The Recall Desk

Hazard

Degradation recalls

297 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
297
Critical
0
Severe
47
Most recent
2026-09-02

Of the 297 degradation recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 47 (16%) are Severe.

Which agencies issued them

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all degradation recalls regardless of agency”, “all listeria recalls in California”, “all airbag recalls in 2025”. The tags are extracted from each recall’s source text during the LLM rewrite step and validated against a fixed schema.

A recall can carry multiple tags — a Listeria recall might also be tagged ready-to-eat and undeclared-allergen. Use the full-text search if you want to combine hazard tags with brand or category filters.

26–50 of 297

  • HighFDA (Drugs)·D-0227-2025·2025-02-26

    Lorazepam Tablets Recalled for Failed Impurity and Potency Specifications

    The FDA is recalling 94,349 cartons of Lorazepam 1mg tablets due to out-of-specification results for impurities and sub-potency discovered during routine stability testing. The affected product was distributed nationwide in the U.S. and Puerto Rico.

    Product
    LORAZEPAM — LORAZEPAM (LORAZEPAM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0226-2025·2025-02-26

    Lorazepam Tablets Recalled Due to Sub-Potency and Failed Stability Testing

    The Harvard Drug Group is recalling Lorazepam Tablets USP 0.5mg due to sub-potency and failed stability test results. Approximately 82,281 cartons are affected nationwide and in Puerto Rico.

    Product
    LORAZEPAM — LORAZEPAM (LORAZEPAM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0219-2025·2025-02-12

    Hydralazine Hydrochloride Tablets Recalled Due to Impurities and Degradation

    SKY Packaging recalls Hydralazine Hydrochloride 25 mg tablets nationwide due to failed quality specifications for impurities and degradation.

    Product
    HydrALAZINE Hydrochloride, 25 mg, 100 Unit Dose Tablets (10x10), USP, Rx only, Manufactured by Strides Pharma Science Ltd, Bengaluru, India, Distributed by McKesson by: McKesson Corporation dba SKY Packaging, TN 38141. NDC 63739-327-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0220-2025·2025-02-12

    HydrALAZINE Hydrochloride tablets recalled for failed purity and degradation specifications

    SKY PACKAGING is recalling HydrALAZINE Hydrochloride 50mg tablets nationwide due to failed impurities and degradation specifications. Four affected lot numbers have expiration dates from April 2025 to February 2026.

    Product
    HydrALAZINE Hydrochloride, 100 Tablets (10x10), USP, 50mg, Rx only, Manufactured by Strides Pharma Science Ltd, Bengaluru, India, Distributed by McKesson by: McKesson Corporation dba SKY Packaging, TN 38141. NDC 63739-328-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0203-2025·2025-01-22

    Prescription Drug Cardura Recalled for Specification Failures in Manufacturing

    Viatris Inc is recalling Cardura (doxazosin mesylate) XL 8 mg tablets due to failed stability testing revealing out-of-specification impurity levels. Approximately 1,215 bottles distributed nationwide are affected.

    Product
    CARDURA — CARDURA (DOXAZOSIN MESYLATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0167-2025·2025-01-08

    Levothyroxine Sodium tablets recalled for impurity specification failure

    Lupin Pharmaceuticals is recalling Levothyroxine Sodium 75 mcg tablets due to out-of-specification impurities detected in stability testing. Affected lot LA01276 (expiring 07/2026) was distributed to one Ohio distributor.

    Product
    LEVOTHYROXINE SODIUM — LEVOTHYROXINE SODIUM (LEVOTHYROXINE SODIUM)
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0117-2025·2024-12-18

    FDA Recalls JAVYGTOR Tablets Due to Failed Impurities and Degradation Specifications

    Dr. Reddy's Laboratories is recalling 7,233 bottles of JAVYGTOR (sapropterin dihydrochloride) tablets nationwide because the medication failed specifications for impurities and degradation products. Affected patients should contact their healthcare provider.

    Product
    JAVYGTOR — JAVYGTOR (SAPROPTERIN DIHYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0050-2025·2024-11-27

    Guaifenesin Dextromethorphan Syrup Recalled for Failed Quality Specifications

    Major Pharmaceuticals has recalled Guaifenesin Dextromethorphan Syrup due to failed impurity and degradation specifications. Three lot numbers were distributed nationwide.

    Product
    Guaifenesin Dextromethorphan Syrup, 100 mg/10mg per 5 mL, Major Pharmaceuticals 8401 Bearing Drive, Suite 100, Indianapolis, IN, 46268, NDC 0904-7134-70
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0049-2025·2024-11-27

    Guaifenesin-Dextromethorphan Cough Syrup Recalled for Failed Impurity Specifications

    Major Pharmaceuticals is recalling Guaifenesin Dextromethorphan Syrup nationwide for specific lots that failed to meet impurity and degradation specifications. Consumers should contact their pharmacist if they possess affected lots.

    Product
    Guaifenesin Dextromethorphan Syrup, 200 mg/20mg per 10 mL, Major Pharmaceuticals 8401 Bearing Drive, Suite 100, Indianapolis, IN, 46268, NDC 0904-7135-72
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0045-2025·2024-11-20

    Hydralazine Tablets Recalled Due to Failed Impurities and Degradation Testing

    Hydralazine HCl Tablets 25mg are recalled nationwide due to failed impurities and degradation specifications. The recall affects approximately 25,814 tablets distributed by Avet Pharmaceuticals and MAJOR Pharmaceuticals.

    Product
    Hydralazine HCl Tablets, USP, 25mg, Rx only, 100 tablets per carton, Distributed by: Avet Pharmaceuticals Inc., East Brunswick, NJ 08816, Distributed by: MAJOR Pharmaceuticals, Livonia, MI, 48152, USA, NDC 0904-6441-61.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0037-2025·2024-11-13

    Morphine Sulfate Extended-Release Tablets Recalled for Failed Impurities Specification

    Dr. Reddy's Laboratories is recalling Morphine Sulfate Extended-Release Tablets 30 mg (Lot FG13996) nationwide due to failed impurities and degradation specifications.

    Product
    Morphine Sulfate Extended-Release Tablets 30 mg, 100-count bottles, Rx Only, Manufactured by Mayne Pharma, Greenville, NC 27834, NDC 51862-186-01.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0041-2025·2024-11-13

    Generic Ibuprofen 800mg Recalled Due to Failed Impurity and Degradation Specifications

    Direct Rx is recalling 1,410 bottles of Ibuprofen 800mg tablets distributed nationwide due to failed impurity specifications discovered during 18-month stability testing.

    Product
    Ibuprofen 800mg, Generic for: Motrin, Each tablet contains: Ibuprofen, USP 800 mg, Packaged and Distributed by: DIRECT Rx, Dawsonville, GA 30534, Mfg By: Dr. Reddy's Laboratories LA, LLC, Shreveport, LA 71106, a) NDC 61919-0621-15 (15 count bottles), b) NDC 61919-0621-30 (30 cou
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0644-2024·2024-09-04

    Prescription Ibuprofen Recalled Due to Failed Impurity Specifications

    Dr. Reddy's Laboratories is recalling IBU (Ibuprofen) 800 mg prescription tablets nationwide due to failed quality specifications. Testing found unknown impurities exceeding acceptable limits.

    Product
    IBU — IBU (IBUPROFEN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0647-2024·2024-09-04

    Ibuprofen Tablets Recalled Due to Failed Impurities and Degradation Specifications

    Preferred Pharmaceuticals is recalling 266 bottles of generic ibuprofen tablets due to failed impurities and degradation specifications discovered during stability testing. The affected lots were distributed in California and Nevada.

    Product
    Ibuprofen Tablets, USP 400mg, Generic for Motrin, Pkg Size: 30 tablets per bottle, Mfg: Dr. Reddy's Laboratories, Louisiana, Shreveport, NDC 68788-9110-03.
    Category
    Drug
    Distribution
    2 states
  • HighFDA (Drugs)·D-0603-2024·2024-07-24

    Cardura XL Extended Release Tablets Recalled for Failed Impurity Specifications

    Viatris Inc is recalling Cardura XL (doxazosin) extended release tablets 8mg because two lots failed impurity and degradation specifications. Approximately 3,694 bottles were distributed nationwide.

    Product
    Cardura XL (doxazosin) extended release tablets 8mg, 30-count bottles, Rx Only Made in Singapore, Distributed by Roerig Division of Pfizer Inc, NY, NY 10017 NDC 0049-2080-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0602-2024·2024-07-24

    Cardura XL Tablets Recalled for Failed Impurities and Degradation Specifications

    Viatris Inc is recalling Cardura XL (doxazosin) 4mg tablets due to failed impurities and degradation specifications. The recall affects 12,691 bottles distributed nationwide.

    Product
    Cardura XL (doxazosin) extended release tablets 4mg, 30-count bottles, Rx Only, Made in Singapore, Distributed by Roerig Division of Pfizer Inc, NY, NY 10017 NDC 0049-2040-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0601-2024·2024-07-24

    Fludrocortisone Acetate Tablets recalled nationwide due to failed impurity and degradation specifications

    Teva Pharmaceuticals is recalling Fludrocortisone Acetate Tablets 0.1mg nationwide and in Puerto Rico due to impurities and degradation substances exceeding specification limits.

    Product
    Fludrocortisone Acetate Tablets, USP 0.1mg, Rx Only, 100 Tablets per bottle, Manufactured in Canada By: Patheon, Inc., Mississauga, ON, Canada L5N 7K9, Manufactured For: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0555-0997-02.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0599-2024·2024-07-17

    Rising Pharma recalls Diflorasone Diacetate ointment for failed impurity specifications

    Rising Pharma is recalling 868 tubes of Diflorasone Diacetate ointment because impurity levels failed to meet safety specifications during stability testing. No illnesses have been reported.

    Product
    DIFLORASONE DIACETATE — DIFLORASONE DIACETATE (DIFLORASONE DIACETATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0543-2024·2024-06-12

    Estradiol transdermal patches recalled for failed quality specifications

    Zydus Pharmaceuticals is recalling 13,440 units of Estradiol transdermal patches distributed nationwide due to failed impurities and degradation specifications. No illnesses or injuries have been reported.

    Product
    ESTRADIOL — ESTRADIOL (ESTRADIOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0542-2024·2024-06-12

    Estradiol Transdermal Patch Recalled for Failed Chemical Specifications

    Zydus Pharmaceuticals is recalling Estradiol Transdermal System patches nationwide due to failed impurities and degradation specifications. The recall affects 21,360 units distributed throughout the United States.

    Product
    ESTRADIOL — ESTRADIOL (ESTRADIOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0504-2024·2024-05-29

    Prescription Drug Sirolimus Recalled for Failed Impurity Specifications

    Dr. Reddy's Laboratories is recalling Sirolimus 1mg tablets nationwide due to failed impurity and degradation specifications. The recall affects 1,176 bottles from lot H2200493 expiring 6/30/2025.

    Product
    SIROLIMUS — SIROLIMUS (SIROLIMUS)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0464-2024·2024-05-01

    FDA Recalls Fluorescein Sodium Ophthalmic Strips for Manufacturing Defect

    The FDA is recalling FUL-GLO Fluorescein Sodium Sterile Ophthalmic Strips (4,648 cartons) nationwide due to unspecified impurities in the active ingredient exceeding USP standards.

    Product
    FUL-GLO, Fluorescein Sodium Sterile Ophthalmic Strips USP (0.6 mg Fluorescein), 300 sterile strips per carton, Manufactured for: Akorn, Inc., Lake Forest, IL 60045, NDC 17478-403-03.
    Category
    Drug
    Distribution
    Distributed nationwide