D-0535-2026 Class III Ongoing
FDA drug recall D-0535-2026 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: 1,620 bottles.
Recall details
- Product Type
- Drugs
- Report Date
- May 27, 2026
- Initiation Date
- Apr 27, 2026
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,620 bottles
Product description
Primidone Tablets, USP, 250 mg, 100-count bottle, RX only, Manufactured by: Lannett Company, Inc., Marketed by: GSMS, Incorporated, Camarillo, CA 93012. NDC 51407-638-01
Reason for recall
Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
Distribution pattern
USA Nationwide
Code information
Lot #: GS067909, Exp 4/30/2028; GS068646, Exp 8/31/2026
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0535-2026
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026