The Recall Desk

Hazard

Failed Dissolution recalls

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

What the numbers show

Total
97
Critical
0
Severe
5
Most recent
2026-08-19

Of the 97 failed dissolution recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 5 (5%) are Severe.

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all failed dissolution 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 97

  • HighFDA (Drugs)·D-0306-2025·2025-04-09

    Biocon Pharma atorvastatin calcium tablets recalled for failed dissolution specifications

    Biocon Pharma is recalling 2,184 bottles of Atorvastatin Calcium Tablets USP 40 mg nationwide. The product failed to meet required dissolution specifications, which may affect medication absorption.

    Product
    ATORVASTATIN CALCIUM — ATORVASTATIN CALCIUM (ATORVASTATIN CALCIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0604-2024·2024-07-24

    Potassium Chloride Extended-Release Capsules Recalled for Failed Dissolution Specifications

    Glenmark Pharmaceuticals is recalling potassium chloride extended-release capsules (750 mg) nationwide due to failed dissolution specifications. Affected patients should contact their healthcare provider before making any changes to their medication.

    Product
    POTASSIUM CHLORIDE — POTASSIUM CHLORIDE (POTASSIUM CHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0426-2024·2024-04-03

    Divalproex Sodium 250 mg tablets recalled for failed dissolution specifications

    Amneal Pharmaceuticals is recalling Divalproex Sodium Extended-release Tablets 250 mg nationwide due to failed dissolution specifications. The tablets may not dissolve properly, affecting medication effectiveness.

    Product
    DIVALPROEX SODIUM — DIVALPROEX SODIUM (DIVALPROEX SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0276-2024·2024-02-07

    Budesonide Extended-Release Tablets recalled for failed dissolution specifications

    Golden State Medical Supply Inc. is recalling 108 bottles of Budesonide Extended-Release Tablets (9 mg) distributed in Illinois due to failed dissolution specifications.

    Product
    Budesonide Extended-Release Tablets, 9 mg, 30-count bottles, Rx only, Marketed by: GSMS, Incorporated, Camarillo, CA, UPC 5140782430, NDC 51407-824-30
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Drugs)·D-0275-2024·2024-02-07

    FDA Recalls Budesonide Extended-Release Tablets for Failed Dissolution

    FDA has recalled approximately 10,672 bottles of Budesonide Extended-Release Tablets 9mg manufactured by Teva Pharmaceuticals due to failed dissolution specifications.

    Product
    BUDESONIDE — BUDESONIDE (BUDESONIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0148-2024·2023-12-20

    Penicillamine Tablets Recalled Due to Failed Dissolution Specifications

    Lupin Pharmaceuticals is recalling Penicillamine Tablets USP 250 mg (Lot M200498) due to failed dissolution specifications. The affected tablets may not dissolve as intended, potentially affecting drug performance.

    Product
    PENICILLAMINE — PENICILLAMINE (PENICILLAMINE)
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0892-2023·2023-07-12

    Prescription Drug Tizanidine Tablets Recalled for Failed Dissolution Specifications

    Amerisource Health Services LLC recalls approximately 4,971 cartons of Tizanidine Tablets due to failed dissolution specifications. Tablets that do not dissolve properly may not provide intended therapeutic benefit.

    Product
    TIZANIDINE — TIZANIDINE (TIZANIDINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0761-2023·2023-05-31

    Bupropion Hydrochloride Extended-Release Tablets Recalled for Failed Dissolution Specifications

    Sun Pharmaceutical is recalling nationwide certain lots of Bupropion Hydrochloride Extended-Release Tablets 150 mg because tablets from these lots failed to meet dissolution specifications during stability testing, potentially affecting drug effectiveness.

    Product
    BUPROPION HYDROCHLORIDE — BUPROPION HYDROCHLORIDE (BUPROPION HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1362-2022·2022-08-31

    Divalproex Sodium Extended-Release Tablets Recalled for Failed Dissolution Specifications

    Amneal Pharmaceuticals is recalling 4,309 bottles of Divalproex Sodium Extended-Release Tablets (250 mg) due to failed dissolution specifications. The tablets may not dissolve properly, potentially affecting medication effectiveness.

    Product
    DIVALPROEX SODIUM — DIVALPROEX SODIUM (DIVALPROEX SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1299-2022·2022-08-03

    Juice Beauty lip moisturizer recalled for failed dissolution specifications

    Juice Beauty The Organic Solution SPF 8 lip moisturizer is being recalled due to failed dissolution specifications. The recall affects 35,313 tubes distributed in California.

    Product
    Juice Beauty, The Organic Solution, SPF 8, Naturally Clear Lip Moisturizer, Hydratant pour les Levres, NET WT 0.15 oz (4.25 g) per tube, Active Ingredient: Zinc oxide 4%, Manufactured for Juice Beauty, Inc., 709 Fifth Ave., San Rafael, California 94901-3566
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Drugs)·D-0854-2022·2022-05-18

    Xanax XR Extended-Release Tablets Recalled for Failed Dissolution Specifications

    Viatris Inc recalls Xanax XR (alprazolam) 3 mg extended-release tablets due to failed dissolution specifications. Affected tablets may not break down properly, potentially reducing medication effectiveness.

    Product
    Xanax XR (alprazolam) extended-release tablets, 3 mg, 60-count bottle, Rx only, Distributed by Pharmacia & Upjohn Co, Division of Fizer Inc, NY, NY 10017, NDC 0009-0068-07.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0649-2022·2022-03-16

    Paliperidone Extended-Release Tablets Recalled for Failed Dissolution

    The Harvard Drug Group is recalling 174 cartons of Paliperidone Extended-Release Tablets, 9 mg, nationwide due to failed dissolution specifications. The affected lots are N00522 (Exp. 09/2022) and N00618 (Exp. 11/2022).

    Product
    PALIPERIDONE — PALIPERIDONE (PALIPERIDONE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0520-2022·2022-02-09

    Tretinoin Capsules 10 mg Recalled for Failed Dissolution Specifications

    Teva Pharmaceuticals USA is recalling Tretinoin Capsules 10 mg due to failed dissolution specifications and out-of-specification test results. Approximately 1,175 bottles distributed nationwide may not dissolve properly.

    Product
    Tretinoin Capsules, 10 mg, 100 count bottle, Rx Only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0555-0808-02
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0393-2022·2022-02-02

    Metoprolol Succinate Extended-Release Tablets Recalled for Failed Dissolution

    Ascend Laboratories is recalling Metoprolol Succinate Extended-Release Tablets 25 mg nationwide because the tablets failed to meet dissolution specifications, which may affect how the medication releases in the body.

    Product
    METOPROLOL SUCCINATE — METOPROLOL SUCCINATE (METOPROLOL SUCCINATE ER TABLETS)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0381-2022·2022-01-26

    Fexofenadine/Pseudoephedrine tablets recalled for failed dissolution

    Dr. Reddy's Laboratories is recalling Kroger Allergy Relief-D tablets (fexofenadine HCl 60mg/pseudoephedrine HCl 120mg) due to failed dissolution specifications. Approximately 11,064 boxes distributed nationwide are affected.

    Product
    FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI — FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI (FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0384-2022·2022-01-26

    QC Quality Choice Fexofenadine/Pseudoephedrine Tablets Recalled for Failed Dissolution

    Dr. Reddy's Laboratories is recalling QC Quality Choice Fexofenadine HCl 60mg and Pseudoephedrine HCl 120mg Extended-Release Tablets nationwide due to failed dissolution specifications that may reduce the medication's effectiveness.

    Product
    QC QUALITY CHOICE, Fexofenadine HCl 60mg and Pseudoephedrine HCl 120mg, Extended-Release Tablets, USP, Allergy & Congestion, 10 Tablets per box, NDC 63868-729-10, Distributed by C.D.M.A., Inc., 43157 W 9 Mile Rd, Novi, MI 48375, Made in India.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0383-2022·2022-01-26

    Equate Allergy Relief D Tablets Recalled for Failed Dissolution

    Dr. Reddy's Laboratories is recalling Equate Allergy Relief D Extended-Release Tablets distributed by Walmart nationwide due to failed dissolution specifications. The recall affects 137,856 boxes across multiple lot numbers.

    Product
    equate, Allergy Relief D, Fexofenadine HCl 60mg/Antihistamine, Pseudoephedrine HCl 120mg/Nasal Decongestant Extended-Release Tablets USP, a) 20 Extended Release Tablets per box, NDC 49035-273-20, b) 30 Extended Release Tablets per box, NDC 49035-273-30, Distributed by: Walmart In
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0270-2022·2021-12-15

    Fexofenadine and Pseudoephedrine Tablets Recalled for Failed Dissolution

    Dr. Reddy's Laboratories is recalling Fexofenadine HCl 60 mg and Pseudoephedrine HCl 120 mg Extended Release Tablets because they failed dissolution specifications, which may affect how the medication works in the body.

    Product
    Antihistamine & Nasal Decongestant, Fexofenadine HCl 60 mg and Pseudoephedrine HCl 120 mg, Extended Release Tablets USP, Allergy & Congestion, 12 Hour, 20 Tablets, Distributed by: Rugby Laboratories, 17177 N. Laurel Park Drive, Suite 233, Livonia, MI 48152, www.rugbylaboratories.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0269-2022·2021-12-15

    OTC Allergy and Congestion Tablets Recalled for Failed Dissolution

    Dr. Reddy's Laboratories is recalling 5,016 cartons of Fexofenadine HCl 60 mg / Pseudoephedrine HCl 120 mg Extended Release Tablets nationwide due to failed dissolution specifications. Affected lot is AC2103329F with expiration 1/2023.

    Product
    FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI — FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI (FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0272-2022·2021-12-15

    Fexofenadine and Pseudoephedrine allergy relief tablets recalled for failed dissolution

    Dr. Reddy's Laboratories is recalling a 12 HR Allergy & Congestion Relief product distributed nationwide because the tablets failed to meet dissolution specifications, which may affect drug effectiveness.

    Product
    12 HR Allergy & Congestion Relief Fexofenadine HCl, 60 mg I Pseudoephedrine HCl, 120 mg Antihistamine I Nasal Decongestant, 20 Extended-Release Tablets USP, Distributed By Cardinal Health, Dublin, Ohio 43107, Made in India, NDC 70000-0518-1.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0020-2022·2021-10-27

    GlipiZIDE Extended-Release Tablets 2.5 mg Nationwide Recall

    American Health Packaging is recalling GlipiZIDE Extended-Release Tablets 2.5 mg (Lot #194141) nationwide because dissolution test results exceeded specification, which may affect the drug's effectiveness.

    Product
    GlipiZIDE Extended-Release Tablets, 2.5 mg, 30 Tablets (3 blister cards each with 10 individually blistered doses), Rx only, Manufactured by: Patheon Pharmaceuticals Inc., Cincinnati, OH 45237; Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054. Carton NDC#: 68084-295-21
    Category
    Drug
    Distribution
    Distributed nationwide