Shionogi Recalls Mefenamic Acid Capsules for Dissolution Failures
Shionogi Inc. is recalling Mefenamic Acid 250mg capsules because stability testing showed low dissolution results.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The FDA classified this as a Class III recall, which by definition is unlikely to cause adverse health consequences. The issue is a failure to meet dissolution specifications without reported injuries.
Plain-English summary
Shionogi Inc. is recalling Mefenamic Acid, 250mg capsules, packaged in 30-count bottles. The product is distributed by Prasco Laboratories and manufactured by Halo Pharmaceutical Inc. The recall involves 6,304 bottles with Lot # 5H66200103G and an expiration date of June 2018.
The recall was initiated because low dissolution results were obtained during stability testing. This indicates that the medication may not dissolve at the required rate, which could affect its performance.
The affected product was distributed nationwide. Consumers and healthcare providers should stop using the recalled product and contact their pharmacist or physician for guidance on replacement or disposal.
The recalled product
- Product
- 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
- Manufacturer
- Shionogi Inc.
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 6,304
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot #: 5H66200103G
- Exp. June 2018.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Shionogi Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
Same manufacturer · Shionogi Inc.
See all →- LowShionogi Recalls Mefenamic Acid Capsules Due to Foreign Particles
FDA (Drugs) · 2018-01-24
- LowShionogi Recalls PONSTEL Capsules Due to Failed Dissolution Specifications
FDA (Drugs) · 2017-07-26
- LowShionogi Recalls Nisoldipine Extended Release Tablets for Failed Dissolution Specifications
FDA (Drugs) · 2015-08-12
- ModerateShionogi Recalls Nisoldipine Extended Release Tablets for Dissolution Failure
FDA (Drugs) · 2012-07-04
Same hazard · dissolution failure
See all →- ModerateApotex Recalls Paxil Tablets for Failed Dissolution and Stability Testing
FDA (Drugs) · 2026-09-02
- ModerateMylan Recalls Acamprosate Calcium Tablets Due to Dissolution Failure
FDA (Drugs) · 2026-08-26
- ModerateChlorthalidone 25mg tablets failed dissolution specifications in two batches
FDA (Drugs) · 2026-06-24
- ModerateNiacin extended-release tablets failed dissolution testing at 24 hours
FDA (Drugs) · 2026-06-17
- ModerateMinocycline extended-release tablets failed dissolution testing during stability analysis
FDA (Drugs) · 2026-06-17