CLASS II Drug recall · Reported 31 Aug 2016 · FDA Enforcement Report
Amoxicillin for Oral Suspension USP, 400 mg recalled
Teva North America is recalling Amoxicillin for Oral Suspension USP, 400 mg, distributed nationwide in the US. The recall was initiated on 24 Jun 2016 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-1470-2016
- FDA event ID
- 74540
- Recalling firm
- Teva North America, Horsham, PA
- Brand
- Amoxicillin
- Manufacturer
- Teva Pharmaceuticals USA, Inc.
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 24 Jun 2016
- FDA classified
- 24 Aug 2016
- Reported
- 31 Aug 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Antibiotics
Timeline
| 24 Jun 2016 | Recall initiated by company | |
| 24 Aug 2016 | Classified by FDA | +61 days |
| 31 Aug 2016 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Superpotent drug: Out of specification test result for assay during stability testing.
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 for Oral Suspension USP, 400 mg/ 5 mL, 50 mL bottle, Rx only, Manufactured In Canada by: Teva Canada Limited, Toronto, Canada, NDC 0093-4161-76
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Superpotent drug: Out of specification test result for assay during stability testing.
Which lots are affected?
Lot # 35434158A, Exp 6/17
Where was it sold?
Nationwide
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 North America
All 12| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Claravis (isotretinoin capsules USP), 10mg recalled | Teva North America | Potency & Assay | Nationwide |
| Drug | CLASS II | Ondansetron Injection USP 40 mg/ (2 mg/mL) recalled | Teva North America | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Eptifibatide Injection 75 mg/ (0.75 mg/mL) single use vial recalled | Teva North America | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Linezolid Injection 600 mg recalled by Teva North America | Teva North America | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Argatroban Injection in 0.9% Sodium Chloride 250 mg/ (1 mg/mL) recalled | Teva North America | Manufacturing (CGMP) Deviations | Nationwide |
Other Amoxicillin recalls
All 13| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Amoxicillin and Clavulanate Potassium recalled | Teva Pharmaceuticals USA | Potency & Assay | CA, MS, OH |
| 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 |