Class II U.S. Food and Drug Administration

Major ChlorproMazine Hydrochloride Tablets, USP, 25 mg recall: CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above

Recall published 1+ years ago

CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit

The hazard: Labelling or manufacturing-practice failure

A labelling or good-manufacturing-practice failure prompted this notice. Pharmacies and patients both rely on the printed carton being right.

What the notice says: CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit

Why it matters: The label, the strength printed on it, the barcode or the manufacturing records do not meet federal requirements. The practical danger is someone taking the wrong drug or the wrong dose while believing they have the right one.

Symptoms and when to call a doctor

If you may have taken a product that turned out to be a different drug or strength from the one on the label, call your prescriber, and call Poison Control on 1-800-222-1222 if you feel unwell. Describe what the pack said and what you actually took.

This page is general information, not medical advice. If you feel unwell, a clinician who can see you is the only person able to judge your case.

Recall details

Recall number
D-0009-2026
Published
October 15, 2025
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Major Pharmaceuticals and Rugby Laboratories
Product type
Prescription & OTC drugs
Units affected
2064 blister packs
Distribution
Nationwide
Made in
United States
Lot / code info
Lots N01943 and Lot N02025, exp. date 02/28/2026
UPC codes
00309047130061

Products covered by this recall

Major ChlorproMAZINE Hydrochloride Tablets, USP, 25 mg, 50 Tablets (5x10) blister package, Rx Only, Packaged and Distributed by Major Pharmaceuticals, Indianapolis, IN 46268, USA, NDC 0904-7130-06, UPC (01)00309047130061

Check your product

The notice names 8 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

UPC / barcode

Read the twelve digits under the barcode on the package.

  • 00309047130061

Lot or batch code

Usually ink-stamped near the seam, the cap or the bottom of the pack.

  • N01943
  • Lot N02025
  • 28

Best-by / use-by date

Printed beside the lot code, not on the price sticker.

  • 02
  • 28

NDC number

On the carton and again on the bottle or blister label.

  • 0904-7130-06

Package size

Match the net weight or the piece count on the front of the pack.

  • 25 mg

Codes are lifted verbatim from the FDA — Drug enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Labelling

Major Pharmaceuticals and Rugby Laboratories — A labelling or good-manufacturing-practice failure prompted this notice. Pharmacies and patients both rely on the printed carton being right.

  1. Compare the lot number and strength on your pack with the codes above and with what your prescription actually says.
  2. Report a mismatch to FDA MedWatch, especially if it reached you rather than being caught at the counter.
  3. If what you were dispensed does not match your prescription, call the pharmacy before taking another dose.
  4. Keep taking the medicine as prescribed unless the notice or your prescriber says otherwise.

Getting a replacement supply

Do not let a refund question interrupt your treatment. Deal with the supply first and the money second.

  • Call the pharmacy before you run low. They can see which lot they dispensed to you and will usually swap it the same day.
  • Insurers do not normally count a recall replacement against a refill limit. If one is refused, ask the pharmacist to call it through as a recall override.
  • Over-the-counter products are refunded at the till like any other purchase; the recall notice on your phone is enough to explain the return.
  • If the manufacturer runs a direct reimbursement form, it will be linked from the official notice on this page.

Company contact: The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories — 341 Mason Rd, La Vergne, TN, 37086-3606

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Drug enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Major Pharmaceuticals and Rugby Laboratories prescription &… recalled?

CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 00309047130061; lot code N01943, Lot N02025, 28; best-by date 02 or 28. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Compare the lot number and strength on your pack with the codes above and with what your prescription actually says.

Can I get my money back?

Call the pharmacy before you run low. They can see which lot they dispensed to you and will usually swap it the same day.

Where was the recalled product sold?

It was distributed nationwide.

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