Shionogi PONSTEL Capsules Recall: Low Dissolution Risk
Shionogi recalls 250mg PONSTEL capsules with low dissolution risk. This may affect medication effectiveness. Check lot numbers for affected items.
Lower-risk recall
Failed Dissolution Specifications: Low dissolution results were obtained during stability testing
Contact the company
What happened, in plain English
Shionogi is recalling 250mg PONSTEL capsules that failed dissolution testing. This could mean the medication doesn't work properly when taken as intended. Read more at govinfonow.com/recall/41597-shionogi-ponstel-capsules-recall-low-dissolution-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/41597-shionogi-ponstel-capsules-recall-low-dissolution-risk · Updated October 8, 2026 · FDA enforcement record: FDA #D-0982-2017
Cite this page
“Shionogi PONSTEL Capsules Recall: Low Dissolution Risk.” GovInfoNow, updated October 8, 2026. https://govinfonow.com/recall/41597-shionogi-ponstel-capsules-recall-low-dissolution-risk. Based on FDA recall #D-0982-2017 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0982-2017%22&limit=1).
Why it’s dangerous
The capsules didn't dissolve properly during stability testing. This could mean the medication isn't released into the body as intended, potentially reducing effectiveness.
Who’s affected
People with prescriptions for these capsules, particularly those who rely on them for pain relief. Those who have the specific lot number 5H66200103 are most at risk.
How to tell if you have this one
Check for the lot number 5H66200103 on the bottle. The product is a 250mg capsule, 30-count bottle, prescription-only item manufactured by Halo Pharmaceutical Inc.
- Brand
Shionogi- Category
Drug
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class III- Status
Terminated- Distribution
Nationwide
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| D-0981-2017 | Mefenamic Acid, 250mg capsules, packaged in 30-count bottles, Rx Only, Distributed by: Prasco Laboratories Mason, OH 45040 USA, Manufactured by: Halo Pharmaceutical Inc. Whippany, NJ 07981, NDC 66993-070-30; Lot #: 5H66200103G, Exp. June 2018. | 6304 bottles |
| D-0982-2017 | PONSTEL (Mefanamic Acid) USP, 250 mg capsules, 30-count bottles, Rx Only, Manufactured for: Shionogi Inc. Florham Park, NJ 07932 Manufactured by: Halo Pharmaceutical Inc. Whippany, NJ 07981; Lot #: 5H66200103, Exp. June 2018 | 455 bottles |
What to do — step by step
Check Product Details
Look for the lot number 5H66200103 on the bottle label.
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 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-0982-2017 (May 24, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0982-2017 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.