Medications & Supplements/Prescription Drugs

Hetero Labs, Ltd. - Unit III: Indomethacin Capsules Recalled for Melted and Stuck Together Pills

Agency Publication Date: July 27, 2018

Summary

Hetero Labs, Ltd. is recalling 18,288 bottles of Indomethacin Capsules, USP, 50 mg due to quality defects where the capsules may be melted, clumped, or stuck together inside the bottle. This recall involves the 100-count bottles of prescription Indomethacin (brand name Camber Pharmaceuticals) distributed nationwide. Consumers should check their medication immediately as these defects can interfere with proper dosing and effectiveness.

Risk

Melted, clumped, or deformed capsules may not contain the correct dose of medication or may fail to dissolve properly in the body. This can lead to ineffective treatment of the condition for which the drug was prescribed or cause unexpected side effects from altered drug delivery.

What You Should Do

Check your medication bottle for Indomethacin Capsules, USP, 50 mg in 100-count bottles with NDC 31722-543-01.
Verify the lot number and expiration date on the side of the label; this recall specifically affects Lot E180315 with an expiration date of 12/19.
Contact your healthcare provider or pharmacist immediately for guidance if you find your medication is affected or if the capsules appear clumped, melted, or deformed.
Return any unused or defective product to your pharmacy for a refund and to obtain a replacement prescription.
Contact the manufacturer, Hetero Labs, Ltd., for further instructions regarding this recall.
For additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

Full Refund

Pharmaceutical product return and pharmacist consultation.

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Indomethacin Capsules, USP, 50 mg (100-count bottle)

Model:

NDC 31722-543-01

Lot Numbers:

E180315 (Exp 12/19)

Date Ranges: Expiration Date: 12/19

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 80589

Status: Resolved

Manufacturer: Hetero Labs, Ltd. - Unit III

Sold By: Pharmacies

Manufactured In: India

Units Affected: 18,288 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

Check your medication bottle for Indomethacin Capsules, USP, 50 mg in 100-count bottles with NDC 31722-543-01.

Verify the lot number and expiration date on the side of the label; this recall specifically affects Lot E180315 with an expiration date of 12/19.

Contact your healthcare provider or pharmacist immediately for guidance if you find your medication is affected or if the capsules appear clumped, melted, or deformed.

Return any unused or defective product to your pharmacy for a refund and to obtain a replacement prescription.

Contact the manufacturer, Hetero Labs, Ltd., for further instructions regarding this recall.

For additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.