The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0619-2025·Announced 2025-09-10

Chlorpromazine 200 mg tablets recalled over micro-organism on packaging component

Amneal chlorpromazine hydrochloride tablets, 200 mg, are recalled because a micro-organism was detected on a lot of auxiliary polyester coil used in packaging. No micro-organism was found on any tablets.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: Rubric level 2 covers precautionary recalls; the contamination was found on a packaging component and the notice states no micro-organism was detected on any tablets.

Plain-English summary

Chlorpromazine Hydrochloride Tablets, USP, 200 mg, in 100-count bottles and available on prescription only, manufactured by Amneal Pharmaceuticals Pvt. Ltd. in Ahmedabad, India and distributed by Amneal Pharmaceuticals LLC of Bridgewater, New Jersey, are being recalled. Affected lots are AM240336 and AM240337, both with an expiry of 02/28/2027. The recall covers 3,363 100-count bottles distributed nationwide.

The recall was issued for the presence of a foreign substance: a specific lot of auxiliary polyester coil used in product packaging was found to contain a micro-organism. The notice states that no micro-organism was detected on any tablets. The FDA classified the action as Class II.

Patients should check the lot number on their bottle against the recall and should speak to their pharmacist about a replacement supply before stopping a prescribed medicine.

The recalled product

Product
CHLORPROMAZINE HYDROCHLORIDE (CHLORPROMAZINE HYDROCHLORIDE)
Brand
CHLORPROMAZINE HYDROCHLORIDE
Manufacturer
Amneal Pharmaceuticals, LLC
Category
Drug — Central Nervous System
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (3)

  • Lot: AM240336
  • AM240337
  • Exp Date 02/28/2027.

UPCs (2)

  • 0369238105612
  • 0369238106213

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 5 recalled by Amneal Pharmaceuticals, LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 5 products in this recall →

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