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.

251–270 of 270

  • LowFDA (Drugs)·D-1067-2013·2013-10-09

    Osmotica Recalls Venlafaxine Extended Release Tablets for Dissolution Failure

    Osmotica Pharmaceutical Corp. is recalling specific lots of Venlafaxine extended release tablets because they failed to meet dissolution specifications at 18 months.

    Product
    Venlafaxine (Venlafaxine Hydrochloride) extended release Tablets, 225 mg, packaged in a) 30- count bottle (NDC 0131-3268-32) and b) 90-count bottle (NDC: 0131-3268-46), Rx only, Manufactured by: Kremers Urban Pharmaceuticals Inc. For: Osmotica Pharmaceutical Corp., Wilmington, NC
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-917-2013·2013-09-04

    Actavis Recalls Bupropion Hydrochloride Extended-Release Tablets for Dissolution Failures

    Actavis South Atlantic LLC is recalling specific lots of Bupropion Hydrochloride Extended-Release Tablets (XL) 300 mg because they failed to meet dissolution specifications.

    Product
    buPROPion Hydrochloride Extended-Release Tablets (XL), 300 mg, 30-count tablets per bottle, Rx only, Distributed by: Actavis South Atlantic, LLC, Sunrise, FL 33325; Packaged by: American Health Packaging, Columbus, OH 43217, NDC 67767-142-30, UPC 3 67767-142-30 6.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-847-2013·2013-08-14

    Teva Recalls Methylphenidate Hydrochloride Capsules for Dissolution Failures

    Teva Pharmaceuticals is recalling 16,293 bottles of Methylphenidate Hydrochloride Extended-Release Capsules because routine stability testing revealed out-of-specification dissolution results.

    Product
    METHYLPHENIDATE HYDROCHLORIDE — METHYLPHENIDATE HYDROCHLORIDE (METHYLPHENIDATE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-848-2013·2013-08-14

    Teva Recalls Methylphenidate Hydrochloride Capsules Due to Dissolution Failures

    Teva Pharmaceuticals is recalling 13,478 bottles of Methylphenidate Hydrochloride Extended-Release Capsules because routine stability testing revealed out-of-specification dissolution results.

    Product
    METHYLPHENIDATE HYDROCHLORIDE — METHYLPHENIDATE HYDROCHLORIDE (METHYLPHENIDATE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-849-2013·2013-08-14

    Teva Recalls Methylphenidate Hydrochloride Extended-Release Capsules Due to Dissolution Failure

    Teva Pharmaceuticals is recalling 7,579 bottles of Methylphenidate Hydrochloride Extended-Release Capsules because routine stability testing revealed out-of-specification dissolution results.

    Product
    METHYLPHENIDATE HYDROCHLORIDE — METHYLPHENIDATE HYDROCHLORIDE (METHYLPHENIDATE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-802-2013·2013-07-24

    Quetiapine Fumarate Tablets Recalled for Failed Dissolution Test

    American Health Packaging is recalling Quetiapine Fumarate 25mg tablets because they failed a dissolution test during stability studies.

    Product
    QUETIAPINE Fumarate Tablets 25mg 100 Tablets (10x10) Blister card, Rx, Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC 68084-530-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-631-2013·2013-07-10

    Pfizer Recalls Prempro Tablets Due to Dissolution Specification Failures

    Pfizer is recalling specific lots of Prempro tablets because they may not meet dissolution specifications for conjugated estrogens.

    Product
    Prempro (Conjugated Estrogen/Medroxyprogesterone Acetate) tablets 0.625 mg/5.0 mg, 1 blister card containing 28 tablets, Rx only, Wyeth Pharmaceuticals Inc., Philadelphia, PA 1910, NDC 0046-0975-11
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-606-2013·2013-06-26

    Teva Recalls Actiq Fentanyl Lozenges Due to Dissolution Failure

    Teva Pharmaceuticals is recalling 316 cartons of Actiq 200 mcg fentanyl lozenges because they failed dissolution specifications during stability testing.

    Product
    Actiq (oral transmucosal fentanyl citrate) 200 mcg, lozenge on a stick, a)Single Blister (NDC 63459-502-01), b) 30 count carton (NDC 63459-502-30), Rx only, Manufactured by: Cephalon, Inc., Salt Lake City, UT 84116
    Category
    Drug
    Distribution
    7 states
  • LowFDA (Drugs)·D-248-2013·2013-04-24

    Actavis Recalls BuPROPion Hydrochloride Extended-Release Tablets Due to Dissolution Failure

    Actavis South Atlantic LLC is recalling 555,672 bottles of buPROPion Hydrochloride Extended-Release Tablets (XL) 300 mg because they failed USP dissolution test requirements.

    Product
    buPROPion Hydrochloride Extended-Release Tablets (XL) 300 mg, 30-count tablets per bottle, Rx only, Distributed by: Actavis South Atlantic LLC, Sunrise, FL 33325; Packaged by: American Health Packaging, Columbus, OH 43217; NDC 67767-142-30.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-190-2013·2013-03-13

    Actavis Recalls Amphetamine Extended-Release Capsules for Dissolution Failure

    Actavis Elizabeth LLC is recalling 9,264 bottles of amphetamine extended-release capsules because the product failed to meet dissolution specifications.

    Product
    DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, AMPHETAMINE SULFATE — DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, AMPHETAMINE SULFATE (DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, AMPHETAMINE SULFATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-173-2013·2013-03-06

    Amedra Recalls Dextroamphetamine Sulfate Capsules for Dissolution Failures

    Amedra Pharmaceuticals is recalling 10,968 bottles of Dextroamphetamine Sulfate Extended Release Capsules because they may not meet dissolution specifications over the product shelf life.

    Product
    Dextroamphetamine Sulfate Extended Release Capsules, 5 mg, 90 capsules, Rx only, Manufactured by Catalent Pharma Solutions for CorePharma, LLC Middlesex, NJ 08846 NDC 64720-329-09
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-172-2013·2013-03-06

    Amedra Recalls Dextroamphetamine Sulfate Capsules for Dissolution Failures

    Amedra Pharmaceuticals is recalling 12,948 bottles of Dextroamphetamine Sulfate Extended Release Capsules because they may not meet dissolution specifications over their shelf life.

    Product
    Dextroamphetamine Sulfate Extended Release Capsules, 5 mg, 90 capsules, Rx only, Manufactured by Catalent Pharma Solutions for CorePharma, LLC Middlesex, NJ 08846 NDC 64720-328-09
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-171-2013·2013-03-06

    Amedra Recalls Dextroamphetamine Sulfate Capsules for Dissolution Failures

    Amedra Pharmaceuticals is recalling 1,176 bottles of Dextroamphetamine Sulfate Extended Release Capsules because they may not meet dissolution specifications.

    Product
    Dextroamphetamine Sulfate Extended Release Capsules, 5 mg, 90 capsules, Rx only, Manufactured by Catalent Pharma Solutions for CorePharma, LLC Middlesex, NJ 08846 NDC 64720-327-09
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-160-2013·2013-02-20

    Upsher Smith Recalls Propranolol Hydrochloride Capsules for Dissolution Failure

    Upsher Smith Laboratories is recalling 60 bottles of Propranolol Hydrochloride Extended-release Capsules, 80 mg, due to failed dissolution test requirements.

    Product
    Propranolol Hydrochloride Extended-release Capsules, USP, 80 mg, 100 Capsules, Rx only, Manufactured for Upsher Smith Laboratories, Inc Minneapolis MN 55447 --- NDC 0245-0085-11, UPC 3 0245-0085-11 9
    Category
    Drug
    Distribution
    2 states
  • ModerateFDA (Drugs)·D-145-2013·2013-02-13

    Watson Pharmaceuticals Recalls Taztia XT Due to Dissolution Failure

    Watson Pharmaceuticals is recalling Taztia XT (diltiazem HCI) capsules because stability testing revealed a failed dissolution specification.

    Product
    Taztia XT(diltiazem HCI extended release capsules, USP, Once-A-Day Dosage, 360 mg, 90 Capsules per bottle, Rx only, Manufactured by: Watson Laboratories, Inc., Corona, CA 92880, Distributed by: Watson Pharma, NDC 62037-700-90.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-007-2013·2012-10-17

    Paddock Recalls Moexipril HCl Tablets Due to Dissolution Failure

    Paddock Laboratories is recalling one lot of Moexipril HCl Tablets 7.5mg due to a dissolution failure found during routine stability testing.

    Product
    Moexipril HCl Tablets 7.5mg, 100 tabs, Rx Only, Paddock Laboratories, Inc., Minneapolis, MN 55427, NDC 0574-0110-01 ,
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-001-2013·2012-10-10

    McKesson Recalls bupropion Hydrochloride Extended-Release Tablets Due to Dissolution Failure

    McKesson Packaging Services is recalling 187 cartons of bupropion Hydrochloride Extended-Release Tablets, 150 mg, because they failed USP dissolution test requirements.

    Product
    buPROPion Hydrochloride Extended-Release Tablets (XL), 150 mg, UD 100 Tablets (10 x 10) per carton, Rx only, Mfg By: CMIC-VPS Corporation, Cranbury, New Jersey 08512; blister barcode N (01)003 63739 449 10 7, Dist By: McKesson Packaging, Concord, NC 28027; NDC 63739-449-10, car
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-002-2013·2012-10-10

    McKesson Recalls bupropion Hydrochloride Extended-Release Tablets for Dissolution Failures

    McKesson Packaging Services is recalling bupropion hydrochloride extended-release tablets because they failed USP dissolution test requirements.

    Product
    buPROPion Hydrochloride Extended-Release Tablets (XL), 300 mg, UD 100 Tablets (10 x 10) per carton, Rx only, Mfg By: CMIC-VPS Corporation, Cranbury, New Jersey 08512; blister barcode N (01)003 63739 450 10 3, Dist By: McKesson Packaging, Concord, NC 28027; NDC 63739-450-10, car
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1398-2012·2012-07-04

    Shionogi Recalls Nisoldipine Extended Release Tablets for Dissolution Failure

    Shionogi Inc. is recalling Nisoldipine Extended Release Tablets, 17mg, because a specific lot failed USP dissolution testing requirements.

    Product
    Nisoldipine Extended Release Tablets, 17mg, 100 count bottle, Rx only, Manufactured for: Prasco Laboratories Mason OH 45040, Manufactured by SkyePharma production SAS 38297, Saint Quentin-Pallavier, France, NDC: 0677-1979-01
    Category
    Drug
    Distribution
    1 state