Zydus Pharmaceuticals (USA) Inc recalls Lansoprazole Delayed-Release Orally Disintegrating Tablets 15 mg, 100 Tablets (10x10 unit dose) blister pack, Rx only,
Zydus Pharmaceuticals recalls 15mg Lansoprazole Delayed-Release tablets due to failed dissolution specifications. Rx-only tablets with NDC 68382-771-77 were manufactured in India and distributed in the US. No remedy specified in recall notice.
Lower-risk recall
Failed Dissolution Specifications
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 tests. This means the medication may not work as intended when taken, potentially affecting treatment effectiveness. Read more at govinfonow.com/recall/36629-zydus-lansoprazole-tablets-recall-failed-dissolution-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/36629-zydus-lansoprazole-tablets-recall-failed-dissolution-risk · Updated October 4, 2026 · FDA enforcement record: FDA #D-0145-2021
Cite this page
“Zydus Lansoprazole Tablets Recall: Failed Dissolution Risk.” GovInfoNow, updated October 4, 2026. https://govinfonow.com/recall/36629-zydus-lansoprazole-tablets-recall-failed-dissolution-risk. Based on FDA recall #D-0145-2021 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0145-2021%22&limit=1).
Why it’s dangerous
The tablets failed dissolution specifications, meaning they may not release the medication properly in the stomach. This could lead to inconsistent drug absorption and reduced effectiveness of the treatment. The hazard does not indicate immediate injury risk.
Who’s affected
Prescription patients using the recalled 15mg Lansoprazole tablets. Those with specific medical conditions requiring consistent medication levels may be most affected.
How to tell if you have this one
Check for the product name 'Lansoprazole Delayed-Release Orally Disintegrating Tablets 15 mg, 100 Tablets' in a blister pack. Look for NDC 68382-771-77 or production dates M915744 (Oct 2021) and M904770 (Feb 2021).
- 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
Nationwide- NDC
68382-771-30, 68382-771-77, 68382-772-30, 68382-772-77
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| D-0145-2021 | Lansoprazole Delayed-Release Orally Disintegrating Tablets 15 mg, 100 Tablets (10x10 unit dose) blister pack, Rx only, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534 NDC 68382-771-77; M915744 OCT 2021 M904770 FEB 2021 | 15,144 cartons |
| D-0146-2021 | Lansoprazole Delayed-Release Orally Disintegrating Tablets, 30 mg, 100 Tablets (10 x 10 unit-dose) blister pack, Rx only, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534 NDC 68382-772-77; M900412 December 2020 M904772 February 2021 M915745 October 2021 | 22,848 cartons |
What to do — step by step
Check Product Details
Verify the product name, NDC number, and production dates to confirm if it matches the recalled items.
Questions people ask
Why is this product being recalled?
The tablets failed dissolution specifications, meaning they may not release medication properly in the stomach, potentially reducing effectiveness.
Is there a remedy for this recall?
The recall notice does not specify any remedy or action for consumers.
How can I tell if I have the recalled product?
Check for the product name 'Lansoprazole Delayed-Release Orally Disintegrating Tablets 15 mg, 100 Tablets' in a blister pack with NDC 68382-771-77 or production dates M915744 (Oct 2021) and M904770 (Feb 2021).
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-0145-2021 — Zydus Pharmaceuticals Zydus Pharmaceuticals Hello, I own a Zydus Pharmaceuticals that is covered by recall D-0145-2021 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-0145-2021 (December 3, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0145-2021 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.