Mefenamic Acid Capsules — Class III drug recall D-0219-2018
Terminated recall by Shionogi Inc., reported 2018-01-24, distributed nationwide. Presence of foreign substance: The recall was initiated due to black particles being observed while performing
| Recall number | D-0219-2018 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Shionogi Inc., Alpharetta, GA, United States |
| Recall initiated | 2017-05-24 |
| Classified | 2018-01-12 |
| Reported by FDA | 2018-01-24 |
| Terminated | 2018-02-28 |
| Distributed | Nationwide (US) |
| Quantity | 968 bottles |
| Reason classes | specification failure |
| NDC | 66993-0070-30 |
| Lot numbers | 12/19, 7H66200103G |
Product
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
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0219-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.