Shionogi Recalls Mefenamic Acid Capsules Due to Foreign Particles
Shionogi Inc. is recalling 968 bottles of Mefenamic Acid Capsules, 250 mg, due to the presence of black particles found during routine stability testing.
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 the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences.
Plain-English summary
Shionogi Inc. is recalling 968 bottles of Mefenamic Acid Capsules, USP, 250 mg, 30-count bottles. The product is distributed by Prasco Laboratories and manufactured by Halo Pharmaceutical Inc. The specific lot number is 7H66200103G with an expiration date of 12/19.
The recall was initiated because black particles were observed during routine post-release stability testing. The FDA has classified this as a Class III recall, indicating that the product is unlikely to cause adverse health consequences.
Consumers should check their medication for the specific lot number and expiration date listed above. If the product matches the recall details, they should stop using it and contact their healthcare provider or pharmacist for instructions on how to dispose of or return the medication.
The recalled product
- 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
- Manufacturer
- Shionogi Inc.
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 968
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#: 7H66200103G
- Exp 12/19
Distribution
Distributed nationwide across the United States.
Related recalls
Same manufacturer · Shionogi Inc.
See all →- LowShionogi Recalls PONSTEL Capsules Due to Failed Dissolution Specifications
FDA (Drugs) · 2017-07-26
- LowShionogi Recalls Mefenamic Acid Capsules for Dissolution Failures
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 · foreign substance
See all →- ModerateHeritage Pharmaceuticals Recalls Clindamycin Palmitate Hydrochloride Due to Foreign Particles
FDA (Drugs) · 2026-08-19
- HighPrednisolone Acetate Ophthalmic Suspension Recalled for Foreign Substance
FDA (Drugs) · 2026-07-08
- ModerateCorlanor Ivabradine Tablets Recalled for Foreign Substance Contamination
FDA (Drugs) · 2026-07-01
- LowHydroxyzine Hydrochloride Oral Solution recalled for foreign substance
FDA (Drugs) · 2026-07-01
- ModerateCorlanor ivabradine tablets recalled for presence of foreign substance
FDA (Drugs) · 2026-07-01