The Recall Desk

Hazard

Overdose Risk recalls

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

What the numbers show

Total
21
Critical
2
Severe
9
Most recent
2025-10-22

Of the 21 overdose risk recalls we have scored against our rubric, 2 (10%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 9 (43%) are Severe.

Which agencies issued them

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all overdose risk 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.

1–21 of 21

  • HighFDA (Drugs)·D-0029-2026·2025-10-22

    Parkinson's tablets recalled after bottles contained a higher strength tablet

    Rising Pharma is recalling 2,064 bottles of Carbidopa, Levodopa and Entacapone Tablets 25/100/200 mg after a sealed bottle was found to contain the 37.5/150/200 mg strength instead.

    Product
    CARBIDOPA, LEVODOPA AND ENTACAPONE — CARBIDOPA, LEVODOPA AND ENTACAPONE (CARBIDOPA, LEVODOPA AND ENTACAPONE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1991-2025·2025-06-25

    ICU Medical Plum Solos Infusion Pump Software Safety Defect Recall

    ICU Medical is recalling Plum Solos infusion pumps (Item 400011001) with software version 1.1.1 due to a workflow that may bypass the Maximum Dose Limit alert, which is designed to prevent overdose. The defect affects 214 units distributed across nine US states and the Philippines.

    Product
    ICU Medical Plum Solos, Item number 400011001; infusion pump
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0291-2025·2025-03-26

    FDA Recalls Super-Potent Levothyroxine Sodium Tablets Due to Potency Deviation

    Mylan Institutional is recalling 1,068 cartons of levothyroxine sodium 125 mcg tablets (Lot 3115773) distributed nationwide due to out-of-specification potency. The tablets contain higher-than-specified amounts, potentially resulting in excessive doses.

    Product
    LEVOTHYROXINE SODIUM — LEVOTHYROXINE SODIUM (LEVOTHYROXINE SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0249-2025·2025-03-12

    Morphine Sulfate Tablets Recalled Over Failed Dissolution Specifications

    Sun Pharmaceutical is recalling Morphine Sulfate Extended-Release 100 mg tablets (lot AD16615) because they fail dissolution specifications, potentially resulting in unpredictable drug delivery.

    Product
    MORPHINE SULFATE — MORPHINE SULFATE (MORPHINE SULFATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0637-2024·2024-08-28

    Testosterone Gel Recalled by Teva for Excessive Potency

    Teva Pharmaceuticals recalls 7,080 packets of Testosterone Gel nationwide due to higher-than-labeled potency. Patients using the recalled product may receive unintended overdoses.

    Product
    TESTOSTERONE — TESTOSTERONE (TESTOSTERONE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0442-2024·2024-04-24

    Vancomycin Hydrochloride Oral Solution Recalled Nationwide for Superpotency Due to Overfilling

    Amneal Pharmaceuticals is recalling Vancomycin Hydrochloride Oral Solution nationwide due to manufacturing overfilling causing superpotency with higher-than-labeled concentration. The FDA classified this as Class I.

    Product
    VANCOMYCIN HYDROCHLORIDE — VANCOMYCIN HYDROCHLORIDE (VANCOMYCIN HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0279-2024·2024-02-07

    Phenylephrine IV Bags Recalled for Double-Dose Filling System Malfunction

    Denver Solutions is recalling 29,016 Phenylephrine HCl IV bags distributed nationwide. A filling system malfunction can result in some bags receiving double doses of this potent injectable drug.

    Product
    PHENYLephrine HCl 20 mg per 250 mL 0.9% Sodium Chloride (80 mcg per mL), Item F3360, for IV use only; Leiters 13796 Compark Blvd Englewood, CO 80112; NDC 71449-148-94.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1539-2022·2022-09-21

    Teva Amphetamine Tablets Recalled Due To Incorrect Strength Labeling

    Teva Pharmaceuticals is recalling 83,703 bottles of prescription amphetamine tablets nationwide because bottles labeled as 15 mg strength actually contain 20 mg tablets, creating risk of unintended overdose. Patients should contact their pharmacy or healthcare provider.

    Product
    DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE — DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE (DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1522-2022·2022-08-31

    INTERA 3000 implantable pump recalled for higher-than-expected flow rate

    The FDA is recalling INTERA 3000 implantable hepatic infusion pumps due to a malfunction causing higher-than-expected medication flow rates. Patients should contact their healthcare provider.

    Product
    INTERA 3000 Hepatic Artery Infusion Pump, 30 mL, Sterile, Rx Only. implantable infusion pump.
    Category
    Medical Device
    Distribution
    13 states
  • SevereFDA (Drugs)·D-1166-2022·2022-07-06

    Tegsedi Injection Recalled for Higher-Than-Labeled Content

    Akcea Therapeutics recalls certain Tegsedi (inotersen) Injection lots due to higher-than-labeled active ingredient content. Affected lots were distributed in Kentucky.

    Product
    Tegsedi (inotersen) Injection 284 mg/1.5 mL, Rx Only, Sterile solution for Subcutaneous Use, 4 prefilled syringes, each containing 284 mg of inotersen, (equivalent to 300 mg inotersen sodium in 1.5 ml of solution), Distributed by Sobi, Inc. Inc Waltham MA 02451, NDC: 72126-007-01
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0295-2022·2022-01-05

    Lidocaine Hydrochloride Topical Solution recalled for being superpotent

    Teligent Pharma has recalled 6,816 bottles of Lidocaine Hydrochloride Topical Solution 4% nationwide due to the drug being superpotent. The recall is voluntary and involves Lot #16345 with expiration date 01/2024.

    Product
    LIDOCAINE HYDROCHLORIDE — LIDOCAINE HYDROCHLORIDE (LIDOCAINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0092-2022·2021-11-10

    Methocarbamol Tablets Mislabeled with Incorrect Strength

    Bryant Ranch Prepack is recalling Methocarbamol 500mg tablets nationwide because the bottles are mislabeled—they actually contain 750mg tablets. The affected lot was distributed in 30-, 60-, and 90-count bottles.

    Product
    Methocarbamol 500mg Tablet, packaged in a) #30 count (NDC 7133517952), b) #60 count (NDC 7133517954), and c) #90 count (NDC 7133517957) bottles, Rx only, Prinston Laboratories, Packaged by Bryant Ranch Prepack Burbank, CA 91504
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2443-2021·2021-09-22

    Hero Model 100 Smart Pill Dispenser Recalled for Software Dose-Prompting Error

    Hero Health is recalling the Model 100 smart pill dispenser due to a software defect causing the device to prompt users to take medication doses that have already been dispensed, creating overdose risk.

    Product
    The Hero Model 100 (H-100) is a system consisting of a smart pill dispenser and a medication management app.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0332-2021·2021-04-21

    Lupin Recalls Cefprozil Oral Suspension Due to Superpotent Drug Concerns

    Lupin Pharmaceuticals is recalling specific lots of Cefprozil for Oral Suspension because the drug may be superpotent. The recall covers bottles distributed nationwide in the USA and Puerto Rico.

    Product
    CEFPROZIL — CEFPROZIL (CEFPROZIL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0494-2019·2019-02-20

    Tris Pharma Recalls Superpotent Infant Ibuprofen Suspension

    Tris Pharma is recalling specific lots of infant ibuprofen suspension because the medication may contain higher concentrations than labeled.

    Product
    infants* IBUPROFEN, Concentrated Ibuprofen Oral Suspension, USP (NSAID), 50 mg per 1.25 mL, Dye-Free Berry Flavor, 1 FL OZ (30 mL) bottle, Distributed by Wal-Mart Stores, Inc., Bentonville, AR 72716, NDC 49035-125-24.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0336-2019·2018-12-26

    Tris Pharma Recalls Superpotent Infants' Ibuprofen Suspension

    Tris Pharma is recalling 19,488 bottles of Infants' Ibuprofen due to potential higher-than-labeled ibuprofen concentrations.

    Product
    Infants' Ibuprofen, Concentrated Ibuprofen Oral Suspension, USP, (NSAID), 50 mg per 1.25 mL, Dye-Free Non-Staining Berry Flavor, 0.5 FL OZ (15 mL) bottle, Distributed by Family Dollar Services, Inc., 10301 Monroe Road, Matthews, NC 28105, NDC 55319-250-23, UPC 0 32251 03374 2.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1487-2016·2016-09-14

    Amerisource Health Services Recalls Mispackaged Amphetamine Extended-Release Capsules

    Amerisource Health Services is recalling 126 cartons of amphetamine extended-release capsules due to unit dose mispackaging where blister cavities may contain multiple capsules.

    Product
    Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate (Mixed Salts of a Single-Entity Amphetamine Product) Extended-Release Capsules CII 15 mg 20 UD Capsules (5 x 4), Rx, Packaged and Distributed by: American Health Pa
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1483-2016·2016-09-14

    Amerisource Recalls Mispackaged Amphetamine Tablets Due to Unit Dose Errors

    Amerisource Health Services is recalling 1,416 cartons of 15 mg amphetamine tablets because blister cavities may contain more than one tablet.

    Product
    Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Tablets (Mixed Salts of a Single Entity Amphetamine Product) CII 15 mg, 30 UD Tablets (5 x 6), Rx, Packaged and Distributed by: American Health Packaging, Columbus,
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1486-2016·2016-09-14

    Amerisource Health Services Recalls Mispackaged Amphetamine Extended-Release Capsules

    Amerisource Health Services is recalling 834 cartons of amphetamine extended-release capsules because blister cavities may contain more than one tablet or capsule.

    Product
    Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate (Mixed Salts of a Single-Entity Amphetamine Product) Extended-Release Capsules CII 10 mg 30 UD Capsules (5 x 6), Rx, Packaged and Distributed by: American Health P
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1150-2015·2015-07-08

    Oxycodone HCl Tablets Recalled Due to Blister Cavity Containing Two Units

    The Harvard Drug Group is recalling 12,717 Oxycodone HCl 5 mg tablets because a blister cavity was found containing two tablets instead of one.

    Product
    OXYCODONE HCl C-II Tablets, 5 mg USP, 100-count blister cards, Rx only, Manufactured by Nesher Pharmaceuticals USA LLC., St. Louis, MO 63044, Distributed by Major Pharmaceuticals, Livonia, MI 48150, NDC 0904-6444-61.
    Category
    Drug
    Distribution
    Distributed nationwide