The Recall Desk

Hazard

Dissolution Failure recalls

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

What the numbers show

Total
270
Critical
0
Severe
10
Most recent
2026-09-02

Of the 270 dissolution failure recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 10 (4%) 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 dissolution failure 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.

176–200 of 270

  • LowFDA (Drugs)·D-0509-2017·2017-03-08

    Dr. Reddy's Recalls Zenatane Capsules Due to Dissolution Failure

    Dr. Reddy's Laboratories is recalling Zenatane (isotretinoin) capsules because they failed to meet dissolution specifications. The recall covers 4,404 cartons distributed nationwide.

    Product
    ZENATANE — ZENATANE (ISOTRETINOIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0476-2017·2017-02-22

    Actavis Recalls Glipizide Extended-Release Tablets Due to Dissolution Failure

    Actavis Inc is recalling specific lots of Glipizide extended-release tablets because they failed to meet dissolution specifications at the 10-hour testing point.

    Product
    Glipizide extended-release tablets, 2.5mg, 30-count bottle, Rx Only, Manufactured By Patheon Pharmaceuticals Inc Cincinnati OH 45237 USA, NDC 0591-0900-30, UPC 3-0591090030-4
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0449-2017·2017-02-08

    Dr. Reddy's Recalls Flucanazole Tablets for Dissolution Failures

    Dr. Reddy's Laboratories is recalling Flucanazole tablets because they failed dissolution and stability specifications.

    Product
    FLUCONAZOLE — FLUCONAZOLE (FLUCONAZOLE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0450-2017·2017-02-08

    Dr. Reddy's Recalls Flucanazole Tablets for Dissolution Failures

    Dr. Reddy's is recalling Flucanazole tablets that failed dissolution and stability specifications. Patients should stop using the affected lots and consult their healthcare provider.

    Product
    FLUCONAZOLE — FLUCONAZOLE (FLUCONAZOLE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0451-2017·2017-02-08

    Dr. Reddy's Recalls Flucanazole Tablets Due to Dissolution Failures

    Dr. Reddy's Laboratories is recalling Flucanazole 150 mg tablets because they failed dissolution specifications and 18-month stability testing.

    Product
    FLUCONAZOLE — FLUCONAZOLE (FLUCONAZOLE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0452-2017·2017-02-08

    Dr. Reddy's Recalls Flucanazole Tablets for Dissolution Failures

    Dr. Reddy's Laboratories is recalling Flucanazole 200 mg tablets nationwide due to failed dissolution specifications and stability issues.

    Product
    FLUCONAZOLE — FLUCONAZOLE (FLUCONAZOLE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0446-2017·2017-02-01

    Sun Pharmaceutical Recalls BuPROPion Hydrochloride Tablets for Dissolution Failures

    Sun Pharmaceutical Industries is recalling 11,618 bottles of buPROPion Hydrochloride Extended-release Tablets due to failed dissolution specifications and stability issues.

    Product
    buPROPion Hydrochloride Extended-release Tablets, USP (SR), 200 mg, 60 count bottles, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India NDC 47335-0
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0445-2017·2017-02-01

    Sun Pharmaceutical Recalls Bupropion Hydrochloride Tablets for Dissolution Failures

    Sun Pharmaceutical Industries is recalling specific lots of Bupropion Hydrochloride Extended-release Tablets because they failed dissolution specifications and a 18-month stability time point.

    Product
    BUPROPION HYDROCHLORIDE — BUPROPION HYDROCHLORIDE (BUPROPION HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1045-2017·2016-11-30

    West-Ward Recalls Phenobarbital Tablets Due to Dissolution Failure

    West-Ward Pharmaceuticals is recalling specific lots of Phenobarbital Tablets because they failed to meet dissolution specifications at the 12-month stability time point.

    Product
    PHENOBARBITAL — PHENOBARBITAL (PHENOBARBITAL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0137-2017·2016-11-23

    Amerisource Recalls Bupropion Hydrochloride Extended-Release Tablets for Dissolution Failure

    Amerisource Health Services is recalling specific lots of Bupropion Hydrochloride Extended-Release Tablets because stability samples failed dissolution specifications.

    Product
    Bupropion Hydrochloride Extended-Release Tablets, USP (XL), 300 mg, a) 90-count bottle (NDC 68001-264-05), b) 500-count bottle (NDC 68001-264-03) , Rx only, Manufactured by: Cadila Healthcare Limited, Ahmedabad, India For BluePoint Laboratories
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0007-2017·2016-10-12

    Sun Pharmaceutical Recalls Bupropion Hydrochloride Tablets for Dissolution Failures

    Sun Pharmaceutical Industries is recalling 31,762 bottles of Bupropion Hydrochloride Extended-Release Tablets because they failed dissolution specifications.

    Product
    BUPROPION HYDROCHLORIDE — BUPROPION HYDROCHLORIDE (BUPROPION HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1501-2016·2016-09-21

    Amerisource Recalls bupropion Hydrochloride Tablets for Dissolution Failure

    Amerisource Health Services is recalling 2,626 bottles of bupropion hydrochloride extended-release tablets due to failed dissolution specifications.

    Product
    buPROPion Hydrochloride Extended-Release Tablets, USP (XL), 300mg, 500-count bottle, Rx only, Manufactured by: Cadila Healthcare Ltd., Ahmedabad, India For BluePoint Laboratories, NDC 68001-264-03
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1479-2016·2016-09-14

    Stason Recalls Selegiline HCl Tablets Due to Dissolution Failure

    Stason Pharmaceuticals is recalling Selegiline HCl tablets 5mg due to out-of-specification dissolution results for stability samples.

    Product
    Selegiline HCL Tablets USP 5mg, 60- count bottles, Rx only, Manufactured by: Stason Pharmaceuticals, Inc. Irvine, CA 92618 Distributed by: Libertas Pharma, Inc. Montgomery, AL 36117. NDC 51862-146-06
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-1461-2016·2016-08-24

    Zydus Recalls Venlafaxine Hydrochloride Capsules for Dissolution Failures

    Zydus Pharmaceuticals USA Inc. is recalling specific lots of Venlafaxine Hydrochloride Extended-Release Capsules because retained samples failed dissolution specifications.

    Product
    VENLAFAXINE HYDROCHLORIDE — VENLAFAXINE HYDROCHLORIDE (VENLAFAXINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1457-2016·2016-08-24

    Actavis Recalls Glipizide 2.5 mg Extended-Release Tablets for Dissolution Failure

    Actavis Inc is recalling specific lots of Glipizide 2.5 mg Extended-Release tablets because they failed to meet dissolution specifications.

    Product
    Glipizide 2.5 mg Extended-release tablets, 30-count bottle, Rx Only, Manufactured By: Patheon Pharmaceuticals Inc Cincinnati, OH 45237, NDC 00591-0900-30
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1460-2016·2016-08-24

    Zydus Recalls Venlafaxine Hydrochloride Capsules for Dissolution Failures

    Zydus Pharmaceuticals is recalling 223,776 bottles of Venlafaxine Hydrochloride ER capsules because retained samples failed dissolution specifications.

    Product
    VENLAFAXINE HYDROCHLORIDE — VENLAFAXINE HYDROCHLORIDE (VENLAFAXINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1459-2016·2016-08-24

    Venlafaxine Hydrochloride Extended-Release Capsules Recalled for Dissolution Failures

    Golden State Medical Supply Inc. is recalling 40,631 bottles of Venlafaxine Hydrochloride Extended-Release Capsules, 75 mg, due to out-of-specification dissolution results.

    Product
    Venlafaxine Hydrochloride Extended-Release Capsules, 75 mg, 90 capsules per bottle, Rx Only, GSMS, NDC # 60429-122-90
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1448-2016·2016-08-03

    Actavis Recalls Dextroamphetamine Sulfate Capsules for Dissolution Failures

    Actavis Inc is recalling Dextroamphetamine Sulfate Extended-Release Capsules because they failed to meet dissolution specifications. The recall covers 8,062 units distributed nationwide.

    Product
    DEXTROAMPHETAMINE SULFATE — DEXTROAMPHETAMINE SULFATE (DEXTROAMPHETAMINE SULFATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1446-2016·2016-07-27

    Sun Pharmaceutical Recalls Bupropion Hydrochloride Tablets for Dissolution Failure

    Sun Pharmaceutical Industries is recalling 16,085 bottles of Bupropion Hydrochloride Extended Release Tablets because they failed dissolution specifications.

    Product
    BUPROPION HYDROCHLORIDE — BUPROPION HYDROCHLORIDE (BUPROPION HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1436-2016·2016-07-20

    Apotex Recalls Duloxetine Capsules Due to Dissolution Failure

    Apotex Scientific is recalling Duloxetine Delayed-Release Capsules, 60 mg, because stability testing revealed out-of-specification dissolution results.

    Product
    Duloxetine Delayed-Release Capsules, USP, 60 mg, 30-count bottles, Rx only, Manufactured by Apotex Inc, Toronto, Ontario M9L 1T9, Manufactured for Apotex Corp. Weston Florida 33326, NDC 60505-2997-3; UPC # 360505299737;
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1437-2016·2016-07-20

    Apotex Recalls Duloxetine Capsules Due to Dissolution Failure

    Apotex Scientific is recalling Duloxetine Delayed-Release Capsules because stability testing revealed out-of-specification dissolution results.

    Product
    Duloxetine Delayed-Release Capsules, USP, 30 mg, 30-count bottles, Rx only, Manufactured by Apotex Inc, Toronto, Ontario M9L 1T9, Manufactured for Apotex Corp. Weston Florida 33326, NDC 60505-2996-3; UPC # 360505299638.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0840-2016·2016-05-18

    Mylan Recalls Paliperidone Extended-Release Tablets Due to Dissolution Failures

    Mylan Pharmaceuticals is recalling 2,928 bottles of Paliperidone Extended-Release Tablets, 1.5 mg, because they failed dissolution specifications at a three-month stability time point.

    Product
    Paliperidone Extended-release Tablets, 1.5 mg, 30 count bottles, Rx only, Mylan Pharmaceuticals, Inc., Morgantown, WV --- NDC 0378-3978-93
    Category
    Drug
    Distribution
    Distributed nationwide