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.

8251–8275 of 21595

  • ModerateFDA (Drugs)·D-1720-2019·2019-08-21

    Lupin Recalls Lisinopril and Hydrochlorothiazide Tablets Due to Foreign Substance

    Lupin Pharmaceuticals is recalling specific bottles of Lisinopril and Hydrochlorothiazide tablets due to the presence of brownish or blackish stains and powder.

    Product
    LISINOPRIL AND HYDROCHLOROTHIAZIDE — LISINOPRIL AND HYDROCHLOROTHIAZIDE (LISINOPRIL AND HYDROCHLOROTHIAZIDE)
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Food)·F-2013-2019·2019-08-21

    Kerry Breader CFS Recalled for Nylon String Foreign Material

    Kerry, Inc. is recalling 153 bags of Breader CFS due to the presence of nylon string. The product was distributed to manufacturers and food service distributors in nine US states.

    Product
    Breader CFS, Item Number 30753188.49, Net Wt. 50 lb, Distributed by Kerry Ingredients & Flavours, Beloit, WI
    Category
    Food
    Distribution
    10 states
  • ModerateFDA (Drugs)·D-1722-2019·2019-08-21

    Alvogen Recalls Nitrofurantoin Capsules Due to Failed Dissolution Specifications

    Alvogen, Inc. is recalling 2,784 bottles of Nitrofurantoin Monohydrate/Macrocrystalline capsules because they failed to meet dissolution specifications.

    Product
    NITROFURANTOIN MONOHYDRATE/ MACROCRYSTALLINE — NITROFURANTOIN MONOHYDRATE/ MACROCRYSTALLINE (NITROFURANTOIN MONOHYDRATE/MACROCRYSTALLINE)
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Food)·F-2037-2019·2019-08-21

    Kerry CKN Tender Batter Recalled for Nylon String Foreign Material

    Kerry, Inc. is recalling CKN Tender Batter/Breader due to the presence of nylon string. The product was distributed to manufacturers and food service distributors in nine states.

    Product
    CKN Tender Batter/Breader, Item Number 30753269.43, Net Wt. 50 lb, Distributed by Kerry Ingredients & Flavours, Beloit, WI
    Category
    Food
    Distribution
    10 states
  • ModerateFDA (Food)·F-2047-2019·2019-08-21

    Kerry Homestyle Breader Recalled for Nylon String Foreign Material

    Kerry, Inc. is recalling 104 bags of Homestyle Breader because the product contains nylon string. The product was distributed to manufacturers and food service distributors in nine US states.

    Product
    Homestyle Breader, Item Number 30753347.49, Net Wt. 50 lb, Distributed by Kerry Ingredients & Flavours, Beloit, WI
    Category
    Food
    Distribution
    10 states
  • ModerateFDA (Food)·F-2003-2019·2019-08-21

    Kerry Breader Recalled for Nylon String Foreign Material

    Kerry, Inc. is recalling 1,470 bags of Breader containing nylon string. The product was distributed to manufacturers and food service distributors in nine states.

    Product
    Breader, Item Number 30753156.49, Net Wt. 50 lb, Distributed by Kerry Ingredients & Flavours, Beloit, WI
    Category
    Food
    Distribution
    10 states
  • ModerateFDA (Food)·F-2027-2019·2019-08-21

    Kerry CFS Breader Recalled for Nylon String Foreign Material

    Kerry, Inc. is recalling 642 bags of CFS Breader because the product contains foreign material (nylon string). The product was distributed to manufacturers and food service distributors in nine US states.

    Product
    CFS Breader, Item Number 30753213.49, Net Wt. 50 lb, Distributed by Kerry Ingredients & Flavours, Beloit, WI
    Category
    Food
    Distribution
    10 states
  • ModerateFDA (Food)·F-2030-2019·2019-08-21

    Kerry Batter Mix Recalled for Nylon String Foreign Material

    Kerry, Inc. is recalling 91 bags of Batter Mix because the product contains foreign material (nylon string). The product was distributed to manufacturers and food service distributors in nine US states.

    Product
    Batter Mix, Item Number 30753221.49, Net Wt. 50 lb, Distributed by Kerry Ingredients & Flavours, Beloit, WI
    Category
    Food
    Distribution
    10 states
  • ModerateFDA (Food)·F-2046-2019·2019-08-21

    Kerry Hot & Spicy Batter Recalled for Nylon String Foreign Material

    Kerry, Inc. is recalling 21 bags of Hot & Spicy Batter NPHO because the product contains foreign material (nylon string). The product was distributed to manufacturers and food service distributors in nine US states.

    Product
    Hot & Spicy Batter NPHO, Item Number 30753342.49, Net Wt. 50 lb, Distributed by Kerry Ingredients & Flavours, Beloit, WI
    Category
    Food
    Distribution
    10 states
  • ModerateFDA (Food)·F-2039-2019·2019-08-21

    Kerry Breader Product Recalled for Nylon String Foreign Material

    Kerry, Inc. is recalling 934 bags of CFS Breader W/More Cracker due to the presence of nylon string. The product was distributed to manufacturers and food service distributors in nine US states.

    Product
    CFS Breader W/More Cracker, Item Number 30753301.49, Net Wt. 50 lb, Distributed by Kerry Ingredients & Flavours, Beloit, WI
    Category
    Food
    Distribution
    10 states
  • ModerateFDA (Devices)·Z-2064-2019·2019-08-21

    Fenwal Volumat MC Agilia Infusion Pump Software Recall

    Fenwal Inc is recalling Volumat MC Agilia infusion pumps to correct four software anomalies and an alarm priority issue in specific software versions.

    Product
    VOLUMAT MC AGILIA US, Infusion Pump, REF Z021135, software versions 1.7 and 1.9a Product Usage: The Volumat MC Agilia is a piece of transportable medical equipment intended to be used in healthcare facilities environment by healthcare trained professionals according to hospit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1741-2019·2019-08-21

    US Pharmaceuticals Recalls CRYO-273 Cold Pain Gel Due to Water Quality Issues

    US Pharmaceuticals is recalling CRYO-273 Cold Pain Relieving Gel because the purified water used in manufacturing failed quality tests for microbial count or organic carbon.

    Product
    CRYO-273 Cold Pain Relieving Gel 128 FL. OZ. Distributed By: CRYO-273.com Tampa, FL 33629. UPC 8 15290 01550 2
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2288-2019·2019-08-21

    Luminex ARIES Extraction Kit Recalled for Partially Sealed Cassette Assemblies

    Luminex Corporation is recalling ARIES Extraction Kits because partially sealed side cassette assemblies may reduce assay sensitivity and stability.

    Product
    ARIES Extraction Kit; ARIES System; SYNCT , REF 50-10026, UDI # 00840487100073
    Category
    Medical Device
    Distribution
    34 states
  • ModerateFDA (Devices)·Z-2286-2019·2019-08-21

    Luminex ARIES Group A Strep Assay Recalled for Seal Defects

    Luminex is recalling ARIES Group A Strep Assay kits because side cassette seals may not meet specifications, potentially affecting test sensitivity and stability.

    Product
    ARIES Group A Strep Assay , REF 50-10041, UDI # 00840487101469
    Category
    Medical Device
    Distribution
    34 states
  • ModerateFDA (Food)·F-2036-2019·2019-08-21

    Kerry Breader Recalled Due to Foreign Material Contamination

    Kerry, Inc. is recalling 142 bags of Breader (Item 30753260.49) because the product contains foreign material (nylon string).

    Product
    Breader, Item Number 30753260.49, Net Wt. 50 lb, Distributed by Kerry Ingredients & Flavours, Beloit, WI
    Category
    Food
    Distribution
    10 states
  • ModerateFDA (Food)·F-2021-2019·2019-08-21

    Kerry Spicy Breader Recalled for Nylon String Foreign Material

    Kerry, Inc. is recalling 160 bags of Spicy Breader due to the presence of nylon string. The product was distributed to manufacturers and food service distributors in nine states.

    Product
    Spicy Breader, Item Number 30753198.49, Net Wt. 50 lb, Distributed by Kerry Ingredients & Flavours, Beloit, WI
    Category
    Food
    Distribution
    10 states
  • ModerateFDA (Drugs)·D-1628-2019·2019-08-14

    Herbal Doctor Remedies Recalls Asma Stopper Capsules for CGMP Deviations

    Herbal Doctor Remedies is recalling Asma Stopper Capsules because they were manufactured outside of current Good Manufacturing Practice controls.

    Product
    Asma Stopper Capsules, Distributed by Herbal Doctor Remedies, Alhambra, CA 91801-7081 USA, 1(800) 600-0808
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1587-2019·2019-08-14

    Herbal Doctor Remedies Recalls Asma Aid Due to Manufacturing Deviations

    Herbal Doctor Remedies is recalling Asma Aid because it was manufactured outside of required Good Manufacturing Practices. The product was distributed nationwide and in Brazil.

    Product
    Asma Aid Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1611-2019·2019-08-14

    Herbal Doctor Remedies Recalls Pain Away Capsules for Manufacturing Deviations

    Herbal Doctor Remedies is recalling Pain Away 500 mg capsules because they were manufactured outside of required Good Manufacturing Practices.

    Product
    Pain Away, 500 mg Capsules, 90-count bottles, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2188-2019·2019-08-14

    Philips CT System Recall for Incorrect Phase Tolerance Image Labeling

    Philips is recalling Ingenuity Core CT systems because images may be incorrectly labeled as having phase tolerance applied when it was not.

    Product
    Ingenuity Core Model # 728321, computed tomography x-ray system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1612-2019·2019-08-14

    Herbal Doctor Remedies Recalls Pain Stopper Capsules for Manufacturing Deviations

    Herbal Doctor Remedies is recalling Pain Stopper 500 mg capsules because they were manufactured outside of required Good Manufacturing Practices controls.

    Product
    Pain Stopper, 500 mg Capsules, 90-count bottles, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1600-2019·2019-08-14

    Herbal Doctor Remedies Recalls Herpes-G Capsules for Manufacturing Violations

    Herbal Doctor Remedies is recalling Herpes-G Capsules because they were manufactured outside of current Good Manufacturing Practices (CGMP) controls.

    Product
    Herpes-G Capsules, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1983-2019·2019-08-14

    Frozen Unbaked Lemon Poppy Seed Muffins Recalled for Plastic Contamination

    Brill, Inc. is recalling 402 cases of frozen, unbaked lemon poppy seed muffins due to potential contamination with small pieces of plastic.

    Product
    48534 MDM 10200921, Natural and Artificial Lemon Flavored Poppy Seed Muffin, pre - deposited - unbaked - keep frozen, UPC 10035074485344, Net Wt. 25.3 lbs, Manufactured by CSM Bakery Products NA, Inc. Tucker, GA
    Category
    Food
    Distribution
    7 states
  • ModerateFDA (Devices)·Z-2216-2019·2019-08-14

    MedComp Recalls Hemodialysis Catheter Kits Due to Labeling Error

    Medical Components, Inc. is recalling 6,830 hemodialysis catheter insertion kits because the tray labels incorrectly describe the included introducer as valved.

    Product
    14F x 24CM SLX Double Lumen Full Tray Hemodialysis catheter insertion kits, Item No. MC061424 Product Usage: An aid for introducing a hemodialysis catheter
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2141-2019·2019-08-14

    Biomet 3i Recalls Titanium Dental Abutments Due to Manufacturing Defect

    Biomet 3i is recalling 17 units of Certain Bellatek Titanium Abutments because a manufacturing defect prevents the screw from seating correctly.

    Product
    CERTAIN(R) BELLATEK(R) TITANIUM ABUTMENT 3.4MM, Item Number IEDAT3 - Product Usage: BIOMET3i Restorative products are intended for use as an accessory to endosseous dental implants for placement in the maxilla and mandible
    Category
    Medical Device
    Distribution
    Distributed nationwide