Medications & Supplements/Prescription Drugs

Dr. Reddy's Lansoprazole Tablets Recalled for Failed Dissolution

Agency Publication Date: July 22, 2022

Summary

Dr. Reddy's Laboratories, Inc. is recalling 5,531 cartons of Lansoprazole (lansoprazole) Delayed-Release Orally Disintegrating Tablets in 15 mg and 35 mg strengths. The tablets, packaged in 100-count blisters, were found to fail dissolution specifications, meaning the medication may not dissolve at the correct rate in the body as required. No incidents or injuries have been reported to date.

Risk

Because the tablets failed dissolution testing, the medication may not be absorbed properly by the body, which can reduce the effectiveness of the drug in treating stomach acid-related conditions.

What You Should Do

This recall involves Dr. Reddy's Lansoprazole (lansoprazole) Delayed-Release Orally Disintegrating Tablets, 15 mg (NDC 43598-560-78) and 35 mg (NDC 43598-561-78), sold in 100-count cartons containing 10 packs of 10 tablets each.
Check your medication packaging for lot numbers T2100514 or T2100515, both of which have an expiration date of January 2023 (01/2023).
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 Dr. Reddy's Laboratories, 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: Lansoprazole Delayed-Release Orally Disintegrating Tablets (15 mg)

Variants: 15 mg, Orally Disintegrating Tablet, 100-count blisters

Lot Numbers:

T2100514 (Exp 01/2023)

NDC:

43598-560-78

Blister barcode: 4359856079; Distributed by: Dr. Reddy's Laboratories, Inc., Princeton, NJ 08540; Recall #: D-1287-2022

Product: Lansoprazole Delayed-Release Orally Disintegrating Tablets (35 mg)

Variants: 35 mg, Orally Disintegrating Tablet, 100-count blisters

Lot Numbers:

T2100515 (Exp 01/2023)

NDC:

43598-561-78

Blister barcode: 4359856179; Distributed by: Dr. Reddy's Laboratories, Inc., Princeton, NJ 08540; Recall #: D-1288-2022

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 90601

Status: Resolved

Manufacturer: Dr. Reddy's Laboratories, Inc.

Sold By: Pharmacies

Manufactured In: India, United States

Units Affected: 2 products (2,892 cartons; 2,639 cartons)

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 involves Dr. Reddy's Lansoprazole (lansoprazole) Delayed-Release Orally Disintegrating Tablets, 15 mg (NDC 43598-560-78) and 35 mg (NDC 43598-561-78), sold in 100-count cartons containing 10 packs of 10 tablets each.

Check your medication packaging for lot numbers T2100514 or T2100515, both of which have an expiration date of January 2023 (01/2023).

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 Dr. Reddy's Laboratories, 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: Lansoprazole Delayed-Release Orally Disintegrating Tablets (15 mg)

Variants: 15 mg, Orally Disintegrating Tablet, 100-count blisters

Lot Numbers:

T2100514 (Exp 01/2023)

NDC:

43598-560-78

Blister barcode: 4359856079; Distributed by: Dr. Reddy's Laboratories, Inc., Princeton, NJ 08540; Recall #: D-1287-2022

Product: Lansoprazole Delayed-Release Orally Disintegrating Tablets (35 mg)

Variants: 35 mg, Orally Disintegrating Tablet, 100-count blisters

Lot Numbers:

T2100515 (Exp 01/2023)

NDC:

43598-561-78

Blister barcode: 4359856179; Distributed by: Dr. Reddy's Laboratories, Inc., Princeton, NJ 08540; Recall #: D-1288-2022