The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories 2025-10-15 Health serious FDA
Health · FDA · Recall #FDA-D-0013-2026
Major ChlorproMAZINE Hydrochloride Tablets, USP, 200 mg, 100 Tablets (10x10) blister… Recall
Issued October 15, 2025 · The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
In October 2025, The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories recalled the Major ChlorproMAZINE Hydrochloride Tablets, USP, 200 mg, 100 Tablets (10x10) blister…, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit
What you should do
- 1 Stop using Major ChlorproMAZINE Hydrochloride Tablets, USP, 200 mg, 100 Tablets (10x10) blister… 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
- October 15, 2025
- Units affected
- Not reported
- Sold at
- Nationwide
- Recall number
- FDA-D-0013-2026
- 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.