The Harvard Drug Group recalls Quetiapine Fumarate Extended-Release Tablets, 150 mg, 100 tablets per unit dose carton, Rx only, Manufactured by: Lupin
The Harvard Drug Group recalls Quetiapine Fumarate Extended-Release Tablets due to incorrect package insert. This may cause confusion about proper use. Contact for details.
Lower-risk recall
Labeling; Incorrect or Missing Package Insert: Product was packaged with the package insert for Quetiapine Fumarate Tablets not Quetiapine Fumarate Extended-Release Tablets.
Contact the company & request your remedy
What happened, in plain English
The Harvard Drug Group recalls Quetiapine Fumarate Extended-Release Tablets (150 mg, 100 tablets) because they were packaged with the wrong insert. This could lead to incorrect use if someone mistakes them for regular tablets. Read more at govinfonow.com/recall/37356-quetiapine-xr-tablets-recall-incorrect-package-insert-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/37356-quetiapine-xr-tablets-recall-incorrect-package-insert-risk · Updated October 5, 2026 · FDA enforcement record: FDA #D-1000-2020
Cite this page
“Quetiapine XR Tablets Recall: Incorrect Package Insert Risk.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/37356-quetiapine-xr-tablets-recall-incorrect-package-insert-risk. Based on FDA recall #D-1000-2020 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1000-2020%22&limit=1).
Why it’s dangerous
The package insert for regular Quetiapine tablets was included instead of the extended-release version. This could cause confusion about dosing and usage, potentially leading to incorrect administration.
Who’s affected
Prescription patients who received this specific Quetiapine product. Those using the product without proper instructions are at higher risk of misuse.
How to tell if you have this one
Check for the product name 'Quetiapine Fumarate Extended-Release Tablets' on the label. The NDC code 0904-6802-61 and lot number N00036 (expiring May 2021) are also indicators.
- Brand
The Harvard Drug Group- Category
Drug
All 4 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 III- Status
Terminated- Distribution
Nationwide- NDC
0904-6801-61, 0904-6802-61, 0904-6803-61, 0904-6804-61, 0904-6805-61
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| D-0999-2020 | Quetiapine Fumarate Extended-Release Tablets, 50 mg, 100 tablets per unit dose carton, Rx only, Manufactured by: Lupin Limited, Pithampur (M.P.) 454775 India; Distributed by: Major Pharmaceuticals, 17177 N. Laurel Park Dr., Suite 233, Livonia, MI 48152 USA. NDC: 0904-6801-61; Lot, expiry: Lot N00028, exp 04/2021; Lot N00044, exp 06/2021 | 330 cartons |
| D-1000-2020 | Quetiapine Fumarate Extended-Release Tablets, 150 mg, 100 tablets per unit dose carton, Rx only, Manufactured by: Lupin Limited, Pithampur (M.P.) 454775 India; Distributed by: Major Pharmaceuticals, 17177 N. Laurel Park Dr., Suite 233, Livonia, MI 48152 USA. NDC: 0904-6802-61; Lot, expiry: Lot N00036, exp 05/2021 | 1 carton |
| D-1001-2020 | Quetiapine Fumarate Extended-Release Tablets, 200 mg, 100 tablets per unit dose carton, Rx only, Manufactured by: Lupin Limited, Pithampur (M.P.) 454775 India; Distributed by: Major Pharmaceuticals, 17177 N. Laurel Park Dr., Suite 233, Livonia, MI 48152 USA. NDC: 0904-6803-61; Lot, expiry: Lot N00037, exp 05/2021 | 115 cartons |
| D-1002-2020 | Quetiapine Fumarate Extended-Release Tablets, 300 mg, 100 tablets per unit dose carton, Rx only, Manufactured by: Lupin Limited, Pithampur (M.P.) 454775 India; Distributed by: Major Pharmaceuticals, 17177 N. Laurel Park Dr., Suite 233, Livonia, MI 48152 USA. NDC: 0904-6804-61; Lot, expiry: Lot N00037, exp 05/2021 | — |
What to do — step by step
Check Product Label
Look for the product name 'Quetiapine Fumarate Extended-Release Tablets' on the label.
Questions people ask
Why is this product being recalled?
The product was packaged with the package insert for regular Quetiapine tablets instead of the extended-release version, which could cause confusion about proper use.
How can I tell if I have the recalled product?
Check for the product name 'Quetiapine Fumarate Extended-Release Tablets' on the label, NDC code 0904-6802-61, and lot number N00036 (expiring May 2021).
What should I do if I have this product?
The recall does not require immediate action, but you should check the label to confirm the product type and contact the manufacturer if unsure.
Contact The Harvard Drug Group
We’ve drafted a message you can send The Harvard Drug Group to request your refund or repair — edit it as you like.
Subject: Recall D-1000-2020 — The Harvard Drug Group The Harvard Drug Group Hello, I own a The Harvard Drug Group that is covered by recall D-1000-2020 from The Harvard Drug Group. 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-1000-2020 (February 27, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1000-2020 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.