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.

1951–1975 of 21588

  • ModerateFDA (Food)·F-0817-2025·2025-05-28

    San Juan Traditional Salsa recalled for potential wood particle contamination

    Frobright Salsary, LLC is recalling San Juan Traditional Salsa due to potential contamination with wood particles. The 14 oz refrigerated salsa products were distributed in Alaska, Idaho, Oregon, and Washington.

    Product
    Traditional Salsa is refrigerated product, packaged in Polypropylene container, net wt. 14oz, UPC 1 18738 54636. San Juan Salsa Co. Arlington, WA 98223, www.sanjuansalsa.com
    Category
    Food
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-0446-2025·2025-05-28

    Phentermine Hydrochloride Capsules 30mg Recalled for cGMP Deviations

    KVK Tech, Inc. is recalling 9,680 bottles of Phentermine Hydrochloride Capsules 30mg nationwide due to cGMP (current Good Manufacturing Practice) deviations. The recall is voluntary and firm-initiated.

    Product
    PHENTERMINE HYDROCHLORIDE — PHENTERMINE HYDROCHLORIDE (PHENTERMINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0422-2025·2025-05-28

    Antifungal Drug Recalled for Manufacturing Process Deviations

    Pharmadel LLC is recalling CURA HONGOS 1% Clotrimazole topical lotion due to Current Good Manufacturing Practice (CGMP) deviations identified during production. The voluntary recall affects approximately 10,128 bottles distributed in Delaware and North Carolina.

    Product
    CURA HONGOS, Antifungal, 1% Clotrimazole, Topical Lotion, 0.76 fl oz (22.5 mL) Bottle, Dist by/por: Pharmadel LLC, New Castle, DE 19720, Made in India, NDC 55758-34-01, UPC 8 10096 77170 4.
    Category
    Drug
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-1786-2025·2025-05-28

    Check-Flo Performer Introducer medical device recall for incorrect sheath sizing

    Cook Incorporated is recalling Check-Flo Performer Introducer devices (10.0Fr) because affected units may contain an incorrectly sized introducer sheath, which could compromise proper device function.

    Product
    Check=Flo Performer Introducer, 10.0Fr, Reference Part Number(RPN) REF RCFW-10.0-0-38-30-RB, Order Number (GPN) REF G08686,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0445-2025·2025-05-28

    Indomethacin Extended-Release Capsules Recalled for cGMP Deviations

    KVK Tech, Inc. is recalling Indomethacin Extended-Release Capsules USP, 75 mg (Lot #18400A) nationwide due to cGMP deviations. The recall affects approximately 9,107 bottles distributed nationwide.

    Product
    INDOMETHACIN — INDOMETHACIN (INDOMETHACIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0429-2025·2025-05-28

    Rapidol Triple Antibiotic Ointment Recalled for CGMP Deviations

    Rapidol Triple Antibiotic First Aid Ointment (Bacitracin Zinc, Neomycin Sulfate, Polymyxin B Sulfate) distributed in Delaware and North Carolina is being recalled for CGMP deviations. The manufacturer initiated a voluntary recall of 9,336 tubes.

    Product
    RAPIDOL — RAPIDOL (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE)
    Category
    Drug
    Distribution
    2 states
  • ModerateFDA (Drugs)·D-0430-2025·2025-05-28

    Cinnafresh Anticavity Gel Toothpaste Recalled Due to CGMP Deviations

    Cinnafresh anticavity gel toothpaste (sodium fluoride 0.22%, Bold Cinnamon Flavor) is being recalled due to Current Good Manufacturing Practice (CGMP) deviations. The manufacturer, KENIL HEALTHCARE PRIVATE LIMITED, initiated this voluntary recall.

    Product
    Cinnafresh anticavity gel toothpaste, sodium fluoride 0.22%, Bold Cinnamon Flavor, NET WT. 0.85 OZ (24 grams) Tube, Made in India, Dist. by Bob Barker Co. Inc., Fuquay-Varina, NC 27526, NDC 53247-133-01
    Category
    Drug
    Distribution
    2 states
  • ModerateFDA (Drugs)·D-0443-2025·2025-05-28

    Esomeprazole Magnesium oral suspension recalled for failed impurity specifications

    Zydus Pharmaceuticals is recalling Esomeprazole Magnesium delayed-release oral suspension, 20 mg, due to out-of-specification test results for unknown degradation products detected during long-term stability testing.

    Product
    ESOMEPRAZOLE MAGNESIUM — ESOMEPRAZOLE MAGNESIUM (ESOMEPRAZOLE MAGNESIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0421-2025·2025-05-28

    Artridon Topical Analgesic Recalled for Manufacturing Process Deviations

    Kenil Healthcare is recalling 9,984 tubes of Artridon topical analgesic (menthol and methyl salicylate) due to Current Good Manufacturing Practice (CGMP) deviations. The recall affects units distributed in Delaware and North Carolina.

    Product
    ARTRIDON — ARTRIDON (MENTHOL, METHYL SALICYLATE)
    Category
    Drug
    Distribution
    2 states
  • ModerateFDA (Food)·F-0816-2025·2025-05-28

    San Juan Salsa Hot Salsa 14oz Recalled for Wood Particle Contamination

    Frobright Salsary, LLC is recalling San Juan Salsa Hot Salsa (14 oz, UPC 1 18738 54634) distributed in Alaska, Idaho, Oregon, and Washington due to potential contamination with wood particles.

    Product
    Hot Salsa is refrigerated product, packaged in Polypropylene container, net wt. 14oz, UPC 1 18738 54634. San Juan Salsa Co. Arlington, WA 98223, www.sanjuansalsa.com
    Category
    Food
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-1803-2025·2025-05-28

    Philips Ingenia Elition X MRI System Alignment Error Recall

    Philips has recalled specific Ingenia Elition X MRI systems due to potential alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.

    Product
    Product Name: Ingenia Elition X; Model Numbers: (1) 781358, (2) 782107, (3) 782136;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1796-2025·2025-05-28

    Philips Ingenia 1.5T S MRI System Alignment Error Recall

    Philips is recalling the Ingenia 1.5T S magnetic resonance imaging (MRI) system due to potential alignment errors in cross reference line functionality when reviewing images generated with the MobiView application.

    Product
    Product Name: Ingenia 1.5T S; Model Number: 781347;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1798-2025·2025-05-28

    Ingenia Ambition S MRI devices recalled for alignment errors

    Philips is recalling certain Ingenia Ambition S MRI devices due to potential alignment errors in the cross reference line functionality when reviewing images with the MobiView application.

    Product
    Product Name: Ingenia Ambition S; Model Numbers: (1) 781359, (2) 782108, (3) 782139;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1802-2025·2025-05-28

    Philips Ingenia Elition S MRI System Alignment Error Recall

    Philips is recalling certain Ingenia Elition S MRI systems due to potential alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.

    Product
    Product Name: Ingenia Elition S; Model Numbers: (1) 781357, (2) 782106, (3) 782137;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1804-2025·2025-05-28

    MR 5300 Medical Device Recall for Cross Reference Line Alignment Error

    Philips is recalling MR 5300 medical devices (Model Numbers 782110 and 782152) due to potential alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.

    Product
    Product Name: MR 5300; Model Numbers: (1) 782110, (2) 782152;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0437-2025·2025-05-28

    Nature Mint Anticavity Fluoride Toothpaste recall due to manufacturing deviations

    KENIL HEALTHCARE PRIVATE LIMITED is recalling Nature Mint Anticavity Fluoride Toothpaste (6.4 oz, Lot B0067, expiring 08/31/2026) distributed in Delaware and North Carolina due to Current Good Manufacturing Practice (CGMP) deviations.

    Product
    Nature Mint, Anticavity Fluoride Toothpaste, Sodium monofluorophosphate 0.76%, NET WT 6.4 OZ (181 grams) Box, Made in India, Dist. by Bob Barker Co. Inc., Fuquay-Varina, NC 27526, NDC 53247-131-07
    Category
    Drug
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-1793-2025·2025-05-28

    Evolution Upgrade 1.5T imaging system alignment error recall

    Philips Evolution Upgrade 1.5T medical imaging systems may display alignment errors in cross-reference line functionality when reviewing images via MobiView application.

    Product
    Product Name: Evolution Upgrade 1.5T; Model Numbers: (1) 782116, (2) 782148;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0428-2025·2025-05-28

    Rapidol Hydrocortisone 1% Anti-Itch Cream Recalled for CGMP Deviations

    Kenil Healthcare is recalling 10,000 tubes of Rapidol Maximum Strength Hydrocortisone 1% Anti-Itch Cream (2 oz, Lot SP26A, Expiration 09/30/2026) distributed in Delaware and North Carolina due to manufacturing quality issues.

    Product
    RAPIDOL — RAPIDOL (HYDROCORTISONE)
    Category
    Drug
    Distribution
    2 states
  • ModerateFDA (Drugs)·D-0439-2025·2025-05-28

    Nature Mint Anticavity Fluoride Toothpaste Recalled for CGMP Deviations

    KENIL HEALTHCARE PRIVATE LIMITED is recalling Nature Mint Anticavity Fluoride Toothpaste due to manufacturing deviations. The recall affects 150,768 tubes distributed in Delaware and North Carolina.

    Product
    Nature Mint Anticavity Fluoride Toothpaste, Sodium monofluorophosphate 0.76%, NET WT 1.5 OZ (43 grams) Tube, Made in India, Dist. by Bob Barker Co. Inc., Fuquay-Varina, NC 27526, NDC 53247-131-04
    Category
    Drug
    Distribution
    2 states
  • ModerateFDA (Drugs)·D-0436-2025·2025-05-28

    Nature Mint Anticavity Fluoride Toothpaste Recall Due to CGMP Deviations

    KENIL HEALTHCARE PRIVATE LIMITED is voluntarily recalling Nature Mint Anticavity Fluoride Toothpaste due to Current Good Manufacturing Practice (CGMP) deviations. The affected toothpaste was distributed in Delaware and North Carolina.

    Product
    Nature Mint, Anticavity Fluoride Toothpaste, Sodium monofluorophosphate 0.76%, NET WT 0.6 OZ (17g) Tube, Made in India, Dist. by Bob Barker Co. Inc., Fuquay-Varina, NC 27526, NDC 53247-131-02
    Category
    Drug
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-1788-2025·2025-05-28

    Philips SmartPath to dStream 1.5T medical device alignment recall

    Philips is recalling certain SmartPath to dStream 1.5T medical imaging devices due to potential alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.

    Product
    Product Name: SmartPath to dStream for 1.5T; Model Numbers: (1) 781260, (2) 782112, (3) 782146
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0435-2025·2025-05-28

    Nature Mint Anticavity Fluoride Toothpaste Recalled for CGMP Deviations

    KENIL HEALTHCARE PRIVATE LIMITED is recalling Nature Mint Anticavity Fluoride Toothpaste due to Current Good Manufacturing Practice (CGMP) deviations. The recall affects approximately 19,500 tubes distributed in Delaware and North Carolina.

    Product
    Nature Mint, Anticavity Fluoride Toothpaste, Sodium monofluorophosphate 0.76%, NET WT 4.6 OZ (130 grams) Tube, Made in India, Dist. by Bob Barker Co. Inc., Fuquay-Varina, NC 27526, NDC 53247-131-06
    Category
    Drug
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-1794-2025·2025-05-28

    Philips Evolution Upgrade 3.0T MRI Cross Reference Line Alignment Error

    Philips is recalling Evolution Upgrade 3.0T MRI systems (Models 782117 and 782143) due to potential alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.

    Product
    Product Name: Evolution Upgrade 3.0T; Model Numbers: (1) 782117, (2) 782143;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1795-2025·2025-05-28

    Ingenia 1.5T MRI Systems Recalled for Alignment Errors

    Philips is recalling Ingenia 1.5T MRI systems due to potential alignment errors in the cross reference line functionality when reviewing images with the MobiView application.

    Product
    Product Name: Ingenia 1.5T; Model Numbers: (1) 781315, (2) 781341, (3) 781396, (4) 782101, (5) 782115, (6) 782140;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1799-2025·2025-05-28

    Philips Ingenia 1.5T CX MRI System Alignment Error Potential

    Philips is recalling Ingenia 1.5T CX MRI systems due to potential alignment errors in the cross reference line functionality when reviewing images with the MobiView application. This could affect image interpretation.

    Product
    Product Name: Ingenia 1.5T CX; Model Number: 781262;
    Category
    Medical Device
    Distribution
    Distributed nationwide