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.

201–225 of 270

  • ModerateFDA (Drugs)·D-0810-2016·2016-04-13

    Purdue Pharma Recalls Intermezzo Tablets for Dissolution Failures

    Purdue Pharma is recalling Intermezzo (zolpidem tartrate) sublingual tablets because they failed to meet dissolution specifications.

    Product
    Intermezzo (zolpidem tartrate) sublingual tablet 1.75 mg, CIV, 30 Ct Cartons, Rx Only. Dist by Purdue Pharma L.P., Stamford, CT 06901-3431. NDC: 59011-256-30.
    Category
    Drug
    Distribution
    8 states
  • ModerateFDA (Drugs)·D-0610-2016·2016-02-03

    Amerisource Recalls Levofloxacin Tablets Due to Dissolution Failures

    Amerisource Health Services is recalling 3,888 cartons of Levofloxacin 500 mg tablets because they failed dissolution specifications.

    Product
    Levofloxacin Tablets USP, 500 mg, packaged in 100-count (10 x 10) blister cards per carton, individual blisters labeled UPC (01) 003 68084 482 11 3, carton labeled NDC 68084-482-01, UPC (01) 0 03 68084 482 01 4; Rx only, Packaged and Distributed by: American Health Packaging, Col
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0520-2016·2015-12-16

    Pfizer Recalls Norpace CR Capsules for Failed Dissolution Specification

    Pfizer is recalling Norpace CR (disopyramide phosphate) capsules because they failed to meet dissolution specifications. The recall covers specific lots distributed nationwide.

    Product
    NORPACE CR — NORPACE CR (DISOPYRAMIDE PHOSPHATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0014-2016·2015-10-21

    Actavis Recalls Metformin Hydrochloride Extended-Release Tablets for Dissolution Failure

    Actavis is recalling 13,284 bottles of Metformin Hydrochloride Extended-Release Tablets, 1000 mg, because they failed dissolution specifications at the 8-hour timepoint.

    Product
    Metformin Hydrochloride Extended-Release Tablets, 1000 mg, 60-count bottle, Rx only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314 USA; Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054 USA; NDC 0591-2720-60; UPC 3 05912 72060 3.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D1834-2015·2015-10-07

    Apotex Recalls Verapamil Hydrochloride Extended-Release Tablets for Dissolution Failure

    Apotex Inc. is recalling 2,075 bottles of Verapamil Hydrochloride Extended-Release tablets, 240 mg, because one lot failed to meet dissolution specification limits.

    Product
    Verapamil Hydrochloride Extended-Release tablets, USP, 240 mg, 500-count bottles, Rx Only, Apotex Corp. Manufactured by Apotex Research Private Limited, Bangalore, Karnataka 560 099, India; Manufactured for: Apotex Corp., Weston, FL 33326. NDC 60505-2742-5.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1430-2015·2015-09-23

    Novartis Recalls Dexmethylphenidate HCl Extended-Release Capsules for Dissolution Failure

    Novartis Pharmaceuticals Corp. is recalling 10,767 bottles of Dexmethylphenidate HCl Extended-Release capsules because stability testing showed the product failed to meet dissolution specifications.

    Product
    Dexmethylphenidate HCl Extended-Release, Capsules, 10mg, Rx only, 100 Capsules. Manufactured by Alkermes Gainesville LLC Gainesville, GA 30504 for Sandoz Inc. Princeton, NJ 08540
    Category
    Drug
    Distribution
    0 states
  • LowFDA (Drugs)·D-1345-2015·2015-08-26

    Sun Pharma Recalls Bupropion Hydrochloride Tablets for Dissolution Failure

    Sun Pharma Global Fze is recalling 35,235 bottles of Bupropion Hydrochloride Extended-Release Tablets because they failed to meet drug release specifications during stability testing.

    Product
    BUPROPION HYDROCHLORIDE — BUPROPION HYDROCHLORIDE (BUPROPION HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1287-2015·2015-08-12

    GlaxoSmithKline Recalls Panadol Acetaminophen Extra Strength for Dissolution Failures

    GlaxoSmithKline is recalling Panadol Extra Strength acetaminophen bottles in Puerto Rico and the Virgin Islands because the product failed dissolution specifications.

    Product
    Panadol (acetaminophen) Extra Strength, 500 mg, a) 30 count (UPC 1-03-53100-91070-8, NDC 0135-0135-02), b) 60 count (UPC 1-03-53100-91080-7, NDC 0135-0135-03) and c) 100 count (UPC 1-03-53100-91090-6, NDC 0135-0135-04) bottles, Distributed by: GlaxoSmithKline Consumer Healthcare
    Category
    Drug
    Distribution
    2 states
  • ModerateFDA (Drugs)·D-1217-2015·2015-07-15

    Mylan Recalls Capecitabine Tablets Due to Dissolution Failures

    Mylan Pharmaceuticals is recalling 1,068 bottles of Capecitabine Tablets, 500 mg, because the product failed to meet dissolution specifications.

    Product
    Capecitabine Tablets, USP, 500 mg, 120-count bottle, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505, NDC 0378-2512-78, UPC 3 0378-2512-78 6.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D1151-2015·2015-07-08

    Qualitest Recalls Disulfiram Tablets Due to Dissolution Failure

    Qualitest Pharmaceuticals is recalling 2,016 bottles of Disulfiram tablets because one lot failed routine stability testing for dissolution specifications.

    Product
    Disulfiram tablets, USP, 500 mg, 100-count bottles, Rx only, Manufactured for and by Qualitest Pharmaceuticals 130 Vintage Drive Huntsville, AL 35811. NDC 0603-3432-21.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1135-2015·2015-06-24

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

    Dr. Reddy's Laboratories is recalling Divalproex Sodium Extended-Release Tablets because they failed to meet dissolution specifications at the 9-hour time point.

    Product
    DIVALPROEX SODIUM — DIVALPROEX SODIUM (DIVALPROEX SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1136-2015·2015-06-24

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

    Dr. Reddy's Laboratories is recalling 5,160 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
  • ModerateFDA (Drugs)·D-1140-2015·2015-06-24

    American Health Packaging Recalls Lamivudine and Zidovudine Tablets for Dissolution Failure

    American Health Packaging is recalling 925 cartons of Lamivudine and Zidovudine Tablets USP 150mg/300mg because they failed dissolution specifications.

    Product
    Lamivudine and Zidovudine Tablets USP 150mg/300mg 30 Unit Dose Blisters, Rx Only, Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217, Carton of 30: NDC 68084-0416-21, Individual dose: NDC 68084-0416-11
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1116-2015·2015-06-17

    Valeant Recalls Nifedipine Extended-Release Tablets Due to Dissolution Failures

    Valeant Pharmaceuticals is recalling Nifedipine Extended-Release Tablets, 90 mg, because some lots failed dissolution specifications.

    Product
    Nifedipine Extended-Release Tablets, USP, 90 mg, 100 Tablet Bottles, Rx Only. Manufactured for: Teva Pharmaceuticals USA Sailorsville, PA 13960. Manufactured in Canada By: Valeant Pharmaceuticals International, Inc. Steinbach, MB R5G 127 Canada. NDC: 0093-2059-01.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1111-2015·2015-06-10

    Mylan Recalls Mycophenolic Acid Tablets for Dissolution Failures

    Mylan Pharmaceuticals is recalling 7,722 bottles of Mycophenolic Acid Delayed-release Tablets, 180 mg, because they failed to meet dissolution specifications.

    Product
    Mycophenolic Acid Delayed-release Tablets, 180 mg, 120-count bottle, Rx only, Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A., NDC 0378-4201-78, UPC 3 0378-4201-78 7.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0997-2015·2015-05-20

    Akorn Recalls Sulfamethoxazole and Trimethoprim Oral Suspension for Dissolution Failure

    Akorn, Inc. is recalling 8,400 cups of Sulfamethoxazole and Trimethoprim oral suspension because the sulfamethoxazole failed to meet dissolution specifications.

    Product
    SULFAMETHOXAZOLE AND TRIMETHOPRIM ORAL SUSPENSION, USP 800 mg/ 160 mg per 5mL, GRAPE FLAVOR, 20 mL unit dose cup (NDC 50383-0824-20), Rx only, HI-TECH PHARMACAL CO. INC, Amityville, NY 11701
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0996-2015·2015-05-20

    Akorn Recalls Sulfamethoxazole and Trimethoprim Oral Suspension for Dissolution Failure

    Akorn, Inc. is recalling specific lots of Sulfamethoxazole and Trimethoprim Oral Suspension because the sulfamethoxazole component failed to meet dissolution specifications.

    Product
    SULFAMETHOXAZOLE AND TRIMETHOPRIM ORAL SUSPENSION, USP,200 mg/ 40 mg per 5mL, GRAPE FLAVOR, 16 fl oz (473 mL) bottles (NDC 50383-0824-16), Rx only, HI-TECH PHARMACAL CO. INC, Amityville, NY 11701
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1082-2015·2015-05-20

    Alvogen Recalls Nitrofurantoin Capsules Due to Failed Dissolution Test

    Alvogen, Inc. is recalling Nitrofurantoin Monohydrate/Macrocrystalline capsules because they failed a dissolution specification test.

    Product
    NITROFURANTOIN MONOHYDRATE/ MACROCRYSTALLINE — NITROFURANTOIN MONOHYDRATE/ MACROCRYSTALLINE (NITROFURANTOIN MONOHYDRATE/MACROCRYSTALLINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0995-2015·2015-05-20

    Akorn Recalls Sulfamethoxazole and Trimethoprim Oral Suspension for Dissolution Failure

    Akorn, Inc. is recalling specific lots of Sulfamethoxazole and Trimethoprim Oral Suspension because the sulfamethoxazole failed to meet dissolution specifications.

    Product
    SULFAMETHOXAZOLE AND TRIMETHOPRIM ORAL SUSPENSION, USP,200 mg/ 40 mg per 5mL, CHERRY FLAVOR, 16 fl oz (473 mL) bottles (NDC 50383-0823-16), Rx only, HI-TECH PHARMACAL CO. INC, Amityville, NY 11701
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0395-2015·2015-03-11

    Actavis Recalls Dextroamphetamine Sulfate Capsules for Dissolution Failures

    Actavis Elizabeth LLC is recalling 42 bottles of Dextroamphetamine Sulfate Extended-Release Capsules, 15 mg, because they failed dissolution specifications.

    Product
    DEXTROAMPHETAMINE SULFATE — DEXTROAMPHETAMINE SULFATE (DEXTROAMPHETAMINE SULFATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0386-2015·2015-02-18

    Sun Pharma Recalls Levetiracetam Extended Release Tablets for Dissolution Failure

    Sun Pharma Global Fze is recalling 3,263 bottles of Levetiracetam extended release tablets because they failed to meet dissolution specifications at the 6-month time point.

    Product
    Levetiracetam, extended release tablets, 750 mg, 60-count bottle, Rx only, Manufactured by Sun Pharmaceutical Ind. Ltd Halol-Baroda Highway, Halol-389 350, Gujarat, India, NDC Number: 47335-576-86
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0304-2015·2014-12-24

    Wockhardt Recalls Metoprolol Succinate Tablets for Dissolution Failure

    Wockhardt USA is recalling specific lots of Metoprolol Succinate Extended-Release Tablets because they failed long-term stability testing for dissolution specifications.

    Product
    Wockhardt Metoprolol Succinate, Extended-Release Tablets USP, 50 mg, a)100-count HDPE bottle (NDC 64679-735-02), b) 4000-count pack (64679-735-08), Manufactured by: Wockhardt Limited, Mumbai, India Distributed by Wockhardt USA LLC. 20 Waterview Blvd. Parsippany, NJ 07054 USA
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0236-2015·2014-11-12

    Sun Pharma Recalls Venlafaxine Hydrochloride Extended-Release Tablets for Dissolution Failures

    Sun Pharma Global Inc. is recalling specific batches of Venlafaxine Hydrochloride Extended-Release Tablets because they failed dissolution specifications and a 12-month stability time point.

    Product
    Venlafaxine Hydrochloride Extended-Release Tablets, 37.5 mg, 30-count bottles and 90-count bottles, RX only, Manufactured for Sun Pharma Global Inc. Dubai, United Arab Emirates by Sun Pharmaceutical Industries Limited, Halol, India
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0036-2015·2014-10-29

    Forest Pharmaceuticals Recalls Bystolic Tablets for Dissolution Failure

    Forest Pharmaceuticals is recalling Bystolic (nebivolol) 20 mg tablets because they failed a dissolution specification at a 6-month stability time point.

    Product
    Bystolic (nebivolol) tablets, 20 mg/tablet, packaged as 7 tablets/bottle/carton, and 12 bottles/trays, Professional Sample, Rx only, Forest Pharmaceuticals, Inc., St. Louis, MO. --- NDC 0456-1420-07
    Category
    Drug
    Distribution
    Distributed nationwide