The Recall Desk
ModerateFDA (Drugs)·D-0534-2026·Announced 2026-05-27

Primidone Tablets Recalled Due to API Cross-Contamination

Golden State Medical Supply Inc. is recalling Primidone 50 mg tablets due to cross-contamination of the active pharmaceutical ingredient with trace amounts of Acemetacin API. The recall affects 8,526 bottles distributed nationwide.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The source text classifies this as FDA Class III, which by definition is unlikely to cause adverse health consequences. The recall involves trace-level cross-contamination with no reported illnesses or injuries, qualifying it as a Moderate (score 2) recall per the rubric for low-risk manufacturing/labeling issues.

Plain-English summary

Golden State Medical Supply Inc. is recalling Primidone (Primidone Tablets, USP, 50 mg) because the active pharmaceutical ingredient (API) has been contaminated with trace amounts of Acemetacin API. This cross-contamination resulted from manufacturing issues.

The affected product is Primidone 50 mg tablets in 50-count bottles with NDC 51407-637-05, distributed nationwide in the United States. The following lot numbers are affected: GS066750, GS067084, GS067710, GS067873 (expiration 3/31/2028); and GS068339, GS068897 (expiration 8/31/2028). A total of 8,526 bottles have been recalled.

Patients currently taking this medication should contact their healthcare provider or pharmacist to discuss their treatment options. Consumers should not stop taking their medication without consulting a healthcare professional. Return unused product to the pharmacy where it was obtained.

The recalled product

Product
PRIMIDONE (PRIMIDONE)
Brand
PRIMIDONE
Manufacturer
Golden State Medical Supply Inc.
Category
Drug — Prescription - Antiepileptic
Hazard
Affected units
8,526

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 (8)

  • Lot#: GS066750
  • GS067084
  • GS067710
  • GS067873
  • Exp 3/31/2028
  • GS068339
  • GS068897
  • Exp 8/31/2028

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by Golden State Medical Supply 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 brand · PRIMIDONE

Same manufacturer · Golden State Medical Supply Inc.

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Same hazard · cross contamination

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