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.

226–250 of 21708

  • ModerateFDA (Drugs)·D-0843-2026·2026-09-23

    Safecor Health Recalls Fluphenazine HCl Elixir Due to Stability Failures

    Safecor Health is recalling specific lots of Fluphenazine HCl Elixir because they failed stability specifications. The product is distributed nationwide in the USA.

    Product
    Fluphenazine HCl Elixir, USP, 5 mg per 10 mL, Delivers: 10 mL, Oral Elixir, PAI, Alcohol 14% by volume, For Oral Use Only, Rx Only, Pkg by: Safecor Health, Woburn, MA 01801. NDC: 00121-0654-16
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0841-2026·2026-09-23

    Safecor Health Recalls Fluphenazine HCl Elixir Due to Stability Failures

    Safecor Health is recalling specific lots of Fluphenazine HCl Elixir because they failed stability specifications. The product was distributed nationwide.

    Product
    Fluphenazine HCl Elixir, USP, 2.5 mg per 5 mL, Delivers: 5 mL, Oral Elixir, PAI, Alcohol 14% by volume, For Oral Use Only, Rx Only, Pkg by: Safecor Health, Woburn, MA 01801. NDC: 00121-0654-16
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0836-2026·2026-09-16

    Ajanta Pharma Recalls Fluphenazine Hydrochloride Tablets Due to Impurity Failure

    Ajanta Pharma USA Inc. is recalling Fluphenazine Hydrochloride tablets because testing revealed an organic impurity level slightly above the allowed limit.

    Product
    FLUPHENAZINE HYDROCHLORIDE — FLUPHENAZINE HYDROCHLORIDE (FLUPHENAZINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3116-2026·2026-09-16

    C.R. Bard Recalls Foley Catheter Trays Due to Wipe Contamination

    C.R. Bard Inc. is recalling specific Bardex and SureStep Foley catheter trays because complaints indicated surface contamination on the included Pericare wipes.

    Product
    Products that contain the Pericare Wipes: *Bardex¿ I.C. Complete Care¿ Foley Catheter Tray REF: 300316A UDI codes: 00801741024344¿ 10801741024341 *Bardex¿ I.C. Complete Care¿ Foley Catheter Tray and Urine Meter REF: 303314A 303316A 303318A UDI code: 00801741024252¿…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3115-2026·2026-09-16

    C.R. Bard Recalls Foley Catheter Trays Due to Wipe Contamination

    C.R. Bard Inc is recalling specific Foley and Intermittent Catheter Trays because complaints indicated contamination on the surface of the included Pericare wipes.

    Product
    Products that contain the Pericare Wipes: Bard¿ Foley Tray With Lubri-Sil¿ All-Silicone Foley Catheter REF: 947314 947316 947318 UDI codes: 00801741024924¿ 10801741024921 00801741024931¿ 10801741024938 00801741024948¿ 10801741024945 Lubri-Sil¿ I.C. Complete Care¿ All-Silicone…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0864-2026·2026-09-16

    OurPharma Recalls Fentanyl Injection Bags Due to Expiry Date Discrepancy

    OurPharma LLC is recalling 1,610 bags of fentanyl citrate injection solution due to a discrepancy between IV bag and product expiry dates.

    Product
    fentaNYL Citrate, 1,000 mcg/100 mL (10mcg/mL) Injection solution in 100 mL, 0.9% NaCl Bag, OurPharma LLC, 2512 S. City Lake, Fayetteville, AR, NDC 73013-1013-01.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateNHTSA·26T014000·2026-09-10

    Wheel Pros Recalls 549 Avix TrailTek RT Tires for Incorrect Markings

    Wheel Pros is recalling 549 Avix TrailTek RT tires because the sidewall is incorrectly labeled 'Not for Highway Use,' failing to meet federal safety standards.

    Product
    TIRES:MARKINGS recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0823-2026·2026-09-09

    Allies Group Recalls Subpotent SPF 50 Sunscreen Gel Nationwide

    Allies Group Inc. is recalling 29,014 tubes of THE ONE SPF 50 Invisible Sunscreen Gel because testing showed the product may not provide the labeled SPF 50 protection.

    Product
    THE ONE SPF 50 INVISIBLE SUNSCREEN GEL, (Avobenzone 3%, Homosalate 7%, Octocrylene 10%, Octisalate 5%), 50ML - 1.7 fl. oz Tube, Made in U.S.A, Distributed by Allies Group Pte Ltd, Singapore 068914. UPC 8 885014 073224
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·H-1322-2026·2026-09-09

    Wonton Specialist Lo Mein Noodle Recalled for Undeclared Red Dye

    Wonton Specialist is recalling 16 oz Lo Mein Noodles sold in New York, New Jersey, and Pennsylvania due to undeclared FD&C Red No. 40.

    Product
    Wonton Specialist Inc. Lo Mein Noodle, 16 oz, packaged in clear plastic bags
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Food)·H-1323-2026·2026-09-09

    Wonton Skin Recalled for Undeclared Red Dye

    Wonton Specialists is recalling 16 oz wonton skins sold in NY, NJ, and PA due to undeclared FD&C Red No. 40.

    Product
    Wonton Specialist Inc. Wonton Skin, 16 oz - packaged in foam tray overwrapped with clear plastic
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0824-2026·2026-09-09

    Allies Group Recalls Subpotent SPF 50 Sunscreen Gel Sachets

    Allies Group Inc. is recalling 27,492 sachets of THE ONE SPF 50 Invisible Sunscreen Gel because firm testing indicated the product may not reliably provide the stated SPF 50 protection.

    Product
    THE ONE SPF 50 INVISIBLE SUNSCREEN GEL, (Avobenzone 3%, Homosalate 7%, Octocrylene 10%, Octisalate 5%), 3ml - 0.1 fl. oz, Sachet: Single use only, Made in the U.S.A, Distributed by Allies Group Pte Ltd, Singapore 068914.UPC 8 885014 073293
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3092-2026·2026-09-09

    Fresenius NaturaLyte Liquid Acid Concentrate Recalled for Discoloration

    Fresenius Medical Care is recalling NaturaLyte Liquid Acid Concentrate for Bicarbonate Hemodialysis due to reports of blue-green discoloration in the product.

    Product
    NaturaLyte, Liquid Acid Concentrate for Bicarbonate Hemodialysis: Product Numbers: 08-1251-1, 08-2251-0, 08-2301-3, 08-3251-9, 08-3301-2, 13-2201-5, 13-2251-0, 13-3251-9; Liquid Acid Concentrate for Bicarbonate Hemodialysis
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0829-2026·2026-09-09

    Lexia LLC Recalls Broadway Joe's Pain Cream Due to Contamination

    Lexia LLC is recalling Broadway Joe's Pain Cream in Colorado due to potential raw material contamination.

    Product
    Broadway Joe's Pain Cream, 3000 gm CBD, (Histamine Dihydrochloride 0.025%) (CDB Isolate 3000mg, HempSeed Oil 2000mg),4 oz-jar, Produced for Broadway Joe's, Franklin, TN, 37067, NDC 83088-8120-6; UPC 8 50041 64004 4
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-3103-2026·2026-09-09

    Cardinal Health Recalls Urinary Catheter Trays with Potentially Contaminated Wipes

    Cardinal Health is recalling 175 units of Presource Packs containing CliniClean Pericare Wipes due to potential lubricant contamination that may cause localized skin effects.

    Product
    Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays: 1) PBCGLVBLI, Catalog Number: KIT, BLO LAVH ; 2) PB15HYFCY, Catalog Number: KIT, UMMC AB HYST II 170032 ; 3) SMA4FTLSCA, Catalog Number: TLH PACK
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0828-2026·2026-09-09

    Lexia LLC Recalls Broadway Joe's Pain Cream Due to CGMP Deviations

    Lexia LLC is recalling Broadway Joe's Pain Cream in Colorado due to CGMP deviations and potential raw material contamination.

    Product
    Broadway Joe's Pain Cream, (Histamine Dihydrochloride 0.025%), 1500mg CBD Isolate, 1000mg Hempseed oil, 2 oz-jar, Produced for Broadway Joe's, Franklin, TN, 37067, NDC 83088-8120-5, UPC 8 50041 64003 7
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-3095-2026·2026-09-09

    Cardinal Health Recalls Presource Packs with Potentially Contaminated Wipes

    Cardinal Health 200, LLC is recalling 846 Presource Packs containing CliniClean Pericare Wipes that may be contaminated with a manufacturing lubricant, posing a risk of localized skin irritation.

    Product
    Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays: 1) KIT, GYN ROBOTIC GSAM , Catalog Number: PBCCGRSGD; 2) KIT, GYN ROBOT ACCESSORY , Catalog Number: PB35GYBJC; 3) KIT, PRIMARY RESECTION , Catalog Number: PGVMOTBB19…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0816-2026·2026-09-09

    Baxter Recalls Clindamycin Phosphate Injection Due to CGMP Deviations

    Baxter Healthcare is voluntarily recalling Clindamycin Phosphate Injection due to Current Good Manufacturing Practice (CGMP) deviations. The affected product was distributed in the US, Puerto Rico, and Chile.

    Product
    CLINDAMYCIN PHOSPHATE — CLINDAMYCIN PHOSPHATE (CLINDAMYCIN PHOSPHATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·H-1324-2026·2026-09-09

    Wonton Specialist Dumpling Skin Recalled for Undeclared Red Dye

    Wonton Specialist Inc. is recalling 16 oz bags of Dumpling Skin due to undeclared FD&C Red No. 40. The product was distributed in New York, New Jersey, and Pennsylvania.

    Product
    Wonton Specialist Inc. Dumpling Skin, 16 oz - packaged in foam tray overwrapped with clear plastic
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-3105-2026·2026-09-09

    Cardinal Health Recalls Urinary Catheter Trays with Contaminated Wipes

    Cardinal Health is recalling 44 units of urinary catheter trays containing CliniClean Pericare Wipes that may be contaminated with a manufacturing lubricant.

    Product
    Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays: 1) KIT, CHONY ORTHO MAJOR SPINE , Catalog Number: POV2SCCPP; 2) KIT,ORTHOPLASTIC MICROVASCULAR, Catalog Number: PWVMFFABLI
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0822-2026·2026-09-09

    Bionpharma Recalls Doxylamine Succinate Tablets Due to Foreign Material Presence

    Bionpharma Inc. is recalling Doxylamine Succinate and Pyridoxine HCl tablets because foreign tablets or capsules were found in the product.

    Product
    DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE — DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE (DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3104-2026·2026-09-09

    Cardinal Health Recalls Surgical Kits with Potentially Contaminated Wipes

    Cardinal Health is recalling 645 surgical kits containing CliniClean Pericare Wipes that may be contaminated with a manufacturing lubricant.

    Product
    Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays: 1) KIT, ASLMC CRANIOTOMY , Catalog Number: PNCGCNAUM; 2) KIT, ORP MAJOR SPINE , Catalog Number: PNHDFSVCI; 3) KIT,ORP NEURO TRAUMA , Catalog Number: PNHDOTVCQ…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3100-2026·2026-09-09

    Cardinal Health Recalls Urinary Catheter Trays with Potentially Contaminated Wipes

    Cardinal Health is recalling 61 units of urinary catheter trays containing CliniClean Pericare Wipes that may be contaminated with a manufacturing lubricant.

    Product
    Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays: 1) KIT, ENT HARVEST , Catalog Number: PEVMETBJX; 2) KIT, ENT HARVEST , Catalog Number: PEVMETB37
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3096-2026·2026-09-09

    Cardinal Health Recalls Urinary Catheter Trays with Contaminated Wipes

    Cardinal Health is recalling 19 units of urinary catheter trays containing CliniClean Pericare Wipes that may be contaminated with a manufacturing lubricant.

    Product
    Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays: 1) KIT, LUNG TX CIRCULATOR , Catalog Number: OVC3507231
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3093-2026·2026-09-09

    Fresenius Citrasate Liquid Acid Concentrate Recalled for Discoloration

    Fresenius Medical Care is recalling Citrasate Liquid Acid Concentrate for Bicarbonate Hemodialysis due to complaints of blue-green discoloration.

    Product
    Citrasate, Liquid Acid Concentrate for Bicarbonate Hemodialysis: Product Numbers: 08-2251-CA, 08-3251-CA, 13-2251-CA; Liquid Acid Concentrate for Bicarbonate Hemodialysis
    Category
    Medical Device
    Distribution
    Distributed nationwide