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.

3326–3350 of 21589

  • ModerateFDA (Drugs)·D-1096-2023·2023-08-30

    Blis-To-Sol Tolnaftate Liquid Recalled for Manufacturing Practice Deviations

    Ecometics, Inc. is recalling Blis-To-Sol Liquid (Tolnaftate) nationwide due to manufacturing practice violations. No illnesses have been reported.

    Product
    Blis-To-Sol Liquid (Tolnaftate), 1%, packaged in a) 1 FLUID OZ. (29.5 mL) bottles, UPC 0 11169 20011 8 and b) 1.85 FLUID OZ. (54.5 mL) bottles, UPC 0 11169 20012 5, Distributed by Oakhurst Company, Levittown, NY 11756.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1098-2023·2023-08-30

    ALCOLADO RELAMPAGO topical liniment recalled for manufacturing process violations

    Ecometics, Inc. is recalling ALCOLADO RELAMPAGO (menthol and camphor) topical liniment nationwide due to manufacturing process deviations. Products were not manufactured under current good manufacturing practices.

    Product
    ALCOLADO RELAMPAGO (Menthol and Camphor), 1% and 1.5% respectively, packaged in a 7 FLUID OZ (207 ml) bottles, UPC 7 18864 20102 9 and b) 16 FLUID OZ (472 ml) bottles, UPC 7 18864, 20110 4, Distributed by: The Larkspur Group, Inc., Norwalk, CT 06854.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1092-2023·2023-08-30

    Helix CBD Therapy Cream Recalled Due to Manufacturing Deviations

    Parker Laboratories voluntarily recalled Helix CBD Therapy Cream due to Current Good Manufacturing Practice deviations. The recall affects specific lot numbers distributed nationwide and internationally.

    Product
    Helix CBD Therapy Cream (Menthol 7.4%), packaged in a) 3 g pouch (NDC 30775-053-01), b) 2 fl. oz. tubes (NDC 30775-053-02), c) 4 fl. oz. tubes (NDC 30775-053-04), Parker Laboratories Inc., Fairfield, NJ, 07004
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1103-2023·2023-08-30

    Prescription Injection Recalled Due to Missing or Peeled Labels

    Baxter Healthcare Corporation recalls Bendamustine Hydrochloride injection nationwide because labels are missing or partially peeled off vials, raising the risk of medication errors.

    Product
    BENDAMUSTINE HYDROCHLORIDE — BENDAMUSTINE HYDROCHLORIDE (BENDAMUSTINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1456-2023·2023-08-30

    Fanta Orange Zero Sugar bottles mislabeled; contain regular sugar product

    RQA, Inc. is recalling 150 bottles of Fanta Orange Zero Sugar that were mislabeled and actually contain regular Fanta Orange with 73g of sugar instead of 0g. Affected products were distributed to retail locations in North Carolina, South Carolina, and Virginia.

    Product
    FANTA ZERO SUGAR orange 20 FL OZ (1.25 PT) 591 mL UPC 0 49000 04143 9 THE COCA-COLA COMPANY
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-1095-2023·2023-08-30

    Prescription Drug Trandolapril and Verapamil Tablets Recalled for Subpotency

    Glenmark Pharmaceuticals is recalling Trandolapril and Verapamil Extended-Release Tablets because they are subpotent—they do not contain their full specified amount of active ingredient. The issue was found during three-month stability testing.

    Product
    TRANDOLAPRIL AND VERAPAMIL HYDROCHLORIDE — TRANDOLAPRIL AND VERAPAMIL HYDROCHLORIDE (TRANDOLAPRIL AND VERAPAMIL HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2457-2023·2023-08-30

    Medicrea Recalls IMPIX TLIF Fusion Devices for Packaging Defects

    Medicrea International is recalling IMPIX TLIF intervertebral fusion devices due to potential packaging defects. The devices may have pinholes in the inner or outer packaging pouches.

    Product
    IMPIX TLIF, REF numbers: a) B15130607S, b) B15130609S, c) B15130611S, d) B15130613S, e) B15130615S, f) B15900806, g) B15900906, h) B15901006, i) B15901106, j) B15901206, k) B15901306; intervertebral fusion device - lumbar
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1099-2023·2023-08-30

    Unguentine Ointment Recalled Due to Manufacturing Practice Deviations

    Ecometics, Inc. is recalling Unguentine Ointment because products were not manufactured under current good manufacturing practices. The recall affects 6,660 tubes distributed nationwide.

    Product
    Unguentine Ointment, (Camphor 3.0%, Phenol 2.5%, Tannic Acid 2.2%, Zinc Oxide 6.6%), labeled as a) NET WT 1 OZ (28 g) tubes, Improved Formula, UPC 0 11169 10216 0, and b) NET WT 1 OZ (28.3g) tubes, Maximum Strength, UPC 0 11169 11250 3, Distributed by: Oakhurst Company, Levittown
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1091-2023·2023-08-30

    Helix Tri-Active Therapy Cream Recalled for Manufacturing Quality Deviations

    Parker Laboratories is voluntarily recalling Helix Tri-Active Therapy Cream due to manufacturing quality control deviations. The recall affects products with lot numbers A1221010 and A1221011, expiring December 9, 2023, distributed in the United States, Singapore, Korea, and Hong Kong.

    Product
    Helix Tri-Active Therapy Cream (Camphor 3.2%, Menthol 7.4%, Methyl salicylate 12.5%), packaged in a) 3 fl. oz. roll-on (NDC 30775-052-03) and b) 4 fl. oz. tube (NDC 30775-052-04) Parker Laboratories, Inc. 286 Eldridge Road, Fairfield, NJ 07004
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2461-2023·2023-08-30

    Cervical intervertebral fusion devices recalled for packaging defect

    Medicrea International is recalling IMPIX S cervical intervertebral fusion devices due to a potential packaging defect involving pinholes in the inner or outer pouch. No injuries have been reported.

    Product
    IMPIX S, REF numbers: a) B15328071S, b) B15328073S, c) B15328074S, d) B15334072S, e) B15334073S, f) B15334074S; intervertebral fusion device - cervical
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2453-2023·2023-08-30

    Medicrea IMPIX ALIF Lumbar Fusion Devices Recalled for Packaging Defect

    Medicrea International is recalling 11 IMPIX ALIF lumbar intervertebral fusion devices distributed nationwide due to a potential packaging defect with pinholes in the device pouch.

    Product
    IMPIX ALIF, REF numbers: a) B15111209, b) B15111212, c) B15111409, d) B15111412; intervertebral fusion device - lumbar
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1094-2023·2023-08-30

    Moxifloxacin-Bromfenac Eye Drops Recalled for Subpotent Bromfenac Levels

    Imprimis NJOF, LLC is recalling 2,683 bottles of Moxifloxacin-Bromfenac eye drops nationwide because Bromfenac levels fall below the 90-110% specification (affected lots: 22DEC047 exp. 9/16/23, 23FEB057 exp. 11/24/23).

    Product
    Moxifloxacin - Bromfenac Sterile Ophthalmic Solution 0.5% / 0.075%, 5mL bottle, Imprimis NJOF, LLC. 1705 Route 46 West, Unit 6B, Ledgewood, NJ 07852 (844)-446-6979, NDC: 71384-311-05.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1088-2023·2023-08-30

    Rufinamide Tablets Recalled Due to Manufacturing Quality Deviation

    Aurobindo Pharma USA Inc. is recalling Rufinamide 400 mg tablets due to manufacturing quality deviations. The affected batch was released prior to approval.

    Product
    RUFINAMIDE — RUFINAMIDE (RUFINAMIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1411-2023·2023-08-23

    Dilettante Dark Ginger Bulk Truffles Recalled for Inadequate Milk Allergen Labeling

    Dilettante Chocolates recalled Dark Ginger Bulk Truffles from Washington retail stores because the display placard's allergen declaration fails to clearly identify milk. The product boxes have the correct label.

    Product
    Dilettante Mocha Cafe brand Dark Ginger Bulk Truffles, perishable, sold individual pieces out of retail display cases. The display placard declares milk in the ingredients statement, but the Contains statement declares "Contains: Dairy". Bulk truffle boxes sent to retail stores
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Food)·F-1407-2023·2023-08-23

    Dilettante Mocha Cafe Dark Raspberry Truffles display placard mislabeled for allergens

    Dilettante Chocolates recalls Mocha Cafe Dark Raspberry Bulk Truffles sold at retail stores in Washington due to incomplete allergen labeling on display placards. The product contains dairy but the allergen declaration is incomplete.

    Product
    Dilettante Mocha Cafe brand Dark Raspberry Bulk Truffles, perishable, sold individual pieces out of retail display cases. The display placard declares cream and butter in the ingredients statement, but the Contains statement declares "Contains: Dairy". Bulk truffle boxes sent t
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2412-2023·2023-08-23

    Medtronic ventricular catheter system recalled due to incorrect labeling expiration date

    Medtronic is recalling 44 units of the Duet External Drainage and Monitoring system because the product labels contain an incorrect expiration date. The affected lot (226632942) was distributed nationwide.

    Product
    Medtronic REF 46915 Duet External Drainage and Monitoring system, Interlink Injection sites, Ventricular Catheter, STERILE EO, Rx Only
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1445-2023·2023-08-23

    Bacon Cure Product Recalled for Possible Metal Contamination

    Newly Weds Foods recalls a bacon cure product due to possible contamination with small metal pieces. Consumers who purchased this product should not use it.

    Product
    Newly Weds Foods R03361 HAHN'S SPECIAL BACON CURE HS X1 40lbs
    Category
    Food
    Distribution
    10 states
  • ModerateFDA (Food)·F-1409-2023·2023-08-23

    Dilettante Mocha Cafe Dark Chocolate Truffles Display Placard Allergen Labeling Error

    Dilettante Chocolates recalls display placards for L'Orange Dark Bulk Truffles due to incomplete allergen labeling. The placard's allergen warning does not clearly state milk, though the actual product packaging is correctly labeled.

    Product
    Dilettante Mocha Cafe brand L'Orange Dark Bulk Truffles, perishable, sold individual pieces out of retail display cases. The display placard declares milk in the ingredients statement, but the Contains statement declares "Contains: Dairy". Bulk truffle boxes sent to retail stor
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Food)·F-1413-2023·2023-08-23

    Dilettante Espresso Truffles Recall: Incomplete Allergen Labeling on Display

    Dilettante Chocolates recalls Mocha Cafe Espresso Bulk Truffles sold at Washington retail locations. The retail display placard's allergen statement declares 'Contains: Dairy' instead of the required 'Contains: Milk.'

    Product
    Dilettante Mocha Cafe brand Espresso Bulk Truffles, perishable, sold individual pieces out of retail display cases. The display placard declares milk in the ingredients statement, but the Contains statement declares "Contains: Dairy". Bulk truffle boxes sent to retail stores co
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-1086-2023·2023-08-23

    Tobramycin Ophthalmic Solution recalled for failed quality specifications

    Alembic Pharmaceuticals is recalling 82,400 bottles of Tobramycin Ophthalmic Solution nationwide because the product failed to meet impurities and degradation specifications.

    Product
    TOBRAMYCIN OPHTHALMIC SOLUTION — TOBRAMYCIN OPHTHALMIC SOLUTION (TOBRAMYCIN OPHTHALMIC SOLUTION)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1439-2023·2023-08-23

    Trader Joe's Tiniest Chocolate Chip Cookies Recalled for Undeclared Peanut

    Commercial Bakeries is recalling Trader Joe's Tiniest Chocolate Chip Cookies due to undeclared peanut. Consumers with peanut allergies should not consume this product.

    Product
    Trader Joe's Tiniest Chocolate Chip Cookies Net Wt. 8 oz (227 g) UPC: 0076 3691 Packaged in bags. 24 bags per case.
    Category
    Food
    Distribution
    7 states
  • ModerateFDA (Food)·F-1419-2023·2023-08-23

    Dilettante Mocha Cafe Caramels Display Placard Allergen Labeling Inconsistency

    Dilettante Chocolates Inc is recalling caramels sold from display cases because the display placard's allergen statement is incomplete. The placard lists only 'Contains: Dairy' despite cream and butter being shown in the ingredients list.

    Product
    Dilettante Mocha Cafe brand Himalayan Pink Salt Bulk Caramels, perishable, sold individual pieces out of retail display cases. The display placard declares cream and butter in the ingredients statement, but the Contains statement declares "Contains: Dairy". Bulk truffle boxes s
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Food)·F-1447-2023·2023-08-23

    Newly Weds Foods Curing Salt Recalled Due to Metal Contamination

    Newly Weds Foods, Inc. is recalling its G25928 Curing Salt product because it may contain small pieces of metal. Affected consumers should not use this product.

    Product
    Newly Weds Foods G25928 CURE 6.25% W/SALT W/O ADDITIVES X1 50lbs
    Category
    Food
    Distribution
    10 states
  • ModerateFDA (Food)·F-1418-2023·2023-08-23

    Dilettante Mocha Cafe Espresso Bulk Caramels Recalled for Labeling Discrepancy

    Dilettante Chocolates is recalling Mocha Cafe Espresso Bulk Caramels sold at its Washington retail locations due to a display placard allergen declaration that states 'Contains: Dairy' instead of 'Contains: Milk,' though milk is listed in the ingredients.

    Product
    Dilettante Mocha Cafe brand Espresso Bulk Caramels, perishable, sold individual pieces out of retail display cases. The display placard declares milk in the ingredients statement, but the Contains statement declares "Contains: Dairy". Bulk truffle boxes sent to retail stores co
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-1085-2023·2023-08-23

    PLUVICTO Injection Recalled for Incorrect Lot and Expiration Date Labels

    PLUVICTO (lutetium Lu 177 vipivotide tetraxetan) injection vials were labeled with incorrect lot numbers and expiration dates. The manufacturer is recalling affected lots distributed nationwide.

    Product
    PLUVICTO 1,000MBq/mL (27 mCi/mL), lutetium Lu 177 vipivotide tetraxetan injection, 9.2 mL Single-dose vial, Manufacturer: Advanced Accelerator Appllications USA, Inc., 57 E. Willow Street NJ 07041, Milburn, USA, NDC 69488-010-61
    Category
    Drug
    Distribution
    Distributed nationwide