Ascend Laboratories LLC recalls Quetiapine Tablets USP 400 mg, 100 tablet bottles, Rx Only, Manufactured by: Alkem Laboratories Ltd., Mumbai - 400 013,
Ascend Laboratories recalls 400mg Quetiapine tablets with metal shard risk. Stop using if you have these specific bottles. Details include NDC 67877-248-01 and lot 7143908.
Use caution until it’s fixed
Presence of Foreign Substance; metal shard found in tablet
Contact the company & request your remedy
What happened, in plain English
Ascend Laboratories is recalling 400mg Quetiapine tablets that contain a metal shard. This hazard could cause injury if the tablet is swallowed or chewed. Affected products were sold in India and the U.S. between 2019 and 2020. Read more at govinfonow.com/recall/39431-ascend-quetiapine-tablets-400mg-recall-metal-shard-hazard.
Source Summary by GovInfoNow · govinfonow.com/recall/39431-ascend-quetiapine-tablets-400mg-recall-metal-shard-hazard · Updated October 5, 2026 · FDA enforcement record: FDA #D-0287-2019
Cite this page
“Ascend Quetiapine Tablets 400mg Recall: Metal Shard Hazard.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/39431-ascend-quetiapine-tablets-400mg-recall-metal-shard-hazard. Based on FDA recall #D-0287-2019 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0287-2019%22&limit=1).
Why it’s dangerous
A metal shard was found inside some tablets. If swallowed, it could cause cuts or other injuries. The hazard is not immediate but requires careful handling.
Who’s affected
People with a prescription for Quetiapine 400mg tablets from Ascend Laboratories in the U.S. or India. Those who have the specific NDC 67877-248-01 bottles are most at risk.
How to tell if you have this one
Check for the NDC code 67877-248-01 and lot number 7143908 on the bottle. Products were sold in India and the U.S. from 2019 to 2020.
- Brand
Ascend Laboratories- Product
Ascend Laboratories LLC recalls Quetiapine Tablets USP 400 mg, 100 tablet bottles, Rx Only, Manufactured by: Alkem Laboratories Ltd., Mumbai - 400 013- Category
Drug
What to do — step by step
Check for Metal Shard
Inspect the tablets for any visible metal shards before use.
Questions people ask
Is this product safe to use?
No, the presence of a metal shard makes these tablets unsafe. Do not use them.
How can I tell if I have the recalled product?
Look for the NDC code 67877-248-01 and lot number 7143908 on the bottle.
What should I do if I have the recalled product?
Do not use the tablets. Contact your doctor for alternative treatment options.
Contact Ascend Laboratories
We’ve drafted a message you can send Ascend Laboratories to request your refund or repair — edit it as you like.
Subject: Recall D-0287-2019 — Ascend Laboratories Ascend Laboratories LLC recalls Quetiapine Tablets USP 400 mg, 100 tablet bottl Hello, I own a Ascend Laboratories LLC recalls Quetiapine Tablets USP 400 mg, 100 tablet bottles, Rx Only, Manufactured by: Alkem Laboratories Ltd., Mumbai - 400 013 that is covered by recall D-0287-2019 from Ascend Laboratories. 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.
Similar recalls
Keep exploring
From people who’ve dealt with this
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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-0287-2019 (November 14, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0287-2019 to see it in context.
- Plain-language summary written by qwen3:4b on October 5, 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.