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 the agency’s own highest classification or reported deaths or serious injuries, 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.

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15126–15150 of 18001

  • LowFDA (Drugs)·D-1444-2014·2014-07-30

    X-Gen Recalls Clonidine HCl Injection Due to Labeling Error

    X-Gen Pharmaceuticals is recalling Clonidine HCl Injection vials because the side label incorrectly states the drug strength.

    Product
    CLONIDINE — CLONIDINE (CLONIDINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1445-2014·2014-07-30

    Sandoz Recalls Orphenadrine Citrate Tablets for Dissolution Failures

    Sandoz Inc. is recalling Orphenadrine Citrate Extended Release Tablets because they failed dissolution specifications during stability testing.

    Product
    ORPHENADRINE CITRATE — ORPHENADRINE CITRATE (ORPHENADRINE CITRATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1452-2014·2014-07-30

    Estee Lauder Recalls DENBLAN Toothpaste Due to Stability Data Issues

    Estee Lauder Inc is recalling 3,791 tubes of DENBLAN Anticavity Fluoride Toothpaste because stability data does not support the product's expiry date.

    Product
    DENBLAN Anticavity Fluoride Toothpaste, Whitening formula, sodium monofluorophosphate 0.76%, 2.6 oz/75 mL tube, Laboratories Darphin, Dist, Paris France
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1433-201·2014-07-23

    Hospira Recalls Fentanyl Citrate Injection Due to Sterility Concerns

    Hospira is recalling 47,400 vials of Fentanyl Citrate Injection because loose or missing vial crimps raise concerns about sterility.

    Product
    FENTANYL CITRATE — FENTANYL CITRATE (FENTANYL CITRATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1442-2014·2014-07-23

    CareFusion Recalls ChloraPrep Applicators Due to Sterility Concerns

    CareFusion is recalling 23,000 ChloraPrep applicators because immediate product pouches may not be properly sealed, potentially compromising sterility.

    Product
    ChloraPrep With Tint, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA), 26 mL APPLICATOR, Hi-Lite Orange. Rx Only. CareFusion, El Paso, TX 79912. NDC: 054365-400-13.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1434-2014·2014-07-23

    Axcentria Recalls Hemo-Stat Solution for Lack of FDA Approval

    Axcentria Pharmaceuticals is recalling Hemo-Stat Solution because it was marketed without an approved NDA/ANDA and lacks an NDC number.

    Product
    Hemo-Stat Solution, Aluminum chloride 25%, in 37.2 g glass bottles, distributed by Benco Dental, Pittston, PA; Also distributed by Henry Shein, Melville, NY; and Hemoban distributed by iSmile Dental Products, Sacramento, CA
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1439-2014·2014-07-23

    Teva Recalls Velivet Birth Control Pills Due to Impurity Test Failures

    Teva Pharmaceuticals is recalling 5,265 blister packs of Velivet birth control pills nationwide because impurity test results were out of specification.

    Product
    VELIVET — VELIVET (DESOGESTREL AND ETHINYL ESTRADIOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1440-2014·2014-07-23

    Fougera Recalls Triamcinolone Acetonide Lotion Due to pH Specification Concerns

    Fougera Pharmaceuticals is recalling specific lots of Triamcinolone Acetonide Lotion because the pH may not meet specifications at expiry.

    Product
    Triamcinolone Acetonide Lotion USP, 0.1%, 60 mL Bottle, Rx Only, For Dermatologic Use Only, Not for Ophthalmic Use, E. Fougera & Co, A Division of Fougera Pharmaceuticals Inc., Melville, New York, 11747, NDC 0168-0337-60.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1441-2014·2014-07-23

    Fougera Recalls Triamcinolone Acetonide Lotion Due to pH Specification Concerns

    Fougera Pharmaceuticals is recalling 3,594 bottles of Triamcinolone Acetonide Lotion because the pH may not meet specifications at expiry.

    Product
    Triamcinolone Acetonide Lotion USP, 0.025%, 60 mL Bottle, Rx Only, For Dermatologic Use Only, Not for Ophthalmic Use, E. Fougera & Co, A Division of Fougera Pharmaceuticals Inc., Melville, New York, 11747, NDC 0168-0336-60.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1443-2014·2014-07-23

    Pfizer Recalls Viracept Tablets Due to Incorrect Expiration Date Labeling

    Pfizer is recalling Viracept (nelfinavir mesylate) tablets because some bottles were labeled with an incorrect expiration date of 11/2016 instead of 09/2016.

    Product
    VIRACEPT — VIRACEPT (NELFINAVIR MESYLATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1437-2014·2014-07-23

    Teva Recalls Mircette Tablets Due to Out-of-Specification Impurities

    Teva Pharmaceuticals is recalling Mircette tablets because impurity test results were out of specification. The recall covers 984 blister packs distributed nationwide.

    Product
    Mircette (desogestrel/ethinyl estradiol and ethinyl estradiol) Tablets 0.15 mg/0.02 mg and 0.01 mg, 6 Cyclic dispensers X 28 tablets, Rx only Teva Pharmaceuticals, USA, Sellersville, PA. NDC 51285-114-58
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1431-2014·2014-07-23

    Poly Pharmaceuticals Recalls Poly-Tussin AC Liquid Due to Labeling and Specification Issues

    Poly Pharmaceuticals is recalling 208 bottles of Poly-Tussin AC Liquid because phenylephrine levels are below specifications and the label inaccurately states 'Rx Only'.

    Product
    POLY-TUSSIN AC LIQUID, Each 5 mL (1 teaspoonful) contains: Brompheniramine Maleate 4 mg, Codeine Phosphate 10 mg, Phenylephrine HCl 7.5 mg, 16 fl oz. (473 mL) Bottle, Rx Only. Manufactured by: Great Southern Laboratories, Houston, TX 77099, Distributed for: Poly Pharmaceuticals…
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1432-2014·2014-07-23

    Poly Pharmaceuticals Recalls Lortuss Ex Due to Labeling and Specification Issues

    Poly Pharmaceuticals is recalling 102 bottles of Lortuss Ex because the product does not meet monograph specifications and has inaccurate labeling.

    Product
    LORTUSS EX, Each 5 mL (1 teaspoonful) contains: Codeine Phosphate 10 mg, Guaifenesin 100 mg, Psuedoephedrine HCl 22.5 mg, 16 fl oz. (473 mL), Rx Only. Manufactured by: Great Southern Laboratories, Houston, TX 77099, Distributed for: Poly Pharmaceuticals, Mobile, AL 36619.…
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1435-2014·2014-07-23

    Mylan Recalls Diltiazem HCl Extended-Release Capsules Due to Impurities

    Mylan Institutional, Inc. is recalling Diltiazem HCl Extended-Release Capsules, 120 mg, due to high out-of-specification results for a related compound found during routine stability testing.

    Product
    Diltiazem HCl Extended-release Capsules, USP, 120 mg, packaged in 80 Capsules (8 x 10) blister cards per carton, Rx only, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV 26505, NDC 51079-947-08.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1424-2014·2014-07-16

    Hospira Recalls Labetalol Hydrochloride Injection Due to Particulate Matter

    Hospira Inc. is recalling Labetalol Hydrochloride Injection due to the presence of particulate matter, including metal embedded in glass vials and visible particles in the solution.

    Product
    LABETALOL HYDROCHLORIDE — LABETALOL HYDROCHLORIDE (LABETALOL HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1425-2014·2014-07-16

    Hospira Recalls Heparin Sodium Bags Due to Sterility Concerns

    Hospira is recalling 142,152 bags of Heparin Sodium in 5% Dextrose Injection due to a confirmed report of fluid leaking from the primary container, which compromises sterility.

    Product
    HEPARIN SODIUM AND DEXTROSE — HEPARIN SODIUM AND DEXTROSE (HEPARIN SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1430-2014·2014-07-16

    Teva Recalls Fluvastatin Capsules Due to Reported Capsule Breakage

    Teva Pharmaceuticals is voluntarily recalling one lot of Fluvastatin Capsules USP, 20 mg, due to a customer complaint trend regarding capsule breakage.

    Product
    FLUVASTATIN — FLUVASTATIN (FLUVASTATIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1422-2014·2014-07-16

    Healix Recalls Bupivacaine HCl Bags Due to Particulate Matter

    Healix Infusion Therapy is recalling 10 bags of BUPivacaine HCl 0.25% in On-Q C-bloc bags distributed in Texas due to visible particles.

    Product
    BUPivacaine HCl 0.25% Preservative Free (2.5 mg/mL) 500 mL in On-Q C-bloc (2-14 mL/hr) bag, Healix Infusion Therapy, Inc., 1075 West Park One Drive, Suite 200, Sugar Land, Texas 77478, NDC 75901-7210-53.
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-1423-2014·2014-07-16

    United Therapeutics Recalls Tyvaso Inhalation Systems Due to Software Defect

    United Therapeutics is voluntarily recalling Tyvaso Inhalation Systems with specific medical devices that may have incorrect software, potentially causing them to not operate as instructed.

    Product
    Tyvaso (treprostinil) Inhalation Solution, Treprostinil 1.74 mg/2.9 mL, Four 2.9 mL Ampules, For Oral Inhalation Use Only, Manufactured for United Therapeutics Corporation, Triangle Park, NC 27709
    Category
    Medical Device
    Distribution
    2 states
  • LowFDA (Drugs)·D-1426-2014·2014-07-16

    Ferring Recalls Endometrin Vaginal Inserts Due to Discoloration

    Ferring Pharmaceuticals is recalling 72,046 cartons of Endometrin vaginal inserts nationwide due to discoloration caused by heat exposure.

    Product
    ENDOMETRIN — ENDOMETRIN (PROGESTERONE)
    Category
    Drug
    Distribution
    Distributed nationwide