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.

126–150 of 270

  • ModerateFDA (Drugs)·D-1341-2019·2019-06-19

    Chiesi Recalls ZYFLO CR Tablets Due to Dissolution Failure

    Chiesi USA is recalling ZYFLO CR (zileuton) extended-release tablets because they failed to meet dissolution specifications. The recall affects 2,118 bottles distributed nationwide.

    Product
    ZYFLO CR (zileuton) extended-release tablets, 600 mg, 120-count bottles, Rx only, Distributed by Chiesi USA, Inc., Cary, NC 27518, NDC 10122-902-12.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1342-2019·2019-06-19

    Chiesi Recalls Zileuton Extended-Release Tablets Due to Dissolution Failure

    Chiesi USA is recalling 2,598 bottles of Zileuton Extended-Release Tablets, 600 mg, because they failed dissolution specifications.

    Product
    Zileuton Extended-Release Tablets, 600 mg, 120-count bottles, Rx only, Distributed by: Prasco Laboratories, Mason, OH 45040 USA; NDC 66993-485-32.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1276-2019·2019-05-08

    American Health Packaging Recalls Glipizide Extended-Release Tablets for Dissolution Failure

    American Health Packaging is recalling 2,203 cartons of Glipizide Extended-Release Tablets, 2.5 mg, due to failed dissolution specifications at time zero.

    Product
    GlipiZIDE Extended-release Tablets, 2.5 mg, 30 Tablets (3 x 10), Rx Only, Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC: 68084-295-21
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1066-2019·2019-03-13

    Ascend Recalls Tamsulosin Hydrochloride Capsules Due to Dissolution Failure

    Ascend Laboratories is recalling 3,072 bottles of Tamsulosin Hydrochloride 0.4 mg capsules because stability testing revealed high out-of-specification dissolution results.

    Product
    TAMSULOSIN HYDROCHLORIDE — TAMSULOSIN HYDROCHLORIDE (TAMSULOSIN HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0519-2019·2019-03-13

    Jubilant Cadista Recalls Bupropion Hydrochloride Extended-Release Tablets for Dissolution Failure

    Jubilant Cadista Pharmaceuticals is recalling specific lots of Bupropion Hydrochloride Extended-Release Tablets because they failed dissolution specifications at a 9-month stability timepoint.

    Product
    BuPROPion Hydrochloride Extended-Release Tablets, USP (XL) 150 mg, a) 30 count (NDC 59746- 758-30) & b) 90 count (NDC 59746-758-90) bottles, Rx only, Manufactured b Jubilant Generis Ltd, Roorkee, India, Marketed by: Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD
    Category
    Drug
    Distribution
    0 states
  • HighFDA (Drugs)·D-0507-2019·2019-02-27

    Dr. Reddy's Recalls Divalproex Sodium Tablets for Dissolution Failure

    Dr. Reddy's is recalling 10,656 bottles of Divalproex Sodium Extended-release Tablets because they failed to meet dissolution specifications.

    Product
    DIVALPROEX SODIUM — DIVALPROEX SODIUM (DIVALPROEX SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0516-2019·2019-02-27

    Amerigen Recalls Temozolomide Capsules Due to Dissolution Failures

    Amerigen Pharmaceuticals is recalling Temozolomide Capsules, 5 mg, because the product failed to meet dissolution specifications.

    Product
    Temozolomide Capsules, 5 mg, packaged in a) 5-count bottle (NDC 43975-252-05) b) 14-count bottle (NDC 43975-252-14), Rx only, Mfd. by: Stason Pharmaceuticals, Inc., Irvine, CA 92618, Dist. By: Amerigen Pharmaceuticals, Lyndhurst, NJ 07071
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0489-2019·2019-02-20

    Valeant Recalls Cardizem CD Capsules for Dissolution Failures

    Valeant Pharmaceuticals is recalling 390 bottles of Cardizem CD capsules because they failed to meet dissolution specifications, potentially affecting drug release.

    Product
    CARDIZEM CD — CARDIZEM CD (DILTIAZEM HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0487-2019·2019-02-20

    Valeant Recalls Cardizem CD Capsules for Dissolution Failures

    Valeant Pharmaceuticals is recalling 1,023 bottles of Cardizem CD (diltiazem hydrochloride) 120 mg capsules because they failed to meet dissolution specifications.

    Product
    CARDIZEM CD — CARDIZEM CD (DILTIAZEM HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0490-2019·2019-02-20

    Valeant Recalls Cardizem CD Capsules for Dissolution Failures

    Valeant Pharmaceuticals is recalling 22 bottles of Cardizem CD capsules because they failed to meet dissolution specifications, potentially affecting drug release.

    Product
    CARDIZEM CD — CARDIZEM CD (DILTIAZEM HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0488-2019·2019-02-20

    Valeant Recalls Cardizem CD Capsules for Dissolution Failures

    Valeant Pharmaceuticals is recalling 206 bottles of Cardizem CD capsules because they failed to meet dissolution specifications, meaning the drug may not release properly.

    Product
    CARDIZEM CD — CARDIZEM CD (DILTIAZEM HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0491-2019·2019-02-20

    Valeant Recalls Diltiazem HCl Capsules for Dissolution Failures

    Valeant Pharmaceuticals is recalling 23,884 bottles of Diltiazem HCl CD capsules because they failed dissolution specifications, potentially affecting drug release.

    Product
    Diltiazem HCl CD capsules, 360 mg, 90-count bottles, Rx Only, Manufactured for: Oceanside Pharmaceuticals, a division of Valeant Pharmaceuticals North America LLC, Bridgewater, NJ 08807 USA; By: Valeant Pharmaceuticals International, Inc., Steinbach, MB R5G 1Z7 Canada; NDC 68682-
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0381-2019·2019-01-23

    Teva Recalls Olmesartan Medoxomil and Hydrochlorothiazide Tablets for Dissolution Failure

    Teva Pharmaceuticals USA is recalling specific lots of Olmesartan Medoxomil and Hydrochlorothiazide Tablets because they failed to meet dissolution specifications.

    Product
    Olmesartan Medoxomil and Hydrochlorothiazide Tablets, 40 mg/25 mg, packaged in a) 30-count bottle (NDC 0093-7617-56), b) 90-count bottle (NDC 0093-7617-98), Rx only, Manufactured In Israel By: Teva Pharmaceutical, IND. LTD., Jerusalem, 9777402, Israel, Manufactured For: Teva Phar
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0344-2019·2019-01-02

    Amerigen Recalls Temozolomide Capsules Due to Dissolution Failures

    Amerigen Pharmaceuticals is recalling specific lots of Temozolomide Capsules because they failed to meet dissolution specifications.

    Product
    Temozolomide Capsules, 20 mg, packaged in a a) 5-count (NDC 43975-253-05) and b) 14 count (NDC 43975-253-14) bottles, Rx only, Mfd, by: Stason Pharmaceuticals, Inc., Irvine, CA, Dist. By: Amerigen Pharmaceuticals, Lyndhurst, NJ
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0382-2019·2018-12-26

    Cipla Recalls Nevirapine Extended Release Tablets for Dissolution Failure

    Cipla Limited is recalling 4,800 bottles of Nevirapine Extended Release Tablets, 400 mg, because they failed to meet dissolution specifications.

    Product
    Nevirapine Extended Release Tablets, 400 mg, 30-count bottle, Rx Only, Manufactured by: Cipla Ltd. Verna Goa, India, Manufactured for: Cipla USA Inc. 9100 S Dadeland Blvd., Suite 1500 Miami, FL 33156, NDC 69097-403-02
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0294-2019·2018-12-19

    Dr. Reddy's Recalls Clopidogrel Tablets Due to Dissolution Failure

    Dr. Reddy's Laboratories is recalling specific lots of Clopidogrel Bisulfate 300 mg tablets because they failed dissolution specifications during stability testing.

    Product
    CLOPIDOGREL BISULFATE — CLOPIDOGREL BISULFATE (CLOPIDOGREL BISULFATE)
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0283-2019·2018-11-28

    Dr. Reddy's Recalls Clopidogrel Tablets Due to Dissolution Failure

    Dr. Reddy's Laboratories is recalling specific lots of Clopidogrel Bisulfate tablets because they failed dissolution testing during stability checks.

    Product
    CLOPIDOGREL BISULFATE — CLOPIDOGREL BISULFATE (CLOPIDOGREL BISULFATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0128-2019·2018-11-07

    Boehringer Ingelheim Recalls Catapres Tablets Due to Dissolution Failures

    Boehringer Ingelheim is recalling specific bottles of Catapres tablets because routine stability testing revealed they failed to meet dissolution specifications.

    Product
    Catapres .2 (clonidine hydrochloride, USP) 0.2mg, 100-count bottles, Rx only, Dist. by: Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT 06877 USA. Made in Germany. NDC 0597-0007-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0129-2019·2018-10-31

    Teva Recalls Metoprolol Succinate Extended Release Tablets Due to Dissolution Failure

    Teva Pharmaceuticals USA is recalling 53,451 bottles of Metoprolol Succinate Extended Release Tablets 50 mg because routine stability testing revealed out-of-specification dissolution results.

    Product
    Metoprolol Succinate Extended Release Tablets, USP 50 mg, 100-count bottle, Rx only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054, NDC 62037-831-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1024-2018·2018-08-08

    West-Ward Recalls Doxycycline Hyclate Tablets for Dissolution Failures

    West-Ward Columbus Inc is recalling Doxycycline Hyclate 100 mg tablets because they failed to meet dissolution specifications.

    Product
    DOXYCYCLINE HYCLATE — DOXYCYCLINE HYCLATE (DOXYCYCLINE HYCLATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0710-2018·2018-05-09

    Rhodes Pharmaceuticals Recalls Aptensio XR Capsules Due to Dissolution Failure

    Rhodes Pharmaceuticals is recalling Aptensio XR capsules because they failed to meet dissolution specifications. The affected lot was distributed nationwide.

    Product
    Aptensio XR (methylphenidate HCl extended-release) capsules 15 mg Rx Only 90-count bottle. Marketed by: Rhodes Pharmaceuticals L.P., Coventry, RI 02816. Manufactured by: Patheon Manufacturing Services LLC, Greenville, NC 27834. NDC 42858-402-45
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0716-2018·2018-05-02

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

    McKesson Packaging Services is recalling Diltiazem HCl Extended-Release Capsules, 240 mg, because stability testing showed high dissolution results.

    Product
    Diltiazem HCl Extended-Release Capsules, USP 240 mg, 100-count bottles, Rx Only, Mfg. By: Par Pharmaceutical One Ram Ridge Rd Chestnut Ridge, NY 10977. NDC: 63739-016-10
    Category
    Drug
    Distribution
    Distributed nationwide