Shionogi Recalls Mefenamic Acid Capsules Due to Foreign Particles
Shionogi recalls 968 bottles of Mefenamic Acid Capsules (250 mg) distributed by Prasco Laboratories due to black particles found during testing.
Use caution until it’s fixed
Presence of foreign substance: The recall was initiated due to black particles being observed while performing routine post-release stability testing on Mefenamic acid capsules
Contact the company
What happened, in plain English
Shionogi Inc. is recalling Mefenamic Acid Capsules, USP, 250 mg, in 30-count bottles because black particles were observed during stability testing. The product was distributed nationwide by Prasco Laboratories. No specific remedy or action steps are currently listed in the record. Read more at govinfonow.com/recall/41598-shionogi-recalls-mefenamic-acid-capsules-due-to-foreign-particles.
Source Summary by GovInfoNow · govinfonow.com/recall/41598-shionogi-recalls-mefenamic-acid-capsules-due-to-foreign-particles · Updated October 11, 2026 · FDA enforcement record: FDA #D-0219-2018
Cite this page
“Shionogi Recalls Mefenamic Acid Capsules Due to Foreign Particles.” GovInfoNow, updated October 11, 2026. https://govinfonow.com/recall/41598-shionogi-recalls-mefenamic-acid-capsules-due-to-foreign-particles. Based on FDA recall #D-0219-2018 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0219-2018%22&limit=1).
Why it’s dangerous
The presence of black particles indicates a foreign substance in the capsules, which could pose an unknown health risk if ingested. The record does not specify the nature of the particles or potential injury mechanisms beyond their presence.
Who’s affected
Consumers who purchased Mefenamic Acid Capsules, USP, 250 mg, 30-count bottles from pharmacies across the United States. Individuals taking this prescription medication for pain or inflammation are most at risk.
How to tell if you have this one
Check for Mefenamic Acid Capsules, USP, 250 mg, in 30-count bottles with NDC 66993-070-30. Look for Lot number 7H66200103G with an expiration date of 12/19. The product was distributed by Prasco Laboratories in Mason, OH.
- Brand
Shionogi- Category
Drug
What to do — step by step
Check Your Medication
Verify if you have Mefenamic Acid Capsules, USP, 250 mg, 30-count bottles with NDC 66993-070-30 and Lot 7H66200103G.
Contact Your Pharmacist
Since no remedy is stated, contact your pharmacy or healthcare provider for guidance on what to do with the affected bottles.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “U.S.A. 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 9 months after the firm started it.
- Firm started the recall
- FDA classified it Class III
- 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-0219-2018 (May 24, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0219-2018 to see it in context.
- Plain-language summary written by qwen3.6:35b-a3b on October 11, 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.