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.

101–125 of 270

  • ModerateFDA (Drugs)·D-0148-2021·2020-12-23

    Biogen Recalls Vumerity Capsules Due to Dissolution Test Failures

    Biogen is recalling 5,307 bottles of Vumerity capsules because they failed dissolution testing. The medication may not release the drug as intended.

    Product
    VUMERITY — VUMERITY (DIROXIMEL FUMARATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0112-2021·2020-12-09

    Golden State Medical Supply Recalls Aripiprazole Tablets for Dissolution Concerns

    Golden State Medical Supply is recalling Aripiprazole 15 mg tablets due to potential out-of-specification dissolution limits.

    Product
    ARIPIPRAZOLE TABLETS, 15 mg, 30-count. bottles, Rx Only, GSMS Incorporated, Manufactured by: Apotex Inc. Toronto, Ontario, Canada, Packaged by GSMS, Incorporated, Camarillo, CA 93012 USA, NDC #60429-449-30
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0114-2021·2020-12-09

    Harvard Drug Group Recalls Aripiprazole Tablets for Dissolution Failure

    The Harvard Drug Group is recalling 841 cartons of Aripiprazole Tablets, 15 mg, because the product failed to meet dissolution specifications.

    Product
    Aripiprazole Tablets, USP, 15 mg, 30 tablets per unit dose carton, Rx Only, Manufactured by: Apotex, Inc, Toronto, Ontario Canada M9L 1T9, Distributed by: Major Pharmaceuticals, 17177 N. Laurel Park Dr., Suite 233, Livonia, MI 48152 USA, NDC 0904-6512-04
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0106-2021·2020-11-25

    Apotex Recalls Aripiprazole Tablets Due to Dissolution Failures

    Apotex Corp. is recalling Aripiprazole Tablets 15 mg because they failed to meet dissolution specifications. The affected products were distributed nationwide in the USA.

    Product
    Aripiprazole Tablets, USP 15 mg tablets, packaged in a) 1000 count bottle, NDC 60505-2675-8; b) 30 count bottle, NDC 60505-2675-3; Rx Only, Manufactured by: Apotex Inc. Toronto, Ontario Canada M9L 1T9 Manufactured for: Apotex Corp. Weston, Florida 33326
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0069-2021·2020-11-18

    Teva Recalls Mesalamine Tablets Due to Failed Dissolution Testing

    Teva Pharmaceuticals is recalling 133,829 bottles of Mesalamine Delayed-Release Tablets because stability testing revealed out-of-specification dissolution results.

    Product
    MESALAMINE — MESALAMINE (MESALAMINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1387-2020·2020-07-22

    RemedyRepack Recalls Carbamazepine 200 mg Tablets Due to Dissolution Failure

    RemedyRepack Inc. is recalling Carbamazepine 200 mg tablets because routine stability testing revealed low dissolution results.

    Product
    Carbamazepine 200 mg Tablets, 100-unit dose tablets per box, Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC 70518-2489-00 for box; 70518-2489-01 per unit dose.
    Category
    Drug
    Distribution
    1 state
  • LowFDA (Drugs)·D-1342-2020·2020-07-01

    Pfizer Recalls Duavee Tablets Due to Failed Dissolution Specifications

    Pfizer is recalling Duavee tablets because they failed to meet dissolution specifications. The recall covers 544,400 packages distributed nationwide.

    Product
    Duavee (conjugated estrogens/bazedoxifene) tablets 0.45/20 mg, packaged in 2 blister cards containing 15 tablets each (30 tablets), Rx Only, Distributed by Wyeth Pharmaceuticals LLC A subsidiary of Pfizer In Philadelphia, PA 19101 Made in Ireland, NDC 00008-1123-12
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1274-2020·2020-06-03

    West-Ward Recalls Doxycycline Hyclate Tablets Due to Dissolution Failure

    West-Ward Columbus Inc. is recalling Doxycycline Hyclate 100 mg tablets because they failed a dissolution test at the end of their shelf life.

    Product
    DOXYCYCLINE HYCLATE — DOXYCYCLINE HYCLATE (DOXYCYCLINE HYCLATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1262-2020·2020-05-20

    Memantine Hydrochloride Extended-Release Capsules Recalled for Dissolution Failures

    The Harvard Drug Group is recalling 678 cartons of Memantine Hydrochloride Extended-Release Capsules due to low stage 3 dissolution results found during routine stability testing.

    Product
    MEMANTINE HYDROCHLORIDE — MEMANTINE HYDROCHLORIDE (MEMANTINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    6 states
  • ModerateFDA (Drugs)·D-0862-2020·2020-03-11

    Teva Recalls Mesalamine Tablets Due to Dissolution Test Failures

    Teva Pharmaceuticals USA is recalling 3,695 bottles of Mesalamine Delayed-Release Tablets because stability testing showed low dissolution results.

    Product
    MESALAMINE — MESALAMINE (MESALAMINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0855-2020·2020-02-19

    Lupin Recalls Memantine Hydrochloride Capsules for Dissolution Failure

    Lupin Pharmaceuticals is recalling 6,294 bottles of Memantine Hydrochloride Extended Release Capsules because they failed to meet dissolution specifications during stability testing.

    Product
    MEMANTINE HYDROCHLORIDE — MEMANTINE HYDROCHLORIDE (MEMANTINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0827-2020·2020-02-12

    Ascend Recalls Minocycline Hydrochloride Tablets for Dissolution Failures

    Ascend Laboratories is recalling Minocycline Hydrochloride Extended-Release Tablets due to low dissolution test results.

    Product
    MINOCYCLINE HYDROCHLORIDE — MINOCYCLINE HYDROCHLORIDE (MINOCYCLINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0823-2020·2020-02-05

    Macleods Pharma Recalls Montelukast Sodium Chewable Tablets for Dissolution Failure

    Macleods Pharma USA is recalling 10,680 bottles of Montelukast Sodium Chewable Tablets, 5 mg, because testing revealed low out-of-specification dissolution results in one lot.

    Product
    MONTELUKAST SODIUM — MONTELUKAST SODIUM (MONTELUKAST SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0629-2020·2019-12-25

    Lupin Recalls Memantine Hydrochloride Capsules Due to Dissolution Failure

    Lupin Pharmaceuticals is recalling 3,726 bottles of Memantine Hydrochloride Extended-release Capsules because stability studies showed high out-of-specification dissolution results.

    Product
    MEMANTINE HYDROCHLORIDE — MEMANTINE HYDROCHLORIDE (MEMANTINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0120-2020·2019-10-02

    EPI Health Recalls Minolira Tablets for Dissolution Failures

    EPI Health is recalling 1,626 bottles of Minolira extended-release tablets because they failed dissolution specifications. The recall is limited to EPI field representatives.

    Product
    minolira (minocycline hydrochloride) extended-release tablets 135 mg* Physician Sample Not for Sale 5 Tablets, Rx Only, Mfg by: Dr. Reddy's Laboratories Limited, FTO-SEZ, Process Unit-01 Devunipalavalasa Village Srikakulam (District) Andhra Pradesh, INDIA. Manufactured for: EPI
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-1837-2019·2019-08-07

    Jubilant Cadista Recalls Drospirenone and Ethinyl Estradiol Tablets for Dissolution Failure

    Jubilant Cadista Pharmaceuticals is recalling specific lots of Drospirenone and Ethinyl Estradiol Tablets because they failed dissolution specifications during stability testing.

    Product
    Drospirenone and Ethinyl Estradiol Tablets, USP, 3 mg/0.02 mg, packaged into a carton containing 3 blister cards each blister card contains 28-film coated, biconvex tablets, Rx Only, Manufactured by: Cyndea Pharma, S.L., Olvega (Soria), 42110 Spain, Distributed by: Jubilant Cadis
    Category
    Drug
    Distribution
    Distributed nationwide