The Recall Desk

Recalls

All US Product Recalls

Searchable archive of product recalls from the FDA, USDA FSIS, CPSC, NHTSA, and EPA — translated into plain English, severity-scored from objective criteria, and always linked back to the original government notice.

How to read this listing

Every recall on this list has been scored 1–5 against an objective rubric from the agency’s own classification, presence of reported injuries or deaths, distribution scope, and hazard type. The colored severity badge on each card is the score — 5 (Critical) means deaths or serious injuries are reported, 4 (Severe) means significant injury or hospitalization risk, and 3 (High) means a known hazard with no confirmed harm yet. Filter to 3+ (High and above) if you want to skip routine Class-III notices.

The agency chips above control which streams are visible. FDA spans food, drugs, and medical devices. USDA FSIS is meat, poultry, and processed egg products. CPSC is household consumer products. NHTSA is vehicles, tires, and child seats. Nationwide on a card means the recall affects every US state — most do — while a state list means distribution was limited.

Click any recall to see the full summary, affected lot codes and model numbers, the agency’s own classification, and a direct link back to the original government notice for verification.

Filters

Agency

All agenciesFDA (Food)FDA (Drugs)FDA (Devices)USDA FSISCPSCNHTSAEPA

Category

All categoriesFoodDrugMedical DeviceVehicleConsumer Product

Minimum severity

Any3+ (High and above)4+ (High and above)5+ (High and above)

Clear filters

9701–9725 of 17785

  • ModerateFDA (Drugs)·D-0612-2018·2018-04-04

    Akorn Recalls 24-Hour Oral Care Kits Due to Low Chlorhexidine Levels

    Akorn, Inc. is recalling 24-Hour Oral Care q2 Kits because the chlorhexidine gluconate oral rinse contained in some units had low potency levels.

    Product
    24-HOUR Oral Care q2 Kit with Ballard* Technology, containing 2 Toothbrush Packs with CHG Solution, Chlorhexidine Gluconate Oral Rinse, 0.12%, 15 mL unit dose cup (NDC 50383-720-15), Rx Only, Hi-Tech Pharmacal Co., Inc. Amityville, NY 11701; Kit Manufactured by Halyard Health, In
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0605-2018·2018-04-04

    Renaissance Lakewood Recalls Flucanazole Injection Due to Stability Failures

    Renaissance Lakewood, LLC is recalling 1,277 bags of Flucanazole Injection due to superpotent and failed stability specifications.

    Product
    Flucanazole Injection, USP 200 mg in in 100 mL (2 mg/mL), 10 Single Dose Flexible Containers, Rx Only, Manufactured for: Claris Lifesciences, Inc. North Brunswick, NJ 08902 By; Claris Injectables Ltd. Gujarat, India --- NDC 36000-006-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0613-2018·2018-04-04

    Akorn Recalls Subpotent Chlorhexidine Oral Rinse Kits

    Akorn, Inc. is recalling 24-HOUR Oral Care q4 Kits containing subpotent Chlorhexidine Gluconate Oral Rinse due to product crystallization.

    Product
    24-HOUR Oral Care q4 Kit with Ballard* Technology, containing 2 Toothbrush Packs with CHG Solution, Chlorhexidine Gluconate Oral Rinse, 0.12%, 15 mL unit dose cup (NDC 50383-720-15), Rx Only, Hi-Tech Pharmacal Co., Inc. Amityville, NY 11701; Kit Manufactured by Halyard Health, In
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0604-2018·2018-03-28

    Fresenius Recalls DELFLEX Peritoneal Dialysis Solution Due to Bag Leakage

    Fresenius Medical Care is recalling specific lots of DELFLEX Peritoneal Dialysis Solution because bag leakage may compromise sterility.

    Product
    DELFLEX — DELFLEX (DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE)
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0607-2018·2018-03-28

    Pine Pharmaceuticals Recalls Brilliant Blue G Intraocular Injection Due to Labeling Error

    Pine Pharmaceuticals is recalling 136 units of Brilliant Blue G for Intraocular Injection because the vial label contains incorrect active and inactive ingredient information.

    Product
    Brilliant Blue G for Intraocular Injection 0.5mL vial 0.25 mg/mL Compounded by: Pine Pharmaceuticals 355 Riverwalk Pkwy Tonawanda, NY 14150. NDC 69194-0358-01
    Category
    Drug
    Distribution
    1 state
  • LowFDA (Drugs)·D-0617-2018·2018-03-28

    Akorn Recalls Triamcinolone Acetonide Lotion Due to Impurity Levels

    Akorn, Inc. is recalling 4,128 bottles of Triamcinolone Acetonide Lotion, USP 0.1% due to high impurity levels. The product was distributed nationwide and in Puerto Rico.

    Product
    Triamcinolone Acetonide Lotion, USP 0.1%, 60 mL bottle, Rx Only, Marketed by: VersaPharm Incorporated, Marietta, GA 30062; Manufactured by: Ei LLC, Kannapolis, NC 28083, NDC 61748-220-60.
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0596-2018·2018-03-21

    Pfizer Recalls Hydromorphone Hydrochloride Injection Due to Non-Sterility Concerns

    Pfizer is recalling 53,600 vials of Hydromorphone Hydrochloride Injection due to confirmed customer complaints of empty or cracked glass vials.

    Product
    HYDROMORPHONE HYDROCHLORIDE — HYDROMORPHONE HYDROCHLORIDE (HYDROMORPHONE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0586-2018·2018-03-21

    Sagent Pharmaceuticals Recalls Methylprednisolone Sodium Succinate Injection Vials

    Sagent Pharmaceuticals is recalling 205,370 vials of methylprednisolone sodium succinate for injection due to high impurity levels.

    Product
    methylPREDNISolone Sodium Succinate for Injection, USP, 40 mg* per vial, Single-Dose Vial, Rx only, Mfd. for: Sagent Pharmaceuticals, Schaumburg, IL 60195 (USA), Made in India. NDC 25021-807-05.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0587-2018·2018-03-21

    Sagent Pharmaceuticals Recalls Methylprednisolone Sodium Succinate Injection Vials

    Sagent Pharmaceuticals is recalling 176,410 vials of methylprednisolone sodium succinate injection due to high impurity levels.

    Product
    methylPREDNISolone Sodium Succinate for Injection, USP, 125 mg* per vial, Single-Dose Vial, Rx only, Mfd. for: Sagent Pharmaceuticals, Schaumburg, IL 60195 (USA), Made in India. NDC 25021-808-10.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0597-2018·2018-03-21

    Pfizer Recalls Hydromorphone Hydrochloride Injection Vials Due to Non-Sterility

    Pfizer is recalling 29,680 vials of Hydromorphone Hydrochloride Injection due to confirmed customer complaints of empty or cracked glass containers.

    Product
    HYDROMORPHONE HYDROCHLORIDE — HYDROMORPHONE HYDROCHLORIDE (HYDROMORPHONE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0588-2018·2018-03-21

    Sagent Pharmaceuticals Recalls Methylprednisolone Sodium Succinate Injection Vials

    Sagent Pharmaceuticals is recalling methylprednisolone sodium succinate for injection vials due to high impurity levels. The affected lots were distributed nationwide.

    Product
    methylPREDNISolone Sodium Succinate for Injection, USP, 1 gram* per vial, Single-Dose Vial, Rx only, Mfd. for: Sagent Pharmaceuticals, Schaumburg, IL 60195 (USA), Made in India. NDC 25021-810-30.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0602-2018·2018-03-21

    Hetero Labs Recalls Valacyclovir Tablets Due to Temperature Exposure

    Hetero Labs Limited is recalling Valacyclovir Tablets USP 1 gram because they were exposed to higher temperatures during transport. The recall covers 48,132 bottles distributed nationwide.

    Product
    VALACYCLOVIR — VALACYCLOVIR (VALACYCLOVIR)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0599-2018·2018-03-21

    Novel Laboratories Recalls Hydrocodone Bitartrate and Homatropine Methylbromide Tablets

    Novel Laboratories is recalling specific lots of Hydrocodone Bitartrate and Homatropine Methylbromide tablets due to failed impurities and degradation specifications.

    Product
    HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE — HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE (HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0591-2018·2018-03-21

    Oxytocin USP Powder Recalled Due to Insufficient Stability Data

    American Pharmaceutical Ingredients LLC is recalling Oxytocin USP powder because stability data does not support the listed expiration dates.

    Product
    Oxytocin USP, powder, 1g-bottle, API American Pharmaceutical Ingredients, NDC 58597-7042-3
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0601-2018·2018-03-21

    Valganciclovir Tablets Recalled Due to Temperature Exposure During Shipping

    Hetero Labs Limited is recalling Valganciclovir Tablets 450 mg because they were exposed to high temperatures during shipping. The recall covers 1,764 bottles distributed nationwide.

    Product
    VALGANCICLOVIR — VALGANCICLOVIR (VALGANCICLOVIR)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0592-2018·2018-03-21

    American Pharmaceutical Ingredients Recalls Sermorelin Acetate Powder Due to Stability Data

    American Pharmaceutical Ingredients LLC is recalling Sermorelin Acetate powder because stability data does not support the listed expiration dates.

    Product
    Sermorelin Acetate, powder, a) 1 GM-bottle (NDC58597-8092-1) b) 5 GM-bottle (NDC 58597-8092-2) c) 10 GM-bottle (NDC 58597-8092-4) API American Pharmaceutical Ingredients
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0598-2018·2018-03-21

    Dr. Reddy's Recalls Clocortolone Pivalate Cream Due to Stability Issues

    Dr. Reddy's Laboratories is recalling Clocortolone Pivalate Cream, 0.1%, 90-gram tubes because viscosity failed stability specifications.

    Product
    Clocortolone Pivalate Cream, 0.1%, 90-gram tube, Rx only, Distributed by: Dr. Reddy's Laboratories, Inc. Princeton, NJ 08540, Manufactured by: DPT, Laboratories Ltd. San Antonio, TX 78215, NDC 43598-341-90
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0589-2018·2018-03-21

    Psoriasin Daytime Relief Cream Recalled for Subpotent Coal Tar Content

    Alva-Amco Pharmacal Companies is recalling Psoriasin Daytime Relief Cream because it failed to maintain its label claim of coal tar throughout its expiry period.

    Product
    Psoriasin Daytime Relief Cream with Vitamin D & Oatmeal, (Coal Tar 1.25%), packagedin 57 g plastic tubes, Distributed by: ALVA-AMCO Pharmacal Cos., Inc., Niles, IL 60714, USA. NDC 52389-745-56, UPC 0 72959 01045 4.
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0593-2018·2018-03-14

    Bella Capsules Recalled for Undeclared Sibutramine Content

    Bella All Natural is recalling Bella Capsules because they contain undeclared sibutramine, a withdrawn controlled substance, making them unapproved drugs.

    Product
    Bella Capsules, 600mg, 30-count bottles, Manufactured for: Bella All Natural 304 E 11th Street, Los Angeles, CA 90015
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0580-2018·2018-03-14

    Apollo Care Recalls Vancomycin IV Bags Due to Unsupported Expiry Date

    Apollo Care is recalling 312 bags of Vancomycin IV solution because stability data does not support the assigned 90-day beyond use date.

    Product
    Vancomycin 1.25g added to 250mL of 0.9% Sodium Chloride IV bag, Rx only, APOLLOcare, 3801 Mojave Ct., Suite 101, Columbia, MO 65202, NDC 71170-264-25.
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0579-2018·2018-03-14

    Apollo Care Recalls Vancomycin IV Bags Due to Stability Data Issues

    Apollo Care is recalling 360 bags of Vancomycin IV solution because stability data does not support the assigned 90-day beyond use date.

    Product
    Vancomycin 1g added to 250mL of 0.9% Sodium Chloride IV bag, Rx only, APOLLOcare, 3801 Mojave Ct., Suite 101, Columbia, MO 65202, NDC 71170-254-25.
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0581-2018·2018-03-14

    Osmotica Recalls Subpotent Methylphenidate Hydrochloride Extended-Release Tablets

    Osmotica Pharmaceutical Corp is recalling specific lots of Methylphenidate Hydrochloride Extended-Release Tablets because some 100-count bottles contain one 27 mg tablet instead of 36 mg.

    Product
    METHYLPHENIDATE HYDROCHLORIDE — METHYLPHENIDATE HYDROCHLORIDE (METHYLPHENIDATE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0582-2018·2018-03-14

    Kalchem Recalls Vardenafil HCl Due to Missing Stability Data

    Kalchem International is recalling Vardenafil HCl 500 GM jars due to a lack of stability data supporting the expiration date.

    Product
    Vardenafil HCl, USP (trihydrate), 500 GM Part # 330-05, Rx only, For Manufacturing, Repackaging and Processing for Rx and Research Only, Kalchem International, Inc. 224 South Main Street Lindsay, OK 73052 888-298-9905, NDC 60592-330-05
    Category
    Drug
    Distribution
    1 state