CLASS II Drug recall · Reported 5 Dec 2018 · FDA Enforcement Report
Quetiapine Tablets USP 400 mg recalled by Ascend Laboratories
Ascend Laboratories is recalling Quetiapine Tablets USP 400 mg, distributed nationwide in the US. The recall was initiated on 14 Nov 2018 and the FDA has classified it as Class II.
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-0287-2019
- FDA event ID
- 81568
- Recalling firm
- Ascend Laboratories, Parsippany, NJ
- Brand
- Quetiapine
- Manufacturer
- Ascend Laboratories, LLC
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 14 Nov 2018
- FDA classified
- 28 Nov 2018
- Reported
- 5 Dec 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Foreign Material
Timeline
| 14 Nov 2018 | Recall initiated by company | |
| 28 Nov 2018 | Classified by FDA | +14 days |
| 5 Dec 2018 | 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
Presence of Foreign Substance; metal shard found in tablet
Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.
Product as listed by the FDA
Quetiapine Tablets USP 400 mg, 100 tablet bottles, Rx Only, Manufactured by: Alkem Laboratories Ltd., Mumbai - 400 013, India. Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054 --- NDC 67877-248-01, UPC code: 3 67877-248-01 1
Where it was distributed
Nationwide
Questions about this recall
Is Quetiapine Tablets USP 400 mg recalled?
Yes. Ascend Laboratories recalled Quetiapine Tablets USP 400 mg on 14 Nov 2018. The recall is Class II and its status is Terminated. Recall number D-0287-2019.
Why was it recalled?
Presence of Foreign Substance; metal shard found in tablet
Which lots are affected?
Lot 7143908, exp Nov 2020
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 II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Ascend Laboratories
All 50| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Dabigatran Etexilate Capsules, 150 mg recalled by Ascend LaboratoriesDabigatran Etexilate | Ascend Laboratories | Potency & Assay | Nationwide |
| Drug | CLASS III | Dabigatran Etexilate Capsules, 75 mg recalled by Ascend LaboratoriesDabigatran Etexilate | Ascend Laboratories | Potency & Assay | Nationwide |
| Drug | CLASS III | Dabigatran Etexilate Capsules, 75 mg recalled by Ascend LaboratoriesDabigatran Etexilate | Ascend Laboratories | Potency & Assay | Nationwide |
| Drug | CLASS III | Dabigatran etexilate Capsules, 110 mg recalled by Ascend LaboratoriesDabigatran Etexilate | Ascend Laboratories | Potency & Assay | Nationwide |
| Drug | CLASS II | Amlodipine and Olmesartan Medoxomil Tablets, 10 mg/20 mg recalledAmlodipine And Olmesartan Medoxomil | Ascend Laboratories | Potency & Assay | Nationwide |
Other Quetiapine recalls
All 8| 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, 300 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 Fumarate Tablet, 100 mg recalled by Aidapak Services | Aidapak Services | Labeling Errors | 4 states |