CLASS II ONGOING Drug recall · Reported 12 Nov 2025 · FDA Enforcement Report
Amoxicillin and Clavulanate Potassium recalled
Teva Pharmaceuticals USA is recalling Amoxicillin and Clavulanate Potassium for Oral Suspension USP, 200 mg/28.5 mg per (when, distributed in California, Mississippi, Ohio. The recall was initiated on 13 Oct 2025 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0151-2026
- FDA event ID
- 97795
- Recalling firm
- Teva Pharmaceuticals USA, Parsippany, NJ
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 13 Oct 2025
- FDA classified
- 3 Nov 2025
- Reported
- 12 Nov 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Antibiotics
Timeline
| 13 Oct 2025 | Recall initiated by company | |
| 3 Nov 2025 | Classified by FDA | +21 days |
| 12 Nov 2025 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Subpotent drug; Clavulanate Potassium component
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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.
Where it was distributed
Distributed in three (3) States: MS, OH, CA.
Questions about this recall
Why was it recalled?
Subpotent drug; Clavulanate Potassium component
Which lots are affected?
Lot # 100062316, Exp Date: 01/2026
Where was it sold?
Distributed in three (3) States: MS, OH, CA.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Teva Pharmaceuticals USA
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|---|---|---|---|---|---|
| Drug | CLASS II | traZODone Hydrochloride Tablets, USP, 50 mg recalledTrazodone Hydrochloride | Teva Pharmaceuticals USA | Other | Nationwide |
| Drug | CLASS II | Octreotide Acetate for Injectable Suspension recalledOctreotide Acetate | Teva Pharmaceuticals USA | Sterility | Nationwide |
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| Drug | CLASS II | Isotretinoin Capsules, USP, 30 mg recalled by Teva Pharmaceuticals USAIsotretinoin | Teva Pharmaceuticals USA | Potency & Assay | 4 states |
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Other Amoxicillin recalls
All 13| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Amoxicillin and Clavulanate Potassium Tablets recalled | Teva Pharmaceuticals USA | Potency & Assay | Nationwide |
| Drug | CLASS II | Amoxicillin for Oral Suspension USP, 400MG/ (when reconstituted) recalledAmoxicillin | Cardinal Healthcare | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Amoxicillin Tablets, USP, 875MG recalled by Cardinal HealthcareAmoxicillin | Cardinal Healthcare | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Amoxicillin Capsules, USP, 500 mg recalled by Mckesson Medical-SurgicalAmoxicillin | Mckesson Medical-Surgical Inc. Corporate Office | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Amoxicillin and Clavulanate Potassium Tablets, USP, 875 mg/125 mg recalled | AuroMedics Pharma | Other | Nationwide |