Class II U.S. Food and Drug Administration

Amneal Pharmaceuticals, LLC chlorproMazine Hydrochloride Tablets, USP recall: Presence of a foreign substance.A specific lot of auxiliary polyester coil

Recall published 1+ years ago

Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. No micro-organism was detected on any tablets.

The hazard: Foreign material — foreign objects

This is a foreign-material recall — foreign objects where there should be none. An affected pack looks identical to a sound one from the outside.

What the notice says: Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. No micro-organism was detected on any tablets.

Why it matters: Pieces of foreign objects may be inside the product. The risk here is physical rather than microbial: cuts to the mouth or throat, a broken tooth, or an injury further down if a fragment is swallowed.

Symptoms and when to call a doctor

If someone has swallowed a fragment and has mouth or throat pain, trouble swallowing, chest or stomach pain, vomiting, or blood in saliva or stool, they should be seen the same day. A fragment swallowed without symptoms usually passes on its own, but tell the clinician exactly what the product was: whether it shows up on imaging depends entirely on the material, so describe the product and the notice to them.

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-0618-2025
Published
September 10, 2025
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Amneal Pharmaceuticals, LLC
Product type
Prescription & OTC drugs
Units affected
14,923 100-count bottles
Distribution
Nationwide
Made in
United States
Lot / code info
Lot: AM240334, AM240335, Exp Date 02/28/2027, AM241031, Exp Date 06/30/2027.

Products covered by this recall

chlorproMAZINE Hydrochloride Tablets, USP, 100 mg, 100-count bottle, Rx Only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Oral Solid Dosage Unit, Ahmedabad 382213, INDIA; Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807, NDC 69238-1060-1.

Check your product

The notice names 14 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

Lot or batch code

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

  • AM240334
  • AM240335
  • 28
  • 2027
  • AM241031
  • 30

Best-by / use-by date

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

  • 02
  • 28
  • 2027
  • AM241031
  • 30

NDC number

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

  • 69238-1060-1

Package size

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

  • 100 mg
  • 100 count

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 Foreign material

Amneal Pharmaceuticals, LLC — This is a foreign-material recall — foreign objects where there should be none. An affected pack looks identical to a sound one from the outside.

  1. Stop eating it, and do not pick through it to find the fragment — sorting it by hand is how people get cut.
  2. Check the freezer and the pantry for other packs carrying the same codes before you consider the matter closed.
  3. If someone has already bitten into something hard, have them stop, spit out what is in their mouth and rinse rather than swallow.
  4. Keep the pack if you can. If anyone was hurt, the fragment and the packaging together are the evidence that matters.

Getting a refund without the pack

The commonest reason people skip the refund is that they have already thrown the item away. That rarely matters.

  • A photo of the label and lot code is accepted by most grocers, and so is a card statement line showing the purchase.
  • Store credit is often offered first. You can ask for the original payment method instead, and it is normally granted.
  • No photo either? Ask anyway. Grocery chains settle recall refunds at the service desk because disputing them costs more than paying them.
  • For a multi-pack or a case, ask for the full purchase price rather than a per-unit figure — the recall covers what you paid.

Company contact: Amneal Pharmaceuticals, LLC — 400 Crossing Blvd Fl 3, Bridgewater, NJ, 08807-2863

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 Amneal Pharmaceuticals, LLC prescription & otc drugs recalled?

Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. No micro-organism was detected on any tablets. Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. No micro-organism was detected on any tablets.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: lot code AM240334, AM240335, 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?

Stop eating it, and do not pick through it to find the fragment — sorting it by hand is how people get cut.

Can I get my money back?

A photo of the label and lot code is accepted by most grocers, and so is a card statement line showing the purchase.

Where was the recalled product sold?

It was distributed nationwide.

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