Donnatal Elixir Recall: Label Error on Dose Strength
Safecor Health recalls Donnatal Elixir because the label incorrectly states a 5 ml dose instead of 10 ml. Check your lot number and expiration date.
Use caution until it’s fixed
Labeling: Label Error on Declared Strength: Label incorrectly identifies product dose as 5ml instead of 10 ml.
Contact the company
What happened, in plain English
Safecor Health, LLC is recalling a specific lot of Donnatal Elixir due to a labeling error. The product's label incorrectly identifies the declared strength as a 5 ml dose, whereas the actual required dose is 10 ml. This discrepancy could lead to patients taking the wrong amount of medication. Read more at govinfonow.com/recall/44083-safecor-health-llc-recalls-phenobarbital-hyoscyamine-atropine-scopolamine-16-2.
Source Summary by GovInfoNow · govinfonow.com/recall/44083-safecor-health-llc-recalls-phenobarbital-hyoscyamine-atropine-scopolamine-16-2 · Updated October 12, 2026 · FDA enforcement record: FDA #D-0785-2016
Cite this page
“Donnatal Elixir Recall: Label Error on Dose Strength.” GovInfoNow, updated October 12, 2026. https://govinfonow.com/recall/44083-safecor-health-llc-recalls-phenobarbital-hyoscyamine-atropine-scopolamine-16-2. Based on FDA recall #D-0785-2016 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0785-2016%22&limit=1).
Why it’s dangerous
The label states that a 5 ml cup contains the full dose, but the actual dose is contained in 10 ml. If a patient follows the label and takes only 5 ml, they will receive half the intended medication, potentially leading to under-treatment of their condition.
Who’s affected
Patients who have been prescribed Donnatal Elixir and purchased it in New York between the manufacturing date and July 16, 2015. Individuals with this specific lot number are at risk of incorrect dosing.
How to tell if you have this one
Check your bottle for the brand name Donnatal Elixir containing Phenobarbital/Hyoscyamine/Atropine/Scopolamine. Verify that the lot number is 914227 and the expiration date is 06/16. The product was distributed in New York.
- Brand
Donnatal- Category
Drug
What to do — step by step
Check Your Bottle
Verify if your Donnatal Elixir bottle has lot number 914227 and an expiration date of 06/16.
Contact Your Pharmacist
If you have the recalled product, contact your pharmacist or healthcare provider for instructions on how to proceed with replacement or disposal.
Where it went and when
Where it was distributed
Distributed in New York.
FDA distribution: “NY” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: New York.
Recall timeline
FDA terminated this recall 8 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- FDA terminated the recall
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
Similar recalls
Other Donnatal recalls
Latest drug recalls
Keep exploring
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-0785-2016 (July 16, 2015) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0785-2016 to see it in context.
- Plain-language summary written by qwen3.6:35b-a3b on October 12, 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.