Medications & Supplements/Prescription Drugs

Nitrofurantoin Capsules Recalled for Failed Dissolution Specifications

Agency Publication Date: July 12, 2024

Summary

Sun Pharmaceutical Industries Inc. is recalling Nitrofurantoin (Macrocrystals) 100 mg capsules because the medication failed to meet dissolution specifications during testing. Verbatim from the manufacturer, 5,752 bottles are affected by this recall. Consumers who are currently taking this medication should contact their healthcare provider or pharmacist to discuss alternatives, as the defect may affect how the drug is absorbed by the body.

Risk

The failure to meet dissolution specifications means the capsules may not break down properly in the digestive tract, potentially leading to a lower-than-intended dose of the antibiotic and reducing its effectiveness in treating infections.

What You Should Do

This recall affects 100-count bottles of Nitrofurantoin Capsules, USP (Macrocrystals), 100 mg, labeled with NDC 57664-233-88 and distributed by Sun Pharmaceutical Industries, Inc.
Identify if your medication is included by checking the prescription bottle for lot numbers 231067 or 231069, both with an expiration date of 04/30/2025.
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 Sun Pharmaceutical Industries Inc for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls for additional information 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: Nitrofurantoin Capsules, USP (Macrocrystals) (100-count bottle)

Variants: 100 mg, Capsule

Lot Numbers:

231067 (Exp 04/30/2025)

231069 (Exp 04/30/2025)

NDC:

57664-233-88

Manufactured by Sidmak Laboratories (India) Pvt. Ltd.; Distributed by Sun Pharmaceutical Industries, Inc.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 94950

Status: Resolved

Manufacturer: SUN PHARMACEUTICAL INDUSTRIES INC

Sold By: Pharmacies

Manufactured In: India

Units Affected: 5752 bottles

Distributed To: Nationwide

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

This recall affects 100-count bottles of Nitrofurantoin Capsules, USP (Macrocrystals), 100 mg, labeled with NDC 57664-233-88 and distributed by Sun Pharmaceutical Industries, Inc.

Identify if your medication is included by checking the prescription bottle for lot numbers 231067 or 231069, both with an expiration date of 04/30/2025.

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 Sun Pharmaceutical Industries Inc for further instructions.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls for additional information regarding this recall.