Category
    Food
    Distribution
    21 states
  • ModerateFDA (Devices)·Z-2253-2025·2025-08-13

    Lap chole packs contain an inadvertently resterilized visualization system

    Lap Chole Pack medical convenience kits are being recalled because the Clearify Visualization System inside was inadvertently resterilized, causing discoloration. 85 units are affected.

    Product
    LAP CHOLE PACK. Medical convenience kit.
    Category
    Medical Device
    Distribution
    7 states
  • ModerateFDA (Devices)·Z-2263-2025·2025-08-13

    Robotic uro/gyn packs contain an inadvertently resterilized visualization system

    Robotic Uro/Gyn Pack medical convenience kits are being recalled because the Clearify Visualization System inside was inadvertently resterilized, causing discoloration. 372 units are affected.

    Product
    ROBOTIC URO/GYN PACK. Medical convenience kit.
    Category
    Medical Device
    Distribution
    7 states
  • ModerateFDA (Devices)·Z-2267-2025·2025-08-13

    DxI 800 immunoassay analyzer motor current resets below the required setting

    A DxI 800 Access Immunoassay Analyzer is being recalled because software overwrites the factory PnP X-motor current setting, causing increased motion errors that could delay patient results.

    Product
    DxI 800 Access Immunoassay Analyzer W/Dual Gantry, Part Number A71457
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2237-2025·2025-08-13

    BD Trucount 664343 control kits carry incorrect standard deviation values

    BD Trucount Controls 30 Test kits, REF 664343, are being recalled because they contain incorrect standard deviation values for the low and high control beads. 10 kits are affected.

    Product
    BD Trucount Controls, 30 Test - REF: 664343, RxOnly, IVD
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2246-2025·2025-08-13

    General laparoscopy packs contain an inadvertently resterilized visualization system

    Gen Laparoscopy Pack medical convenience kits are being recalled because the Clearify Visualization System inside was inadvertently resterilized, causing discoloration. 321 units are affected.

    Product
    GEN LAPAROSCOPY PACK. Medical convenience kit.
    Category
    Medical Device
    Distribution
    7 states
  • ModerateFDA (Devices)·Z-2243-2025·2025-08-13

    daVinci urology and prostate packs contain a resterilized visualization system

    DA VINCI PACK URO/PROSTATE medical convenience kits are being recalled because the Clearify Visualization System inside was inadvertently resterilized, causing discoloration. 21 units affected.

    Product
    DA VINCI PACK URO/PROSTATE. Medical convenience kit.
    Category
    Medical Device
    Distribution
    7 states
  • ModerateFDA (Devices)·Z-2270-2025·2025-08-13

    DxI 600 immunoassay analyzer motor current resets below the required setting

    A DxI 600 Access Immunoassay Analyzer is being recalled because software overwrites the factory PnP X-motor current setting, causing increased motion errors that could delay patient results.

    Product
    DxI 600 Access Immunoassay Analyzer W/Dual Gantry, Part Number A71461
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0571-2025·2025-08-13

    Xolair auto-injectors exposed to temperatures outside labeled storage requirements

    Xolair (omalizumab injection) 150 mg/mL auto-injectors are being recalled because of CGMP deviations: the product was exposed to temperatures outside its labeled storage requirements. 6 units affected.

    Product
    XOLAIR — XOLAIR (OMALIZUMAB)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2257-2025·2025-08-13

    LAVH packs contain an inadvertently resterilized visualization system

    LAVH Pack medical convenience kits are being recalled because the Clearify Visualization System inside was inadvertently resterilized, causing discoloration. 292 units are affected.

    Product
    LAVH PACK. Medical convenience kit.
    Category
    Medical Device
    Distribution
    7 states
  • ModerateFDA (Devices)·Z-2266-2025·2025-08-13

    UniCel DxI 800 analyzer motor current resets below the required setting

    UniCel DxI 800 Access Immunoassay Analyzers are being recalled because software overwrites the factory PnP X-motor current setting, causing increased motion errors that could delay patient results. 2,203 systems affected.

    Product
    UniCel DxI 800 Access Immunoassay Analyzer, Part Number 973100
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2247-2025·2025-08-13

    General laparoscopy trays contain an inadvertently resterilized visualization system

    General Laparoscopy Tray medical convenience kits are being recalled because the Clearify Visualization System inside was inadvertently resterilized, causing discoloration. 574 units are affected.

    Product
    GENERAL LAPAROSCOPY TRAY. Medical convenience kit.
    Category
    Medical Device
    Distribution
    7 states