West-Ward Recalls Dexamethasone Injections Due to Impurities
West-Ward Pharmaceuticals recalls specific lots of Dexamethasone Sodium Phosphate Injection due to failed impurity specifications. Check your vials immediately.
Use caution until it’s fixed
Failed Impurities/Degradation Specifications: high out of specification results for Dexamethasone adduct (related compound).
Contact the company
What happened, in plain English
West-Ward Pharmaceuticals Corp. is recalling Dexamethasone Sodium Phosphate Injection, USP, 4 mg/mL, 1 mL Vials (NDC 0641-6145-01) because they contain high levels of out-of-specification impurities. The affected product was distributed nationwide in the USA and Puerto Rico. No remedy or return instructions are currently listed in the record. Read more at govinfonow.com/recall/41105-west-ward-recalls-dexamethasone-injections-due-to-impurities.
Source Summary by GovInfoNow · govinfonow.com/recall/41105-west-ward-recalls-dexamethasone-injections-due-to-impurities · Updated October 11, 2026 · FDA enforcement record: FDA #D-0093-2018
Cite this page
“West-Ward Recalls Dexamethasone Injections Due to Impurities.” GovInfoNow, updated October 11, 2026. https://govinfonow.com/recall/41105-west-ward-recalls-dexamethasone-injections-due-to-impurities. Based on FDA recall #D-0093-2018 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0093-2018%22&limit=1).
Why it’s dangerous
The recalled vials failed impurity specifications due to high results for Dexamethasone adduct (a related compound). While the record does not specify the exact health consequences, deviations in pharmaceutical purity can affect the safety or efficacy of the medication.
Who’s affected
Patients who have been prescribed Dexamethasone Sodium Phosphate Injection from West-Ward Pharmaceuticals, specifically those with vials from lots 106390, 106393, or 106395. Healthcare providers and pharmacies that stocked these items are also affected.
How to tell if you have this one
Look for Dexamethasone Sodium Phosphate Injection, USP, 4 mg/mL, in 1 mL vials. Check the NDC number 0641-6145-01 (or shelf pack NDC 0641-6145-25). Verify the lot numbers are 106390, 106393, or 106395 and that the expiration date is 10/18.
- Brand
West-Ward- Category
Drug
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class III- Status
Terminated- Distribution
Nationwide in the USA and Puerto Rico- NDC
0641-0367-21, 0641-0367-25, 0641-6145-01, 0641-6145-25, 0641-6146-01, 0641-6146-10, 0641-6146-25
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| D-0093-2018 | Dexamethasone Sodium Phosphate Injection, USP, 4 mg/mL, 1 mL Vials (NDC 0641-6145-01), packaged in 25 x 1 mL Vials per shelf pack (NDC 0641-6145-25), Rx Only, Manufactured by WEST-WARD, Eatontown, NJ 07724 USA.; Lot #: 106390, 106393, 106395, Exp 10/18 | 16,157 shelf packs |
| D-0094-2018 | 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.; Lot #: 106352, Exp 10/18 | 1,896 shelf packs |
What to do — step by step
Check Your Medication
Verify if your vials match the recalled NDC 0641-6145-01 and lot numbers 106390, 106393, or 106395.
Contact Your Provider
Consult your healthcare provider or pharmacist to determine if you have the recalled product and what steps to take next.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide in the USA and Puerto Rico” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 2.4 years after the firm started it.
- Firm started the recall
- FDA classified it Class III
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0093-2018 (November 6, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0093-2018 to see it in context.
- Plain-language summary written by qwen3.6:35b-a3b on October 11, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.