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.

151–175 of 270

  • ModerateFDA (Drugs)·D-0633-2018·2018-04-25

    AvKARE Recalls Amantadine HCl Capsules for Dissolution Failure

    AvKARE Inc. is recalling 2,135 cartons of Amantadine HCl Capsules, 100 mg, because the product failed dissolution specifications.

    Product
    AMANTADINE HCL — AMANTADINE HCL (AMANTADINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0619-2018·2018-04-11

    InvaGen Recalls Bupropion Hydrochloride Tablets for Dissolution Failures

    InvaGen Pharmaceuticals is recalling specific lots of Bupropion Hydrochloride Extended-Release Tablets because they failed dissolution specifications during stability testing.

    Product
    BUPROPION HYDROCHLORIDE (SR) — BUPROPION HYDROCHLORIDE (SR) (BUPROPION HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0222-2018·2018-01-24

    AvKARE Recalls Lovastatin Tablets Due to Dissolution Failures

    AvKARE Inc. is recalling 237 cartons of Lovastatin Tablets USP, 40 mg, because annual stability testing revealed low dissolution results.

    Product
    Lovastatin Tablets USP, 40 mg, 50 Tablets (5x10) Unit Dose carton, Rx only, Manufactured for AvKARE, Inc. Pulaski, TN 38478, NDC 50268-512-15.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0098-2018·2017-12-06

    Mayne Pharma Recalls Liothyronine Sodium Tablets for Dissolution Failures

    Mayne Pharma Inc is recalling 11,364 bottles of Liothyronine Sodium Tablets 25 mcg because they failed dissolution specifications. The affected lot is distributed nationwide.

    Product
    Liothyronine Sodium Tablets, USP 25 mcg ,100-count bottles, Rx Only, Distributed by Perrigo Minneapolis, MN 55427, NDC 0574-0222-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0069-2018·2017-11-08

    Teva Recalls Dutasteride and Tamsulosin HCl Capsules for Dissolution Failures

    Teva Pharmaceuticals is recalling specific lots of Dutasteride and Tamsulosin HCl capsules because they failed dissolution specifications.

    Product
    Dutasteride and Tamsulosin HCl Capsules, 0.5 mg/ 0.4 mg, packaged in a) 30-count bottle (NDC 0591-3771-30), b) 90-count bottle (NDC 0591-3771-19), Rx only, Manufactured by: Actavis Laboratories FL, Inc. Fort Lauderdale, FL 33314 USA; Distributed by: Actavis Pharma, Inc. Parsippan
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0052-2018·2017-11-01

    Teva Recalls Methylphenidate Hydrochloride Tablets Due to Dissolution Failures

    Teva Pharmaceuticals USA is recalling 58,292 bottles of Methylphenidate Hydrochloride Tablets USP, 20 mg, because they failed to meet dissolution specifications.

    Product
    Methylphenidate Hydrochloride Tablets USP, 20 mg, 100-count bottles, Rx only, Manufactured by: Watson Laboratories, Inc., Corona, CA 92880 USA, NDC 0591-5884-01.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1163-2017·2017-09-27

    Pfizer Recalls Quillivant XR Methylphenidate Suspension for Dissolution Failures

    Pfizer is recalling 14,712 bottles of Quillivant XR methylphenidate extended-release oral suspension because the product failed dissolution specifications.

    Product
    Quillivant XR methylphenidate HCl, for extended-release oral suspension, 600 mg/120 mL total volume (When constituted with 105 mL of water, 25 mg/5 mL (5 mg/mL) when reconstituted, Rx Only, Distributed by Nextwave Pharmaceuticals, Inc. A subsidiary of Pfizer Inc., New York, NY
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1164-2017·2017-09-27

    Pfizer Recalls Quillivant XR Methylphenidate Suspension Due to Dissolution Failure

    Pfizer is recalling 11,790 bottles of Quillivant XR methylphenidate extended-release oral suspension because the product failed dissolution specifications.

    Product
    Quillivant XR methylphenidate HCl, for extended-release oral suspension, 750mg/150 mL total volume (When constituted with 131 mL of water, 25 mg/5 mL (5 mg/mL) when reconstituted, Rx Only, Distributed by Nextwave Pharmaceuticals, Inc. A subsidiary of Pfizer Inc., New York, NY 1
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0981-2017·2017-07-26

    Shionogi Recalls Mefenamic Acid Capsules for Dissolution Failures

    Shionogi Inc. is recalling Mefenamic Acid 250mg capsules because stability testing showed low dissolution results.

    Product
    Mefenamic Acid, 250mg capsules, packaged in 30-count bottles, Rx Only, Distributed by: Prasco Laboratories Mason, OH 45040 USA, Manufactured by: Halo Pharmaceutical Inc. Whippany, NJ 07981, NDC 66993-070-30
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0960-2017·2017-07-19

    Teva Recalls Paliperidone Extended-Release Tablets Due to Dissolution Failure

    Teva Pharmaceuticals is recalling 360 bottles of Paliperidone Extended-Release Tablets because one tablet failed a routine stability test for drug release.

    Product
    Paliperidone Extended-Release Tablets, 3 mg, 90 count bottles, Rx only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314 USA Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054, USA, NDC: 0591-3693-19
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0883-2017·2017-06-14

    Dr. Reddy's Recalls Zenatane Isotretinoin Capsules for Dissolution Failures

    Dr. Reddy's Laboratories is recalling Zenatane (isotretinoin) capsules because some lots failed to meet dissolution specifications, potentially affecting drug absorption.

    Product
    ZENATANE — ZENATANE (ISOTRETINOIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0885-2017·2017-06-14

    Dr. Reddy's Recalls Zenatane Isotretinoin Capsules for Dissolution Failures

    Dr. Reddy's Laboratories is recalling Zenatane (isotretinoin) capsules because some lots failed to meet dissolution specifications, potentially affecting drug absorption.

    Product
    ZENATANE — ZENATANE (ISOTRETINOIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0886-2017·2017-06-14

    Dr. Reddy's Recalls Zenatane Capsules for Low Dissolution

    Dr. Reddy's Laboratories is recalling Zenatane (isotretinoin) capsules because some lots failed to meet dissolution specifications.

    Product
    ZENATANE — ZENATANE (ISOTRETINOIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0706-2017·2017-05-31

    Mylan Recalls Alprazolam Extended-Release Tablets for Dissolution Failures

    Mylan Pharmaceuticals is recalling specific lots of Alprazolam Extended-Release Tablets because they failed to meet dissolution specifications.

    Product
    Alprazolam Extended-release Tablets, USP, 1 mg, 60-count bottle, Rx Only, Manufactured and Distributed by: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A., NDC 0378-5022-91
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0689-2017·2017-05-10

    Fluconazole Tablets Recalled for Failed Dissolution Specifications

    The Harvard Drug Group is recalling 914 cartons of Fluconazole 200 mg tablets because they failed to meet required dissolution specifications.

    Product
    FLUCONAZOLE — FLUCONAZOLE (FLUCONAZOLE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0696-2017·2017-05-10

    Akorn Recalls Sulfamethoxazole and Trimethoprim Oral Suspension for Dissolution Failures

    Akorn Inc is recalling 55,968 bottles of Sulfamethoxazole and Trimethoprim Oral Suspension because the product failed to meet dissolution specifications.

    Product
    Sulfamethoxazole and Trimethoprim Oral Suspension, USP 200 mg / 40 mg per 5 mL , Grape Flavor, Rx Only, 16 fl oz. (473 mL), HI-TECH PHARMACAL CO., INIC, Amityville, NY 11701, NDC 50383-824-16
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0607-2017·2017-03-29

    Pfizer Recalls Quillivant XR Methylphenidate Suspension for Dissolution Failure

    Pfizer is recalling Quillivant XR extended-release oral suspension because it failed to meet dissolution specifications at 12 months. The recall affects 28,938 units distributed nationwide.

    Product
    Quillivant XR (methylphenidate HCl) for extended-release oral suspension, 300 mg/60 mL (25mg/5mL), Rx Only, Distributed by: NextWave Pharmaceuticals, Inc. A subsidiary of Pfizer Inc, New York, NY 10017 Manufactured by: Tris Pharma, Inc., Monmouth Junction, NJ 08852 (NDC 24478-19
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0609-2017·2017-03-29

    Pfizer Recalls Quillivant XR Methylphenidate Suspension for Dissolution Failure

    Pfizer is recalling specific lots of Quillivant XR extended-release oral suspension because the product failed to meet dissolution specifications at 12 months.

    Product
    Quillivant XR (methylphenidate HCl) for extended-release oral suspension, 900 mg/180 mL (25mg/5mL), Rx Only, Distributed by: NextWave Pharmaceuticals, Inc. A subsidiary of Pfizer Inc, New York, NY 10017 Manufactured by: Tris Pharma, Inc., Monmouth Junction, NJ 08852 (NDC 24478-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0520-2017·2017-03-22

    Amerisource Recalls Glipizide Extended-Release Tablets Due to Dissolution Failure

    Amerisource Health Services is recalling specific lots of Glipizide Extended-Release tablets because they failed to meet dissolution specifications.

    Product
    GlipiZIDE Extended-release tablets, 2.5 mg, 30-count carton (NDC 68084-295-21), Individual dose (NDC 68084-395-11), Rx Only, Packaged and Distributed by American Health Packaging, Columbus, Ohio 43217, NDC 68084-295-21
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0511-2017·2017-03-15

    Teva Recalls Risedronate Sodium Tablets Due to Dissolution Failures

    Teva Pharmaceuticals is recalling Risedronate Sodium Delayed-release Tablets because stability testing revealed low out-of-specification dissolution results.

    Product
    Risedronate Sodium Delayed-release Tablets, 35 mg, Once-a-Week, 1 tablet per blister (NDC 0093-5509-19), packaged in 4 blisters per carton (NDC 0093-5509-44), Rx only, TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0515-2017·2017-03-15

    Sandoz Recalls Pioglitazone and Glimepiride Tablets Due to Dissolution Failure

    Sandoz Inc is recalling specific lots of Pioglitazone and Glimepiride Tablets because they failed to meet dissolution specifications.

    Product
    Pioglitazone and Glimepiride Tablets, USP, 30 mg/4 mg, 30 count bottles, Rx only, Manufactured by Lek Pharmaceuticals d.d., Verovskova Ulica 57, Ljubljana, - SI-1526, Slovenia --- NDC 0781-5635-31
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0508-2017·2017-03-08

    Dr. Reddy's Recalls Zenatane Capsules for Dissolution Failure

    Dr. Reddy's Laboratories is recalling Zenatane (isotretinoin) 30 mg capsules because they failed to meet dissolution specifications.

    Product
    Zenatane (isotretinoin) capsules, 30 mg, packaged in 30-count cartons (3 x 10 blister cards), Rx Only, Manufactured By:Cipla Limited Kurkumbh Village Pune 413802 India, Manufactured For: Dr. Reddy's Laboratories, Bachupally 500 090 India, NDC 5511-113-81
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0507-2017·2017-03-08

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

    Dr. Reddy's Laboratories is recalling specific lots of Zenatane (isotretinoin) 20 mg capsules because they failed to meet dissolution specifications.

    Product
    ZENATANE — ZENATANE (ISOTRETINOIN)
    Category
    Drug
    Distribution
    Distributed nationwide