Medications & Supplements/Prescription Drugs

Dr. Reddy's Laboratories, Inc.: Progesterone Capsules Recalled Due to Failed Dissolution Specifications

Agency Publication Date: March 3, 2021

Summary

Dr. Reddy's Laboratories, Inc. has recalled 16,449 bottles of Progesterone Capsules (200 mg) because the medication failed dissolution testing during quality stability checks. This means the drug may not dissolve properly in the body, which can prevent the patient from receiving the correct amount of active medication. These prescription capsules were sold in 100-count bottles and distributed nationwide across the United States. Consumers should check their prescription bottles immediately for the specific batch and expiration date listed below.

Risk

The failure of the drug to dissolve at the required rate can lead to decreased absorption of the medication into the bloodstream. This may result in ineffective treatment for the patient's underlying condition, as the body is not receiving the intended dose of progesterone.

What You Should Do

Check your Progesterone Capsule bottle to see if it matches the recalled product: Progesterone Capsules, 200 mg, 100-count bottles with NDC 43598-350-01.
Verify the batch and expiration date on your packaging: Look for Batch # 1399851P1 with an expiration date of 02/2021 (February 2021).
Contact your healthcare provider or pharmacist immediately to discuss whether your treatment has been affected and to obtain a replacement prescription if necessary.
Return any remaining unused capsules from this specific batch to the pharmacy where you purchased them for a refund and proper disposal.
Contact Dr. Reddy's Laboratories, Inc. at their Princeton, NJ office for further instructions regarding this recall.
For additional questions or to report a side effect, 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

Contact healthcare provider and return product to pharmacy.

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

Affected Products

Product: Progesterone Capsules (200 mg, 100-count bottle)

Model:

NDC 43598-350-01

Recall #: D-0292-2021

Lot Numbers:

1399851P1 (Exp 02/2021)

Date Ranges: Expiration 02/2021

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 87411

Status: Resolved

Manufacturer: Dr. Reddy's Laboratories, Inc.

Sold By: Pharmacies

Manufactured In: France, United States

Units Affected: 16,449 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 Progesterone Capsule bottle to see if it matches the recalled product: Progesterone Capsules, 200 mg, 100-count bottles with NDC 43598-350-01.

Verify the batch and expiration date on your packaging: Look for Batch # 1399851P1 with an expiration date of 02/2021 (February 2021).

Contact your healthcare provider or pharmacist immediately to discuss whether your treatment has been affected and to obtain a replacement prescription if necessary.

Return any remaining unused capsules from this specific batch to the pharmacy where you purchased them for a refund and proper disposal.

Contact Dr. Reddy's Laboratories, Inc. at their Princeton, NJ office for further instructions regarding this recall.

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