Lower riskDrug recall · FDA · Published February 9, 2022
Lannett Diazepam Oral Solution Recall: Impurities May Cause Harm
Lannett recalls Diazepam Oral Solution bottles with specific lot numbers due to impurities that may cause harm. Consumers should contact the manufacturer for details.
“Lannett Diazepam Oral Solution Recall: Impurities May Cause Harm.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/35227-lannett-diazepam-oral-solution-recall-impurities-may-cause-harm. Based on FDA recall #D-0558-2022 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0558-2022%22&limit=1).
The FDA announced on Feb. 9, 2022, that Lannett Company Inc. is recalling Diazepam Oral Solution (Concentrate) due to failed impurity specifications. The recall affects 23,598 bottles distributed nationwide.
How to tell if you have it
Brand: Lannett
Product: Diazepam Oral Solution (Concentrate), 25 mg per 5 mL (5 mg/mL), 30 mL BOTTLE and DROPPER
NDC: 0527-1768-36
Lot codes: 2664A, 2664B, Exp. date 07/2022; 2874A, 2874B, Exp. date 01/2023
Quantity: 23,598 bottles
The hazard
The product failed to meet specifications for related substances, resulting in out-of-specification results for impurities.
Context
GovInfoNow's records show Lannett Company Inc. has 13 other recalls on record since Oct. 11, 2018. Other recent recalls of similar products include Dextroamphetamine Extended-Release Capsules (2026-06-26), Lannett Niacin Extended-release Tablets (2026-05-27), and Lannett Primidone Tablets (2026-04-24). Other recent recalls of similar products include Sun Pharmaceutical Fluocinolone Acetonide Solution (2025-12-30), Novadoz Glycopyrrolate Oral Solution (2025-12-15), and Sagent Busulfan Injection (2026-05-04).
How to tell if you have this one
Check for lot numbers 2664A, 2664B (expiring 07/2022) or 2874A, 2874B (expiring 01/2023) on the bottle. The product is a 30 mL bottle with a dropper, available by prescription.
Brand
Lannett
Category
Drug
Based on the official FDA remedy
What to do — step by step
Check Product Details
Look for lot numbers 2664A, 2664B (expiring 07/2022) or 2874A, 2874B (expiring 01/2023) on the bottle.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “Product was distributed nationwide in the USA.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 15 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #D-0558-2022 (February 9, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0558-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.