Primidone Tablets, 50 mg recall — Golden State Medical Supply Inc. (Class III)

Golden State Medical Supply Inc. is recorded by the U.S. Food and Drug Administration (FDA) as recalling Primidone Tablets, 50 mg — a Class III recall, initiated 2026-04-27 and posted to the FDA enforcement report on 2026-05-27, under recall number D-0534-2026. Status Ongoing, with no termination date on the record. The reason the FDA record carries is, verbatim: “Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.”. From the product description, the form is tablets, the strength given is 50 mg, the package is described as 50-count bottle and it is marked Rx only. 1 National Drug Code number is printed in the record: 51407-637-05. Distribution is recorded as “USA Nationwide” — Nationwide (US), with the recalling firm on record in CA, United States. The FDA files it under event ID 98856 together with 1 other recall number, all listed and linked below. Within that event this is the strength 50 mg, package 50-count bottle and ndc 51407-637-05 configuration; the sibling records differ on strength, package and ndc and match on everything else the source states. Values are reproduced from the linked openFDA report; regulatory information, not medical advice.

Regulatory snapshot

Recall number D-0534-2026
FDA event ID 98856 (2 recall numbers)
Classification Class III (least serious regulatory tier)
Status Ongoing
Recalling firm Golden State Medical Supply Inc.
Recall initiated 2026-04-27
Reported by FDA 2026-05-27
Report lag 30 days from initiation to report
Distribution USA Nationwide — Nationwide (US)
Firm location on record CA, United States
Product description (source) 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 reported by FDA

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

13 words from the enforcement report field reason_for_recall, reproduced without edit — the firm's own wording, not an assessment.

Product identifiers in this record

6 identifying values matched by exact pattern in the 23-word product description above; each is a literal substring of it.

Product named Primidone Tablets
Form Tablets
Strength 50 mg
Package 50-count bottle
NDC 51407-637-05
Marketing category Rx only
Manufactured by Lannett Company, Inc.

Which configuration this record is

2 recall numbers share event 98856. They differ on strength, package and ndc and agree on everything else the source states, so those are the values to check a package against.

Attribute This record (D-0534-2026) D-0535-2026
Strength 50 mg 250 mg
Package 50-count bottle 100-count bottle
NDC 51407-637-05 51407-638-01

Shared across all 2 records under this event: form Tablets; product named Primidone Tablets; fda tier Class III; recalling firm Golden State Medical Supply Inc.; the same reason text; initiated 2026-04-27; reported 2026-05-27.

Event context: 2 recall numbers under event 98856

One enforcement action, 2 recall numbers: the FDA filed 1 further configuration of this action under event 98856. Each keeps its own recall number and dates.

Recall recordRecall numberFDA tierStrength / formNDCReported
Primidone Tablets, 250 mgD-0535-2026Class III250 mg · Tablets51407-638-012026-05-27

Other indexed recalls from Golden State Medical Supply Inc.

3 indexed records name Golden State Medical Supply Inc. as the recalling firm, across 2 FDA events, reported 2026-05-27 to 2026-06-17. A coverage-limited activity count over the ingested window, not a quality rating.

Recall recordRecall numberFDA tierStrength / formReported
GSMS Incorporated, 1,000 MGD-0587-2026Class II1,000 MG · Extended-Release Tablets2026-06-17

Other indexed recalls of primidone

6 indexed records name primidone as the recalled substance. Matching is on the product-name prefix of the FDA's own text, so other strengths and packages are included.

Recall recordRecall numberRecalling firmStrength / formReported
Primidone Tablets, 50 mgD-0585-2026Amneal Pharmaceuticals, LLC50 mg · Tablets2026-06-17
Primidone Tablets USP, 250mgD-0533-2026Lannett Company Inc.250mg · Tablets2026-05-27
Primidone Tablets, 250 mgD-0536-2026Amerisource Health Services LLC250 mg · Tablets2026-05-27
Primidone Tablets, 50 mgD-0537-2026Amerisource Health Services LLC50 mg · Tablets2026-05-27

Reported in the same month (2026-05)

48 enforcement reports carry a report date in 2026-05; these 4 are the Class III ones nearest this record.

Recall recordRecall numberRecalling firmFDA tierReported
Busulfan Injection, 60 mgD-0539-2026Sagent PharmaceuticalsClass III2026-05-27
busPIRone Hydrochloride Tablets, 5 mgD-0511-2026Unichem Pharmaceuticals Usa Inc.Class III2026-05-13
Levocarnitine Injection, 1 g/5 mLD-0494-2026American Regent, Inc.Class III2026-05-06
Lidocaine Wound Gel, 0.13%D-0509-2026Water-jel Technologies, LLCClass III2026-05-06

Nearest Class III recalls by date

25 of 250 indexed records share the Class III tier; the 6 nearest to 2026-05-27 by report date are listed here.

Recall recordRecall numberRecalling firmStrength / formReported
Nicotine Transdermal System Patch, 14 mgD-0550-2026Aveva Drug Delivery Systems, Inc.14 mg · Transdermal System2026-06-03
PRED MILD, 0.12%D-0551-2026Abbvie Inc.0.12% · Ophthalmic Suspension2026-06-03
Lidocaine HCl Injection, 2%D-0552-2026Eugia US LLC2% · Injection2026-06-10
Epinephrine Injection, 1mg/mLD-0581-2026Fresenius Kabi Usa, LLC1mg/mL · Injection2026-06-17
Premier, 8 mLD-0490-2026Premier Dental Products Co8 mL · Solution2026-04-29
Focalin XR (dexmethylphenidate HCl) 5 mgD-0608-2026Sandoz Inc5 mg · Extended-Release Capsules2026-06-24

Reading this record

Class III is the FDA's own severity tier for the recall action — 25 of the 250 indexed records carry it — and it describes the agency's assessment of the action, not a risk statement about any individual. A search on event 98856 returns all 2 of these recall numbers; a search on D-0534-2026 returns only this configuration. Match a package against 51407-637-05 at the FDA source to confirm it is covered.

Namespace context: the Class III index (25 records) and the recall hub (250 records, 118 FDA events); Golden State Medical Supply Inc. (3 indexed records) aggregates this firm across datasets.

Coverage and limits of this record

This page reflects the openFDA enforcement report for D-0534-2026 as ingested on 2026-08-22, which can lag the live FDA record and omits detail held only in primary documents. It offers no clinical assessment, no advice about whether to use any product, and no substitute. For any health question consult a qualified healthcare professional.

Source & provenance

Official source
https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0534-2026%22
Source dataset
openFDA Drug Enforcement API
Publication date
2026-05-27
Ingested
2026-08-22
Record hash
66541ecf15407c73

Verify every value against the official FDA source above. This site links to the regulator's record rather than replacing it.