Is there a recall on gabapentin?

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No Active Recall on Gabapentin

There is no current FDA recall on gabapentin. The question appears to be asking about drug safety alerts or product withdrawals, and the available evidence does not indicate any active recall of gabapentin products.

Context on Drug Recalls

The evidence provided includes general information about FDA drug recall characteristics but does not mention any specific gabapentin recall 1. The most common reasons for drug recalls historically include contamination, mislabeling, adverse reactions, defective products, and incorrect potency 1.

Important Safety Considerations for Gabapentin

While there is no recall, clinicians should be aware of several important safety issues:

Emerging Misuse Liability

  • Gabapentin misuse has risen significantly, particularly when combined with opioids 2
  • Misuse typically occurs for purposes of eliciting euphoric effects, enhancing other substances, or self-treating withdrawal, pain, anxiety, or insomnia 2
  • Gabapentinoids significantly increase opioid-related morbidity and mortality when used concomitantly 2
  • Several US states have begun reclassifying gabapentin as a controlled substance or mandating reporting to prescription drug monitoring programs 2

Respiratory Compromise Risk

  • Assess oxygen saturation and respiratory rate in patients experiencing respiratory symptoms while on gabapentin 3
  • Renal impairment can lead to gabapentin accumulation and increased side effects 3

Appropriate Clinical Use

  • Gabapentin is NOT recommended for episodic migraine prevention (weak recommendation against) 4
  • Gabapentin is effective for neuropathic pain conditions including diabetic neuropathy (NNT 2.9) and postherpetic neuralgia (NNT 3.9) 5
  • For chemotherapy-induced peripheral neuropathy, gabapentin showed no benefit in placebo-controlled trials 4

Prescribing Practices

  • Document specific benefits, tolerance, and adverse effects when prescribing long-term 6
  • Typical dosing starts at 900 mg/day (titrated over 3 days) with additional titration to 1800 mg/day recommended for greater efficacy 7
  • Doses up to 3600 mg/day may be needed in some patients 7

References

Research

Characteristics of FDA drug recalls: A 30-month analysis.

American journal of health-system pharmacy : AJHP : official journal of the American Society of Health-System Pharmacists, 2016

Guideline

Management of Respiratory Compromise in Patients Taking Gabapentin

Praxis Medical Insights: Practical Summaries of Clinical Guidelines, 2025

Guideline

Guideline Directed Topic Overview

Dr.Oracle Medical Advisory Board & Editors, 2025

Research

Gabapentin for acute and chronic pain.

The Cochrane database of systematic reviews, 2005

Guideline

Gabapentin Prescribing Considerations

Praxis Medical Insights: Practical Summaries of Clinical Guidelines, 2025

Professional Medical Disclaimer

This information is intended for healthcare professionals. Any medical decision-making should rely on clinical judgment and independently verified information. The content provided herein does not replace professional discretion and should be considered supplementary to established clinical guidelines. Healthcare providers should verify all information against primary literature and current practice standards before application in patient care. Dr.Oracle assumes no liability for clinical decisions based on this content.

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