Teva Recalls Amoxicillin Oral Suspension Due to Potency Issues
Teva North America is recalling specific lots of Amoxicillin for Oral Suspension due to out-of-specification assay results. Check your bottle details.
Use caution until it’s fixed
Superpotent drug: Out of specification test result for assay during stability testing.
Contact the company
What happened, in plain English
Teva North America has recalled a specific lot of Amoxicillin for Oral Suspension USP, 400 mg/5 mL in 50 mL bottles because it failed stability testing for assay. This means the drug may not contain the correct amount of active ingredient, potentially affecting its effectiveness. The recall affects 53,328 bottles distributed nationwide. Read more at govinfonow.com/recall/42575-teva-recalls-amoxicillin-oral-suspension-due-to-potency-issues.
Source Summary by GovInfoNow · govinfonow.com/recall/42575-teva-recalls-amoxicillin-oral-suspension-due-to-potency-issues · Updated October 9, 2026 · FDA enforcement record: FDA #D-1470-2016
Cite this page
“Teva Recalls Amoxicillin Oral Suspension Due to Potency Issues.” GovInfoNow, updated October 9, 2026. https://govinfonow.com/recall/42575-teva-recalls-amoxicillin-oral-suspension-due-to-potency-issues. Based on FDA recall #D-1470-2016 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1470-2016%22&limit=1).
Why it’s dangerous
The product failed an out-of-specification test result for assay during stability testing. This indicates that the concentration of the active drug ingredient may be higher or lower than labeled, which could lead to under-treatment of infection or unexpected side effects from superpotency.
Who’s affected
Patients who have been prescribed Amoxicillin for Oral Suspension USP, 400 mg/5 mL from Teva Canada and purchased it anywhere in the United States. Individuals using the specific recalled lot are at risk of receiving a medication with incorrect potency.
How to tell if you have this one
Check your bottle for NDC 0093-4161-76 and Lot # 35434158A with an expiration date of 6/17. The product is Amoxicillin for Oral Suspension USP, 400 mg/5 mL in a 50 mL bottle, manufactured by Teva Canada Limited.
- Brand
Teva- Category
Drug
What to do — step by step
Check Your Bottle Details
Verify if your medication matches NDC 0093-4161-76 and Lot # 35434158A with an expiration date of 6/17.
Contact Your Pharmacist
If you have the recalled product, contact your pharmacist or healthcare provider for instructions on replacement or disposal.
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 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-1470-2016 (June 24, 2016) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1470-2016 to see it in context.
- Plain-language summary written by qwen3.6:35b-a3b 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.