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.

2676–2700 of 3531

  • ModerateFDA (Food)·F-0870-2022·2022-03-23

    Seasoning Recall: Undeclared Wheat in Honey BBQ Snack Stick Seasoning

    PS Seasoning & Spices, Inc. recalled Honey BBQ Snack Stick Seasoning containing undeclared wheat, affecting approximately 10,441 units distributed across multiple U.S. states and Canada. Consumers with wheat allergies should not consume affected products.

    Product
    Honey BBQ Snack Stick Seasoning packaged in the following sizes: 1. 765-A, Net Wt 21 lbs. (9.52kg). Part #020001203. 2. 765-B, Net Wt 5.25 lbs. (2.38kg). Part #020001299. 3. 765-C, Net Wt 2.63 lbs (1.19kg). Part #020001513. Ingredients: Sugar, Salt, Dried Ho
    Category
    Food
    Distribution
    27 states
  • ModerateFDA (Food)·F-0878-2022·2022-03-23

    Port City Soups Thai Green Curry recalled for unapproved production process

    Tony's Tejas Salsa is recalling Port City Soups Thai Green Curry (32oz glass jars) because the production process has not been approved for acidified foods. The product was distributed in Alabama, Louisiana, Mississippi, and Tennessee.

    Product
    Port City Soups Thai Green Curry 32oz glass mason jar sold by individual unit
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Food)·F-0872-2022·2022-03-23

    FDA Recalls Seasoning Product for Undeclared Wheat Allergen

    PS Seasoning & Spices, Inc. recalled Maplewood Meats Honey BBQ Stick Seasoning (lot 2022-53578) for undeclared wheat. The product was distributed across multiple U.S. states and Canada; consumers with wheat allergies should not use it.

    Product
    Maplewood Meats Honey BBQ Stick Seasoning Net Wt 21 lbs. (9.50kg). Part #180002067. Ingredients: Sugar, Salt, Dried Honey, Spices, Brown Sugar, Onion and Garlic Powder, Monosodium Glutamate, Natural Smoke Flavor, Sodium Erythorbate (0.26%), Dried Molasses, Natural Flavors,
    Category
    Food
    Distribution
    27 states
  • ModerateFDA (Devices)·Z-0784-2022·2022-03-23

    Mycoplasma genitalium Control Panel Distributed Without Proper Release Testing

    Microbiologics Inc is recalling Mycoplasma genitalium Control Panel units that did not undergo proper release testing before distribution. Affected lots were distributed across the U.S. and internationally.

    Product
    Mycoplasma genitalium Control Panel (Inactivated Pellet)
    Category
    Medical Device
    Distribution
    18 states
  • ModerateFDA (Food)·F-0876-2022·2022-03-23

    Port City Soups Tex-Mex Chili Recalled for Unapproved Acidified Food Process

    Tony's Tejas Salsa is recalling Port City Soups Tex-Mex Chili because the production process was not approved for acidified foods. The recall affects 81 units distributed in Alabama, Louisiana, Mississippi, and Tennessee.

    Product
    Port City Soups Tex-Mex Chili 32oz glass mason jar sold by individual unit
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0788-2022·2022-03-23

    LYFO Disk Quality Control Product Recalled for Organism Mislabeling

    Microbiologics Inc recalls LYFO Disk lot 983-40-3 because it is labeled as Candida tropicalis but actually contains Yersinia enterocolitica. The mislabeling may cause laboratory quality control failures and delayed test results.

    Product
    LYFO Disk
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0653-2022·2022-03-23

    hydrALAZINE HCl Tablets 10 mg Recalled for Failed Impurity Specifications

    The Harvard Drug Group is recalling hydrALAZINE HCl Tablets, USP, 10 mg due to failed impurity and degradation specifications detected during routine stability testing. The recall affects 5,953 cartons distributed nationwide.

    Product
    hydrALAZINE HCl Tablets, USP, 10 mg, 100 Tablets per carton (10x10 blister packs), Rx only, Distributed by: MAJOR PHARMACEUTICALS, Livonia, MI 48152 USA. NDC # 0904-6440-61
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0731-2022·2022-03-16

    Celltrion DiaTrust COVID-19 Rapid Test Kits Recalled for Incorrect Expiration Dates

    Celltrion USA Inc. is recalling 1.2 million DiaTrust COVID-19 rapid test kits due to incorrect expiration dates on packaging. The kits were distributed to 11 states.

    Product
    Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02
    Category
    Medical Device
    Distribution
    11 states
  • ModerateFDA (Drugs)·D-0649-2022·2022-03-16

    Paliperidone Extended-Release Tablets Recalled for Failed Dissolution

    The Harvard Drug Group is recalling 174 cartons of Paliperidone Extended-Release Tablets, 9 mg, nationwide due to failed dissolution specifications. The affected lots are N00522 (Exp. 09/2022) and N00618 (Exp. 11/2022).

    Product
    PALIPERIDONE — PALIPERIDONE (PALIPERIDONE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0650-2022·2022-03-16

    Alprazolam 1 mg recalled for potential cross-contamination at manufacturer

    Direct Rx is recalling Alprazolam C-IV 1 mg 60-count bottles due to potential cross-contamination at the contract manufacturer, Ultra Tab Laboratories Inc. The recall affects 16 bottles distributed to Florida, Georgia, and Louisiana.

    Product
    Alprazolam C-IV 1 mg 60-count bottles, Rx Only, Dist. By: Par Pharmaceutical Chestnut Ridge, NY 10977 Packaged and Distributed By: Direct Rx Dawsonville, GA 30534, NDC 61919-836-60
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-0726-2022·2022-03-16

    HeartWare HVAD System: Updated Cleaning Instructions for Power Connectors

    Updated cleaning instructions are being provided for the HeartWare HVAD System's power connectors. Improper cleaning can remove protective lubricant required for proper power switching.

    Product
    HeartWare Ventricular Assist Device (HVAD) System
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0651-2022·2022-03-16

    Alprazolam 2 mg tablets recalled due to potential cross-contamination

    Direct Rx is recalling Alprazolam C-IV 2 mg tablets (Lot #07NO1901, expiration 5/31/22) distributed in Florida, Georgia, and Louisiana due to potential cross-contamination identified at the contract manufacturer Ultra Tab Laboratories Inc.

    Product
    Alprazolam C-IV 2 mg, 60-count bottles, Rx Only, Dist. By: Par Pharmaceutical Chestnut Ridge, NY 10977 Packaged and Distributed By: Direct Rx Dawsonville, GA 30534, NDC 72189-0058-60
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-0723-2022·2022-03-16

    CIRRUS HD-OCT Optic Nerve Angiography Feature Requires Deactivation

    Carl Zeiss Meditec is recalling CIRRUS HD-OCT Models 5000 and 6000 AngioPlex devices. The optic nerve head angiography feature was distributed without FDA pre-market clearance and must be disabled.

    Product
    CIRRUS HD-OCT, Models 5000 AngioPlex and 6000 AngioPlex
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0744-2022·2022-03-16

    PuraSinus Nasal Hemostat Recalled Due to Unvalidated Shipping Boxes

    3-D Matrix, Inc. is recalling PuraSinus Absorbable Nasal Hemostat units because the shipping boxes used for transport were not validated.

    Product
    PuraSinus Absorbable Nasal Hemostat, Part Numbers 651-006
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0644-2022·2022-03-09

    HEB Isopropyl Alcohol First Aid Antiseptic Label Mix-Up Recall

    HEB 50% Isopropyl Alcohol First Aid Antiseptic bottles contain 3% Hydrogen Peroxide instead due to a label mix-up. The front label incorrectly identifies the product as isopropyl alcohol when the contents are actually a hydrogen peroxide topical solution.

    Product
    HEB 50% Isopropyl Alcohol First Aid Antiseptic, packaged in 16 FL OZ 91 PT) 473 mL brown bottles with brown colored closures. Distributed by HEB San Antonio, TX 78204. UPC 0 41220 25111 7
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0679-2022·2022-03-09

    DARCO Locking Bone Plate System Recalled for Incorrect Manufacturing and Distribution Dates

    Wright Medical Technology is recalling the DARCO Locking Bone Plate System because product labels contain incorrect manufacturing and distribution dates. The recall affects 12 units distributed to Japan and the United Kingdom.

    Product
    The DARCO¿ Locking Bone Plate System is designed with rhombus (parallelogram) plates of biocompatible titanium. The plates use either 2.7mm or 3.5mm screws which intersect each other in pairs. The drill holes of the plates are aligned to assure the screws do not touch. The var
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0637-2022·2022-03-09

    Moxifloxacin Ophthalmic Solution Recalled for Failed Impurity Specifications

    Direct Rx is recalling Moxifloxacin Ophthalmic Solution USP 0.5% due to failed impurities and degradation specifications. The recall affects 44 bottles distributed in Florida.

    Product
    Moxifloxacin Ophthalmic Solution USP 0.5%, 3 mL, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 Dist. By Aurobindo Pharma USA, Inc. East Windsor, NJ 08520, NDC 72189-076-05
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0641-2022·2022-03-09

    Over-The-Counter Drug Products Sold by Family Dollar Stores Recalled

    Dollar Tree Distribution is recalling all over-the-counter drug products sold by Family Dollar retail stores in six states due to potential rodent exposure at a distribution center.

    Product
    All Over-The-Counter (OTC) drug products sold by Family Dollar retail stores located in Alabama, Arkansas, Louisiana, Mississippi, Missouri and Tennessee.
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0642-2022·2022-03-09

    Alprazolam Tablets 1mg Recalled for CGMP Deviations

    Preferred Pharmaceuticals is recalling 276 bottles of Alprazolam Tablets USP 1mg (generic Xanax) distributed nationwide due to Current Good Manufacturing Practice (CGMP) deviations. The recall was initiated voluntarily by the manufacturer.

    Product
    Alprazolam Tablets, USP 1mg, Generic for Xanax, Pkg Size: a) 30 tablets per bottle, NDC: 68788-6381-03, b) 60 tablets per bottle, NDC: 68788-6381-06, c) 90 tablets per bottle, NDC: 68788-6381-09, Mfg: Par Pharmaceutical.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0639-2022·2022-03-09

    Olanzapine 10 mg tablets recalled due to cGMP deviations

    Macleods Pharma USA is voluntarily recalling Olanzapine 10 mg tablets nationwide due to cGMP (current good manufacturing practices) deviations identified during manufacturing. The recall affects 3,672 bottles distributed across the United States.

    Product
    OLANZAPINE — OLANZAPINE (OLANZAPINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0636-2022·2022-03-09

    TSM Brands Isopropyl Alcohol Recalled for Undeclared Ethyl Alcohol

    TSM Brands LLC is recalling Luxury 70% Isopropyl Alcohol bottles nationwide because the product contains undeclared ethyl alcohol that is not identified on the label.

    Product
    Luxury 70% Isopropyl Alcohol, 16 FL. OZ. (1PT) 473 ML bottle, Distributed by: TSM Brands LLC, 540 Equinox Ln, Manalapan, NJ 07726, UPC 868275965734.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0713-2022·2022-03-09

    Dexamethasone Elixir Recalled for Impurities Above Permissible Levels

    Morton Grove Pharmaceuticals is recalling Dexamethasone Elixir USP 0.5 mg/5 mL nationwide due to unknown impurities found at higher than permissible levels in affected lots.

    Product
    Dexamethasone Elixir, USP 0.5 mg/5 mL, Net: 8 fl oz (237 mL) bottle, Rx only, Manufactured By: Morton Grove Pharmaceuticals, Inc., Morton Grove, IL 60053, NDC 60432-466-08.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0704-2022·2022-03-09

    Diagnostic Quality Control Material Yields False-Positive Results in GBS Testing

    A quality control negative control material in GBS diagnostic testing sets is yielding false-positive results, causing laboratory test failures and operational disruptions.

    Product
    QC Sets and Panels: KWIK-STIK Cepheid Smart GBS QC Set (Live Culture). Sets include: 1. 0864E4 Streptococcus agalactiae (Group B, lb) derived from ATCC 12401; 2. 0864E5 Streptococcus agalactiae (Group B, lb) derived from ATCC 12401; 3. 0864E7 Streptococcus agalactiae (Grou
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0635-2022·2022-03-09

    70% Isopropyl Alcohol First Aid Antiseptic Contains Undeclared Ethyl Alcohol

    TSM Brands LLC is recalling 70% Isopropyl Alcohol First Aid Antiseptic with Wintergreen due to undeclared ethyl alcohol in the product. The recall affects bottles distributed nationwide.

    Product
    70% Isopropyl Alcohol First Aid Antiseptic with Wintergreen, 12 FL. OZ. 355 ML bottle, Distributed By: TSM Brands LLC, 540 Equinox LN, Manalapan, NJ 07726, www.tsmbrands.com, Made in Turkey, UPC 868275965765
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0697-2022·2022-03-09

    Microbiologics QC Panel Recalled Due to Shelf Life Testing Failure

    Microbiologics Inc is recalling its Helix Elite Extended Enteric Bacterial Verification Panel because real-time shelf life testing failed at 24 months.

    Product
    Microbiologics QC Sets and Panels: Helix Elite. Extended Enteric Bacterial Verification Panel (Inactivated Pellet) includes 21 pellets each comprised of the following 8 organisms: 1. S. Typhimurium derived from NCTC 74, 2. S. sonnei derived from NCTC 12984, 3. E. coli derive
    Category
    Medical Device
    Distribution
    Distributed nationwide