Methocarbamol Recalled: Quality Assurance Issues in Prescription Compounding
American Pharmaceutical Ingredients LLC recalls prescription methocarbamol products due to lack of quality assurance at the API manufacturer. These products were sold with specific NDC codes and expiration dates.
Recall notice
CGMP Deviations: Lack of quality assurance at the API manufacturer.
Contact the company
What happened, in plain English
American Pharmaceutical Ingredients LLC is recalling prescription methocarbamol products that were manufactured with quality assurance issues. This recall affects specific container sizes and NDC codes that were sold under prescription compounding only. Read more at govinfonow.com/recall/41594-methocarbamol-recalled-quality-assurance-issues-in-prescription-compounding.
Source Summary by GovInfoNow · govinfonow.com/recall/41594-methocarbamol-recalled-quality-assurance-issues-in-prescription-compounding · Updated October 8, 2026 · FDA enforcement record: FDA #D-0937-2017
Cite this page
“Methocarbamol Recalled: Quality Assurance Issues in Prescription Compounding.” GovInfoNow, updated October 8, 2026. https://govinfonow.com/recall/41594-methocarbamol-recalled-quality-assurance-issues-in-prescription-compounding. Based on FDA recall #D-0937-2017 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0937-2017%22&limit=1).
Why it’s dangerous
The recall is due to lack of quality assurance at the API manufacturer, which means the products may not meet safety standards. This could lead to potential safety issues for patients using the medication.
Who’s affected
Prescription compounding pharmacies and healthcare providers who use these methocarbamol products. Patients receiving these products through prescription compounding are at risk if they use the recalled items.
How to tell if you have this one
Check for the product names and NDC codes: 100g (NDC 58597-8023-6), 500g (NDC 58597-8023-7), and 1000g (NDC 58597-8023-8) containers. These were sold under prescription compounding only with specific expiration dates.
- Brand
American Pharmaceutical Ingredients- Category
Drug
What to do — step by step
Check Product Details
Identify the NDC codes and container sizes to confirm if your product is recalled.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 12 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0937-2017 (May 26, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0937-2017 to see it in context.
- Plain-language summary written by qwen3:4b on October 8, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.