Forest Laboratories Saphris 10mg Tablets Recalled Due to Label Mixup
Forest Laboratories recalls Saphris 10mg sublingual tablets with incorrect labeling; actual tablets are 5mg but labeled as 10mg. This may lead to incorrect dosing.
Lower-risk recall
Labeling; Label Mixup; blister lidding foil and shell-pack labeled as 10 mg but package actually contains 5 mg tablets
Contact the company
What happened, in plain English
Forest Laboratories is recalling Saphris 10mg subling: 6x10 blister packs that are labeled as 10mg but actually contain 5mg tablets. This mix-up could lead to incorrect dosing if taken as 10mg when only 5mg is present. Read more at govinfonow.com/recall/41616-forest-laboratories-saphris-10mg-tablets-recalled-due-to-label-mixup.
Source Summary by GovInfoNow · govinfonow.com/recall/41616-forest-laboratories-saphris-10mg-tablets-recalled-due-to-label-mixup · Updated October 8, 2026 · FDA enforcement record: FDA #D-0880-2017
Cite this page
“Forest Laboratories Saphris 10mg Tablets Recalled Due to Label Mixup.” GovInfoNow, updated October 8, 2026. https://govinfonow.com/recall/41616-forest-laboratories-saphris-10mg-tablets-recalled-due-to-label-mixup. Based on FDA recall #D-0880-2017 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0880-2017%22&limit=1).
Why it’s dangerous
The tablets are labeled as 10mg but actually contain 5mg. This mix-up could lead to incorrect dosing if the patient takes the tablets as intended. The risk is low because the medication is prescription-only and the mix-up is a labeling error.
Who’s affected
Prescription patients who have received Saphris 10mg sublingual tablets labeled as 10mg but contain 5mg tablets. Patients taking this medication for conditions like schizophrenia or bipolar disorder are most at risk.
How to tell if you have this one
Check for Saphris 10mg sublingual tablets in 6x10 blister packs with Black Cherry Flavor. The product was manufactured in lots W00733 and W00946, expiring April 2019.
- Brand
Forest Laboratories- Category
Drug
What to do — step by step
Check Label
Verify the tablet strength on the label; if it says 10mg but the tablets are actually 5mg, this is the recalled product.
Where it went and when
Where it was distributed
Distributed nationwide.
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 18 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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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-0880-2017 (May 18, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0880-2017 to see it in context.
- Plain-language summary written by qwen3:4b on October 8, 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.