Medications & Supplements/Prescription Drugs

Risedronate Sodium Tablets Recalled for Failed Quality Specifications

Agency Publication Date: April 7, 2022

Summary

Macleods Pharma USA Inc has recalled 4,872 bottles of Risedronate Sodium Tablets (5 mg), a prescription medication used to treat and prevent osteoporosis. The recall was issued because the tablets failed content uniformity specifications, which means the amount of active medication may not be consistent across all tablets. No incidents or injuries have been reported to date.

Risk

If a tablet does not contain the specified amount of the active ingredient, the medication may be less effective at treating the patient's condition or could result in inconsistent dosing.

What You Should Do

The recalled product is Risedronate Sodium Tablets, USP, 5 mg, sold in 30-count bottles with NDC 33342-107-07.
Identify affected bottles by checking for lot number BRD2001A with an expiration date of 05/2022 printed on the label.
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 Macleods Pharma USA Inc for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.

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: Risedronate Sodium Tablets, USP, 5 mg (30-count bottle)

Variants: 5 mg, 30-count bottle, Rx Only

Lot Numbers:

BRD2001A (Exp 5/2022)

NDC:

33342-107-07

Manufactured for: Macleods Pharma USA, Plainsboro, NJ 08536; Manufactured by: Macleods Pharmaceuticals Ltd., Baddi, Himachal Pradesh, INDIA

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 89766

Status: Resolved

Manufacturer: Macleods Pharma Usa Inc

Sold By: pharmacies

Manufactured In: India, United States

Units Affected: 4872 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 product is Risedronate Sodium Tablets, USP, 5 mg, sold in 30-count bottles with NDC 33342-107-07.

Identify affected bottles by checking for lot number BRD2001A with an expiration date of 05/2022 printed on the label.

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 Macleods Pharma USA Inc for further instructions.

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