CLASS II Drug recall · Reported 23 Feb 2022 · FDA Enforcement Report
Diazepam Oral Solution (Concentrate), 25 mg recalled by Lannett Company
Lannett Company is recalling Diazepam Oral Solution (Concentrate), 25 mg per (5 mg/mL) Bottle and Dropper, distributed nationwide in the US. The recall was initiated on 9 Feb 2022 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0558-2022
- FDA event ID
- 89551
- Recalling firm
- Lannett Company, Philadelphia, PA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 9 Feb 2022
- FDA classified
- 14 Feb 2022
- Reported
- 23 Feb 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Anxiety & Sleep Medication
Timeline
| 9 Feb 2022 | Recall initiated by company | |
| 14 Feb 2022 | Classified by FDA | +5 days |
| 23 Feb 2022 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Impurities/Degradation Specifications: Out of specification results for related substances.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Diazepam Oral Solution (Concentrate), 25 mg per 5 mL (5 mg/mL), 30 mL BOTTLE and DROPPER, Rx Only, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136, NDC 0527-1768-36.
Where it was distributed
Product was distributed nationwide in the USA.
Questions about this recall
Is Diazepam Oral Solution (Concentrate), 25 mg per (5 mg/mL) Bottle and Dropper recalled?
Yes. Lannett Company recalled Diazepam Oral Solution (Concentrate), 25 mg per (5 mg/mL) Bottle and Dropper on 9 Feb 2022. The recall is Class II and its status is Terminated. Recall number D-0558-2022.
Why was it recalled?
Failed Impurities/Degradation Specifications: Out of specification results for related substances.
Which lots are affected?
Lot #: 2664A, 2664B, Exp. date 07/2022; 2874A, 2874B, Exp. date 01/2023
Where was it sold?
Product was distributed nationwide in the USA.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Lannett Company
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|---|---|---|---|---|---|
| Drug | CLASS II | Dextroamphetamine Saccharate recalled by Lannett CompanyDextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate And Amphetamine Sulfate | Lannett Company | Packaging Defects | Nationwide |
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Other Diazepam recalls
All 8| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Diazepam Rectal Gel, 5 mg, Twin Pack that Contains recalledDiazepam | Valeant Pharmaceuticals North America | Other | Nationwide |
| Drug | CLASS II | Diazepam Injection USP 10mg/ (5 mg/mL recalled by HospiraDiazepam | Hospira | Particulate Matter | Nationwide |
| Drug | CLASS II | Diazepam Injection, USP, 5 mg/mL recalled by HospiraDiazepam | Hospira | Sterility | Nationwide |
| Drug | CLASS II | Diazepam Injection, USP 5 mg/mL, Multiple-dose fliptop vial recalledDiazepam | Hospira | Sterility | Nationwide |
| Drug | CLASS II | Diazepam Injection, USP 5 mg/mL, Multiple-dose fliptop vial recalledDiazepam | Hospira | Sterility | Nationwide |