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 21710

  • ModerateFDA (Drugs)·D-0536-2025·2025-07-30

    Compounded quadruple ophthalmic solution returned subpotent assay results in stability testing

    A compounded Tropicamide-Proparacaine-Phenylephrine-Ketorolac sterile ophthalmic solution is being recalled because of subpotent assay results during stability testing. 2,890 vials are affected.

    Product
    Tropicamide-Proparacaine-Phenylephrine-Ketorolac, Sterile Ophthalmic Solution, 1% 0.5% 2.5% 0.5%, 5mL, 2x5ML vial per carton, Rx Only, Imprimis NJOF, LLC, 1705 Route 46 West, Unit 6B, Ledgewood, NJ 07852, NDC 71384-733-05.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·H-0390-2025·2025-07-30

    Herbalife Relaxation Tea made with an incorrect ingredient from the supplier

    Herbalife Nutrition Relaxation Tea is being recalled because an incorrect ingredient was received from the supplier and used in manufacturing the finished product. 5,888 units are affected.

    Product
    Herbalife Nutrition, Relaxation Tea, Net Wt: 1.69 OZ (48g) UPC# L044KUS0A-00
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2144-2025·2025-07-30

    Ellik Evacuator latex bulb has conflicting sterilization instructions in Japan

    The Ellik Latex Bulb, model 194-2, is being recalled because of discrepancies between the Japanese language package insert sterilization instructions and the manufacturer's IFU. 48 units affected.

    Product
    Ellik Latex Bulb, Ellik Evacuator. Model Number: 194-2. The Ellik Evacuator and adapter accessories are compatible with Gyrus ACMI Elite and Elite 2 Resection Sheaths.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2142-2025·2025-07-30

    Ellik Evacuator male connector tubing has conflicting sterilization instructions in Japan

    The Tubing for Male Connector 194, Ellik Evacuator, model 190-4, is being recalled because of discrepancies between the Japanese language package insert sterilization instructions and the manufacturer's IFU.

    Product
    Tubing for Male Connector 194, Ellik Evacuator. Model Number: 190-4. The Ellik Evacuator and adapter accessories are compatible with Gyrus ACMI Elite and Elite 2 Resection Sheaths.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Food)·H-0307-2025·2025-07-30

    Middle East Coast tahini dip may contain spoilage organisms

    Middle East Coast brand Tahini Dip in 6 oz tubs is being recalled because the product may be contaminated with spoilage organisms. 658 tubs are affected.

    Product
    Middle East Coast brand Tahini Dip; NET WT: 6 OZ (170g); INGREDIENTS: TAHINI, ORGANIC LEMON JUICE, GARLIC, OLIVE OIL, SEA SALT, ORGANIC TOASTED SESAME. CONTAINS SESAME; Locally Crafted by SHOVEL AND SPOON; UPC 8 60005 50281 3
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-2163-2025·2025-07-30

    ACUVUE OASYS MAX multifocal daily lenses have bubbles and voids

    ACUVUE OASYS MAX 1-Day MULTIFOCAL contact lenses are being recalled because of defects, specifically bubbles and voids, identified during standard finished goods testing. 114,165 lenses affected.

    Product
    ACUVUE¿ OASYS MAX 1-Day MULTIFOCAL
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateNHTSA·25V490000·2025-07-28

    2026 Tesla Model Y vehicles recalled for inoperable horn

    Tesla is recalling certain 2026 Model Y vehicles because the horn ground wire ring terminal may be improperly secured, causing the horn to fail. An inoperable horn increases the risk of crashes.

    Product
    TESLA — TESLA MODEL Y
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2127-2025·2025-07-23

    Medtronic SmartSync software update removes an erroneous electrical reset message

    Medtronic SmartLink Software on the SmartSync Patient Connector is being updated because the system could display an erroneous electrical reset message on interrogation when no reset had occurred. 3,909 units affected.

    Product
    Medtronic SmartLink Software loaded on SmartSync Patient Connector, Model Number 24967 with the following software components: 1. Azure Astra application, Software Model Number D00U003; 2. Percepta Serena Solara application, Software Model Number D00U004; 3. Cobalt…
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0516-2025·2025-07-23

    Lisdexamfetamine 60 mg capsules failed dissolution testing at nine month stability

    Lisdexamfetamine Dimesylate Capsules 60 mg are being recalled because an out of specification result was observed in dissolution testing at the nine month long term stability station. 5,448 bottles affected.

    Product
    LISDEXAMFETAMINE DIMESYLATE — LISDEXAMFETAMINE DIMESYLATE (LISDEXAMFETAMINE DIMESYLATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0549-2025·2025-07-23

    Power Stick Spring Fresh roll-on antiperspirant recalled over manufacturing deviations

    Beauty & Skincare Power Stick Original Nourishing Invisible Protection Roll-On Antiperspirant/Deodorant Spring Fresh is being recalled because of CGMP deviations. 22,482 cases are affected.

    Product
    Beauty & Skincare Power Stick original nourishing invisible protection roll-on Antiperspirant/Deodorant Spring Fresh, 1.8 oz./53 mL, A.P Deauville, LLC, PA 18040, NDC# 42913-039-00, UPC Code 815195018194
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·H-0321-2025·2025-07-23

    Boar's Head smoked gouda recalled in Florida over product mislabeling

    Boar's Head Smoked Gouda in 8 oz packages is being recalled because of mislabeling. 65 cases are affected, distributed in Florida.

    Product
    Boar's Head Smoked Gouda, Net Wt 8 oz (226g). UPC 0 42421-50006 6. Keep Refrigerated. Distributed by Brunckhorst Co., NY,NY 11206.
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Food)·H-0280-2025·2025-07-23

    Pasteurized donor human milk bottles have plastic particulate under the cap

    Pasteurized Donor Human Milk in 4 oz bottles is being recalled because plastic particulate from the outer closure was found between the foil seal and the plastic cap. 209 bottles are affected.

    Product
    Pasteurized Donor Human Milk , 4oz plastic bottle
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0548-2025·2025-07-23

    Power Stick for her roll-on antiperspirant recalled over manufacturing deviations

    Power Stick for her PH Balanced Roll-On Antiperspirant Deodorant with Powder Fresh Scent is being recalled because of CGMP deviations. 21,265 cases are affected.

    Product
    Power Stick for her PH Balanced Roll-On Antiperspirant Deodorant with Powder Fresh Scent, 1.8 oz./53 mL, A.P Deauville, LLC, PA 18040, NDC# 42913-038-00, UPC Code 815195019313
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0550-2025·2025-07-23

    Power Stick roll-on antiperspirant recalled over manufacturing practice deviations

    Power Stick Original Nourishing Invisible Protection Roll-On Antiperspirant/Deodorant is being recalled because of CGMP deviations. 23,467 cases are affected.

    Product
    Shave and Skincare Power Stick Original Nourishing Invisible Protection Roll-On Antiperspirant/Deodorant, 1.8 oz./ 53 mL, A.P Deauville, LLC, PA 18040, NDC# 42913-040-00 UPC Code 815195018224
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0530-2025·2025-07-23

    Compounded parenteral nutrition bags recalled over insufficiently documented cleaning step

    Two bags of compounded Peripheral Parenteral Nutrition are being recalled because a daily cleaning step in the ISO-5 compounding area was not sufficiently documented.

    Product
    PERIPHERAL PARENTERAL NUTRITION, Compounded Sterile Preparation, Refrigerated Injection, Rx Only, Single Dose Injection, a) 1440 mL bag, b) 1700 mL bag, Central Admixture Pharmacy Services, Inc, Los Angeles, 13128 Imperial Hwy, Santa Fe Spr., CA 90870.
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2114-2025·2025-07-23

    NeuroSync EYE-SYNC headsets are inoperable and cannot be repaired

    NeuroSync EYE-SYNC systems containing Pico Neo 2 headsets are being recalled because eye syncing issues render the device inoperable and it cannot be repaired. 27 units are affected.

    Product
    NeuroSync EYE-SYNC containing Pico Neo 2 Headsets. Each unit consists of a Pico Neo 2 headset with embedded sensors, a paired Android tablet, and proprietary software, packaged in a portable field case. Eye-tracking headset system is intended for recording, viewing, and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2124-2025·2025-07-23

    Culture media quality control kits contain the wrong bacterial organism

    KWIK-STIK and LYFO DISK quality control kits for culture media are being recalled because affected products contain Staphylococcus epidermidis instead of the expected Brevundimonas diminuta. 21 units affected.

    Product
    KWIK-STIK and LYFO DISK, quality control kit for culture media Catalog # 0805K and 0805L
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-2128-2025·2025-07-23

    Medtronic CareLink SmartSync software update removes an erroneous reset message

    Medtronic SmartLink software on the CareLink SmartSync Device Manager is being updated because the system could display an erroneous electrical reset message on interrogation when no reset had occurred. 5,418 units affected.

    Product
    Medtronic SmartLink software loaded on CareLink SmartSync Device Manager, Model Number 24967A with the following software components: 1. Azure Astra application, Software Model Number D00U003; 2. Percepta Serena Solara application, Software Model Number D00U004; 3.…
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Food)·H-0273-2025·2025-07-23

    New Mexico Pinon single serve coffee cup ink can run

    New Mexico Pinon Coffee Dark Pinon Single Serve cups are being recalled because an inconsistent clear coat seal allows the food safe ink printing to run in a K-cup machine. 154 units affected.

    Product
    New Mexico Pinon Coffee. Dark Pinon Single Serve 10ct. Product Number:F03308 UPC:812361033081. Single Serve (Keurig) Cups, filled with ground coffee flavored with natural flavorings.
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·H-0253-2025·2025-07-16

    Daniele extra virgin olive oil is likely canola oil instead

    Daniele brand First Cold Press Extra Virgin Olive Oil in 3 L containers is being recalled because the product is likely canola oil, not extra virgin olive oil. 10 cases are affected.

    Product
    Daniele brand First Cold Press EXTRA VIRGIN OLIVE OIL; NET 101.4 FL. OZ. (3 QT. 5.4 FL. OZ.) 3L; IMPORTED; Distributed by: dfs international ltd Springfield, ma 01104; INGREDIENTS: EXTRA VIRGIN OLIVE OIL; Product contains select high quality Extra Virgin Olive Oil from the…
    Category
    Food
    Distribution
    1 state