Lorazepam Tablets recall
FDA recall D-0228-2025 · initiated Jan 21, 2025
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories recalled Lorazepam Tablets in Jan 2025 — an FDA Class II recall (D-0228-2025) because Failed impurities/degradation specifications and Sub-potent Drug: Out-of-specification results were obtained during routine stability testing for Assay and Impurities.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Failed impurities/degradation specifications and Sub-potent Drug: Out-of-specification results were obtained during routine stability testing for Assay and Impurities.
Wrong strength, or it did not keep
The product did not contain what the label promised, or stopped meeting specification before its expiry date. Under-strength medicine can mean an untreated condition.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 27,525 cartons
Details
- Product
- Lorazepam Tablets, USP, 2mg, Unit Dose, 100 tablets per carton (10 x 10 blister packs), Rx only, The drug product contained in this package is from NDC # 69315-906 Leading Pharma, LLC., Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 26268 USA, NDC: 0904-6009-61.
- Recalling company
- The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide U.S. and Puerto rico
- Initiated
- Jan 21, 2025
- FDA report date
- Feb 26, 2025
Frequently asked
- Was Lorazepam Tablets recalled?
- The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories recalled Lorazepam Tablets in Jan 2025 — an FDA Class II recall (D-0228-2025) because Failed impurities/degradation specifications and Sub-potent Drug: Out-of-specification results were obtained during routine stability testing for Assay and Impurities. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Lorazepam Tablets recalled?
- Per the FDA enforcement record, the reason for recall D-0228-2025 was: Failed impurities/degradation specifications and Sub-potent Drug: Out-of-specification results were obtained during routine stability testing for Assay and Impurities.
- Is a recalled Lorazepam Tablets dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Lorazepam Tablets are affected?
- Distributed: Nationwide U.S. and Puerto rico. The recall covers these lots — Lot #s: N01422, N01423, Exp 03/31/2025; N01661, N01662, Exp 09/30/2025; N01746, N01750, Exp 10/31/2025; N01876, N01877, Exp 03/31/2026; N01899, N01900, N01975, Exp 04/30/2026.. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0228-2025.