The Recall Desk

Hazard

Quality Failure recalls

13 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
13
Critical
0
Severe
2
Most recent
2021-09-29

Of the 13 quality 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 2 (15%) 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 quality 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.

1–13 of 13

  • ModerateFDA (Drugs)·D-0813-2021·2021-09-29

    Sirolimus Tablets Recalled for Failed Impurities and Degradation Specifications

    American Health Packaging is recalling Sirolimus 1 mg tablets (Lot #1000789, expiring 10/31/2022) distributed nationwide because they failed impurities and degradation specifications.

    Product
    SIROLIMUS — SIROLIMUS (SIROLIMUS)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0629-2021·2021-06-23

    Dr. Reddy's Atorvastatin Calcium Tablets Recalled for Failed Impurity Specifications

    Dr. Reddy's Laboratories is recalling Atorvastatin Calcium Tablets USP 10 mg nationwide because certain lots contain impurities that exceeded acceptable specifications.

    Product
    ATORVASTATIN CALCIUM — ATORVASTATIN CALCIUM (ATORVASTATIN CALCIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0618-2018·2018-04-11

    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
  • LowFDA (Drugs)·D-0577-2018·2018-03-14

    Akorn Recalls Atropine Sulfate Ophthalmic Solution Due to Viscosity Failure

    Akorn, Inc. is recalling 31,812 bottles of Atropine Sulfate Ophthalmic 1% Solution because testing revealed low viscosity results.

    Product
    Atropine Sulfate Ophthalmic 1% Solution, USP, 5mL per bottle, Sterile, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-215-05
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0158-2017·2016-12-07

    Burel Pharmaceuticals Recalls UROPHEN MB Urinary Antiseptic Tablets

    Burel Pharmaceuticals is recalling UROPHEN MB Urinary Antiseptic Tablets due to manufacturing deviations that may cause assay or content uniformity failures.

    Product
    UROPHEN MB URINARY ANTISEPTIC Tablets, Each tablet contains: Methenamine 81.6 mg, Benzoic Acid 9.0 mg, Phenyl Salicylate 36 mg, Methylene Blue 10.8 mg, Hyoscyamine Sulfate 0.12 mg, 100 count bottles, Rx only, Manufactured for: BUREL PHARMACEUTICALS, Richland, MS --- NDC 35573-30
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1436-2016·2016-07-20

    Apotex Recalls Duloxetine Capsules Due to Dissolution Failure

    Apotex Scientific is recalling Duloxetine Delayed-Release Capsules, 60 mg, because stability testing revealed out-of-specification dissolution results.

    Product
    Duloxetine Delayed-Release Capsules, USP, 60 mg, 30-count bottles, Rx only, Manufactured by Apotex Inc, Toronto, Ontario M9L 1T9, Manufactured for Apotex Corp. Weston Florida 33326, NDC 60505-2997-3; UPC # 360505299737;
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1483-2014·2014-08-06

    McKesson Recalls Aspirin DR Tablets for Dissolution Failure

    McKesson Packaging Services is recalling Aspirin DR Enteric Coated Tablets because they failed to meet dissolution specifications at the 12-month time interval.

    Product
    Aspirin DR Enteric Coated Tablets, USP 325 mg, UD 750 tablets (25x30), Dist. By: McKesson Packaging Services a business unit of McKesson Corporation, concord, NC
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1243-2014·2014-04-30

    GlaxoSmithKline Recalls Nicorette Lozenges Due to Quality Failures

    GlaxoSmithKline is recalling Nicorette 4 mg lozenges because they failed specifications for thickness, softness, and potency.

    Product
    Nicotine polacrilex lozenge, 4 mg, Mint Flavor, 81 Lozenge and 189 Lozenge Vials. OTC. Labeled Nicorette, Distributed By: GlaxoSmithKline Consumer Healthcare, L.P., Moon Township, PA 15108. Made in Switzerland. 81 Count NDC: 0135-0511-05, 189 Count NDC: 0135-0511-03.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1245-2014·2014-04-30

    GlaxoSmithKline Recalls Nicorette Lozenges Due to Failed Specifications

    GlaxoSmithKline is recalling specific lots of Nicorette Lozenges Mini because they failed quality specifications, including being overly thick, soft, and sub or superpotent.

    Product
    NICORETTE — NICORETTE (NICOTINE POLACRILEX)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1244-2014·2014-04-30

    GlaxoSmithKline Recalls Nicorette and Nicoderm CQ Products for Quality Failures

    GlaxoSmithKline is recalling specific lots of Nicorette and Nicoderm CQ products because the lozenges failed quality specifications, including being overly thick, soft, and having incorrect potency.

    Product
    Nicorette Lozenge, Nicoderm CQ, and Nicorette Gum nicotine polacrilex combination. Contains 30 Pieces/ Pallet. OTC only. GlaxoSmithKlein, 1000 GSK Drive, Moon Township, PA 15108. UPC: 0-03-0766-1442-81-2.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-444-2013·2013-05-29

    Lloyd Inc. Recalls Thyro-Tab Tablets Due to Quality Failures

    Lloyd Inc. of Iowa is recalling 5.7 million Thyro-Tab tablets because stability failures in previous lots make it impossible to verify the quality of the current lots.

    Product
    Lloyd Thyro-Tab 0.200 mg., packaged in 150,000-tablet bulk drums (2/75,000-tablet bags/drum) for repackaging, RX. The firm name on the label is Lloyd Pharmaceutical, Shenandoah, IA.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-059-2013·2012-11-28

    Dr. Reddy's Quetiapine Fumarate Tablets Recalled for Dissolution Failure

    Dr. Reddy's is recalling Quetiapine Fumarate Tablets, 25mg, because they failed USP dissolution testing during stability studies.

    Product
    Dr. Reddy's Quetiapine Fumarate Tablets, 25mg, Rx Only, 500 tablets. Mfd By: Dr. Reddy's Laboratories Limited, Bachepalli - 502 325, India NDC 55111-249-05
    Category
    Drug
    Distribution
    Distributed nationwide