High FDA (Drugs)·D-0634-2025·Announced 2025-09-17

Chlorpromazine 50 mg tablets recalled over nitrosamine exceeding acceptable intake limit

Zydus Chlorpromazine Hydrochloride Tablets, USP, 50 mg, are recalled nationwide because N-Nitroso Desmethyl Chlorpromazine was found above the recommended acceptable intake limit.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: Rubric level 3 covers risk-of-harm products where injury has not yet been reported; a nitrosamine above the recommended acceptable intake limit is a potential harm and no injuries are reported.

Plain-English summary

Chlorpromazine Hydrochloride Tablets, USP, 50 mg, in 100-count bottles and available on prescription only, manufactured by Zydus Lifesciences Ltd. in Baddi, India and distributed by Zydus Pharmaceuticals (USA) Inc. of Pennington, New Jersey, NDC 70710-1131-1, are being recalled. Affected lots include Z306327 and Z306748 expiring 30-11-25, Z401154 expiring 28-02-26 and Z403738, with the full list in the recall notice. Distribution was nationwide.

The recall follows current good manufacturing practice deviations: the presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit. The FDA classified the action as Class II.

Patients should check the lot number on their bottle against the recall and should not stop taking a prescribed medicine without speaking to their pharmacist or prescriber about a replacement supply.

The recalled product

Product: CHLORPROMAZINE HYDROCHLORIDE (CHLORPROMAZINE HYDROCHLORIDE)
Brand: CHLORPROMAZINE HYDROCHLORIDE
Manufacturer: Zydus Pharmaceuticals (USA) Inc
Category: Drug — Central Nervous System
Hazard: nitrosamine-impurity
cgmp-deviation
prescription-drug
class-ii

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 (9)

Lot #: Z306327
Exp Date 30-11-25
Z306748
Z401154
Exp Date 28-02-26
Z403738
Exp Date 31-05-26
Z405645
Exp Date 30-09-26

UPCs (3)

0370710112912
0370710113216
0370710113018

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 10 recalled by Zydus Pharmaceuticals (USA) Inc 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 10 products in this recall →

Same brand · CHLORPROMAZINE HYDROCHLORIDE

Moderate
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FDA (Drugs) · 2025-09-24
Moderate
Chlorpromazine 50 mg blisterpacks recalled over micro-organism on packaging coil
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Moderate
Packaged chlorpromazine cartons recalled over micro-organism on packaging coil
FDA (Drugs) · 2025-09-24
Moderate
Chlorpromazine 25 mg blisterpacks recalled over micro-organism on packaging coil
FDA (Drugs) · 2025-09-24
High
Zydus chlorpromazine 100 mg tablets recalled over nitrosamine impurity above limit
FDA (Drugs) · 2025-09-17

Same manufacturer · Zydus Pharmaceuticals (USA) Inc

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Same hazard · nitrosamine impurity