The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories 2025-02-26 Health serious FDA
Health · FDA · Recall #FDA-D-0226-2025
Lorazepam Tablets, USP, 0.5mg, Unit Dose, 100 tablets per carton (10 x 10 blister packs),… Recall
Issued February 26, 2025 · The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
In February 2025, The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories recalled the Lorazepam Tablets, USP, 0.5mg, Unit Dose, 100 tablets per carton (10 x 10 blister packs),…, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
Failed impurities/degradation specifications and Sub-potent Drug: Out-of-specification results were obtained during routine stability testing for Assay and Impurities.
What you should do
- 1 Stop using Lorazepam Tablets, USP, 0.5mg, Unit Dose, 100 tablets per carton (10 x 10 blister packs),… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
- Category
- Health
- Recall date
- February 26, 2025
- Units affected
- Not reported
- Sold at
- Nationwide U.S. and Puerto rico
- Recall number
- FDA-D-0226-2025
- Made in
- United States
- Issuing agency
- FDA
In context
- The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories has 12 recalls in our database, including 2 rated Critical.
- We're tracking 3,576 Health recalls in our database.
- This is the 691st Health recall we've logged in 2025.