Primidone recalls: 6 FDA reports
Recalls involving Primidone. What was wrong with each batch, and how the FDA graded the risk.
6Reports
0Class I
6Ongoing
2026-06-17Most recent
What the classes mean
The FDA sorts every recall into one of three classes. The class is the whole story. It is also the part people skip.
Class II is the bulk of every list here. That matters. A long list of Class II says something different from one Class I.
By class
Checking whether it affects you
The lot or code number is what matters. Not the product name. A recall covers
specific lots. Yours may not be one of them.
Check the code on your package against the report. The FDA keeps the current
list at fda.gov/safety/recalls.
The reports
The text below is quoted from the FDA record word for word.
Primidone Tablets, USP, 50 mg, 100 Tablets per Bottle, Rx only, Manufactured by: Amneal Pharmaceuticals Pvt. L
D-0585-2026 · Class III · reported 2026-06-17 · Ongoing
- Why it was recalled
- Cross Contamination with Other Products: due to a potential for cross-contamination with Acemetacin API due to an issue at the API manufacturer.
- Product
- Primidone Tablets, USP, 50 mg, 100 Tablets per Bottle, Rx only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Oral Solid Dosage Unit, Ahmedabad 382213, INDIA. Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807. NDC: 53746-544-01
- Where it went
- Nationwide within the USA.
- How much
- 27,936 100-count bottles
Primidone Tablets, USP, 50 mg, 100 Tablets (10 x 10 unit dose blister) per carton, Rx only, Distributed by: Am
D-0537-2026 · Class III · reported 2026-05-27 · Ongoing
- Why it was recalled
- Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
- Product
- Primidone Tablets, USP, 50 mg, 100 Tablets (10 x 10 unit dose blister) per carton, Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217. Carton NDC: 68084-202-01; Individual Dose NDC: 68084-202-11
- Where it went
- USA Nationwide
- How much
- 225,000 tablets
Primidone Tablets, USP, 50 mg, 50-count bottle, RX only, Manufactured by: Lannett Company, Inc., Marketed by:
D-0534-2026 · Class III · reported 2026-05-27 · Ongoing
- Why it was recalled
- Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
- Product
- 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
- Where it went
- USA Nationwide
- How much
- 8,526 bottles
Primidone Tablets, USP, 250 mg, 100-count bottle, RX only, Manufactured by: Lannett Company, Inc., Marketed by
D-0535-2026 · Class III · reported 2026-05-27 · Ongoing
- Why it was recalled
- Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
- Product
- 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
- Where it went
- USA Nationwide
- How much
- 1,620 bottles
Primidone Tablets, USP, 250 mg, 100 Tablets (10 x 10 unit dose blister) per carton, Rx only, Distributed by: A
D-0536-2026 · Class III · reported 2026-05-27 · Ongoing
- Why it was recalled
- Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
- Product
- Primidone Tablets, USP, 250 mg, 100 Tablets (10 x 10 unit dose blister) per carton, Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217. Carton NDC: 68084-203-01; Individual Dose NDC: 68084-203-11
- Where it went
- USA Nationwide
- How much
- 63,500 tablets
Primidone Tablets USP, 250mg, 100-count bottle, Rx only, Distributed by: Lannett Company, Inc., Philadelphia,
D-0533-2026 · Class III · reported 2026-05-27 · Ongoing
- Why it was recalled
- Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
- Product
- Primidone Tablets USP, 250mg, 100-count bottle, Rx only, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136, NDC 0527-1231-01.
- Where it went
- USA Nationwide
- How much
- 44865 bottles
Read these counts with three things in mind
A firm with more recalls usually makes more products. A contract packer runs
hundreds of lines. It will out-recall a company with one product whatever either
does. This is not a safety ranking.
Most recalls here are voluntary. A firm found its own fault and pulled the stock.
That is the system working. It lands in this database looking the same as a recall
the FDA had to push for.
Terminated means the FDA considers the recall finished. It is not a verdict.
It does not mean anyone was harmed.
Source: openFDA enforcement reports, retrieved 2026-08-05. FDA dataset last updated 2026-07-29.
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