CLASS II Drug recall · Reported 24 Jul 2013 · FDA Enforcement Report
Quetiapine Fumarate Tablets 25mg Blister card, Rx, Packaged recalled
American Health Packaging is recalling Quetiapine Fumarate Tablets 25mg Blister card, Rx, Packaged, distributed nationwide in the US. The recall was initiated on 10 Oct 2012 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-802-2013
- FDA event ID
- 65683
- Recalling firm
- American Health Packaging, Columbus, OH
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 10 Oct 2012
- FDA classified
- 15 Jul 2013
- Reported
- 24 Jul 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
Timeline
| 10 Oct 2012 | Recall initiated by company | |
| 15 Jul 2013 | Classified by FDA | +278 days |
| 24 Jul 2013 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Dissolution Test Requirements: During analysis of long term stability studies at 3 months time point, an OOS was reported for Quetiapine Fumarate Tablets, 25 mg.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
QUETIAPINE Fumarate Tablets 25mg 100 Tablets (10x10) Blister card, Rx, Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC 68084-530-01
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Failed Dissolution Test Requirements: During analysis of long term stability studies at 3 months time point, an OOS was reported for Quetiapine Fumarate Tablets, 25 mg.
Which lots are affected?
Lot 122600 Exp. 03/14
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.
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|---|---|---|---|---|---|
| Drug | CLASS III | Buprenorphine Sublingual Tablets (C-iii), 2 mg recalledBuprenorphine | American Health Packaging | Packaging Defects | Nationwide |
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| Drug | CLASS II | Oxycodone Hydrochloride Oral Solution, USP (C-II), 5 mg recalledOxycodone Hydrochloride | American Health Packaging | Potency & Assay | Nationwide |
| Drug | CLASS II | Metoprolol Succinate Extended-Release Tablets, USP 50 mg recalledMetoprolol Succinate | American Health Packaging | 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 Tablets USP 400 mg recalled by Ascend LaboratoriesQuetiapine | Ascend Laboratories | Foreign Material | Nationwide |