G&W Laboratories Recalls Indocin Suppositories Due to Impurity Risks
G&W Laboratories recalls Indocin (Indomethacin) suppositories with impurity issues that could affect safety. Affected lots expired by Jan 2018 and Aug 2018. Contact for details.
Recall notice
Failed Impurities/Degradation Specifications: Out of specification (OOS) for total impurity and out of trend for known impurity results encountered during stability testing.
Contact the company
What happened, in plain English
G&W Laboratories is recalling Indocin suppositories that may contain impurities. This could lead to safety issues if used as intended. The recall affects specific lots with expiration dates up to September 2018. Read more at govinfonow.com/recall/42047-g-w-laboratories-recalls-indocin-suppositories-due-to-impurity-risks.
Source Summary by GovInfoNow · govinfonow.com/recall/42047-g-w-laboratories-recalls-indocin-suppositories-due-to-impurity-risks · Updated October 8, 2026 · FDA enforcement record: FDA #D-0501-2017
Cite this page
“G&W Laboratories Recalls Indocin Suppositories Due to Impurity Risks.” GovInfoNow, updated October 8, 2026. https://govinfonow.com/recall/42047-g-w-laboratories-recalls-indocin-suppositories-due-to-impurity-risks. Based on FDA recall #D-0501-2017 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0501-2017%22&limit=1).
Why it’s dangerous
The suppositories failed impurity and degradation tests during stability testing. This means they may contain harmful substances that could affect safety when used.
Who’s affected
Prescription users of Indocin suppositories with specific lot numbers from G&W Laboratories. Those who have the recalled lots are most at risk.
How to tell if you have this one
Check for the lot numbers 017600011 (expiring Jan 2018), 0176000014 (expiring Aug 2018), or 017600015 (expiring Sep 2018) on the packaging.
- Brand
G&W Laboratories- Category
Drug
What to do — step by step
Check Product Lot Number
Look for lot numbers 017600011, 0176000014, or 017600015 on the packaging.
How this recall unfolded
Recall timeline
FDA terminated this recall 16 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.
Similar recalls
Latest drug recalls
Keep exploring
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-0501-2017 (February 7, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0501-2017 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.