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.

1926–1950 of 21710

  • ModerateFDA (Food)·H-0338-2025·2025-08-06

    Suspiros tres leches cajeta cake contains goat milk labeled as milk

    Suspiros Tres Leches Cajeta Cake is being recalled because it contains goat milk, which was labeled simply as "milk". 1,249 units are affected.

    Product
    Suspiros Tres Leches Cajeta Cake. 15 P: 25 servings (2500 gr), 4P: 7 servings (700gr), Pocket: 3.7 servings (370gr). UPC= 15P: 1335, 4P: 6982, POCKET: 35256. Type of packaging: Plastic dome and plate (15P and 4P) and Blister plastic tray with lid (in Pocket presentation). Firm…
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-2191-2025·2025-08-06

    BostonSight PROSE lenses made with sagittal height or haptic errors

    BostonSight PROSE Lenses are being recalled because select orders were manufactured with errors impacting sagittal height, haptics, or both. 38 units are affected.

    Product
    BostonSight PROSE Lens.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0542-2025·2025-08-06

    Amlodipine and benazepril capsules released with the wrong expiry date

    Amlodipine and Benazepril HCl Capsules USP 2.5 mg/10 mg are being recalled because they were released with the wrong expiry date, printed as February 2027 instead of January 2027. 7,668 bottles affected.

    Product
    AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE — AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE (AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0543-2025·2025-08-06

    Timolol eye drop caps can lodge a spike in the nozzle

    Timolol Maleate Ophthalmic Solution USP 0.5% is being recalled because of a defective container: the spike of the cap becomes lodged in the nozzle of the bottle. 154,176 bottles affected.

    Product
    TIMOLOL MALEATE — TIMOLOL MALEATE (TIMOLOL MALEATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2192-2025·2025-08-06

    Phasor neurosurgical drills may have a reverse battery orientation

    The Phasor Drill, used in neurosurgical procedures, is being recalled because it may have a reverse battery orientation, which may increase surgical time. 1,064 units are affected.

    Product
    Phasor Drill, REF: 2.70S, 3.20L, 4.50, 5.30, 6.35
    Category
    Medical Device
    Distribution
    29 states
  • ModerateFDA (Devices)·Z-2219-2025·2025-08-06

    ASPIRE Cristalle mammography systems shipped with unapproved slabbing software enabled

    ASPIRE Cristalle Mammography Systems with the Digital Breast Tomosynthesis option are being recalled because devices had an unapproved slabbing software function enabled for use. 293 units affected.

    Product
    ASPRIRE Cristalle Mammography System (cleared under K212873) installed with the ASPIRE Cristalle Digital Breast Tomosynthesis (DBT) Option (approved under P160031).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·H-0345-2025·2025-08-06

    Suspiros German cake contains goat milk labeled only as milk

    Suspiros German Cake is being recalled because it contains goat milk, which was labeled simply as "milk". 93 units are affected.

    Product
    Suspiros German Cake. 15 P: 37.5 servings (2062 gr), 4P: 10 servings (550gr). UPC= 15 P: 1342, 4P: 6971. Type of packaging: Plastic dome and plate (15P and 4P). Firm name: NOVACAB SAPI de CV. Address listed on label: El paso, TX 79901, USA.
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0547-2025·2025-08-06

    Sucralfate tablets recalled because bankruptcy left the quality program unmonitored

    Sucralfate Tablets USP 1 gram from Nostrum Laboratories are being recalled across all lots within expiry because the firm cannot monitor its quality program after filing for Chapter 11. 60,608 bottles affected.

    Product
    Sucralfate Tablets, USP 1 gram, packaged in a) 100-count bottles NDC 29033-0003-01, and b) 500-count bottles, NDC 29033-0003-05), Rx Only, Manufactured by: Nostrum Laboratories, Inc., Kansas City, MO 64120.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·H-0381-2025·2025-08-06

    Pure Monk Fruit Sweetener bottles actually contain mislabeled stevia powder

    Pure Monk Fruit Sweetener, 0.71 oz, is being recalled because the product is stevia powder but the bottle was mislabeled as Pure Monk Fruit Sweetener. 78 bottles are affected.

    Product
    Pure Monk Fruit Sweetener, net wt. 0.71oz. UPC 7 39223 00187 6. Product is packaged in a plastic bottle with white cap. Ingredient: Monk Fruit (Luo Han Guo) Extract. Monk Fruit is so much sweeter than sugar, a pinch is all you need. Suggested Use: Add to sweeten your food or…
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·H-0341-2025·2025-08-06

    Suspiros four leches cake contains goat milk labeled only as milk

    Suspiros 4 Leches Cake is being recalled because it contains goat milk, which was labeled simply as "milk". 612 units are affected.

    Product
    Suspiros 4 Leches Cake. 15 P: 26 servings (2600 gr), 4P: 7 servings (700 gr), Pocket: 4.1 servings (410gr). UPC=15P: 1343, 4P: 6969, POCKET: 7904. Type of packaging: Plastic dome and plate (15P and 4P) and Blister plastic tray with lid (in Pocket presentation). Firm name…
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Food)·H-0328-2025·2025-07-30

    Gedney dill pickles slated for disposal were inadvertently sold

    Gedney dill pickle products, including Whole Pickles and Mini Munchers Kosher Dill, are being recalled because product slated for disposal due to damage was inadvertently sold. 3,520 cases affected.

    Product
    Dill Pickles packaged under the following label: 1. Gedney Whole Pickles, item 15100, Net 32 fl oz. (1Qt)946mL. UPC 0 41660-00151 8. 2. Gedney Mini Munchers Kosher Dill, item 17100, Net 32 fl oz. (1Qt)946mL. UPC 0 41660-00171 6. 3. Gedney Kosher Dill Babies, item 17200, Net…
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Food)·H-0329-2025·2025-07-30

    Gedney Zinger pickle products slated for disposal were inadvertently sold

    Gedney Zinger pickle products are being recalled because product slated for disposal due to product and container damage was inadvertently sold. 3,520 cases are affected.

    Product
    Zinger Pickle products under the following labels: 1. Gedney Zinger Chips, item 18800, 24 fl oz. (1-1/2 Pt) 710mL. UPC 0 41660-00188 4. 2. Gedney Zingers Dill Babies, item 18600, Net 24 fl oz. (1-1/2 Pts) 710mL. UPC 0 41660-00186 0. Refrigerate after opening.…
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2139-2025·2025-07-30

    Reusable endoscope silicone seals have conflicting sterilization instructions in Japan

    Blue Silicone Reusable Silicone Seals 6-12 FR, model CS-B612, are being recalled because of discrepancies between the Japanese language package insert sterilization instructions and the manufacturer's IFU.

    Product
    Blue Silicone, Reusable Silicone Seal 6 - 12 FR. Model Number: CS-B612. The reusable silicone seals fit over the biopsy port of endoscopes to seal off the working channel. Some contain a lumen which allows instruments to be passed through the seal and minimize or prevent…
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Food)·H-0330-2025·2025-07-30

    Gedney ghost pepper pickles slated for disposal were inadvertently sold

    Gedney Ghost Pepper LIL Pickles are being recalled because product slated for disposal due to product and container damage was inadvertently sold. 3,520 cases are affected.

    Product
    Gedney Ghost Pepper LIL Pickles, item 75802, Net 24 fl oz. (1.5Pts) 710mL. UPC 0 41660-00758 9. Refrigerate after opening. Distributed by Gedney Foods Co, Burnsville, MN 55438 Product of Mexico.
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2146-2025·2025-07-30

    Ellik Evacuator non-locking cone has conflicting sterilization instructions in Japan

    The Cone with Male Tubing, Non-Locking, Ellik Evacuator, model 191-NRS, is being recalled because of discrepancies between the Japanese language package insert sterilization instructions and the manufacturer's IFU.

    Product
    Cone with Male Tubing, Non-Locking, Ellik Evacuator. Model Number: 191-NRS. 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-2143-2025·2025-07-30

    Ellik Evacuator recalled over conflicting sterilization instructions in Japanese inserts

    The Ellik Evacuator, model 194, is being recalled because of discrepancies between the Japanese language package insert sterilization instructions and the manufacturer's IFU. 11 units are affected.

    Product
    Ellik Evacuator. Model Number: 194. The Ellik Evacuator and adapter accessories are compatible with Gyrus ACMI Elite and Elite 2 Resection Sheaths.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0537-2025·2025-07-30

    Clomipramine capsules failed a degradation product specification at expiry testing

    Clomipramine Hydrochloride Capsules USP 25 mg are being recalled after an out of specification result for an unspecified degradation product during retention sample testing at expiry. 2,724 bottles affected.

    Product
    CLOMIPRAMINE HYDROCHLORIDE — CLOMIPRAMINE HYDROCHLORIDE (CLOMIPRAMINE HYDROCHLORIDE CAPSULES)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2140-2025·2025-07-30

    Green endoscope silicone seals have conflicting sterilization instructions in Japan

    Green Silicone Seals for Accessories, reusable 0-7 FR, model CS-G7, are being recalled because of discrepancies between the Japanese language package insert sterilization instructions and the manufacturer's IFU.

    Product
    Green Silicone Seal for Accessories, Reusable Silicone Seal 0 - 7 FR. Model Number: CS-G7. The reusable silicone seals fit over the biopsy port of endoscopes to seal off the working channel. Some contain a lumen which allows instruments to be passed through the seal and…
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2145-2025·2025-07-30

    Ellik Evacuator locking adapter has conflicting sterilization instructions in Japan

    The Ellik Evacuator Adapter, Locking, model 190-NRS, is being recalled because of discrepancies between the Japanese language package insert sterilization instructions and the manufacturer's IFU. 5 units affected.

    Product
    Ellik Evacuator Adapter, Locking. Model Number: 190-NRS. 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-0327-2025·2025-07-30

    Sushi wasabi mini packs do not declare Yellow 5 on label

    Sushi Wasabi 5 gram ready to eat mini packs are being recalled because the individual consumer size label does not declare the ingredient Yellow 5. 1,848 cases are affected.

    Product
    Sushi Wasabi; 5 grams (Ready to eat) Ingredients: Horseradish, Corn Oil, Salt, Water, Citric Acid, Tumeric, FD&C Blue#1 Distributed by: Tokyo Nori U.S.A, City of Industry, CA 91746
    Category
    Food
    Distribution
    21 states
  • ModerateFDA (Devices)·Z-2141-2025·2025-07-30

    Ellik Evacuator glass body has conflicting sterilization instructions in Japan

    The Glass Body for the 194 Ellik Evacuator, model 190A, is being recalled because of discrepancies between the Japanese language package insert sterilization instructions and the manufacturer's IFU.

    Product
    Glass Body For 194 Ellik Evacuator. Model Number: 190A. 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-2157-2025·2025-07-30

    EasiSlush sterile slush solution missed a quarterly gamma sterilization dose audit

    Bridge to Life EasiSlush is being recalled because quarterly dose audits monitoring the gamma sterilization process were not completed on time for three lots in the first quarter of 2024. 4,528 units affected.

    Product
    Bridge to Life EasiSlush, (Sodium Chloride Solution for Sterile Slush Preparation) (0.9% Sodium Chloride Irrigation, USP), Part Number REF BTLE-1250
    Category
    Medical Device
    Distribution
    16 states