West-Ward Amoxicillin Suspension Recall: Label Error on Strength Display
West-Ward Pharmaceuticals recalls Amoxicillin oral suspension due to missing colored strength panel on labels. This error may cause incorrect dosing. Consumers should contact the manufacturer for details.
Lower-risk recall
Labeling: Label Error on Declared Strength- bottles missing colored coded panel where strength of the product is displayed.
Contact the company
What happened, in plain English
West-Ward Pharmaceuticals is recalling Amoxicillin For Oral Suspension, Dye Free, 400 mg/5 mL, 100 mL (when reconstituted) because the label lacks the colored panel showing the product's strength. This error could lead to incorrect dosing if the strength is not visible. Read more at govinfonow.com/recall/42484-west-ward-amoxicillin-suspension-recall-label-error-on-strength-display.
Source Summary by GovInfoNow · govinfonow.com/recall/42484-west-ward-amoxicillin-suspension-recall-label-error-on-strength-display · Updated October 9, 2026 · FDA enforcement record: FDA #D-1515-2016
Cite this page
“West-Ward Amoxicillin Suspension Recall: Label Error on Strength Display.” GovInfoNow, updated October 9, 2026. https://govinfonow.com/recall/42484-west-ward-amoxicillin-suspension-recall-label-error-on-strength-display. Based on FDA recall #D-1515-2016 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1515-2016%22&limit=1).
Why it’s dangerous
The label error means the colored panel that displays the product's strength is missing. This could cause incorrect dosing if the user cannot see the strength information. The medication is prescription-only and requires precise dosing.
Who’s affected
Prescription holders of Amoxicillin For Oral Suspension, Dye Free, 400 mg/5 mL, 100 mL (when reconstituted) manufactured by Hikma Pharmaceuticals and distributed by West-Ward Pharmaceuticals. Patients using this medication are most at risk due to potential dosing errors.
How to tell if you have this one
Check for the product name 'Amoxicillin For Oral Suspension, USP - Dye Free, 400 mg/5 mL, 100 mL (when reconstituted)' on the label. Look for the lot numbers AS1413A or AS1414A and expiration date 11/18.
- Brand
West-Ward- Category
Drug
What to do — step by step
Check Label for Strength Panel
Ensure the colored panel indicating the product's strength is visible on the label.
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 12 months after the firm started it.
- Firm started the recall
- FDA classified it Class III
- 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-1515-2016 (August 18, 2016) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1515-2016 to see it in context.
- Plain-language summary written by qwen3:4b on October 9, 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.