The Recall Desk

Hazard

Strength Mislabeling recalls

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

What the numbers show

Total
5
Critical
0
Severe
2
Most recent
2025-02-12

Of the 5 strength mislabeling 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 (40%) 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 strength mislabeling 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.

1–5 of 5

  • ModerateFDA (Drugs)·D-0222-2025·2025-02-12

    Guaifenesin and Codeine Cough Syrup Recalled for Superpotent Strength

    PAI Pharmaceutical Associates is recalling Guaifenesin and Codeine Phosphate Oral Solution because the product contains higher-than-labeled active ingredient concentrations. The affected product was distributed in Ohio.

    Product
    GUAIFENESIN AND CODEINE PHOSPHATE — GUAIFENESIN AND CODEINE PHOSPHATE (GUAIFENESIN AND CODEINE PHOSPHATE)
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0181-2025·2025-01-15

    Clonazepam Tablets Recalled Due to Carton Labeling Error

    Endo USA, Inc. is recalling 22,513 cartons of clonazepam tablets due to incorrect strength labeling on some carton exteriors. The actual tablets inside have correct labeling.

    Product
    CLONAZEPAM — CLONAZEPAM (CLONAZEPAM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0155-2024·2023-12-27

    Nystatin Powder Recall Due to Incorrect Assay Strength on Label

    Fagron, Inc. is recalling 46 containers of Nystatin 500 MU bulk powder used for prescription compounding due to an incorrect assay value on the product label. The mislabeled strength could affect proper compounding of patient medications.

    Product
    NYSTATIN 500 MU, Activity (as is): 6482 Units/mg, bulk powder container, Rx Only, For Prescription Compounding, Fagron, Inc. - 2400 Pilot Knob Rd. St Paul, MN 55120. NDC 51552-0041-3, Bar code 3 51552 00413 9
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-1179-2023·2023-10-04

    Clearasil Rapid Rescue Deep Treatment Pads Recalled for Label Error

    RB Health (US) is recalling Clearasil Rapid Rescue Deep Treatment Pads (Salicylic Acid 2%) due to an incorrect label on the back of the packaging. The recall affects 36,426 individual units distributed nationwide.

    Product
    CLEARASIL RAPID RESCUE DEEP TREATMENT PADS — CLEARASIL RAPID RESCUE DEEP TREATMENT PADS (SALICYLIC ACID)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0773-2021·2021-09-01

    Trulicity autoinjector pens recalled for incorrect strength labeling

    Eli Lilly & Company is recalling Trulicity (dulaglutide) 0.75 mg autoinjector pens because some contain double the labeled strength. Affected patients may receive an incorrect dose.

    Product
    TRULICITY — TRULICITY (DULAGLUTIDE)
    Category
    Drug
    Distribution
    Distributed nationwide