CLASS III Drug recall · Reported 28 Sep 2016 · FDA Enforcement Report
Amoxicillin For Oral Suspension, USP - Dye Free, 400 mg recalled
West-Ward Pharmaceuticals is recalling Amoxicillin For Oral Suspension, USP - Dye Free, 400 mg/ (when reconstituted), distributed nationwide in the US. The recall was initiated on 18 Aug 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-1515-2016
- FDA event ID
- 75083
- Recalling firm
- West-Ward Pharmaceuticals, Eatontown, NJ
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 18 Aug 2016
- FDA classified
- 19 Sep 2016
- Reported
- 28 Sep 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Drug class
- Antibiotics
Timeline
| 18 Aug 2016 | Recall initiated by company | |
| 19 Sep 2016 | Classified by FDA | +32 days |
| 28 Sep 2016 | 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
Labeling: Label Error on Declared Strength- bottles missing colored coded panel where strength of the product is displayed.
Product as listed by the FDA
Amoxicillin For Oral Suspension, USP - Dye Free, 400 mg/5 mL, 100 mL (when reconstituted), Rx only, Manufactured by: Hikma Pharmaceuticals, PO Box 182400, Amman 11118 - Jordan, Distributed by: West-Ward Pharmaceutical Corp. Eatontown, NJ 07724, NDC 00143-9887-01,
Where it was distributed
Nationwide
Questions about this recall
Is Amoxicillin For Oral Suspension, USP - Dye Free, 400 mg/ (when reconstituted) recalled?
Yes. West-Ward Pharmaceuticals recalled Amoxicillin For Oral Suspension, USP - Dye Free, 400 mg/ (when reconstituted) on 18 Aug 2016. The recall is Class III and its status is Terminated. Recall number D-1515-2016.
Why was it recalled?
Labeling: Label Error on Declared Strength- bottles missing colored coded panel where strength of the product is displayed.
Which lots are affected?
Lot #: AS1413A, AS1414A; Exp. 11/18
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 21 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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Other Amoxicillin for recalls
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Amoxicillin for Oral Suspension USP, 125 mg recalled | Teva Pharmaceuticals U | Potency & Assay | Nationwide |
| Drug | CLASS II | Amoxicillin for Oral Suspension USP, 125 mg recalled | Teva Pharmaceuticals U | Potency & Assay | PR |
| Drug | CLASS II | Amoxicillin for Oral Suspension, 125mg/, a) recalled | Dr Reddys Laboratories Tennessee | Mold | Nationwide |