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.

851–875 of 3531

  • ModerateFDA (Drugs)·D-0478-2024·2024-05-08

    Injectable epinephrine-lidocaine recalled for failing potency specification

    Imprimis NJOF, LLC is recalling epinephrine-lidocaine injectables nationwide because they failed to meet potency specifications. Patients should contact their healthcare provider regarding affected lots.

    Product
    Epinephrine-Lidocaine HCl 0.25 mg/mL and 7.5 mg/mL Preservative-Free, 1 mL Single-Use vials, Rx only, Imprimis NJOF, LLC 1705 Route 46 West, Unit 6B, Ledgewood, NJ, 07852, NDC 71384-640-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1209-2024·2024-05-08

    Puerto Rican Wedding Cake Recall: Undeclared Food Dyes

    Reposteria Artesanal Laura is recalling Bizcocho de Boda Puertorriqueño cakes in Puerto Rico due to undeclared artificial food dyes (Red #40, Red #3, Yellow #5, Yellow #6, Blue #1, Blue #2).

    Product
    Bizcocho de Boda Puertorrique¿o Naked "Puerto Rican wedding cake naked", packaged in aluminum mold/plastic showcase, 24 Pack per case of 10 oz / 6 pack per case of 32 oz/ 4 pack per case of 51.2 oz, Net Wt. 10 oz UPC 851249003075, 32 oz. UPC 851249003112 and 52.2 oz UPC 85124900
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0480-2024·2024-05-08

    Fentanyl Injection Bags Recalled Due to Incorrect Barcode Labels

    Hikma Injectables USA Inc. has recalled 1,895 bags of Fentanyl 1000mcg/100mL injection (lot CH0324001) due to incorrect barcodes on the product labeling.

    Product
    Fentanyl 1000mcg/100mL (10mcg/mL) in 0.9% Sodium Chloride Injection, packaged in 100mL bags, Rx only, Compounded by: Hikma Injectables USA Inc. 2 Esterbrook Lane, Cherry Hill, NJ 08003, Distributed by: Hikma Injectables USA Inc. 36 Stults Road, Dayton, NJ 08810, NDC 63037-100-05
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0481-2024·2024-05-08

    Prescription Valacyclovir Tablets Recalled Due to Missing Imprint

    Viatris Inc is recalling 143,230 bottles of Valacyclovir Hydrochloride 500 mg tablets due to missing imprints on some tablets. The recall is nationwide and affects two lot numbers expiring in June 2024 and May 2025.

    Product
    VALACYCLOVIR HYDROCHLORIDE — VALACYCLOVIR HYDROCHLORIDE (VALACYCLOVIR)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateCPSC·24222·2024-05-02

    DR Power Equipment Leaf Blowers and Vacuums Recalled for Laceration Hazard

    DR Power Equipment is recalling about 57,200 walk-behind and tow-behind leaf blowers and vacuums because internal pieces can come loose and be ejected, posing a laceration risk to users and bystanders. No injuries have been reported.

    Product
    Walk-Behind Leaf Blowers and Vacuums, and Tow-Behind Leaf Vacuums
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1689-2024·2024-05-01

    Baxter Seprafilm Adhesion Barrier Recalled for Unapproved Distribution

    Baxter Healthcare is recalling Seprafilm Adhesion Barrier units (165 units, Lot DBYSEP046) that were distributed nationwide without FDA approval. Affected units distributed in LA, GA, IN, VA, FL, NY, and CA.

    Product
    Baxter Seprafilm Adhesion Barrier 1 Half Sheet, 5-PK, REF 664103, for use in abdominal and pelvic surgery
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1633-2024·2024-05-01

    3M Durapore Surgical Tape incorrectly labeled with extended shelf life

    Select lots of 3M Durapore Surgical Tape (Catalog Number 1538-118) were labeled with a 5-year shelf life when the actual shelf life is 3 years. The recall affects over 3.5 million rolls distributed worldwide.

    Product
    3M Durapore Surgical Tape, Catalog Number 1538-118
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0468-2024·2024-05-01

    Prescription Drug Recall: ABILIFY Tablets Due to Cross Contamination

    ABILIFY (aripiprazole) 15 mg tablets from lot AMS00223A are being recalled due to cross contamination with other products. The recall affects packages distributed nationwide.

    Product
    ABILIFY — ABILIFY (ARIPIPRAZOLE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0465-2024·2024-05-01

    FUL-GLO Fluorescein Sodium Ophthalmic Strips Recalled for API Manufacturing Defect

    Nomax Inc recalls FUL-GLO Fluorescein Sodium Ophthalmic Strips (Lot 14776) nationwide due to API manufacturing specification failures. The active ingredient was not manufactured to current USP standards regarding unspecified impurities.

    Product
    FUL-GLO, Fluorescein Sodium Ophthalmic Strips USP 1 mg, 100 sterile strips per carton, Manufactured for: Akorn, Inc., Lake Forest, IL 60045, NDC 17478-404-01.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1203-2024·2024-05-01

    PepsiCo Root Beer Mislabeled; Regular Mug Sold as Zero Sugar

    PepsiCo is recalling 2,801 cases of 12-pack Mug root beer that were mislabeled as Mug Zero Sugar but contain regular Mug. The error affects product distributed across six states.

    Product
    12 oz Aluminum cans of root beer packaged 12 cans per carton. 2/12pks per case
    Category
    Food
    Distribution
    6 states
  • ModerateFDA (Drugs)·D-0466-2024·2024-05-01

    Prescription medication Abilify recalled for cross contamination with other products

    Otsuka America Pharmaceutical is recalling certain lots of Abilify (aripiprazole) 5 mg tablets distributed nationwide due to cross contamination with other products. This is classified as a Class III recall.

    Product
    ABILIFY — ABILIFY (ARIPIPRAZOLE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0461-2024·2024-05-01

    Eyewash Solution Recalled for Manufacturing Compliance Deviations

    Honeywell Inc. is recalling FENDALL 2000 PURE FLOW eyewash solution due to Current Good Manufacturing Practice deviations. The recall affects 10,605 cartridges distributed nationwide in the USA and Canada with expiration dates through June 2025.

    Product
    FENDALL 2000 PURE FLOW — FENDALL 2000 PURE FLOW (PURIFIED WATER)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateCPSC·24205·2024-04-25

    3M Peltor X4 Series Earmuffs Noise Reduction Risk Recall

    3M is recalling about 40,000 Peltor X4 Series earmuffs sold from May through June 2023 because cracks can develop in the plastic cups, allowing overexposure to loud noise. No injuries have been reported.

    Product
    3M™ Peltor™ X4 Series Earmuffs
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • ModerateCPSC·24209·2024-04-25

    Crate & Barrel Hampshire Cribs Recalled Due to Fall Hazard

    Crate & Barrel is recalling about 3,200 Hampshire Cribs sold online from June 2022 through November 2023 because mattress support pins can become loose, posing a fall hazard. No injuries have been reported.

    Product
    Crate & Barrel Hampshire Cribs
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1153-2024·2024-04-24

    Aromitalia Malasia Coconut Paste Recalled for Missing Coconut Allergen in Contains Statement

    Aromitalia Malasia Coconut Paste is being recalled because coconut is listed in the ingredients but not declared in the contains statement, potentially affecting consumers with coconut allergies.

    Product
    Aromitalia Malasia Coconut Paste + 35.27 oz milk-based mix, Net Weight 123.46 oz, plastic container.
    Category
    Food
    Distribution
    7 states
  • ModerateFDA (Devices)·Z-1524-2024·2024-04-24

    Baxter surgical tool marketing brochures contain inaccurate Instructions for Use

    Baxter Healthcare Corporation recalled marketing brochures for surgical tools that contain inaccurate information conflicting with the product Instructions for Use. Over 82,000 units were distributed worldwide.

    Product
    Surgical Tools and Cardiovascular Specialty marketing brochures, Reference numbers: US-AS18-210002 Surgical Tools Brochure 2021, US-AS18-210004 Surgical Tools Website v1, and US-AS46-230002 CV Specialty Brochure US version which affect: Vascular Probe, Item Numbers: a) 708101
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0441-2024·2024-04-24

    Prescription drug NEXLIZET recalled for dissolution specification failure

    Esperion is recalling certain NEXLIZET (bempedoic acid and ezetimibe) tablets nationwide because the active ingredient may not dissolve properly, potentially reducing effectiveness.

    Product
    NEXLIZET — NEXLIZET (BEMPEDOIC ACID AND EZETIMIBE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1173-2024·2024-04-24

    Abdallah Sea Salt Almond Alligators Recalled for Wrong Back Label

    Abdallah Candies is recalling Sea Salt Almond Alligators due to incorrect back label showing chocolate covered cherries information instead of the actual product.

    Product
    Abdallah Sea Salt Almond Alligators. Net Weight 8 ounces (226g). UPC 7 66684-00412 2. Abdallah Candies, Made in Apple Valley, MN.
    Category
    Food
    Distribution
    15 states
  • ModerateFDA (Devices)·Z-1596-2024·2024-04-24

    NPWT Canister Recalled Due to Carbon Filter Contamination Risk

    Smith & Nephew is recalling RENASYS EDGE 300ML canisters due to black particulate matter from the carbon filter that may enter the pump. The recall affects 6,895 units distributed in the US, Canada, and Chile.

    Product
    RENASYS EDGE 300ML CANISTER WITH Solidifier- Indicated for patients who would benefit from a suction pump (NPWT), as it may promote wound healing. Product Number: 66803139
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0443-2024·2024-04-24

    Digoxin Tablets Recalled Due to Failed Impurity and Degradation Specifications

    Novitium Pharma LLC is recalling 1,003 bottles of Digoxin tablets (Lot M23011A, expiring 12/2024) distributed nationwide due to failed impurity and degradation specifications. Patients should consult their healthcare provider immediately.

    Product
    DIGOXIN — DIGOXIN (DIGOXIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1149-2024·2024-04-24

    Windsor Black Peppercorns Mislabeled; Contains Pink Himalayan Salt Instead

    Windsor Black Peppercorns are mislabeled. Products labeled as black peppercorn actually contain Pink Himalayan salt. Affected lot code ZX23060001, distributed in Canada.

    Product
    Windsor Black Peppercorns, 34g grinder, UPC 0 66010 08200 9, 6 units per wholesale case
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Food)·F-1134-2024·2024-04-17

    Cherry Pie Recalled for Missing Sub-Ingredient Label Information

    Robeson Enterprises is recalling cherry pie products because labels do not list sub-ingredients. Products were distributed in Georgia, North Carolina, and South Carolina.

    Product
    PIES & SIDES CHERRY PIE INGREDIENTS: CHERRY PIE FILLING, SUGARS, VANILLA, BLEACHED FLOUR SPICES. CONTAINS: WHEAT PIES & SIDES MOUNT HOLLY, NC
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Food)·F-1141-2024·2024-04-17

    Peach pie recalled for missing sub-ingredient information

    Robeson Enterprises is recalling Peach Pie distributed to GA, NC, and SC because the label fails to list sub-ingredients. The recall affects all lots shipped before February 23, 2024.

    Product
    PIES & SIDES PEACH PIE INGREDIENTS: PEACH PIE FILLING, SUGARS, VANILLA, BLEACHED FLOUR, SPICES, CONTAINS: WHEAT PIES & SIDES MOUNT HOLLY, NC
    Category
    Food
    Distribution
    3 states