CLASS III Drug recall · Reported 26 Jul 2017 · FDA Enforcement Report
Mefenamic Acid, 250mg capsules recalled by Shionogi
Shionogi is recalling Mefenamic Acid, 250mg capsules, distributed nationwide in the US. The recall was initiated on 24 May 2017 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0981-2017
- FDA event ID
- 77605
- Recalling firm
- Shionogi, Alpharetta, GA
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 24 May 2017
- FDA classified
- 14 Jul 2017
- Reported
- 26 Jul 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
Timeline
| 24 May 2017 | Recall initiated by company | |
| 14 Jul 2017 | Classified by FDA | +51 days |
| 26 Jul 2017 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Dissolution Specifications: Low dissolution results were obtained during stability testing
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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
Where it was distributed
Nationwide
Questions about this recall
Is Mefenamic Acid, 250mg capsules recalled?
Yes. Shionogi recalled Mefenamic Acid, 250mg capsules on 24 May 2017. The recall is Class III and its status is Terminated. Recall number D-0981-2017.
Why was it recalled?
Failed Dissolution Specifications: Low dissolution results were obtained during stability testing
Which lots are affected?
Lot #: 5H66200103G, Exp. June 2018.
Where was it sold?
Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Shionogi
All 5| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Mefenamic Acid Capsules, USP, 250 mg recalled by Shionogi | Shionogi | Particulate Matter | Nationwide |
| Drug | CLASS III | Ponstel (Mefanamic Acid) recalled by Shionogi | Shionogi | Potency & Assay | Nationwide |
| Drug | CLASS III | Nisoldipine Extended Release Tablets, 17 mg recalled by ShionogiNisoldipine | Shionogi | Potency & Assay | Nationwide |
| Drug | CLASS II | Nisoldipine Extended Release Tablets, 17mg recalled by Shionogi | Shionogi | Potency & Assay | PA |