Medications & Supplements/Prescription Drugs

Jubilant Cadista Prochlorperazine Maleate Tablets Recalled for Subpotency

Agency Publication Date: January 5, 2023

Summary

Jubilant Cadista Pharmaceuticals, Inc. has voluntarily recalled 14,061 bottles of Prochlorperazine Maleate (the generic equivalent of Compazine) 5mg tablets. The recall was issued because the medication was found to be subpotent during stability testing at the 18-month mark. There have been no reports of injuries or illnesses related to this recall to date.

Risk

Subpotent medication contains less of the active ingredient than specified, which means the drug may not be effective in treating the symptoms or conditions for which it was prescribed.

What You Should Do

The recalled products are 100-count bottles of Prochlorperazine Maleate Tablets, USP 5mg, labeled under the Jubilant Cadista Pharmaceuticals, Inc. brand with NDC 59746-113-06.
Check the bottle packaging for lot number 21P0336 with an expiration date of 04/2023.
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.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) if you have 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: Prochlorperazine Maleate Tablets, USP 5mg (100 tablets)

Variants: 5mg, 100 tablets, RX Only

Lot Numbers:

21P0336 (Exp: 04/2023)

NDC:

59746-113-06

Recall #: D-0096-2023; Manufactured in Salisbury, Maryland.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 91412

Status: Resolved

Manufacturer: Jubilant Cadista Pharmaceuticals, Inc.

Sold By: pharmacies

Manufactured In: United States

Units Affected: 14,061 bottles

Distributed To: Nationwide

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

The recalled products are 100-count bottles of Prochlorperazine Maleate Tablets, USP 5mg, labeled under the Jubilant Cadista Pharmaceuticals, Inc. brand with NDC 59746-113-06.

Check the bottle packaging for lot number 21P0336 with an expiration date of 04/2023.

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.

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