Medications & Supplements/Prescription Drugs

Chlorpromazine Hydrochloride Tablets Recalled for Impurity Level

Agency Publication Date: September 10, 2025

Summary

Zydus Pharmaceuticals (USA) Inc. is voluntarily recalling multiple lots of Chlorpromazine Hydrochloride Tablets (10 mg, 25 mg, 50 mg, 100 mg, and 200 mg) because they may contain N-Nitroso Desmethyl Chlorpromazine at levels above the recommended limit. These prescription medications, used to treat various psychiatric disorders and severe nausea, were manufactured by Zydus Lifesciences Ltd. in India and distributed nationwide across the United States. No specific patient injuries or adverse events have been reported to date, but the recall was initiated due to deviations in manufacturing standards regarding chemical impurities.

Risk

The tablets contain a nitrosamine impurity, N-Nitroso Desmethyl Chlorpromazine, at levels that exceed the daily acceptable intake limit. Nitrosamines are classified as probable human carcinogens, meaning long-term exposure to levels above the safety limit may increase the risk of cancer.

What You Should Do

Check your medication bottle for the brand name (Zydus or Northstar Rx LLC) and the dosage strength (10 mg, 25 mg, 50 mg, 100 mg, or 200 mg).
If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.
See the Affected Products section below for the full list of affected codes.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions regarding this recall.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Chlorpromazine Hydrochloride Tablets, USP, 10 mg (100-count bottle)

Variants: 10 mg, Tablet

Lot Numbers:

Z403012 (Exp 30-04-26)

Z406657 (Exp 30-11-26)

NDC:

70710-1129-1

Distributed by: Zydus Pharmaceuticals (USA) Inc.

Product: Chlorpromazine Hydrochloride Tablets, USP, 10 mg (100-count bottle)

Variants: 10 mg, Tablet

Lot Numbers:

Z403011 (Exp 30-04-26)

Z407335 (Exp 30-11-26)

NDC:

16714-047-01

Manufactured for: Northstar Rx LLC

Product: Chlorpromazine Hydrochloride Tablets, USP, 25 mg (100-count bottle)

Variants: 25 mg, Tablet

Lot Numbers:

Z305060 (Exp 31-08-25)

Z305061 (Exp 31-08-25)

Z306323 (Exp 30-11-25)

Z401153 (Exp 28-02-26)

Z403015 (Exp 30-04-26)

Z403016 (Exp 30-04-26)

Z405591 (Exp 30-09-26)

NDC:

70710-1130-1

Distributed by: Zydus Pharmaceuticals (USA) Inc.

Product: Chlorpromazine Hydrochloride Tablets, USP, 25 mg (100-count bottle)

Variants: 25 mg, Tablet

Lot Numbers:

Z305062 (Exp 31-08-25)

Z306324 (Exp 30-11-25)

Z401151 (Exp 28-02-26)

Z401152 (Exp 28-02-26)

NDC:

16714-048-01

Manufactured for: Northstar Rx LLC

Product: Chlorpromazine Hydrochloride Tablets, USP, 50 mg (100-count bottle)

Variants: 50 mg, Tablet

Lot Numbers:

Z306327 (Exp 30-11-25)

Z306748 (Exp 30-11-25)

Z401154 (Exp 28-02-26)

Z403738 (Exp 31-05-26)

Z405645 (Exp 30-09-26)

NDC:

70710-1131-1

Distributed by: Zydus Pharmaceuticals (USA) Inc.

Product: Chlorpromazine Hydrochloride Tablets, USP, 50 mg (100-count bottle)

Variants: 50 mg, Tablet

Lot Numbers:

Z306326 (Exp 30-11-25)

Z401155 (Exp 28-02-26)

NDC:

16714-049-01

Manufactured for: Northstar Rx LLC

Product: Chlorpromazine Hydrochloride Tablets, USP, 100 mg (100-count bottle)

Variants: 100 mg, Tablet

Lot Numbers:

Z305079 (Exp 30-09-25)

Z305080 (Exp 30-09-25)

Z305454 (Exp 31-12-25)

Z305455 (Exp 31-12-25)

Z305457 (Exp 31-12-25)

Z400492 (Exp 31-12-25)

Z400493 (Exp 31-12-25)

Z400494 (Exp 31-12-25)

Z401158 (Exp 28-02-26)

Z401725 (Exp 28-02-26)

Z401726 (Exp 28-02-26)

Z404118 (Exp 30-06-26)

Z404119 (Exp 30-06-26)

Z404120 (Exp 30-06-26)

Z405648 (Exp 30-09-26)

NDC:

70710-1132-1

Distributed by: Zydus Pharmaceuticals (USA) Inc.

Product: Chlorpromazine Hydrochloride Tablets, USP, 100 mg (100-count bottle)

Variants: 100 mg, Tablet

Lot Numbers:

Z305456 (Exp 31-10-25)

Z401156 (Exp 28-02-26)

Z407306 (Exp 30-11-26)

NDC:

16714-050-01

Manufactured for: Northstar Rx LLC

Product: Chlorpromazine Hydrochloride Tablets, USP, 200 mg (100-count bottle)

Variants: 200 mg, Tablet

Lot Numbers:

Z305083 (Exp 30-09-25)

Z305084 (Exp 30-09-25)

Z305468 (Exp 30-09-25)

Z305469 (Exp 30-09-25)

Z305470 (Exp 30-09-25)

Z401163 (Exp 28-02-26)

Z401165 (Exp 28-02-26)

Z402217 (Exp 31-03-26)

Z402218 (Exp 31-03-26)

Z405518 (Exp 31-08-26)

Z405520 (Exp 31-08-26)

Z406235 (Exp 31-10-26)

NDC:

70710-1133-1

Distributed by: Zydus Pharmaceuticals (USA) Inc.

Product: Chlorpromazine Hydrochloride Tablets, USP, 200 mg (100-count bottle)

Variants: 200 mg, Tablet

Lot Numbers:

Z305085 (Exp 30-09-25)

Z401166 (Exp 28-02-26)

Z401167 (Exp 28-02-26)

NDC:

16714-051-01

Manufactured for: Northstar Rx LLC

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 97534

Status: Active

Manufacturer: Zydus Pharmaceuticals (USA) Inc

Sold By: Retail pharmacies; Wholesalers

Manufactured In: India, United States

Distributed To: Nationwide

Agency Last Updated: September 11, 2025

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

Check your medication bottle for the brand name (Zydus or Northstar Rx LLC) and the dosage strength (10 mg, 25 mg, 50 mg, 100 mg, or 200 mg).

If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.

See the Affected Products section below for the full list of affected codes.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions regarding this recall.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Chlorpromazine Hydrochloride Tablets, USP, 10 mg (100-count bottle)

Variants: 10 mg, Tablet

Lot Numbers:

Z403012 (Exp 30-04-26)

Z406657 (Exp 30-11-26)

NDC:

70710-1129-1

Distributed by: Zydus Pharmaceuticals (USA) Inc.

Product: Chlorpromazine Hydrochloride Tablets, USP, 10 mg (100-count bottle)

Variants: 10 mg, Tablet

Lot Numbers:

Z403011 (Exp 30-04-26)

Z407335 (Exp 30-11-26)

NDC:

16714-047-01

Manufactured for: Northstar Rx LLC

Product: Chlorpromazine Hydrochloride Tablets, USP, 25 mg (100-count bottle)

Variants: 25 mg, Tablet

Lot Numbers:

Z305060 (Exp 31-08-25)

Z305061 (Exp 31-08-25)

Z306323 (Exp 30-11-25)

Z401153 (Exp 28-02-26)

Z403015 (Exp 30-04-26)

Z403016 (Exp 30-04-26)

Z405591 (Exp 30-09-26)

NDC:

70710-1130-1

Distributed by: Zydus Pharmaceuticals (USA) Inc.

Product: Chlorpromazine Hydrochloride Tablets, USP, 25 mg (100-count bottle)

Variants: 25 mg, Tablet

Lot Numbers:

Z305062 (Exp 31-08-25)

Z306324 (Exp 30-11-25)

Z401151 (Exp 28-02-26)

Z401152 (Exp 28-02-26)

NDC:

16714-048-01

Manufactured for: Northstar Rx LLC

Product: Chlorpromazine Hydrochloride Tablets, USP, 50 mg (100-count bottle)

Variants: 50 mg, Tablet

Lot Numbers:

Z306327 (Exp 30-11-25)

Z306748 (Exp 30-11-25)

Z401154 (Exp 28-02-26)

Z403738 (Exp 31-05-26)

Z405645 (Exp 30-09-26)

NDC:

70710-1131-1

Distributed by: Zydus Pharmaceuticals (USA) Inc.

Product: Chlorpromazine Hydrochloride Tablets, USP, 50 mg (100-count bottle)

Variants: 50 mg, Tablet

Lot Numbers:

Z306326 (Exp 30-11-25)

Z401155 (Exp 28-02-26)

NDC:

16714-049-01

Manufactured for: Northstar Rx LLC

Product: Chlorpromazine Hydrochloride Tablets, USP, 100 mg (100-count bottle)

Variants: 100 mg, Tablet

Lot Numbers:

Z305079 (Exp 30-09-25)

Z305080 (Exp 30-09-25)

Z305454 (Exp 31-12-25)

Z305455 (Exp 31-12-25)

Z305457 (Exp 31-12-25)

Z400492 (Exp 31-12-25)

Z400493 (Exp 31-12-25)

Z400494 (Exp 31-12-25)

Z401158 (Exp 28-02-26)

Z401725 (Exp 28-02-26)

Z401726 (Exp 28-02-26)

Z404118 (Exp 30-06-26)

Z404119 (Exp 30-06-26)

Z404120 (Exp 30-06-26)

Z405648 (Exp 30-09-26)

NDC:

70710-1132-1

Distributed by: Zydus Pharmaceuticals (USA) Inc.

Product: Chlorpromazine Hydrochloride Tablets, USP, 100 mg (100-count bottle)

Variants: 100 mg, Tablet

Lot Numbers:

Z305456 (Exp 31-10-25)

Z401156 (Exp 28-02-26)

Z407306 (Exp 30-11-26)

NDC:

16714-050-01

Manufactured for: Northstar Rx LLC

Product: Chlorpromazine Hydrochloride Tablets, USP, 200 mg (100-count bottle)

Variants: 200 mg, Tablet

Lot Numbers:

Z305083 (Exp 30-09-25)

Z305084 (Exp 30-09-25)

Z305468 (Exp 30-09-25)

Z305469 (Exp 30-09-25)

Z305470 (Exp 30-09-25)

Z401163 (Exp 28-02-26)

Z401165 (Exp 28-02-26)

Z402217 (Exp 31-03-26)

Z402218 (Exp 31-03-26)

Z405518 (Exp 31-08-26)

Z405520 (Exp 31-08-26)

Z406235 (Exp 31-10-26)

NDC:

70710-1133-1

Distributed by: Zydus Pharmaceuticals (USA) Inc.

Product: Chlorpromazine Hydrochloride Tablets, USP, 200 mg (100-count bottle)

Variants: 200 mg, Tablet

Lot Numbers:

Z305085 (Exp 30-09-25)

Z401166 (Exp 28-02-26)

Z401167 (Exp 28-02-26)

NDC:

16714-051-01

Manufactured for: Northstar Rx LLC