West-Ward Pharmaceuticals Corp. FDA Record

Warning letters, Form 483s, inspections, recalls and 510(k) clearances

  • No warning letters matched by name
Inspections 0 0 OAI
Recalls 6 0 Class I (0%)
Warning letters 0 None on file
510(k) clearances 0 None on file

West-Ward Pharmaceuticals Corp. has 6 FDA recalls, 0 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "West-Ward Pharmaceuticals Corp." is on file.

What these totals cover: FDA records filed under the name "West-Ward Pharmaceuticals Corp." and its spelling variant "West-Ward Pharmaceuticals". They do not include records filed under Hikma Pharmaceuticals or other names in its corporate family; those are listed under Related names, each with its own counts.

Latest recall
D-0093-2018 · Class III · Nov 6, 2017

Part of the Hikma Pharmaceuticals corporate family.

Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls6Nov 8, 2026File dated Nov 3, 2026Current
510(k) clearances0Nov 8, 2026File dated Nov 2, 2026Current
Inspections0Nov 15, 2026Newest record Nov 5, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

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Recent recalls

6 recall records from Aug 18, 2016 to Nov 6, 2017.

NumberClassProductDate
D-0093-2018Class IIIDexamethasone Sodium Phosphate Injection, USP, 4 mg/mL, 1 mL Vials (NDC 0641-6145-01), packaged in…Nov 6, 2017
D-0094-2018Class IIIDexamethasone Sodium Phosphate Injection, USP, 20 mg/5 mL (4 mg/mL), 5 mL Vials (NDC 0641-6146-01)…Nov 6, 2017
D-0172-2017Class IIISODIUM FERRIC GLUCONATE COMPLEX IN SUCROSE INJECTION, 62.5mg elemental iron/5mL, 10 (5mL vials) per…Nov 17, 2016
D-0147-2017Class IIIAmoxicillin for Oral suspension, USP 400 mg/5 mL, 100 mL (when reconstituted), Rx only, Manufactured…Nov 4, 2016
D-1045-2017Class IIPhenobarbital Tablets, USP 60mg 100=count bottles, Rx Only, Mfd. by: West-Ward Pharmaceutical Corp…Oct 3, 2016
D-1515-2016Class IIIAmoxicillin For Oral Suspension, USP - Dye Free, 400 mg/5 mL, 100 mL (when reconstituted), Rx only…Aug 18, 2016

West-Ward Pharmaceuticals Corp. and the FDA: common questions

Has West-Ward Pharmaceuticals Corp. received an FDA warning letter?

No FDA warning letter addressed to the name "West-Ward Pharmaceuticals Corp." is on file. This answer covers that name only: letters addressed to a related company name or to one of its sites are listed on that name's or site's own page.

Has West-Ward Pharmaceuticals Corp. received an FDA Form 483?

FDA has not published a Form 483 for "West-Ward Pharmaceuticals Corp." in its reading room. FDA publishes some Form 483s, not all of them.

Has West-Ward Pharmaceuticals Corp. had an FDA recall?

Yes. West-Ward Pharmaceuticals Corp. has 6 FDA recalls on record. The most recent started Nov 6, 2017.

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Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.