CLASS III Drug recall · Reported 24 Jul 2013 · FDA Enforcement Report
Amoxicillin for Oral Suspension, USP 200 mg/, a) recalled
Teva Pharmaceuticals USA is recalling Amoxicillin for Oral Suspension, USP 200 mg/, a), distributed nationwide in the US. The recall was initiated on 18 Jun 2013 and the FDA has classified it as Class III.
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-803-2013
- FDA event ID
- 65516
- Recalling firm
- Teva Pharmaceuticals USA, Sellersville, PA
- Brand
- Amoxicillin
- Manufacturer
- Teva Pharmaceuticals USA, Inc.
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 18 Jun 2013
- FDA classified
- 17 Jul 2013
- Reported
- 24 Jul 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Drug class
- Antibiotics
Timeline
| 18 Jun 2013 | Recall initiated by company | |
| 17 Jul 2013 | Classified by FDA | +29 days |
| 24 Jul 2013 | 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
Discoloration: This recall is being carried out due to an orange to brown discolored Amoxicillin powder on the inner foil seal of the bottles. This is an expansion of RES 65050.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
Amoxicillin for Oral Suspension, USP 200 mg/5 mL, a) 75 mL bottle NDC 0093-4160-78 and b) 100 mL bottle NDC 0093-4160-73, Rx Only, Manufactured in Canada by: Teva Canada Limited, Toronto, Canada M1B2K9, Manufactured for: Teva Pharmaceuticals USA, Sellersville, PA 18960.
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Discoloration: This recall is being carried out due to an orange to brown discolored Amoxicillin powder on the inner foil seal of the bottles. This is an expansion of RES 65050.
Which lots are affected?
Lot #s: a) 35426557A, 35426558A, Exp 08/14; b) 35426554A, 35426555A, 35426556A, Exp 08/14
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 III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
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.
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|---|---|---|---|---|---|
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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 |