CLASS III Drug recall · Reported 24 Jan 2018 · FDA Enforcement Report
Mefenamic Acid Capsules, USP, 250 mg recalled by Shionogi
Shionogi is recalling Mefenamic Acid Capsules, USP, 250 mg, 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-0219-2018
- FDA event ID
- 78851
- Recalling firm
- Shionogi, Alpharetta, GA
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 24 May 2017
- FDA classified
- 12 Jan 2018
- Reported
- 24 Jan 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Particulate Matter
Timeline
| 24 May 2017 | Recall initiated by company | |
| 12 Jan 2018 | Classified by FDA | +233 days |
| 24 Jan 2018 | 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
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
Product as listed by the FDA
Mefenamic Acid Capsules, USP, 250 mg, 30-count bottle, Rx only, Distributed by Prasco Laboratories, Mason, OH 45040, Manufactured by Halo Pharmaceutical Inc., Whippany, NJ 07981, NDC 66993-070-30
Where it was distributed
U.S.A. Nationwide
Questions about this recall
Is Mefenamic Acid Capsules, USP, 250 mg recalled?
Yes. Shionogi recalled Mefenamic Acid Capsules, USP, 250 mg on 24 May 2017. The recall is Class III and its status is Terminated. Recall number D-0219-2018.
Why was it recalled?
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
Which lots are affected?
Lot#: 7H66200103G, Exp 12/19
Where was it sold?
U.S.A. 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, 250mg capsules recalled by Shionogi | Shionogi | Potency & Assay | 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 |