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.

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5501–5525 of 17974

  • SevereFDA (Drugs)·D-0316-2021·2021-04-07

    Zydus Recalls Acyclovir Sodium Injection Due to Crystallization

    Zydus Pharmaceuticals is recalling 1,638 packs of Acyclovir Sodium Injection due to customer complaints of crystallization in the finished product.

    Product
    ACYCLOVIR — ACYCLOVIR (ACYCLOVIR)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0317-2021·2021-04-07

    Ferring Recalls ZOMA-Jet 5 Demonstration Kits Due to Defective Delivery System

    Ferring Pharmaceuticals is recalling 301 ZOMA-Jet 5 Demonstration Kits because the injector pen may break apart and disintegrate into pieces.

    Product
    ZOMA-Jet 5 Demonstration Kit, Needle-free delivery device for use with ZOMACTON (somatropin) for injection 5mg vial, Rx only, ZOMA-Jet 5 Demonstration Kit contains -ZOMA-Jet 5 device - 5 Needle-Free Head A's - 2 Vial Adaptors - 1 Carrying Case - 1 User Manual; Manufactured for: F
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0318-2021·2021-04-07

    Ferring Recalls ZOMA-Jet 10 Demonstration Kits Due to Defective Delivery System

    Ferring Pharmaceuticals is recalling 1,569 ZOMA-Jet 10 Demonstration Kits because the injector pen may break apart and disintegrate into pieces.

    Product
    ZOMA-Jet 10 Demonstration Kit, Needle-free delivery device for use with ZOMACTON (somatropin) for injection 10 mg vial, ZOMA-Jet 10 Demonstration Kit contains -ZOMA-Jet 10 device - 7 Needle-Free Head A's - 1 Carrying Case - 1 User Manual; Manufactured for: Ferring Pharmaceuticals
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0314-2021·2021-04-07

    Cardinal Health Recalls Tremfya Injection Due to Temperature Abuse

    Cardinal Health Inc. is voluntarily recalling 48 boxes of Tremfya (guselkumab) Injection due to temperature abuse. The affected product was distributed to Alabama, Louisiana, Mississippi, and Tennessee.

    Product
    TREMFYA — TREMFYA (GUSELKUMAB)
    Category
    Drug
    Distribution
    4 states
  • CriticalFDA (Drugs)·D-0311-2021·2021-03-31

    Adam's Secret Extra Strength 3000 Recalled for Unapproved Ingredients

    The FDA is recalling Adam's Secret Extra Strength 3000 because it contains unapproved drugs tadalafil and sildenafil.

    Product
    Adam's Secret Extra Strength 3000, 840 mg, 10 count blister packs, Distributed by AS Inc., Made in USA, UPC 6 09728 43452 6.
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0310-2021·2021-03-31

    Adam's Secret Extra Strength Recalled for Unapproved Active Ingredients

    Adam's Secret Extra Strength 1500 is being recalled because FDA analysis found unapproved drugs tadalafil and sildenafil in the product.

    Product
    Adam's Secret Extra Strength 1500, 800 mg, 10 count blister packs, Distributed by KP Inc., Made in USA, UPC 6 09728 43462 5
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0312-2021·2021-03-31

    Golden State Medical Supply Recalls Omeprazole Capsules Due to Impurities

    Golden State Medical Supply is recalling Omeprazole Delayed Release Capsules because stability testing revealed unknown impurities.

    Product
    Omeprazole Delayed Release Capsules, USP, 20 mg, 1000-count bottles, Rx only, Packaged by GSMS Incorporated, Camarillo, CA 93012-8601 USA, NDC 51407-129-10
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0305-2021·2021-03-24

    Sagent Recalls Phenylephrine Hydrochloride Injection Due to Sterility Concerns

    Sagent Pharmaceuticals is recalling specific lots of Phenylephrine Hydrochloride Injection due to customer complaints of loose vial overseals that may compromise sterility.

    Product
    PHENYLEPHRINE HYDROCHLORIDE — PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0303-2021·2021-03-24

    Spironolactone Tablets Recalled Due to Potential Labeling Error

    Bryant Ranch Prepack is recalling 35 bottles of Spironolactone 25 mg tablets because they may contain 50 mg tablets.

    Product
    Spironolactone Tablets, USP, 25 mg, packaged in: a) 30-count bottles (NDC 63629-1064-01), b) 60-count bottles (NDC 63629-1064-02), c) 90-count bottles (NDC 63629-1064-03), Rx only, Manufactured by: Frontida BioPharm, Inc., Philadelphia, PA 19124 USA, Repackaged by: Bryant Ranch P
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0301-2021·2021-03-24

    Akorn Recalls Gabapentin Oral Solution Due to Impurity Specifications

    Akorn, Inc. is recalling Gabapentin Oral Solution because it failed impurity specifications during stability testing. The product was distributed nationwide.

    Product
    Gabapentin Oral Solution, 250 mg/5 mL, 5 mL per unit dose cup, four unit dose cups per tray, For Institutional Use Only, Rx only, Hi-Tech Pharmacal Co., Inc, Amityville, NY 11701, NDC Tray: 50383-311-07; NDC Unit Dose Cup 50383-311-07
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0308-2021·2021-03-24

    Breckenridge Recalls Omeprazole Capsules Due to Unknown Impurities

    Breckenridge Pharmaceutical is recalling 3,146 bottles of Omeprazole Delayed-Release Capsules, 20 mg, due to out-of-specification results for unknown impurities.

    Product
    Omeprazole Delayed-Release Capsules, USP, 20 mg, 1000 count bottles, Rx Only, distributed by Breckenridge Pharmaceutical, Inc., Berlin, CT, Manufactured by Tow Pharmaceutical Europe, S.L., Martorelles (Barcelona), Spain NDC 51991-643-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0300-2021·2021-03-24

    Direct Rx Recalls Nortriptyline HCL Capsules Due to cGMP Deviation

    Direct Rx is recalling 17 bottles of Nortriptyline HCL 10 mg capsules because the active ingredient was taken from an unqualified supplier lot.

    Product
    Nortriptyline HCL capsules, 10 mg, packaged in 30-count bottles, Rx only, Packaged and Distributed By: Direct Rx Dawsonville, GA, NDC 6191985330
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0304-2021·2021-03-24

    Spironolactone Tablets Recalled Due to Potential Labeling Mix-Up

    Bryant Ranch Prepack is recalling 12 bottles of Spironolactone 50 mg tablets because they may contain 25 mg tablets due to a labeling error.

    Product
    Spironolactone Tablets, USP, 50 mg, packaged in 30-count bottles, Rx only, Manufactured by: Frontida BioPharm, Inc., Philadelphia, PA 19124 USA, Repackaged by: Bryant Ranch Prepack, Inc., Burbank, CA 91504 USA, NDC 63629-1067-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0307-2021·2021-03-24

    Edge Pharma Recalls Epinephrine/Lidocaine Ophthalmic Solution Due to Labeling Errors

    Edge Pharma, LLC is recalling 60 syringes of Epinephrine/Lidocaine HCl sterile ophthalmic solution for injection due to incorrect or missing lot and expiration dates.

    Product
    Epinephrine/Lidocaine HCl, Sterile Ophthalmic Solution for Injection, 0.8 mL per syringe, Single Use Syringe, 0.025%/0.75%, Rx only, Edge Pharma LLC 856 Hercules Dr. Colchester, VT 05446, NDC 05446-0863-01
    Category
    Drug
    Distribution
    1 state
  • LowFDA (Drugs)·D-0306-2021·2021-03-24

    Edge Pharma Recalls Methacholine Challenge Test Kits Due to Storage Labeling Error

    Edge Pharma is recalling Methacholine Challenge 5-Syringe Test Kits because they were labeled with incorrect room temperature storage conditions instead of the required refrigerated conditions.

    Product
    Methacholine Challenge 5-Syringe Test Kits, Sterile Inhalation Solution, Preservative Free, 3 mL per syringe, Edge Pharma, LLC, 856 Hercules Dr., Dolchester, VT 06448 NDC # 05446-1600-05
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0309-2021·2021-03-24

    Teva Recalls Romidepsin Injection Vials Due to Impurity Failures

    Teva Pharmaceuticals is recalling 1,416 vials of Romidepsin Injection because stability testing revealed out-of-specification impurities.

    Product
    Romidepsin Injecton, 27.5 mg/5.5 mL (5 mg/mL) Rx Only, 5.5 ml vial, Teva Pharmaceuticals USA, Inc. NDC 0703-4004-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0299-2021·2021-03-17

    Ferring Recalls Menopur Due to Out-of-Specification pH in Diluent

    Ferring Pharmaceuticals is recalling Menopur (menotropins) and its 0.9% Sodium Chloride diluent because the diluent failed pH specifications. The recall covers products distributed nationwide in the USA.

    Product
    MENOPUR — MENOPUR (MENOTROPINS)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0296-2021·2021-03-10

    Noven Recalls Daytrana Patches Due to Defective Delivery System

    Noven Pharmaceuticals is recalling Daytrana (methylphenidate) transdermal patches because the delivery system is out of specification for mechanical peel.

    Product
    DAYTRANA — DAYTRANA (METHYLPHENIDATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0295-2021·2021-03-10

    Noven Recalls Daytrana Patches Due to Defective Delivery System

    Noven Pharmaceuticals is recalling 786,900 Daytrana (methylphenidate) patches because the delivery system failed mechanical peel specifications.

    Product
    DAYTRANA — DAYTRANA (METHYLPHENIDATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0293-2021·2021-03-10

    Noven Recalls Daytrana Patches Due to Defective Delivery System

    Noven Pharmaceuticals is recalling 473,280 Daytrana (methylphenidate) patches because the delivery system failed mechanical peel specifications.

    Product
    DAYTRANA — DAYTRANA (METHYLPHENIDATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0292-2021·2021-03-10

    Dr. Reddy's Recalls Progesterone Capsules Due to Dissolution Failures

    Dr. Reddy's Laboratories is recalling 16,449 bottles of 200 mg Progesterone Capsules because stability testing revealed out-of-specification dissolution results.

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