The Recall Desk

Hazard

Out Of Specification recalls

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

What the numbers show

Total
261
Critical
2
Severe
6
Most recent
2026-07-29

Of the 261 out of specification recalls we have scored against our rubric, 2 (1%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 6 (2%) 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 out of specification 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.

251–261 of 261

  • HighFDA (Drugs)·D-0430-2017·2017-01-18

    Noven Recalls Daytrana Patches Due to Defective Delivery System

    Noven Pharmaceuticals is recalling Daytrana (methylphenidate) transdermal patches because the delivery system failed to meet mechanical peel force specifications.

    Product
    DAYTRANA — DAYTRANA (METHYLPHENIDATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0571-2016·2016-01-27

    Morton Grove Recalls Lindane Lotion Due to Out-of-Specification Assay

    Morton Grove Pharmaceuticals is recalling specific lots of Lindane Lotion because stability samples failed assay testing. Consumers should stop using the product and return it to their pharmacy.

    Product
    Lindane Lotion, USP 1%, For External use Only, Rx Only, 2 fl oz (60 mL) bottle, MGP, NDC 60432-833-60
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0019-2016·2015-10-21

    QC Quality Choice Loratadine Tablets Recalled for Out-of-Specification Assay

    Ohm Laboratories is recalling QC Quality Choice Loratadine Orally Disintegrating Tablets due to an out-of-specification assay result.

    Product
    QC Quality Choice Loratadine Orally Disintegrating Tablets, USP 10 mg, 10-count tablets per box, Distributed by C.D.M.A., Inc., 43157 W. Nine Mile, Novi, MI 48376-0995, NDC 63868-157-10, UPC 6 35515 95777 0
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0039-2016·2015-10-21

    Meijer Loratadine Tablets Recalled for Out-of-Specification Assay

    Ohm Laboratories is recalling Meijer Loratadine Orally Disintegrating Tablets due to an out-of-specification assay result.

    Product
    Meijer Loratadine Orally Disintegrating Tablets, USP, 10 mg, 30-count tablets per box, Dist. By Meijer Distribution Inc. 2929 Walker Avenue NW, Grand Rapids, MI 49544. NDC 41250-527-31, UPC 7 6023662291 8
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0029-2016·2015-10-21

    Ohm Recalls HEB Loratadine Tablets Due to Out-of-Specification Assay

    Ohm Laboratories is recalling HEB Loratadine Orally Disintegrating Tablets because an out-of-specification assay result indicated the drug was superpotent.

    Product
    HEB Loratadine Orally Disintegrating Tablets, USP, 10 mg, 10-count tablets per box, Made with pride & care for HEB, San Antonio, TX 78204, Item code: 188330, UPC 0 4122081968 3
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0031-2016·2015-10-21

    Major Loratadine Tablets Recalled for Out-of-Specification Assay Results

    Ohm Laboratories is recalling Major loratadine orally disintegrating tablets due to out-of-specification assay results. The recall covers 29,360 boxes distributed nationwide.

    Product
    Major loratadine orally disintegrating tablets, USP, 10 mg, 10-count tablets per box, Distributed by Major Pharmaceuticals 31778 Enterprise Drive, Livonia, MI 48150, USA, NDC 0904-5806-15, UPC 3 0904580615 9
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0020-2016·2015-10-21

    Rite Aid Loratadine Tablets Recalled for Out-of-Specification Assay

    Ohm Laboratories is recalling Rite Aid Pharmacy loratadine orally disintegrating tablets because they failed an assay test, resulting in a superpotent drug classification.

    Product
    Rite Aid Pharmacy loratadine orally disintegrating tablets USP, 10 mg, packaged in a) 30-count tablets per box, Item 352712, UPC 0 11822 52712 5; b) 60-count tablets per box, Item 353672, UPC 0 11822 53672 1. Distributed By: Rite Aid, 30 Hunter Lane, Camp Hill, PA 17011.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1131-2015·2015-06-17

    Baxter Recalls Subpotent Heparin Sodium Injection Due to Raw Material Issues

    Baxter Healthcare is recalling specific lots of Heparin Sodium in Sodium Chloride Injection because the raw material was found to be subpotent and out of specification.

    Product
    HEPARIN SODIUM IN SODIUM CHLORIDE — HEPARIN SODIUM IN SODIUM CHLORIDE (HEPARIN SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1062-2013·2013-10-02

    CorePharma Recalls Pyridostigmine Bromide Tablets Due to Stability Failure

    CorePharma is recalling 960 bottles of Pyridostigmine Bromide Tablets 60 mg because stability testing showed out-of-specification results.

    Product
    Pyridostigmine Bromide Tablets 60 mg, USP Rx Only 100 Tablets, Manufactured and Distributed by: CorePharma, LLC Middlesex, NJ 08846 NDC 64720-128-10 NDC 64720-128-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1019-2013·2013-09-18

    FDA Recalls Glutathione Injectable Due to Potential Bacterial Contamination

    Creative Compounds is recalling 16 vials of Glutathione 100 mg/mL Injectable due to out-of-specification results and potential bacterial contamination.

    Product
    Glutathione 100 mg/mL Injectable, 100mL Vial, Use as Directed, RX, Creative Compounds, Wilsonville, OR 97070.
    Category
    Drug
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-1784-2013·2013-07-31

    Instrumentation Laboratory Recalls HemosIL RecombiPlasTin 2G Coagulation Reagent

    Instrumentation Laboratory is recalling HemosIL RecombiPlasTin 2G reagent kits due to out-of-specification quality issues. The product is used for evaluating the extrinsic coagulation pathway.

    Product
    HemosIL RecombiPlasTin 2G, Part Number 0020002950 (8 ml size). The product is used for the evaluation of the extrinsic coagulation pathway and the monitoring of Oral Anticoagulant Therapy.
    Category
    Medical Device
    Distribution
    Distributed nationwide