Dr. Reddy's Lansoprazole Capsules Recall: Failed Dissolution Testing
Dr. Reddy's recalls 30mg Lansoprazole capsules due to failed dissolution testing. This may affect medication effectiveness. Contact for return instructions.
Lower-risk recall
Failed Dissolution Specifications; during long term stability testing.
Contact the company
What happened, in plain English
Dr. Reddy's is recalling 30mg Lansoprazole Delayed-Release Capsules because they failed dissolution testing during stability checks. This could mean the medication doesn't work properly over time. Read more at govinfonow.com/recall/35054-dr-reddy-s-lansoprazole-capsules-recall-failed-dissolution-testing.
Source Summary by GovInfoNow · govinfonow.com/recall/35054-dr-reddy-s-lansoprazole-capsules-recall-failed-dissolution-testing · Updated August 18, 2026 · FDA enforcement record: FDA #D-0738-2022
Cite this page
“Dr. Reddy's Lansoprazole Capsules Recall: Failed Dissolution Testing.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/35054-dr-reddy-s-lansoprazole-capsules-recall-failed-dissolution-testing. Based on FDA recall #D-0738-2022 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0738-2022%22&limit=1).
Why it’s dangerous
The capsules failed dissolution testing during long-term stability checks. This means the medication might not release properly in the stomach, potentially reducing effectiveness over time.
Who’s affected
Prescription patients who received this specific capsule product from Dr. Reddy's Laboratories. Those with ongoing acid reflux treatment are most at risk.
How to tell if you have this one
Check for the 30mg, 90-count bottle labeled 'Rx Only' with NDC 55111-399-90. The lot number C2102911 was manufactured in India and expires December 2023.
- Brand
Dr. Reddy's- Category
Drug
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Terminated- Distribution
Nationwide in the USA- NDC
55111-398-30, 55111-398-60, 55111-398-90, 55111-398-01, 55111-398-05, 55111-398-79, 55111-399-30, 55111-399-60, 55111-399-90, 55111-399-01, 55111-399-05, 55111-399-79
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| D-0737-2022 | Lansoprazole Delayed-Release Capsules, USP, 15 mg, a) 30-count bottle, (NDC 55111-398-30), b) 90-count bottle, (55111-398-90), Rx Only, Manufactured. By: Dr. Reddy's Laboratories Limited, Bachupally - 500 090, India; Lot # a) C2103093, Exp. 12/2023; b)C2103092, Exp. 12/2023. | 8,352 bottles (30-count), 1,368 bottles (90-count) |
| D-0738-2022 | Lansoprazole Delayed-Release Capsules, USP, 30 mg, 90-count bottle, Rx Only, Manufactured By: Dr. Reddy's Laboratories Limited, Bachupally - 500 090, India, NDC 55111-399-90.; Lot# C2102911, Exp. 12/2023 | 7,703 bottles |
What to do — step by step
Check Product Details
Verify the product's NDC number (55111-399-90) and lot number (C2102911) to confirm it's affected.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide in the USA” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 22 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0738-2022 (March 23, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0738-2022 to see it in context.
- Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.