The Recall Desk
HighFDA (Drugs)·D-0636-2025·Announced 2025-09-17

[pending] CHLORPROMAZINE HYDROCHLORIDE (CHLORPROMAZINE HYDROCHLORIDE)

Pending LLM rewrite. Source: FDA_DRUG D-0636-2025.

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: Pending LLM scoring against the rubric.

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 (20)

  • Lot #: Z305079
  • Z305080
  • Exp Date 30-09-25
  • Z305454
  • Z305455
  • Z305457
  • Z400492
  • Z400493
  • Z400494
  • Exp Date 31-12-25
  • Z401158
  • Z401725
  • Z401726
  • Exp. Date 28-02-26
  • Z404118
  • Z404119
  • Z404120
  • Exp Date 30-06-26
  • Z405648
  • Exp Date 30-09-26

UPCs (3)

  • 0370710112912
  • 0370710113216
  • 0370710113018

Distribution

Distributed nationwide across the United States.