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.

76–97 of 97

  • ModerateFDA (Drugs)·D-1043-2017·2017-08-09

    Zydus Recalls Divalproex Sodium Tablets for Failed Dissolution Specifications

    Zydus Pharmaceuticals is recalling Divalproex Sodium Delayed Release Tablets because they failed to meet dissolution specifications.

    Product
    Divalproex Sodium Delayed Release Tablets, USP, 500 mg, a.) 100-count bottle (NDC 68382-033-01) b.) 500-count bottle (NDC 68382-033-05), Rx only, manufactured by Cadila Healthcare Ltd, Ahmedabad, India, Distributed by: Zydus Pharmaceuticals, Pennington, NJ 07054
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0982-2017·2017-07-26

    Shionogi Recalls PONSTEL Capsules Due to Failed Dissolution Specifications

    Shionogi Inc. is recalling 455 bottles of PONSTEL capsules because stability testing showed low dissolution results.

    Product
    PONSTEL (Mefanamic Acid) USP, 250 mg capsules, 30-count bottles, Rx Only, Manufactured for: Shionogi Inc. Florham Park, NJ 07932 Manufactured by: Halo Pharmaceutical Inc. Whippany, NJ 07981
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0693-2017·2017-05-10

    Amneal Recalls Rabeprazole Sodium Tablets for Failed Dissolution Specifications

    Amneal Pharmaceuticals is recalling Rabeprazole Sodium Delayed Release Tablets, 20 mg, because the product failed to meet dissolution specifications.

    Product
    Rabeprazole Sodium Delayed Release Tablets, 20 mg, a) 30-count bottle (NDC 65162-0724-03), b) 90-count bottle (NDC 65162-0724-09), Rx Only, Manufactured by Amneal Pharmaceuticals Pvt. Ltd., Ahmedabad INDIA 382220, Distributed by Amneal Pharmaceuticals, Bridgewater, NJ 08807
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0688-2017·2017-05-10

    Harvard Drug Group Recalls Fluconazole Tablets for Failed Dissolution

    The Harvard Drug Group is recalling 2,341 cartons of Fluconazole 100 mg tablets because they failed to meet dissolution specifications.

    Product
    FLUCONAZOLE — FLUCONAZOLE (FLUCONAZOLE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0617-2017·2017-04-05

    Zydus Recalls Divalproex Sodium Tablets for Failed Dissolution Specifications

    Zydus Pharmaceuticals is recalling Divalproex Sodium Delayed Release Tablets because they failed dissolution specifications and long-term stability testing.

    Product
    Divalproex Sodium Delayed Release Tablets, USP, 500 mg, a) 100 count (NDC 68382-033-01) and b) 500 count (NDC 68382-033-05) bottles, Rx only, manufactured by Cadila Healthcare Ltd, Ahmedabad, India, Distributed by: Zydus Pharmaceuticals, Pennington, NJ
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0482-2017·2017-03-01

    RemedyRepack Recalls Glipizide Tablets for Failed Dissolution Specifications

    RemedyRepack Inc. is recalling Glipizide 2.5 mg ER tablets because they failed to meet dissolution specifications. The product was distributed to a customer in Florida.

    Product
    Glipizide 2.5 mg ER Tablets, Manufactured by Watson Laboratories, Inc., Parsippany, NJ 07054, Repackaged by RemedyRepack, Indiana, PA 15701, NDC 52125-0764-02
    Category
    Drug
    Distribution
    1 state
  • LowFDA (Drugs)·D-0431-2017·2017-01-25

    Teva Recalls Risedronate Sodium Tablets for Failed Dissolution Specifications

    Teva Pharmaceuticals is recalling 6,800 cartons of Risedronate Sodium Delayed-release Tablets, 35 mg, because they failed dissolution specifications.

    Product
    Risedronate Sodium Delayed-release Tablets, 35 mg, Once-a-Week, 1 tablet per blister (NDC 0093-5509-19), packaged in 4 blisters per carton (NDC 0093-5509-44), Rx only, TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0236-2017·2017-01-04

    Sandoz Recalls Nadolol Tablets Due to Failed Dissolution Test

    Sandoz Incorporated is recalling 96 bottles of Nadolol Tablets, 40mg, because the product failed a required dissolution test.

    Product
    Nadolol Tablets, USP, 40mg, packaged in 1000-count bottle, Rx Only, Manufactured by Sandoz Inc., Princeton, NJ 08540, NDC 0781-1182-10
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-1458-2016·2016-08-24

    Golden State Medical Supply Recalls Venlafaxine Hydrochloride Extended-Release Capsules

    Golden State Medical Supply Inc. is recalling specific lots of Venlafaxine Hydrochloride Extended-Release Capsules, 150 mg, due to failed dissolution specifications.

    Product
    Venlafaxine Hydrochloride Extended-Release Capsules, 150 mg, a) 30 capsules per bottle, NDC # 60429-123-30, b) 90 capsules per bottle, NDC # 60429-123-90, Rx Only, GSMS.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1435-2016·2016-07-20

    Apotex Recalls Duloxetine Capsules Due to Failed Dissolution Testing

    Apotex Scientific is recalling specific lots of Duloxetine Delayed-Release Capsules because they failed dissolution specifications during stability testing.

    Product
    Duloxetine Delayed-Release Capsules, USP, 20 mg, 60-count bottles, Rx only, Manufactured by Apotex Inc, Toronto, Ontario M9L 1T9, Manufactured for Apotex Corp. Weston Florida 33326, NDC 60505-2995-6; UPC # 360505299560;
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1030-2016·2016-06-22

    Nostrum Recalls Nitrofurantoin Oral Suspension for Failed Dissolution Specifications

    Nostrum Laboratories is recalling Nitrofurantoin Oral Suspension because it failed to meet dissolution specifications. The recall covers 2,839 bottles distributed nationwide.

    Product
    Nitrofurantoin Oral Suspension, USP, 25 mg/5 mL, FOR ORAL USE ONLY, URINARY TRACT ANTIBACTERIAL, Rx Only , 240 mL bottle, Dist. by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Mfg. by: Sun Pharmaceutical Industries, Inc., Bryan, Ohio 43506, NDC 57664-239-32
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0163-2016·2015-11-11

    Valeant Recalls Fenoglide Tablets Due to Failed Dissolution Testing

    Valeant Pharmaceuticals is recalling specific bottles of Fenoglide (fenofibrate) 120 mg tablets because they failed 24-month dissolution testing.

    Product
    Fenoglide (fenofibrate) tablets, 120 mg Tablets, 90 Ct Bottle, Rx Only. Distributed by: Santarus, Inc. San Diego, CA 92130. NDC: 68012-495-90.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1406-2015·2015-09-09

    Qualitest Recalls Lisinopril Tablets for Failed Dissolution Specifications

    Vintage Pharmaceuticals is recalling 8,705 bottles of Lisinopril 40 mg tablets because they failed dissolution specifications. The affected lots were distributed nationwide and in Puerto Rico.

    Product
    Lisinopril Tablets, USP, 40 mg, a) 45-count bottle (NDC 0603-4214-60), b) 500-count bottle (NDC 0603-4214-28), Rx Only, Manufactured for: Qualitest Pharmaceuticals, Huntsville, AL 35811
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1278-2015·2015-07-29

    Purdue Pharma Recalls Intermezzo Sublingual Tablets for Dissolution Failures

    Purdue Pharma is recalling Intermezzo (zolpidem tartrate) sublingual tablets because they failed to meet dissolution specifications.

    Product
    Intermezzo (zolpidem tartrate), sublingual tablet 3.5 mg, 1 tablet per pouch, 30 pouches per carton, Rx only, Distributed by Purdue Pharma L.P. Stamford, CT 06901-3431, NDC 59011-265-30
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1112-2015·2015-06-10

    Teva Recalls Zebeta Tablets Due to Failed Dissolution Specifications

    Teva Pharmaceuticals is recalling 889 bottles of Zebeta (bisoprolol fumarate) 10mg tablets because they failed dissolution specifications during stability testing.

    Product
    Zebeta¿ (bisoprolol fumarate), tablets, 10mg, 30-count bottle, Rx only, Manufactured for Teva Pharmaceuticals Inc. 425 Privet Road, Horsham, PA by Duramed Pharmaceuticals, Inc., a subsidiary of Barr Pharmaceuticals, Inc., Pomona, NY 10970 for Teva. NDC 51285-061-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0249-2015·2014-11-26

    Prometheus Recalls Mercaptopurine Tablets for Failed Dissolution Specifications

    Prometheus Laboratories is recalling Mercaptopurine Tablets 50mg because the product failed dissolution specifications during stability testing.

    Product
    Mercaptopurine Tablets, USP 50mg, a) 60-count bottle (NDC 49884-922-02), b) 250-count bottle (NDC 49884-922-04), RX only, Manufactured by Stason Pharmaceuticals, Inc., 11 Morgan, Irvine, CA 92618 for Prometheus Laboratories, Inc., 9410 Carroll Park Drive, San Diego, CA 92121
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0008-2015·2014-10-15

    Astellas Recalls Tarceva Tablets Due to Failed Dissolution Specifications

    Astellas Pharma US Inc is recalling 9,236 bottles of Tarceva (erlotinib) 150 mg tablets because they failed routine stability testing for dissolution.

    Product
    Tarceva (erlotinib) Tablets, 150 mg, 30 count bottle, Rx only, Manufactured by: Kremers Urban Pharmaceuticals Inc. Seymour, IN 47274 NDC 50242-064-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-174-2013·2013-03-06

    West-ward Recalls Isoniazid Tablets for Failed Dissolution Specifications

    West-ward Pharmaceutical Corp. is recalling Isoniazid Tablets 300 mg due to failed dissolution specifications and a 36-month stability timepoint issue.

    Product
    Isoniazid Tablets 300 mg tablets USP, Rx Only, a) 30 tablets - NDC 61748-013-30, b) 100 tablets - NDC 61748-013-01, Mfd for: VersaPharm Incorporated Marietta, GA 30065-1505, Mfd by: West - Ward Pharmaceutical Corp.., Eatontown, NJ 07724
    Category
    Drug
    Distribution
    1 state
  • LowFDA (Drugs)·D-175-2013·2013-03-06

    Actavis Recalls BuPROPion Hydrochloride Tablets Due to Dissolution Failure

    Actavis Pharmaceuticals is recalling 14,856 bottles of buPROPion Hydrochloride Extended-Release Tablets 300 mg because they failed dissolution specifications during stability testing.

    Product
    buPROPion Hydrochloride Extended - Release Tablets (XL) 300 mg, 30 tablet bottles, Rx Only, NDC 67767-142-30 Actavis Distributed by: Actavis South Atlantic LLC Sunrise, FL 33325 Packaged by by: America Health Packaging Columbus, OH 43217
    Category
    Drug
    Distribution
    Distributed nationwide