CLASS III Drug recall · Reported 18 Mar 2020 · FDA Enforcement Report
Quetiapine Fumarate Extended-Release Tablets, 300 mg per unit dose recalled
The Harvard Drug Group is recalling Quetiapine Fumarate Extended-Release Tablets, 300 mg per unit dose, distributed nationwide in the US. The recall was initiated on 27 Feb 2020 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1002-2020
- FDA event ID
- 85138
- Recalling firm
- The Harvard Drug Group, Livonia, MI
- Brand
- Quetiapine
- Manufacturer
- Major Pharmaceuticals
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 27 Feb 2020
- FDA classified
- 11 Mar 2020
- Reported
- 18 Mar 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
Timeline
| 27 Feb 2020 | Recall initiated by company | |
| 11 Mar 2020 | Classified by FDA | +13 days |
| 18 Mar 2020 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Labeling; Incorrect or Missing Package Insert: Product was packaged with the package insert for Quetiapine Fumarate Tablets not Quetiapine Fumarate Extended-Release Tablets.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
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
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Labeling; Incorrect or Missing Package Insert: Product was packaged with the package insert for Quetiapine Fumarate Tablets not Quetiapine Fumarate Extended-Release Tablets.
Which lots are affected?
Lot, expiry: Lot N00037, exp 05/2021
Where was it sold?
Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
3 other products · FDA event 85138This product is part of a recall event; the main page for the event is Quetiapine Fumarate Extended-Release Tablets, 150 mg per unit dose recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS III | Quetiapine Fumarate Extended-Release Tablets, 150 mg per unit dose recalledQuetiapine | The Harvard Drug Group | Packaging Defects | Nationwide | |
| CLASS III | Quetiapine Fumarate Extended-Release Tablets, 200 mg per unit dose recalledQuetiapine | The Harvard Drug Group | Packaging Defects | Nationwide | |
| CLASS III | Quetiapine Fumarate Extended-Release Tablets, 50 mg per unit dose recalledQuetiapine | The Harvard Drug Group | Packaging Defects | Nationwide |
More recalls from The Harvard Drug Group
All 79| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Carton Label: Major, Methylergonovine Maleate Tablets recalledMethylergonovine Maleate | The Harvard Drug Group | Potency & Assay | Nationwide |
| Drug | CLASS II | Omega-3-Acid, Ethyl Esters, Capsules recalled by The Harvard Drug GroupOmega-3-acid Ethyl Esters | The Harvard Drug Group | Potency & Assay | Nationwide |
| Drug | CLASS II | Memantine Hydrochloride Extended-Release, Capsules, 7 mg recalledMemantine Hydrochloride | The Harvard Drug Group | Potency & Assay | Nationwide |
| Drug | CLASS II | Midodrine Hydrochloride Tablets, USP, 5 mg ( blister packs) recalledMidodrine Hydrochloride | The Harvard Drug Group | Packaging Defects | Nationwide |
| Drug | CLASS II | Gabapentin Capsules, USP, 100 mg ( blister packs) recalledGabapentin | The Harvard Drug Group | Potency & Assay | Nationwide |
Other Quetiapine recalls
All 9| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Quetiapine Fumarate Extended-Release Tablets, 50 mg per unit dose recalledQuetiapine | The Harvard Drug Group | Packaging Defects | Nationwide |
| Drug | CLASS III | Quetiapine Fumarate Extended-Release Tablets, 200 mg per unit dose recalledQuetiapine | The Harvard Drug Group | Packaging Defects | Nationwide |
| Drug | CLASS III | Quetiapine Fumarate Extended-Release Tablets, 150 mg per unit dose recalledQuetiapine | The Harvard Drug Group | Packaging Defects | Nationwide |
| Drug | CLASS II | Quetiapine Tablets USP 400 mg recalled by Ascend LaboratoriesQuetiapine | Ascend Laboratories | Foreign Material | Nationwide |
| Drug | CLASS II | QUEtiapine Fumarate, Tablet, 25 mg recalled by Aidapak Services | Aidapak Services | Labeling Errors | 4 states |