HIGH

Primidone Tablets USP, 250mg, 100-count bottle, Rx only, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136, NDC 0527-1231-01.

Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.

Quick Facts at a Glance

Recall Date
April 24, 2026
Hazard Level
HIGH
Brands
PRIMIDONE, Lannett Company, Inc.
Geographic Scope
1 states

Hazard Information

Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.

What You Should Do

Consumers and healthcare providers should stop using this product immediately. Contact Lannett Company Inc. or your healthcare provider for guidance. Notification method: Letter

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Full Description

Primidone Tablets USP, 250mg, 100-count bottle, Rx only, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136, NDC 0527-1231-01.. Generic: PRIMIDONE; Brand: PRIMIDONE. Reason: Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.. Classification: Class III. Quantity: 44865 bottles. Distribution: USA Nationwide

Safety Guide

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Product Classification

Product Details

Model Numbers
Lot#: 25283038A
Exp 1/31/2028
25283564A
25283565A
Exp 3/31/2028
+6 more
UPC Codes
0527-1231
0527-1301
0527-1301-01
+5 more
Affected States
ALL
Report Date
May 27, 2026
Source Agency
FDA - Drug Safety
Recall Status
ACTIVE

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