The Recall Desk

Hazard

Efficacy Risk recalls

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

What the numbers show

Total
8
Critical
0
Severe
0
Most recent
2025-01-15

Of the 8 efficacy risk recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) 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 efficacy 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.

1–8 of 8

  • HighFDA (Drugs)·D-0187-2025·2025-01-15

    Colchicine Capsules Recalled Due to Failed Dissolution Specifications

    Granules Pharmaceuticals is recalling Colchicine 0.6 mg capsules nationwide due to failed dissolution specifications detected during stability testing. Patients should contact their healthcare provider for guidance.

    Product
    COLCHICINE — COLCHICINE (COLCHICINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0151-2025·2024-12-25

    VCF Contraceptive Pre-filled Applicators Recalled for Out-of-Specification Active Ingredient

    Apothecus Pharmaceutical recalls 33,659 boxes of VCF nonoxynol-9 contraceptive gel nationwide due to out-of-specification active ingredient assay from manufacturing deviations. No illnesses reported.

    Product
    VCF CONTRACEPTIVE PRE-FILLED APPLICATORS — VCF CONTRACEPTIVE PRE-FILLED APPLICATORS (NONOXYNOL-9)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0668-2024·2024-10-02

    Prescription immunosuppressant tablets recalled due to failed dissolution specifications

    Ascend Laboratories recalled 117,493 bottles of Mycophenolic Acid tablets nationwide because the tablets failed to meet dissolution specifications. Patients taking this medication should consult their doctor.

    Product
    MYCOPHENOLIC ACID — MYCOPHENOLIC ACID (MYCOPHENOLIC ACID)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0441-2024·2024-04-24

    Prescription drug NEXLIZET recalled for dissolution specification failure

    Esperion is recalling certain NEXLIZET (bempedoic acid and ezetimibe) tablets nationwide because the active ingredient may not dissolve properly, potentially reducing effectiveness.

    Product
    NEXLIZET — NEXLIZET (BEMPEDOIC ACID AND EZETIMIBE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0177-2024·2024-01-03

    Donepezil Hydrochloride Tablets Recalled Due to Storage Temperature Deviations

    Cardinal Healthcare is recalling Donepezil Hydrochloride 5 mg tablets (Batch 17605) distributed nationwide because they were exposed to temperatures outside labeled storage conditions, which could affect drug stability.

    Product
    DONEPEZIL HYDROCHLORIDE — DONEPEZIL HYDROCHLORIDE (DONEPEZIL HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0820-2023·2023-06-07

    Levofloxacin Ophthalmic Solution Recalled Due to Manufacturing Practice Deviations

    Akorn, Inc. is recalling all lots of Levofloxacin Ophthalmic Solution 0.5% due to manufacturing practice deviations. The firm went out of business and could not continue required stability studies.

    Product
    Levofloxacin Ophthalmic Solution, 0.5%, 5 mL bottles, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1150-2022·2022-06-22

    Zileuton Extended-Release Tablets recalled for failed dissolution specifications

    Lupin Pharmaceuticals is recalling Zileuton Extended-Release Tablets, 600 mg, due to failed dissolution specifications found during stability testing that may affect medication efficacy.

    Product
    Zileuton Extended-Release Tablets, 600 mg, 120-count bottle, Rx only, Manufactured for Lupin Pharmaceuticals, Inc., Baltimore, MD 21202 by Lupin Limited, Nagpur-441108, India, NDC 68180-169-16
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0669-2022·2022-03-30

    FDA Recalls Betamethasone Dipropionate Lotion Due to Manufacturing Deviations

    Teligent Pharma is recalling Betamethasone Dipropionate Lotion due to manufacturing practice deviations and discontinuation of the stability study program. The recall affects 43,218 bottles distributed nationwide.

    Product
    Betamethasone Dipropionate Lotion USP, 0.05%* (Augmented), packaged in a) 30 mL (29 grams) bottles, NDC 52565-023-29; b) 60 mL (58 grams) bottles, NDC 52565-023-59, Rx Only, Teligent Pharma, Inc., Buena, NJ 08310
    Category
    Drug
    Distribution
    Distributed nationwide