Lower riskDrug recall · FDA · Published June 4, 2024
Teva Amoxicillin Tablets Recall: Subpotent Drug Risk
Teva recalls 20-count chewable amoxicillin-clavulanate tablets due to subpotent drug content. This means the medication may not be as effective as labeled. Consumers should contact Teva for details.
📍Recalling firmTeva Pharmaceuticals USA, Inc400 Interpace Pkwy Bldg A · Parsippany, NJ 07054-1120
✎ GovInfoNow plain-language explainer
Teva is recalling chewable amoxicillin-clavulanate tablets that may not contain the full dose of medication. This could lead to treatment failure if the antibiotic is not strong enough. The recall is for specific lot numbers and expiration dates. Read more at govinfonow.com/recall/32637-teva-amoxicillin-tablets-recall-subpotent-drug-risk.
“Teva Amoxicillin Tablets Recall: Subpotent Drug Risk.” GovInfoNow, updated September 23, 2026. https://govinfonow.com/recall/32637-teva-amoxicillin-tablets-recall-subpotent-drug-risk. Based on FDA recall #D-0561-2024 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0561-2024%22&limit=1).
The FDA announced on June 4, 2024, that Teva Pharmaceuticals USA, Inc. is recalling Amoxicillin and Clavulanate Potassium Tablets USP, Chewable 400mg/57mg due to a subpotent drug hazard. Owners should contact the company for a refund.
Lot #: 100047634, Exp. Date 4/2025; 35449379A, Exp. Date 7/2024
Quantity: 34,448 bottles
The hazard
The recalled tablets are subpotent, meaning they may not contain the expected amount of active ingredient. The FDA classified this as a Class II recall.
Context
GovInfoNow's records show Teva Pharmaceuticals USA, Inc. has had 59 other recalls on record since April 2, 2012. Other recent recalls include the Aug. 24, 2026, recall of traZODone 50mg tablets for foreign tablet risk and the April 24, 2026, recall of Octreotide Acetate 30mg Kit for sterility risk. Other recent recalls of similar products include Somerset Therapeutics Cisatracurium Besylate Injection Recall (Nov. 26, 2025), Major Pharmaceuticals Levothyroxine Tablets Recall (July 13, 2026), and Accord Healthcare Levothyroxine Tablets Recall (Aug. 6, 2026).
How to tell if you have this one
Check for the product name 'Amoxicillin and Clavulanate Potassium Tablets USP, Chewable 400mg/57mg' on the label. Look for lot numbers 100047634 (expiring 4/2025) or 35449379A (expiring 7/2024).
Brand
Teva
Category
Drug
Based on the official FDA remedy
What to do — step by step
Check Product Details
Verify the lot number and expiration date on the packaging to confirm if the product is recalled.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “Nationwide within the United States” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 22 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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-0561-2024 (June 4, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0561-2024 to see it in context.
Plain-language summary written by qwen3:4b on September 23, 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.