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.

5076–5100 of 21589

  • ModerateFDA (Drugs)·D-0359-2022·2022-01-12

    Cefixime Capsules 400 mg Recalled for Failed Impurities and Degradation

    Ascend Laboratories recalls Cefixime 400 mg capsules due to failed impurities and degradation specifications. The affected 42,698 bottles were distributed nationwide.

    Product
    CEFIXIME — CEFIXIME (CEFIXIME)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0336-2022·2022-01-12

    DG/health Aller.Ease Fexofenadine Tablets Recalled for Impurity

    Perrigo Company PLC is recalling DG/health Aller.Ease Fexofenadine Hydrochloride 180 mg tablets nationwide because they failed impurity specifications during stability testing.

    Product
    DG/health Aller.Ease, Fexofenadine Hydrochloride Tablets, 180 mg/Antihistamine, 24HR, 10 count bottle, Distributed by: Made in Czech Republic. Distributed by Dolgencorp, LLC, 100 Mission Ridge Goodlettsville, TN 37072. UPC 3 70030 65779 7
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0297-2022·2022-01-05

    Betamethasone Dipropionate Lotion recalled for failed stability test

    Teligent Pharma is recalling Betamethasone Dipropionate Lotion USP 0.05% (Augmented) due to failure to meet specification for the Active Pharmaceutical Ingredient particle test during routine stability testing.

    Product
    Betamethasone Dipropionate Lotion USP, 0.05% (Augmented), 30 mL bottle, (29 g), Rx Only, Teligent Pharma Inc., Buena, NJ, 08310, NDC 52565-023-29
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0422-2022·2022-01-05

    Diagnostic device recall: incorrect color in package insert reading table

    Biomerieux is recalling RAPID 20 E diagnostic systems because the package insert contains an incorrect color for interpreting negative CIT test results.

    Product
    RAPID 20 E, REF 20701, System for the identification of Enterobacteriaceae in 4 hours, 25 strips/package, IVD.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0424-2022·2022-01-05

    FDA Recalls VIDAS PRG Progesterone Test Kits for Substrate Error

    bioMerieux is recalling 1,818 units of VIDAS PRG Progesterone test kits due to a substrate error that prevents the tests from running properly, causing delayed results when patients need repeat testing.

    Product
    VIDAS PRG Progesterone, REF 30409-01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0427-2022·2022-01-05

    Diagnostic substrate error in medical testing device causes test failures

    bioMerieux is recalling 1,579 VIDAS DEX@ diagnostic devices due to substrate errors that prevent test execution, requiring users to rerun tests and potentially delaying results.

    Product
    VIDAS DEX@, Dimer Exclusion II, REF 30455-01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0296-2022·2022-01-05

    Lidocaine Hydrochloride Topical Solution Recalled for Superpotency

    Teligent Pharma is recalling Lidocaine Hydrochloride Topical Solution USP 4% due to superpotency. The affected lot was distributed nationwide.

    Product
    LIDOCAINE HYDROCHLORIDE — LIDOCAINE HYDROCHLORIDE (LIDOCAINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0438-2022·2022-01-05

    VIDAS SARS-CoV-2 IgM Diagnostic Test Recalled for Substrate Error

    bioMerieux is recalling one lot of VIDAS SARS-CoV-2 IgM tests nationwide due to a substrate defect that prevents the test from running. The defect causes delayed results as users must repeat testing.

    Product
    VIDAS SARS-COV-2 IgM, Ref 423833-01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0432-2022·2022-01-05

    VIDAS RUB IgG Diagnostic Test Kit Recalled for Substrate Defect

    bioMerieux is recalling three lots of VIDAS RUB IgG test kits due to substrate errors that prevent the test from running, potentially delaying diagnostic results.

    Product
    VIDAS RUB IgG (RBG), REF 30226
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0431-2022·2022-01-05

    Diagnostic test kit recalled due to substrate error preventing test execution

    A diagnostic test kit manufactured by bioMerieux has been recalled because a substrate error prevents the test from running, which delays test results for patients.

    Product
    VIDAS TOXO IgG Avidity (TXGA), REF 30222-01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0433-2022·2022-01-05

    VIDAS LH diagnostic test substrate error causes delayed results

    bioMerieux VIDAS LH test kits (lot 1008848600) are affected by a substrate error that prevents test execution, requiring users to repeat testing and potentially delaying results.

    Product
    VIDAS LH, REF 30406-01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0436-2022·2022-01-05

    VIDAS Lyme IgM II Diagnostic Test Kits Recalled for Substrate Error

    bioMerieux is recalling three lots of VIDAS Lyme IgM II diagnostic test kits due to a substrate error that prevents the test from running, requiring users to conduct another test to obtain results.

    Product
    VIDAS Lyme IgM II (LYM), REF 416436
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0340-2022·2021-12-29

    Flora Pastries Fiochetto Recalled for Undeclared Milk

    Cesarina Bakery is recalling Flora Pastries Fiochetto in assorted apricot and raspberry flavors because they contain undeclared milk, which poses a health risk to those with milk allergies.

    Product
    Flora PASTRIES FIOCHETTO Assorted Flavors Apricot and Raspberry, Net. Wt. 16 oz (454g)
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Food)·F-0290-2022·2021-12-29

    Cupcakes Recalled Due to Potential Metal Contamination

    Give and Go is recalling multiple cupcake products totaling approximately 1.14 million units due to potential metal contamination. Affected products were distributed nationwide.

    Product
    two-bite vanilla & chocolate cupcakes 10 oz. UPC 7 70981 04502 3 20 oz. UPC 7 70981 03107 1 meijer mini assorted cupcakes with Holiday inspired sprinkle blend 20 oz. UPC 7 08820 40243 0 Kimberley's bakeshoppe vanilla & chocolate cupcakes 22 oz. UPC 7 70981 31122 7
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0289-2022·2021-12-29

    Fexofenadine Hydrochloride Tablets 60 mg Recalled for Failed Impurities and Degradation Specifications

    The Harvard Drug Group is recalling Fexofenadine Hydrochloride Tablets, 60 mg, distributed by Major Pharmaceuticals nationwide due to failed impurities and degradation specifications. Affected lots are H00005, H00006, and H00007.

    Product
    Fexofenadine Hydrochloride Tablets, 60 mg, 500 Tablets per bottle, Distributed by: Major Pharmaceuticals, 17177 N. Laurel Park Drive, Suite 233, Livonia, MI 48152 NDC 0904-6979-40
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0287-2022·2021-12-29

    Medline Hand Sanitizer Foam Recalled for Defective Containers

    Medline Industries Inc is recalling Hand Sanitizer Foam in multiple sizes due to leaking bottles and dispensing issues reported by customers. The product was distributed nationwide and internationally.

    Product
    Hand Sanitizer Foam (ethyl alcohol), 62% v/v, packaged in a) 1.5 Oz. cans, NDC 53329-970-12; b) 8 Oz. (227 g) cans, NDC 53329-970-08; and c) 16 Oz. (453 g) cans, NDC 53329-970-06; Manufactured for: Medline Industries, Inc., Northfield, IL 60093.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0413-2022·2021-12-29

    Testicular Prosthesis Recalled Due to Incorrect Size Labeling

    Coloplast Manufacturing is recalling Torosa Saline-Filled Testicular Prosthesis (Size Small) due to incorrect size labeling. Nineteen units were distributed in the US and Canada.

    Product
    Torosa Saline-Filled Testicular Prosthesis (Size Small)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0309-2022·2021-12-29

    Freshness Guaranteed Black Forest Tiny Pies recalled for potential metal contamination

    Freshness Guaranteed Black Forest Tiny Pies 18.5 oz. are being recalled nationwide due to potential metal in the product. Consumers should not eat the product and should contact the manufacturer or retailer.

    Product
    Freshness Guaranteed Black Forest Tiny Pies 18.5 oz. UPC 0 78742 37635 6
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0294-2022·2021-12-29

    Penicillin V Potassium Oral Solution recalled for subpotency

    Teva Pharmaceuticals USA is recalling certain lots of Penicillin V Potassium for Oral Solution nationwide because the medication is subpotent—containing less active ingredient than labeled. The recall affects 100 mL and 200 mL bottles distributed nationwide.

    Product
    Penicillin V Potassium for Oral Solution, USP 125 mg (200,000 U) per 5 mL a) 100 mL (NDC 00093-4125-73) and b) 200 mL (NDC 00093-4125-74) (when mixed) bottles, Rx Only, Manufactured For: Teva Pharmaceuticals USA, Inc. North Wales, PA 19454
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0408-2022·2021-12-29

    Malosa Core Phaco Pack 2 Surgical Kit Recalled for Packaging Sterility Risk

    Beaver Visitec International is recalling the Malosa Core Phaco Pack 2 medical refractive kit due to small holes in the kit packaging that may compromise product sterility.

    Product
    Malosa Core Phaco Pack 2- Medical Refractive Kit intended to be used to aid in cataract, corneal, or refractive surgery. Part Number: MMK834/1
    Category
    Medical Device
    Distribution
    9 states
  • ModerateFDA (Food)·F-0316-2022·2021-12-29

    Kimberley's Bakeshoppe Sugar Cookies Recalled for Potential Metal Contamination

    GIVE AND GO is recalling Kimberley's bakeshoppe vanilla mini Frosted soft Sugar Cookies (9.4 oz., UPC 7 70981 30312 3) nationwide due to potential metal in the product.

    Product
    Kimberley's bakeshoppe vanilla mini Frosted soft Sugar Cookies 9.4 oz. UPC 7 70981 30312 3
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0335-2022·2021-12-29

    Coca-Cola Cola 12-Pack Recalled for Potential Foreign Matter

    COCA COLA Consolidated LLC is recalling Coca-Cola cola in 12 oz. aluminum cans (12-pack fridge packs) distributed to Arkansas, Mississippi, and Tennessee due to the potential presence of foreign matter in containers.

    Product
    Coca-Cola cola; 12 oz. aluminum can; 12-pack fridge pack/case
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Food)·F-0344-2022·2021-12-29

    Cesarina Cookies Tutti Frutti Recalled for Undeclared Milk

    Cesarina Bakery, Inc. is recalling Cesarina Cookies Tutti Frutti (16 oz) because the product contains undeclared milk, a common allergen not listed on the label.

    Product
    Cesarina Cookies, Tutti Frutti Cookies, Net Weight 16oz (453.59g)
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Food)·F-0343-2022·2021-12-29

    Cesarina Cookies Recalled Due to Undeclared Milk

    Cesarina Bakery, Inc. is recalling Cesarina Cookies, Fiochetto, Apricot Raspberry Guava (16oz boxes) because they contain undeclared milk, a common allergen. The recall affects domestic distribution and applies to multiple lot codes with expiration dates ranging from March 2022 through May 2022.

    Product
    Cesarina Cookies, Fiochetto, Apricot Raspberry Guava, Net Weight 16oz (453.59g)
    Category
    Food
    Distribution
    0 states