Zydus Pharmaceuticals (USA) Inc recalls Lansoprazole Delayed-Release Orally Disintegrating Tablets 15 mg, 100-count carton (10 x10 unit-dose), Rx only,
Zydus Pharmaceuticals recalls 15mg Lansoprazole Delayed-Release tablets due to failed dissolution specification. Rx-only product with NDC 68382-771-77, lot M005681, exp 3/2022. No specific remedy stated in recall notice.
Recall notice
Failed Dissolution Specification
Contact the company & request your remedy
What happened, in plain English
Zydus Pharmaceuticals is recalling 15mg Lansoprazole Delayed-Release Orally Disintegrating Tablets that failed dissolution testing. This could mean the medication doesn't work properly when taken as intended, potentially affecting treatment effectiveness. Read more at govinfonow.com/recall/36697-zydus-lansoprazole-tablets-15mg-recall-failed-dissolution-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/36697-zydus-lansoprazole-tablets-15mg-recall-failed-dissolution-risk · Updated October 4, 2026 · FDA enforcement record: FDA #D-0074-2021
Cite this page
“Zydus Lansoprazole Tablets 15mg Recall: Failed Dissolution Risk.” GovInfoNow, updated October 4, 2026. https://govinfonow.com/recall/36697-zydus-lansoprazole-tablets-15mg-recall-failed-dissolution-risk. Based on FDA recall #D-0074-2021 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0074-2021%22&limit=1).
Why it’s dangerous
The tablets failed dissolution testing, meaning they may not release the medication properly in the stomach. This could lead to ineffective treatment for conditions like acid reflux or ulcers. The hazard is not described as causing injury but rather affecting medication performance.
Who’s affected
Prescription patients who received this specific lot of Lansoprazole tablets (NDC 68382-771-77, lot M005681) from Zydus Pharmaceuticals. Patients on long-term acid-reducing therapy are most at risk of treatment failure.
How to tell if you have this one
Check for the NDC code 68382-771-77 and lot number M005681 on the packaging. The product is a prescription-only 15mg tablet in a 100-count carton (10 x10 unit-dose) with expiration date 3/2022.
- Brand
Zydus Pharmaceuticals- 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
Distributed Nationwide in the USA- NDC
68382-771-30, 68382-771-77, 68382-772-30, 68382-772-77
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| D-0074-2021 | Lansoprazole Delayed-Release Orally Disintegrating Tablets 15 mg, 100-count carton (10 x10 unit-dose), Rx only, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India, Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534, NDC 68382-771-77; Lot # M005681, EXP 3/2022 | 6,840 units |
| D-0075-2021 | Lansoprazole Delayed-Release Orally Disintegrating Tablets 30 mg, 100-count carton (10 x10 unit-dose), Rx only, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India, Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534, NDC 68382-772-77; Lot # M005682, EXP 3/2022 | 7,908 units |
What to do — step by step
Check Product Details
Look for NDC 68382-771-77 and lot number M005681 on the packaging.
Questions people ask
Is this product dangerous?
The recall states the tablets failed dissolution testing, which could affect medication effectiveness but does not describe a risk of injury or serious harm.
How do I know if I have this product?
Check for NDC 68382-771-77 and lot number M005681 on the packaging. The product is a prescription-only 15mg tablet in a 100-count carton with expiration date 3/2022.
What should I do if I have this product?
The recall notice does not specify a remedy, so no action is required beyond checking if you have the recalled product.
Contact Zydus Pharmaceuticals
We’ve drafted a message you can send Zydus Pharmaceuticals to request your refund or repair — edit it as you like.
Subject: Recall D-0074-2021 — Zydus Pharmaceuticals Zydus Pharmaceuticals Hello, I own a Zydus Pharmaceuticals that is covered by recall D-0074-2021 from Zydus Pharmaceuticals. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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-0074-2021 (October 27, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0074-2021 to see it in context.
- Plain-language summary written by qwen3:4b on October 4, 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.