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.

76–100 of 270

  • ModerateFDA (Drugs)·D-0461-2022·2022-02-09

    Doxylamine Succinate and Pyridoxine Hydrochloride Tablets Recalled for Failed Dissolution

    Teva Pharmaceuticals USA is recalling Doxylamine Succinate and Pyridoxine Hydrochloride delayed-release tablets because dissolution test results for the active ingredient fall below specification limits, which may affect drug effectiveness.

    Product
    DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE — DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE (DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0451-2022·2022-02-02

    Metoprolol Succinate ER Tablets Recall for Failed Dissolution

    American Health Packaging is recalling Metoprolol Succinate Extended-Release Tablets 50 mg nationwide due to failed dissolution specifications. The affected lots may not release the medication properly, potentially reducing its effectiveness.

    Product
    METOPROLOL SUCCINATE — METOPROLOL SUCCINATE (METOPROLOL SUCCINATE ER TABLETS)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0385-2022·2022-01-26

    CVS Health Allergy Relief D Tablets Recalled for Failed Dissolution

    CVS Health Allergy Relief D Extended Release Tablets are being recalled because they failed to meet dissolution specifications. The recall affects 41,784 boxes distributed nationwide.

    Product
    CVS Health, Allergy Relief D, Fexofenadine HCl 60mg/Antihistamine Pseudoephedrine HCl 120mg/Nasal Decongestant, a) 20 Extended Release Tablets per box, UPC 050428436189, b) 30 Extended Release Tablets per box, UPC 050428290538, Distributed by CVS Pharmacy Inc., One CVS Drive, Wo
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0386-2022·2022-01-26

    Leader 12HR Allergy & Congestion Relief tablets fail dissolution test

    Dr. Reddy's Laboratories is recalling Leader brand 12HR Allergy & Congestion Relief tablets due to failed dissolution specifications. The product may not release its active ingredients properly.

    Product
    Leader, 12HR Allergy & Congestion Relief, Fexofenadine HCl, 60mg Pseudoephedrine HCl 120mg Antihistamine Nasal Decongestant, 20 Extended Release Tablets per box, NDC 70000-0518-1, Distributed by Cardinal Health, Dublin, Ohio 43077, Made in India.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0382-2022·2022-01-26

    Dr. Reddy's Fexofenadine/Pseudoephedrine Tablets Fail Dissolution Specification

    Dr. Reddy's Laboratories is recalling Fexofenadine HCl 60 mg and Pseudoephedrine HCl 120 mg Extended-Release Tablets because the tablets failed to meet dissolution specifications, which may affect the drug's effectiveness.

    Product
    Dr. Reddys, Fexofenadine HCl 60 mg & Pseudoephedrine HCl 120 mg Extended-Release Tablets USP, a) 10 tablets per box, UPC 343598823355, b) 20 tablets per box, UPC 343598823140, c) 30 tablets per box, UPC 343598823317, Distributed by: Dr. Reddy's Laboratories, Inc. Princeton, NJ 08
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0380-2022·2022-01-26

    Rite Aid Allergy & Congestion Tablets Fail Dissolution Specifications

    Rite Aid Pharmacy is recalling Allergy & Congestion extended-release tablets because two lots failed to meet dissolution specifications. The affected product was distributed nationwide.

    Product
    Rite Aid Pharmacy, Allergy & Congestion, Fexofenadine HCl 60mg & Pseudoephedrine HCl 120mg, Extended Release Tablets USP, 20 Extended-Release Tablets per box, UPC 011822738873, Distributed by Rite Aid, 30 United Lane, Camp Hill, PA 17011, Made in India.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0379-2022·2022-01-26

    Rugby Antihistamine and Decongestant Tablets Recalled for Failed Dissolution

    Dr. Reddy's Laboratories is recalling Rugby brand antihistamine and nasal decongestant tablets nationwide due to failed dissolution specifications. The affected product is NDC 0536-1242-07, Lot #AC2106452F with expiration date 3/31/2023.

    Product
    Rugby, Antihistamine and Nasal Decongestant, Fexofenadine HCl 60mg and Pseudoephedrine HCl 120mg, Extended-Release Tablets USP, 30 Tablets per box, NDC 0536-1242-07, Distributed by: Rugby Laboratories, 17177 N Laurel Park Drive, Suite 233, Livonia, MI, 49152, Made in India.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0378-2022·2022-01-26

    Wal-Fex D Allergy and Decongestant Tablets Recalled for Failed Dissolution

    Dr. Reddy's Laboratories is recalling Wal-Fex D Extended Release Tablets nationwide due to failed dissolution specifications. The affected product combines fexofenadine (antihistamine) and pseudoephedrine (decongestant).

    Product
    FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI — FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI (FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0365-2022·2022-01-19

    Carbamazepine tablets recalled for failed dissolution specifications

    Torrent Pharma Inc. is recalling Carbamazepine 200 mg tablets nationwide because they failed to meet dissolution specifications, which means the tablets may not release the medication properly in the body.

    Product
    CARBAMAZEPINE — CARBAMAZEPINE (CARBAMAZEPINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0274-2022·2021-12-15

    Walmart Allergy Relief D Extended-Release Tablets Recalled for Failed Dissolution

    Dr. Reddy's Laboratories is recalling Walmart brand Allergy Relief D extended-release tablets (Lot #AC2103329B) nationwide because the tablets failed to meet dissolution specifications, which may affect medication effectiveness.

    Product
    Allergy Relief D Fexofenadine HCl, 60 mg I Pseudoephedrine HCl, 120 mg, Extended Release Tablets, USP, 30 Extended-Release Tablets USP, Distributed By Walmart Inc., Bentonville, AR 72716, Product of India, NDC 49035-273-30.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0267-2022·2021-12-15

    Allergy and Congestion tablets recalled due to failed dissolution specifications

    Dr. Reddy's Laboratories is recalling Allergy and Congestion (Fexofenadine HCl 60 mg & Pseudoephedrine HCl 120 mg) Extended-Release Tablets because they failed to meet dissolution specifications. Approximately 4,896 cartons distributed nationwide are affected.

    Product
    ALLERGY AND CONGESTION — ALLERGY AND CONGESTION (FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0271-2022·2021-12-15

    Antihistamine and Decongestant Tablets Recalled for Failed Dissolution

    Dr. Reddy's Laboratories is recalling Fexofenadine HCl 60 mg and Pseudoephedrine HCl 120 mg extended-release tablets distributed by Rugby Laboratories due to failed dissolution specifications. Affected lot AC2103329D (Exp 1/2023) was distributed nationwide in 2,184 cartons.

    Product
    Antihistamine & Nasal Decongestant, Fexofenadine HCl 60 mg and Pseudoephedrine HCl 120 mg, Extended Release Tablets USP, Allergy & Congestion, 12 Hour, 30 Tablets, Distributed by: Rugby Laboratories, 17177 N. Laurel Park Drive, Suite 233, Livonia, MI 48152, www.rugbylaboratories.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0273-2022·2021-12-15

    CVS Allergy Relief D Extended-Release Tablets Recall

    CVS Allergy Relief D extended-release tablets (Fexofenadine HCl 60 mg / Pseudoephedrine HCl 120 mg) are being recalled because they failed dissolution specifications, meaning the tablets may not release the medication properly.

    Product
    Allergy Relief D Fexofenadine HCl, 60 mg I Pseudoephedrine HCl, 120 mg, Extended Release Tablets, 30 Extended-Release Tablets USP, Distributed By CVS Pharmacy Inc., One CVS Drive, Woonsocket, RI 02985, Made in India, NDC 69842-249-30
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0268-2022·2021-12-15

    CVS Allergy & Congestion Relief Tablets Recalled for Failed Dissolution

    Dr. Reddy's Laboratories is recalling CVS Allergy & Congestion Relief tablets (fexofenadine HCl 60 mg/pseudoephedrine HCl 120 mg extended-release) nationwide due to failed dissolution specifications.

    Product
    Allergy & Congestion Relief Allergy Relief D, Fexofenadine HCl 60 mg/ Pseudoephedrine HCl 120 mg Extended Release Tablets, 20 extended-release tablets, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, Made in India, NDC 69842-249-20
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0275-2022·2021-12-15

    Fexofenadine and Pseudoephedrine Tablets Recalled for Failed Dissolution

    Dr. Reddy's Laboratories is recalling Fexofenadine HCl 60 mg and Pseudoephedrine HCl 120 mg extended-release tablets because they failed to meet dissolution specifications, which may affect how the medication works in the body.

    Product
    FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI — FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI (FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0027-2022·2021-10-27

    Lupin Imipramine Pamoate Capsules Recalled for Failed Dissolution Test

    Lupin Pharmaceuticals is recalling approximately 1,902 bottles of Imipramine Pamoate Capsules 125 mg due to out-of-specification results in dissolution testing at the 9-month stability checkpoint.

    Product
    IMIPRAMINE PAMOATE — IMIPRAMINE PAMOATE (IMIPRAMINE PAMOATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0807-2021·2021-09-29

    Carbamazepine 200mg Tablets Recalled for Failed Dissolution Specifications

    The Harvard Drug Group is recalling Carbamazepine 200mg tablets (Lot R01562, expiring 10/2022) distributed in North Carolina because they failed to meet required dissolution specifications, which may affect the drug's effectiveness.

    Product
    CARBAMAZEPINE — CARBAMAZEPINE (CARBAMAZEPINE)
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0806-2021·2021-09-29

    Entacapone Tablets Recalled for Failed Dissolution Specifications

    The Harvard Drug Group is recalling Entacapone 200 mg tablets distributed in Colorado, Florida, Missouri, and Ohio due to failed dissolution specifications that may affect drug efficacy.

    Product
    ENTACAPONE — ENTACAPONE (ENTACAPONE)
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-0652-2021·2021-07-21

    Nifedipine Extended-Release Tablets Recall for Failed Dissolution

    The Harvard Drug Group is recalling Nifedipine Extended-Release Tablets 30 mg due to failed dissolution specification discovered during routine stability testing. The affected lots were distributed in Ohio and New Jersey.

    Product
    NIFEDIPINE — NIFEDIPINE (NIFEDIPINE)
    Category
    Drug
    Distribution
    2 states
  • ModerateFDA (Drugs)·D-0333-2021·2021-04-21

    Jubilant Cadista Recalls Itraconazole Capsules Due to Dissolution Failures

    Jubilant Cadista Pharmaceuticals is recalling specific lots of Itraconazole Capsules, 100 mg, because they failed to meet dissolution specifications.

    Product
    Itraconazole Capsules, 100 mg, 30-count bottles, Rx only, Manufactured by: Jubilant Generics Ltd., Roorkee - 247661, India; Marketed by: Jubilant Cadista Pharmaceuticals, Inc., Salisbury, MD 21801, NDC 59746-282-30.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0292-2021·2021-03-10

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

    Dr. Reddy's Laboratories is recalling 16,449 bottles of 200 mg Progesterone Capsules because stability testing revealed out-of-specification dissolution results.

    Product
    PROGESTERONE — PROGESTERONE (PROGESTERONE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0287-2021·2021-03-03

    Dr. Reddy's Recalls Imatinib Mesylate Tablets for Dissolution Failures

    Dr. Reddy's Laboratories is recalling specific lots of Imatinib Mesylate 100mg tablets because they failed to meet required dissolution specifications.

    Product
    IMATINIB — IMATINIB (IMATINIB)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0259-2021·2021-02-24

    Wilshire Pharmaceuticals Recalls Meclizine HCl Tablets for Dissolution Failures

    Wilshire Pharmaceuticals is recalling 3,592 bottles of Meclizine HCl 25 mg tablets because they failed dissolution specifications. The affected product was distributed in Florida and Texas.

    Product
    Meclizine HCl Tablets, USP, 25 mg, 100 Tablets bottles, Rx Only, Mfd. for: Wilshire Pharmaceuticals, Inc., Atlanta, GA 30328, Product of India, NDC 52536-133-01
    Category
    Drug
    Distribution
    2 states
  • ModerateFDA (Drugs)·D-0258-2021·2021-02-24

    Wilshire Pharmaceuticals Recalls Meclizine HCl Tablets for Dissolution Failures

    Wilshire Pharmaceuticals is recalling 2,112 bottles of Meclizine HCl 12.5 mg tablets found in Florida and Texas because they failed dissolution specifications.

    Product
    Meclizine HCl Tablets, USP, 12.5 mg, 100 Tablets bottles, Rx Only, Mfd. for: Wilshire Pharmaceuticals, Inc., Atlanta, GA 30328, Product of India, NDC 52536-129-01
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0232-2021·2021-01-27

    American Health Packaging Recalls Nitrofurantoin Capsules for Dissolution Failure

    American Health Packaging is recalling 1,948 cartons of Nitrofurantoin Capsules USP 100 mg because they failed dissolution specifications. The recall is nationwide.

    Product
    Nitrofurantoin Capsules USP (Monohydrate/Macrocrystals), 100 mg, 100 per carton (10 capsules x 10 blister cards), Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC Carton: 68084-446-01; NDC Blister Card: 68084- 446-11
    Category
    Drug
    Distribution
    Distributed nationwide