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.

51–75 of 97

  • ModerateFDA (Drugs)·D-0006-2022·2021-10-20

    Potassium Chloride Extended-Release Tablets Recalled for Failed Dissolution

    Strides Pharma Inc. is recalling Potassium Chloride Extended-Release Tablets, USP 10 mEq because the tablets fail to meet dissolution specifications, which may affect drug effectiveness.

    Product
    POTASSIUM CHLORIDE — POTASSIUM CHLORIDE (POTASSIUM CHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0851-2021·2021-10-06

    Lyrica CR 330 mg Tablets Recalled for Failed Dissolution

    Viatris is recalling Lyrica CR (pregabalin) 330 mg extended-release tablets nationwide due to failed dissolution specifications that may reduce drug effectiveness.

    Product
    Lyrica CR (pregabalin) extended release tablets, 330 mg, 30-count bottles, Rx only, Distributed by Parke-Davis Division of Pfizer Inc., NY, NY 10017, NDC 0071-1029-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0260-2021·2021-02-24

    Auryxia Tablets Recalled for Failed Dissolution Specifications

    Akebia Therapeutics is recalling Auryxia (ferric citrate) tablets because they failed to meet dissolution specifications.

    Product
    Auryxia (ferric citrate) tablets, 210 mg*, 200 tablets bottle, RX ONLY, Manufactured for and distributed by: KERYX BIOPHARMACEUTICALS, INC., 245 First Street, Suite 1400, Cambridge, MA 02142, USA, NDC 59922-0631-01.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0146-2021·2020-12-23

    Zydus Recalls Lansoprazole Tablets for Failed Dissolution Specifications

    Zydus Pharmaceuticals is recalling 22,848 cartons of Lansoprazole 30 mg tablets nationwide because they failed to meet dissolution specifications.

    Product
    LANSOPRAZOLE — LANSOPRAZOLE (LANSOPRAZOLE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0070-2021·2020-11-18

    AvKARE Recalls Mesalamine Tablets for Failed Dissolution Specifications

    AvKARE Inc. is recalling specific lots of Mesalamine Delayed-Release Tablets because they failed to meet dissolution specifications.

    Product
    Mesalamine Delayed-Release Tablets, USP 1.2 gram (Once-Daily), 120 Tablets bottle, Rx Only Manufactured for: AvKARE, Inc. Pulaski, TN 38478 NDC 42291-564-12
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1276-2020·2020-06-03

    PD-Rx Recalls Doxycycline Hyclate Tablets for Failed Dissolution Specifications

    PD-Rx Pharmaceuticals is recalling Doxycycline Hyclate 100 mg tablets because they failed to meet dissolution specifications. The recall covers 14,030 bottles distributed nationwide.

    Product
    DOXYCYCLINE — DOXYCYCLINE (DOXYCYCLINE HYCLATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1722-2019·2019-08-21

    Alvogen Recalls Nitrofurantoin Capsules Due to Failed Dissolution Specifications

    Alvogen, Inc. is recalling 2,784 bottles of Nitrofurantoin Monohydrate/Macrocrystalline capsules because they failed to meet dissolution specifications.

    Product
    NITROFURANTOIN MONOHYDRATE/ MACROCRYSTALLINE — NITROFURANTOIN MONOHYDRATE/ MACROCRYSTALLINE (NITROFURANTOIN MONOHYDRATE/MACROCRYSTALLINE)
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-1821-2019·2019-08-21

    Carbamazepine Extended-Release Tablets Recalled for Failed Dissolution Specifications

    American Health Packaging is recalling Carbamazepine Extended-Release Tablets, 400 mg, because they failed to meet dissolution specifications.

    Product
    Carbamazepine, Extended-Release Tablets, USP, 400 mg, 30 Tablets (3 blister cards x 10 unit doses), Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC Carton: 68084-562-21; NDC Unit Dose: 68084-562-11
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1515-2019·2019-07-31

    Ascend Recalls Atorvastatin Calcium Tablets for Failed Dissolution Specifications

    Ascend Laboratories is recalling Atorvastatin Calcium 80 mg tablets because they failed dissolution specifications. The product was distributed to wholesalers nationwide.

    Product
    Atorvastatin Calcium Tablet USP 80 mg, a) 90 count (NDC 67877-0514-90) and b) 500 count (NDC 67877-0514-05) bottles, Rx only, Manufactured by: Alkem Laboratories, Ltd, Mumbai INDIA, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ
    Category
    Drug
    Distribution
    0 states
  • LowFDA (Drugs)·D-0345-2019·2019-01-02

    Amerigen Recalls Temozolomide Capsules for Failed Dissolution Specifications

    Amerigen Pharmaceuticals is recalling Temozolomide Capsules, 180 mg, due to failed dissolution specifications. The FDA classified this as a Class III recall.

    Product
    Temozolomide Capsules, 180 mg, packaged in a 14 count bottles, Rx only, Mfd, by: Stason Pharmaceuticals, Inc., Irvine, CA, Dist. By: Amerigen Pharmaceuticals, Lyndhurst, NJ ---- NDC 43975-256-14
    Category
    Drug
    Distribution
    0 states
  • LowFDA (Drugs)·D-0714-2018·2018-05-02

    McKesson Recalls Diltiazem HCl Extended-Release Capsules Due to Dissolution Failures

    McKesson Packaging Services is recalling Diltiazem HCl Extended-Release Capsules because stability testing showed high dissolution results, failing specifications.

    Product
    Diltiazem HCl Extended-Release Capsules, USP 120 mg, 100-count bottles, Rx only, Mfg. By: Par Pharmaceutical One Ram Ridge Rd Chestnut Ridge, NY 10977. NDC: 63739-014-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1042-2017·2017-08-09

    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, 250 mg 100-count bottle (NDC 68382-032-01), b.) 500-count bottle (NDC 68382-032-05),Rx only, Manufactured by Cadila Healthcare Ltd, Ahmedabad, India, Distributed by: Zydus Pharmaceuticals, Pennington, NJ 07054
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1041-2017·2017-08-09

    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, 125 mg, 100-count bottle Rx only, Manufactured by Cadila Healthcare Ltd, Ahmedabad, India, Distributed by: Zydus Pharmaceuticals, Pennington, NJ 07054, NDC 68382-031-01
    Category
    Drug
    Distribution
    Distributed nationwide