CLASS III Drug recall · Reported 29 Nov 2017 · FDA Enforcement Report
Dexamethasone Sodium Phosphate Injection, USP, 20 mg recalled
West-Ward Pharmaceuticals is recalling Dexamethasone Sodium Phosphate Injection, USP, 20 mg/ (4 mg/mL) Vials (, distributed nationwide in the US. The recall was initiated on 6 Nov 2017 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-0094-2018
- FDA event ID
- 78415
- Recalling firm
- West-Ward Pharmaceuticals, Eatontown, NJ
- Manufacturer
- Hikma Pharmaceuticals USA Inc.
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 6 Nov 2017
- FDA classified
- 22 Nov 2017
- Reported
- 29 Nov 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Injectable & IV Drugs
Timeline
| 6 Nov 2017 | Recall initiated by company | |
| 22 Nov 2017 | Classified by FDA | +16 days |
| 29 Nov 2017 | 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
Failed Impurities/Degradation Specifications: high out of specification results for Dexamethasone adduct (related compound).
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
Dexamethasone Sodium Phosphate Injection, USP, 20 mg/5 mL (4 mg/mL), 5 mL Vials (NDC 0641-6146-01), packaged in 25 x 5 mL Vials per shelf pack (NDC 0641-6146-25), Rx Only, Manufactured by WEST-WARD, Eatontown, NJ 07724 USA.
Where it was distributed
Nationwide in the USA and Puerto Rico
Questions about this recall
Why was it recalled?
Failed Impurities/Degradation Specifications: high out of specification results for Dexamethasone adduct (related compound).
Which lots are affected?
Lot #: 106352, Exp 10/18
Where was it sold?
Nationwide in the USA and Puerto Rico
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.
Other products in this recall event
1 other product · FDA event 78415This product is part of a recall event; the main page for the event is Dexamethasone Sodium Phosphate Injection, USP, 4 mg/mL Vials recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS III | Dexamethasone Sodium Phosphate Injection, USP, 4 mg/mL Vials recalledDexamethasone Sodium Phosphate | West-Ward Pharmaceuticals | Potency & Assay | Nationwide |
More recalls from West-Ward Pharmaceuticals
All 6| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Dexamethasone Sodium Phosphate Injection, USP, 4 mg/mL Vials recalledDexamethasone Sodium Phosphate | West-Ward Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS III | Sodium Ferric Gluconate Complex IN Sucrose Injection recalledSodium Ferric Gluconate Complex In Sucrose | West-Ward Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS III | Amoxicillin for Oral suspension, USP 400 mg/ (when reconstituted) recalledAmoxicillin | West-Ward Pharmaceuticals | Other | Nationwide |
| Drug | CLASS II | Phenobarbital Tablets, USP 60mg 100=count recalledPhenobarbital | West-Ward Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS III | Amoxicillin For Oral Suspension, USP - Dye Free, 400 mg recalled | West-Ward Pharmaceuticals | Other | Nationwide |
Other Dexamethasone recalls
All 33| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Dexamethasone Sodium Phosphate Injection, USP, 100 mg recalledDexamethasone Sodium Phosphate | Somerset Therapeutics | Potency & Assay | Nationwide |
| Drug | CLASS II | Dexamethasone Sodium Phosphate injection USP, 120mg recalled by Eugia USDexamethasone Sodium Phosphate | Eugia US | Potency & Assay | Nationwide |
| Drug | CLASS II | Dexamethasone 16mg/ML Vial) Injectable recalled by Pharmacy Innovations | Pharmacy Innovations | Sterility | Nationwide |
| Drug | CLASS II | Dexamethasone Elixir, USP 0.5 mg/, Net recalled | Morton Grove Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | Dexamethasone sodium phosphate, sterile otic solution recalled | Edge Pharma | Sterility | Nationwide |