The Recall Desk
Severity pendingFDA (Drugs)·D-0637-2025·Announced 2025-09-17

CHLORPROMAZINE HYDROCHLORIDE (CHLORPROMAZINE HYDROCHLORIDE)

Pending LLM rewrite. Source: FDA_DRUG D-0637-2025.

Severity not yet assessed

We have not scored this recall against our rubric yet, so we are not showing a severity rating or our usual guidance. The agency’s own notice below is the authoritative source — read it first.

Plain-English summary

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

The recalled product

Product
CHLORPROMAZINE HYDROCHLORIDE (CHLORPROMAZINE HYDROCHLORIDE)
Brand
CHLORPROMAZINE HYDROCHLORIDE
Manufacturer
Zydus Pharmaceuticals (USA) Inc

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 (6)

  • Lot #: Z305456
  • Exp Date 31-10-25
  • Z401156
  • Exp Date 28-02-26
  • Z407306
  • Exp Date 30-11-26

Distribution

Distributed nationwide across the United States.