Class II · Moderate risk
Amoxicillin and Clavulanate Potassium for Oral Suspension USP
Subpotent drug; Clavulanate Potassium component
Amoxicillin and Clavulanate Potassium Tablets USP
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Subpotent Drug
Cause type: Wrong potency / content
Sub- or super-potent product, or a failed content-uniformity / assay test. You may receive too little or too much active ingredient - a direct dosing risk. All wrong potency / content recalls.
What was recalled
Amoxicillin and Clavulanate Potassium Tablets USP, Chewable 400mg/57mg, 20-count bottles, Rx only, Manufactured in Canada By: Teva Canada Limited, Toronto, Canada M1B 2K9; Manufactured For: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454 NDC 0093-2272-34
Affected NDC
0093-2272-34
Compare with the code on your package — it is the most precise check available.
Drug: Amoxicillin Category: Antibiotic
- Recalling firm
- Teva Pharmaceuticals USA, Inc
- NDC code
- 0093-2272-34
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0561-2024 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall.
Other Amoxicillin recalls
See all
Class II · Moderate risk
Amoxicillin Capsules
cGMP deviations: Temperature abuse
Class II · Moderate risk
AMOXICILLIN Tablets
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Class II · Moderate risk
AMOXICILLIN for Oral Suspension USP
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Class II · Moderate risk
Amoxicillin 500mg 100
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Other recalls by Teva Pharmaceuticals USA, Inc
All 2024 recalls
Class II · Moderate risk
traZODone Hydrochloride Tablets
Presence of Foreign Tablets/Capsules
Class II · Moderate risk
Octreotide Acetate for Injectable Suspension
Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract manufacturer.
Class II · Moderate risk
Claravis (isotretinoin capsule, USP)
Failed Impurities/Degradation Specifications: Out of specification for specific impurity Tretinoin
Class II · Moderate risk
Clonidine Transdermal System
CGMP Deviations: use of an unapproved raw material
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