D-0534-2026 Class III Ongoing
FDA drug recall D-0534-2026 was initiated by Golden State Medical Supply Inc. on Apr 27, 2026 and is designated Class III. Reason for recall: Cross contamination with other products: API contaminated with trace amounts of Acemetacin API. The recall status is ongoing. Affected quantity: 8,526 bottles.
Recall details
- Product Type
- Drugs
- Report Date
- May 27, 2026
- Initiation Date
- Apr 27, 2026
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 8,526 bottles
Product description
Primidone Tablets, USP, 50 mg, 50-count bottle, RX only, Manufactured by: Lannett Company, Inc., Marketed by: GSMS, Incorporated, Camarillo, CA 93012. NDC 51407-637-05
Reason for recall
Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
Distribution pattern
USA Nationwide
Code information
Lot#: GS066750, GS067084, GS067710, GS067873, Exp 3/31/2028; GS068339, GS068897, Exp 8/31/2028
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0534-2026
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026