Use cautionDrug recall · FDA · Published October 10, 2012
American Health Packaging Recalls Quetiapine Fumarate 25mg Tablets
American Health Packaging recalls Quetiapine Fumarate Tablets 25mg due to failed dissolution test requirements. Check your lot number and expiration date.
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.
Take action
Contact the company
📍Recalling firmAmerican Health Packaging2550 John Glenn Ave, Suite A · Columbus, OH 43217-1188
✎ GovInfoNow plain-language explainer
American Health Packaging is recalling Quetiapine Fumarate Tablets, 25 mg because they failed long-term stability dissolution tests at the three-month mark. This means the medication may not dissolve properly in the body, potentially affecting how much drug you absorb. The recall affects 19,060 blister cards distributed nationwide. Read more at govinfonow.com/recall/48519-american-health-packaging-recalls-quetiapine-fumarate-tablets-25mg-100-tablets.
“American Health Packaging Recalls Quetiapine Fumarate 25mg Tablets.” GovInfoNow, updated October 13, 2026. https://govinfonow.com/recall/48519-american-health-packaging-recalls-quetiapine-fumarate-tablets-25mg-100-tablets. Based on FDA recall #D-802-2013 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-802-2013%22&limit=1).
American Health Packaging voluntarily recalled Quetiapine Fumarate Tablets 25mg due to failed dissolution test requirements, the Food and Drug Administration said on Oct. 10, 2012. The firm initiated the Class II recall after out-of-specification results appeared during long-term stability studies.
How to tell if you have it
Brand: American Health Packaging
Product: Quetiapine Fumarate Tablets 25mg
Package: 100 Tablets (10x10) Blister card, Rx
NDC: 68084-530-01
Lot: 122600
Expiration: 03/14
Units affected: 19,060 blister cards
The hazard
The recall addresses failed dissolution test requirements for Quetiapine Fumarate Tablets 25mg. An out-of-specification result was reported during the analysis of long-term stability studies at the three-month time point.
Context
GovInfoNow's records show American Health Packaging has 41 other recalls on record since July 23, 2012. Recent brand recalls include a Buprenorphine Tablets recall for label mix-up hazards on Aug. 19, 2026, and a Nitrofurantoin Capsules recall for dissolution failure risk on May 3, 2022. Other recent recalls of similar products include Golden State NIACIN Extended-Release Tablets Recall: Failed Dissolution Testing (May 29, 2026), Inventia Chlorthalidone Recall: Failed Dissolution Specs (Sept. 3, 2026), and AvKARE Rosuvastatin Tablets 10mg Recall: Dissolution Issue (Dec. 31, 2025).
How to tell if you have this one
Check if you have Quetiapine Fumarate Tablets 25mg packaged in a 10x10 blister card. Look for NDC 68084-530-01, Lot number 122600, and an expiration date of 03/14.
Brand
American Health Packaging
Category
Drug
Based on the official FDA remedy
What to do — step by step
Check your medication details
Verify if your Quetiapine Fumarate Tablets match NDC 68084-530-01, Lot 122600, and Exp. 03/14.
Contact your pharmacy or provider
Reach out to your pharmacist or healthcare provider for instructions on how to return or replace the recalled product.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 10 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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-802-2013 (October 10, 2012) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-802-2013 to see it in context.
Plain-language summary written by qwen3.6:35b-a3b on October 13, 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.