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.

51–75 of 270

  • HighFDA (Drugs)·D-0536-2023·2023-04-26

    Verapamil Hydrochloride Extended-Release Tablets Recalled for Failed Dissolution Specifications

    Amerisource Health Services LLC is recalling Verapamil Hydrochloride Extended-Release Tablets 180 mg due to failed dissolution specifications affecting lots 1008622 and 1010026 distributed nationwide.

    Product
    Verapamil Hydrochloride Extended-Release Tablets, USP, 180 mg, 100 Tablets (10 x 10) per carton, Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC Carton: 60687-504-01; NDC Unit Dose: 60687-504-11, barcode (01) 003 60687 504 11 7.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0436-2023·2023-03-15

    Verapamil Hydrochloride Tablets Recalled for Failed Dissolution Specification

    Amerisource Health Services LLC is recalling 422 cartons of Verapamil Hydrochloride Extended-Release Tablets, 120 mg due to failed dissolution testing. The tablets did not meet specifications for drug release.

    Product
    Verapamil Hydrochloride Extended-Release Tablets, USP, 120 mg, Rx Only, 100 Tablets per Carton (10 x 10), Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC Carton: 60687-493-01; NDC Unit Dose: 60687-493-11.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0269-2023·2023-02-22

    Metoprolol Succinate ER Tablets Recalled for Failed Dissolution Specifications

    Amerisource Health Services is recalling Metoprolol Succinate Extended-Release Tablets due to failed dissolution specifications that may prevent proper drug release.

    Product
    METOPROLOL SUCCINATE — METOPROLOL SUCCINATE (METOPROLOL SUCCINATE ER TABLETS)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0262-2023·2023-02-08

    Diltiazem Hydrochloride extended-release capsules recalled due to failed quality specifications

    Sun Pharmaceutical is recalling Diltiazem Hydrochloride Extended-Release Capsules (360 mg) due to failed impurity specifications and dissolution testing found during FDA laboratory evaluation. The recall affects five lot numbers distributed nationwide.

    Product
    DILTIAZEM HYDROCHLORIDE — DILTIAZEM HYDROCHLORIDE (DILTIAZEM HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0169-2023·2023-02-01

    Prescription Metoprolol Succinate Extended-Release Tablets Recalled for Failed Dissolution

    Ascend Laboratories recalls 49,632 bottles of Metoprolol Succinate extended-release tablets (25 mg) nationwide and in Puerto Rico due to failure to meet dissolution specifications that could reduce drug effectiveness.

    Product
    METOPROLOL SUCCINATE — METOPROLOL SUCCINATE (METOPROLOL SUCCINATE ER TABLETS)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0171-2023·2023-02-01

    Metoprolol Succinate Extended-Release Tablets Recalled for Failed Dissolution Specification

    Ascend Laboratories is recalling 2,628 bottles of Metoprolol Succinate Extended-Release Tablets (50 mg) nationwide due to failed dissolution specification. The tablets may not dissolve properly, preventing proper medication absorption.

    Product
    METOPROLOL SUCCINATE — METOPROLOL SUCCINATE (METOPROLOL SUCCINATE ER TABLETS)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0170-2023·2023-02-01

    Metoprolol Succinate Tablets Recalled for Failed Dissolution Specification

    Ascend Laboratories is recalling 6,336 bottles of Metoprolol Succinate Extended-Release Tablets, 50 mg, distributed nationwide and in Puerto Rico, due to failed dissolution specification.

    Product
    METOPROLOL SUCCINATE — METOPROLOL SUCCINATE (METOPROLOL SUCCINATE ER TABLETS)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0167-2023·2023-01-25

    SINUVA Sinus Implant Recalled for Failed Drug Release Specification

    Intersect ENT, Inc. is recalling 9,898 pouches of SINUVA sinus implants nationwide after detecting failed drug release specifications during stability testing. The implant may not deliver the medication as intended.

    Product
    SINUVA — SINUVA (MOMETASONE FUROATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0073-2023·2022-12-07

    Allergy Relief D tablets recalled for failed dissolution specifications

    Dr. Reddy's Laboratories is recalling Allergy Relief D extended-release tablets distributed nationwide by Walmart due to failed dissolution specifications. No illnesses or injuries have been reported.

    Product
    Allergy Relief D, Fexofenadine HCL 60mg/Antihistamine, Pseudoephedrine HCL 120mg/Nasal Decongestant, Extended-Release Tablets USP, packaged as (a) 20 count carton NDC 49032-273-20; (b) 30 count carton, NDC49032-273-30; Distributed by: Walmart Inc., Bentonville, AR 72716, Product
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1302-2022·2022-08-10

    Prescription Drug Matzim LA Extended-Release Tablets Recalled for Failed Dissolution

    Teva Pharmaceuticals is recalling Matzim LA (Diltiazem Hydrochloride) 180 mg tablets because they failed to meet dissolution specifications. The recall affects approximately 8,022 bottles distributed nationwide in the United States and Puerto Rico.

    Product
    MATZIM LA — MATZIM LA (DILTIAZEM HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1303-2022·2022-08-10

    Matzim LA Extended-Release Tablets Recalled for Dissolution Specification Failure

    Matzim LA Extended-Release Tablets, 240 mg are being recalled due to failed dissolution specifications. Patients taking this medication should consult their doctor about their treatment.

    Product
    Matzim LA (Diltiazem Hydrochloride) Extended-Release Tablets, 240 mg, 30-count bottles, Rx Only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL USA 33314, USA, Distributed by: Actavis Pharma Inc., Parsippany, NJ 07054 USA; NDC 58544-692-30.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1291-2022·2022-08-03

    FDA Recalls Divalproex Sodium Tablets for Failed Dissolution Specifications

    Sun Pharmaceutical recalls Divalproex Sodium delayed-release tablets due to failed dissolution specifications discovered during stability testing. The tablets may not dissolve as intended.

    Product
    DIVALPROEX SODIUM — DIVALPROEX SODIUM (DIVALPROEX SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1293-2022·2022-08-03

    Irbesartan Blood Pressure Tablets Recalled Due to Failed Dissolution

    Jubilant Cadista is recalling 9,600 bottles of Irbesartan Tablets (150mg) nationwide due to failed dissolution specifications. Affected lot IB220023A expires 08/2022.

    Product
    IRBESARTAN — IRBESARTAN (IRBESARTAN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1287-2022·2022-08-03

    Lansoprazole tablets recalled nationwide due to failed dissolution specifications

    Dr. Reddy's Laboratories is recalling Lansoprazole 15-mg delayed-release tablets nationwide due to failed dissolution specifications. The tablets may not dissolve properly, potentially affecting medication effectiveness.

    Product
    LANSOPRAZOLE — LANSOPRAZOLE (LANSOPRAZOLE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1294-2022·2022-08-03

    Jubilant Cadista Irbesartan tablets recalled due to failed dissolution

    Jubilant Cadista Pharmaceuticals is recalling 28,560 bottles of Irbesartan 75 mg tablets nationwide due to failed dissolution specifications that may compromise drug efficacy.

    Product
    IRBESARTAN — IRBESARTAN (IRBESARTAN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1285-2022·2022-07-27

    Aripiprazole 20mg Tablets Recalled for Failed Dissolution

    Apotex Corp. is recalling 2,010 bottles of Aripiprazole Tablets 20mg nationwide due to failed dissolution specifications. Tablets may not dissolve properly, potentially affecting medication effectiveness.

    Product
    Aripiprazole Tablets, USP 20 mg, packaged in a) 1,000-count bottle (NDC 60505-2676-8, UPC 3 60505 26768 2), b) 30-count bottle (NDC 60505-2676-3, UPC 3 60505 26763 7), Rx only, Manufactured by: Apotex, Inc. Toronto, Ontario Canada M9L 1T9 Manufactured for: Apotex Corp. Weston, F
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1156-2022·2022-06-29

    Tretinoin Capsules Recalled Nationwide for Failed Dissolution Specifications

    Teva Pharmaceuticals is recalling Tretinoin Capsules (10 mg) nationwide due to failed dissolution specifications that may affect medication effectiveness. Patients should contact their pharmacist or doctor to confirm if their prescription is affected.

    Product
    Tretinoin Capsules, 10 mg, Rx Only, 100 capsules per bottle, Teva Pharmaceuticals USA Inc., North Wales, PA, 19454, NDC 0555-0808-02.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1150-2022·2022-06-22

    Zileuton Extended-Release Tablets recalled for failed dissolution specifications

    Lupin Pharmaceuticals is recalling Zileuton Extended-Release Tablets, 600 mg, due to failed dissolution specifications found during stability testing that may affect medication efficacy.

    Product
    Zileuton Extended-Release Tablets, 600 mg, 120-count bottle, Rx only, Manufactured for Lupin Pharmaceuticals, Inc., Baltimore, MD 21202 by Lupin Limited, Nagpur-441108, India, NDC 68180-169-16
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0881-2022·2022-05-25

    Sirolimus Oral Solution Recalled for Failed Dissolution Specifications

    Apotex Corp. recalls Sirolimus Oral Solution lot RZ1598 for exceeding dissolution specifications at the 14-month timepoint. Approximately 2,353 bottles were distributed nationwide.

    Product
    SIROLIMUS — SIROLIMUS (SIROLIMUS)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0880-2022·2022-05-25

    Nitrofurantoin Capsules 100 mg recalled for failed dissolution specifications

    American Health Packaging is recalling Nitrofurantoin Capsules 100 mg due to dissolution failure. The drug release results were above specification. No illnesses have been reported.

    Product
    Nitrofurantoin Capsules, USP (Monohydrate/Macrocrystals), 100 mg, 100 Capsules (10 x 10), 10-count blisters per card, 10 cards per carton, Unit Dose NDC 68084-446-11, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC: 68084-446-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0844-2022·2022-05-11

    Alprazolam XR Extended-Release Tablets Recalled Due to Dissolution Failure

    Viatris Inc. is recalling alprazolam XR 3mg tablets (lot EH8348) distributed nationwide due to failed dissolution testing. Tablets may not dissolve properly, potentially reducing drug effectiveness.

    Product
    ALPRAZOLAM — ALPRAZOLAM (ALPRAZOLAM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0853-2022·2022-05-11

    Lansoprazole Tablets Recalled Due to Failed Dissolution Specifications

    Dr. Reddy's Laboratories is recalling Lansoprazole 30 mg orally disintegrating tablets (Lot T2000645) because they failed dissolution specifications. The tablets may not dissolve properly, affecting medication effectiveness.

    Product
    LANSOPRAZOLE — LANSOPRAZOLE (LANSOPRAZOLE)
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Drugs)·D-0737-2022·2022-04-06

    Lansoprazole Capsules Recalled for Failed Dissolution in Stability Testing

    Dr. Reddy's Laboratories is recalling specific lots of Lansoprazole 15 mg delayed-release capsules nationwide because the capsules failed to dissolve properly during long-term stability testing, which could affect medication effectiveness.

    Product
    LANSOPRAZOLE — LANSOPRAZOLE (LANSOPRAZOLE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0738-2022·2022-04-06

    Lansoprazole Delayed-Release Capsules Recalled for Failed Dissolution Specifications

    Dr. Reddy's Laboratories is recalling 7,703 bottles of Lansoprazole Delayed-Release Capsules (30 mg, 90-count) nationwide due to failed dissolution specifications found during long-term stability testing.

    Product
    LANSOPRAZOLE — LANSOPRAZOLE (LANSOPRAZOLE)
    Category
    Drug
    Distribution
    Distributed nationwide