Accord Healthcare Recalls Lisinopril 5mg Tablets Due to Spec Failure
Accord Healthcare recalls specific lots of Lisinopril 5 mg tablets because they lack the required break line. Check your bottle's lot number and expiration date.
Use caution until it’s fixed
Failed tablet/capsule specification: missing break line on the 5mg tablet.
Contact the company
What happened, in plain English
Accord Healthcare, Inc. is recalling Lisinopril tablets, 5 mg, in 1000-count bottles due to a manufacturing defect. The specific hazard is that the tablets are missing the necessary break line (score) required by specifications. This recall affects 12,896 bottles distributed nationwide and in Puerto Rico. Read more at govinfonow.com/recall/42115-accord-healthcare-recalls-lisinopril-5mg-tablets-due-to-spec-failure.
Source Summary by GovInfoNow · govinfonow.com/recall/42115-accord-healthcare-recalls-lisinopril-5mg-tablets-due-to-spec-failure · Updated October 11, 2026 · FDA enforcement record: FDA #D-0478-2017
Cite this page
“Accord Healthcare Recalls Lisinopril 5mg Tablets Due to Spec Failure.” GovInfoNow, updated October 11, 2026. https://govinfonow.com/recall/42115-accord-healthcare-recalls-lisinopril-5mg-tablets-due-to-spec-failure. Based on FDA recall #D-0478-2017 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0478-2017%22&limit=1).
Why it’s dangerous
The recalled tablets fail to meet product specifications because they lack a break line (score). This defect means patients cannot easily split the tablet in half if their prescribed dose requires it, potentially leading to incorrect dosing or difficulty administering the medication as intended by their healthcare provider.
Who’s affected
Patients prescribed Lisinopril 5 mg tablets who purchased them from pharmacies across the U.S. and Puerto Rico between the manufacturing dates and the recall date of December 20, 2016. Individuals with these specific lot numbers are at risk of receiving non-compliant medication.
How to tell if you have this one
Check your Lisinopril bottle for the following details: Manufacturer is Accord Healthcare, Inc. (Durham, NC). Product is Lisinopril tablets, 5 mg, in a 1000-count bottle. NDC is 16729-376-17. Affected lots are T04483 (Exp 2/18), T04484 (Exp 2/18), T06028 (Exp 4/18), and T08423 (Exp 5/18). Visually inspect the tablets to see if they are missing the break line.
- Brand
Accord Healthcare- Category
Drug
What to do — step by step
Check Your Bottle
Verify your Lisinopril bottle matches the NDC 16729-376-17 and one of the affected lot numbers (T04483, T04484, T06028, or T08423).
Contact Your Pharmacist
If you have the recalled product, contact your pharmacy or healthcare provider to discuss replacing the medication.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “U.S. Nationwide and Puerto Rico” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 7 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-0478-2017 (December 20, 2016) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0478-2017 to see it in context.
- Plain-language summary written by qwen3.6:35b-a3b on October 11, 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.