CLASS III Drug recall · Reported 30 Nov 2016 · FDA Enforcement Report
Amoxicillin for Oral suspension, USP 400 mg/ (when reconstituted) recalled
West-Ward Pharmaceuticals is recalling Amoxicillin for Oral suspension, USP 400 mg/ (when reconstituted), distributed nationwide in the US. The recall was initiated on 4 Nov 2016 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-0147-2017
- FDA event ID
- 75604
- Recalling firm
- West-Ward Pharmaceuticals, Eatontown, NJ
- Brand
- Amoxicillin
- Manufacturer
- Hikma Pharmaceuticals USA Inc.
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 4 Nov 2016
- FDA classified
- 22 Nov 2016
- Reported
- 30 Nov 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Drug class
- Antibiotics
Timeline
| 4 Nov 2016 | Recall initiated by company | |
| 22 Nov 2016 | Classified by FDA | +18 days |
| 30 Nov 2016 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Labeling: Label Error on Declared Strength: Some bottles miss a color coded panel where the strength of the product is typically displayed.
Product as listed by the FDA
Amoxicillin for Oral suspension, USP 400 mg/5 mL, 100 mL (when reconstituted), Rx only, Manufactured by: Hikma Pharmaceuticals, P.O. Box 183400, Amman 11118 - Jordan, NDC 0143-9887-01
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Labeling: Label Error on Declared Strength: Some bottles miss a color coded panel where the strength of the product is typically displayed.
Which lots are affected?
Lot #: AS1466A, Exp. Jan 2019
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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| Drug | CLASS III | Sodium Ferric Gluconate Complex IN Sucrose Injection recalledSodium Ferric Gluconate Complex In Sucrose | West-Ward Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | Phenobarbital Tablets, USP 60mg 100=count recalledPhenobarbital | West-Ward Pharmaceuticals | Potency & Assay | Nationwide |
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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 |