Class II · Moderate risk
Amoxicillin and Clavulanate Potassium Tablets USP
Subpotent Drug
Amoxicillin and Clavulanate Potassium for Oral Suspension USP
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Subpotent drug; Clavulanate Potassium component
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 for Oral Suspension USP, 200 mg/28.5 mg per 5mL, 100 mL (when reconstituted), Rx only, manufactured in Canada by: Teva Canada Limited, Toronto, Canada M1B 2K9; Manufactured For: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054 NDC 0093-2277-7.
Affected NDC
0093-2277-07
Compare with the code on your package — it is the most precise check available.
Drug: Amoxicillin Category: Antibiotic
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Amoxicillin and Clavulanate Potassium NDC 00093-2277 |
AMOXICILLIN 200 mg/5mL; CLAVULANATE POTASSIUM 28.5 mg/5mL | Powder, for Suspension Oral |
Teva Pharmaceuticals USA, Inc. | Rx |
- Recalling firm
- Teva Pharmaceuticals USA, Inc
- NDC code
- 0093-2277-7
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0151-2026 · 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 2025 recalls
Class II · Moderate risk
traZODone Hydrochloride Tablets
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Class II · Moderate risk
Octreotide Acetate for Injectable Suspension
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Class II · Moderate risk
Claravis (isotretinoin capsule, USP)
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Class II · Moderate risk
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CGMP Deviations: use of an unapproved raw material
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