Medications & Supplements/Prescription Drugs

Dr. Reddy's Lansoprazole Delayed-Release Capsules Recalled for Dissolution Failure

Agency Publication Date: March 31, 2022

Summary

Dr. Reddy's Laboratories, Inc. is recalling 16,055 bottles of Lansoprazole (Prevacid) Delayed-Release Capsules (15 mg and 30 mg) because the medication failed to dissolve properly during stability testing. The recall involves Rx-only bottles in both 30-count and 90-count sizes distributed nationwide. When a delayed-release medication fails dissolution tests, it means the drug may not break down and be absorbed by the body as intended, which can prevent it from working effectively to treat stomach acid conditions. No injuries or illnesses have been reported to date.

Risk

The drug failed to meet dissolution specifications during long-term stability testing. This defect could result in the medication being less effective or completely ineffective at treating the patient's condition, as the active ingredient may not be released correctly into the digestive tract.

What You Should Do

This recall affects Lansoprazole Delayed-Release Capsules (15 mg and 30 mg) sold in 30-count and 90-count bottles under the Dr. Reddy's Laboratories brand.
Check your medication bottle for the following NDC numbers: 55111-398-30 (15 mg, 30-count), 55111-398-90 (15 mg, 90-count), or 55111-399-90 (30 mg, 90-count).
Verify the lot numbers and expiration dates: for 15 mg capsules, look for lot C2103093 or C2103092 (both expiring 12/2023); for 30 mg capsules, look for lot C2102911 (expiring 12/2023).
If you have health concerns about how this medication has affected you, 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 Capsules, USP, 15 mg

Variants: 15 mg, 30-count bottle, 90-count bottle

Lot Numbers:

C2103093 (Exp. 12/2023)

C2103092 (Exp. 12/2023)

NDC:

55111-398-30

55111-398-90

Rx Only; Manufactured by Dr. Reddy's Laboratories Limited, India

Product: Lansoprazole Delayed-Release Capsules, USP, 30 mg

Variants: 30 mg, 90-count bottle

Lot Numbers:

C2102911 (Exp. 12/2023)

NDC:

55111-399-90

Rx Only; Manufactured by Dr. Reddy's Laboratories Limited, India

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 89871

Status: Resolved

Manufacturer: Dr. Reddy's Laboratories, Inc.

Sold By: Pharmacies nationwide

Manufactured In: India, United States

Units Affected: 2 products (8,352 bottles (30-count), 1,368 bottles (90-count); 7,703 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 Lansoprazole Delayed-Release Capsules (15 mg and 30 mg) sold in 30-count and 90-count bottles under the Dr. Reddy's Laboratories brand.

Check your medication bottle for the following NDC numbers: 55111-398-30 (15 mg, 30-count), 55111-398-90 (15 mg, 90-count), or 55111-399-90 (30 mg, 90-count).

Verify the lot numbers and expiration dates: for 15 mg capsules, look for lot C2103093 or C2103092 (both expiring 12/2023); for 30 mg capsules, look for lot C2102911 (expiring 12/2023).

If you have health concerns about how this medication has affected you, 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 Capsules, USP, 15 mg

Variants: 15 mg, 30-count bottle, 90-count bottle

Lot Numbers:

C2103093 (Exp. 12/2023)

C2103092 (Exp. 12/2023)

NDC:

55111-398-30

55111-398-90

Rx Only; Manufactured by Dr. Reddy's Laboratories Limited, India

Product: Lansoprazole Delayed-Release Capsules, USP, 30 mg

Variants: 30 mg, 90-count bottle

Lot Numbers:

C2102911 (Exp. 12/2023)

NDC:

55111-399-90

Rx Only; Manufactured by Dr. Reddy's Laboratories Limited, India

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 89871

Status: Resolved

Manufacturer: Dr. Reddy's Laboratories, Inc.

Sold By: Pharmacies nationwide

Manufactured In: India, United States

Units Affected: 2 products (8,352 bottles (30-count), 1,368 bottles (90-count); 7,703 bottles)

Distributed To: Nationwide