Teva Amoxicillin Recall: Subpotency Risk in 100 mL Bottles
Teva Pharmaceuticals recalls specific lots of Amoxicillin for Oral Suspension due to subpotency. Check your bottle's lot number and expiration date immediately.
Use caution until it’s fixed
Subpotency: due to a low, out of specification test result for assay during stability testing.
Contact the company
What happened, in plain English
Teva Pharmaceuticals USA is recalling Amoxicillin for Oral Suspension USP, 125 mg per 5 mL, packaged in 100 mL bottles because the medication may be subpotent. This issue stems from a low, out-of-specification test result for assay during stability testing. The recall affects 133,601 bottles distributed across the United States and Puerto Rico. Read more at govinfonow.com/recall/42111-teva-amoxicillin-recall-subpotency-risk-in-100-ml-bottles.
Source Summary by GovInfoNow · govinfonow.com/recall/42111-teva-amoxicillin-recall-subpotency-risk-in-100-ml-bottles · Updated October 11, 2026 · FDA enforcement record: FDA #D-0440-2017
Cite this page
“Teva Amoxicillin Recall: Subpotency Risk in 100 mL Bottles.” GovInfoNow, updated October 11, 2026. https://govinfonow.com/recall/42111-teva-amoxicillin-recall-subpotency-risk-in-100-ml-bottles. Based on FDA recall #D-0440-2017 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0440-2017%22&limit=1).
Why it’s dangerous
The recalled product has a subpotency issue, meaning it contains less active ingredient than labeled due to failed stability testing. Taking subpotent antibiotics can lead to inadequate treatment of bacterial infections, potentially allowing the infection to persist or worsen.
Who’s affected
Patients who have been prescribed Amoxicillin for Oral Suspension by Teva Pharmaceuticals USA are affected. Individuals using the specific lots listed below are at risk of receiving medication that may not contain the full intended dose.
How to tell if you have this one
Check if you have Amoxicillin for Oral Suspension USP, 125 mg per 5 mL in a 100 mL bottle manufactured for TEVA PHARMACEUTICALS USA. Verify the NDC is 0093-4150-73 and the lot number is one of: 35432507A, 35434914A, 35435798A, or 35437490A. The expiration date on these bottles is 9/19.
- Brand
Teva- Category
Drug
What to do — step by step
Check Your Bottle
Verify if your bottle matches the NDC 0093-4150-73 and has one of the recalled lot numbers with an expiration date of 9/19.
Contact Your Pharmacist
If you have a recalled bottle, contact your pharmacist or healthcare provider to discuss replacing the medication or obtaining a new prescription.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “United States 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 14 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.
Questions people ask
What is the NDC number for the recalled product?
The National Drug Code (NDC) for the recalled product is 0093-4150-73.
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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-0440-2017 (December 21, 2016) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0440-2017 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.