West-Ward Pharmaceutical Corp.

Complete recall history across all FDA and CPSC categories — 28 total recalls

West-Ward Pharmaceutical Corp. appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Drug Recalls (28)

FDA drug safety enforcement actions by West-Ward Pharmaceutical Corp.

Date Product Reason Class
May 13, 2015 Fentanyl Citrate Inj., USP, CII, 250 mcg/5 mL (50 mcg/mL) (0.05 mg/mL), Rx On... Failed Impurities/Degradation Specifications; 12 month stability testing (Exp... Class III
Oct 2, 2014 VERSAPHARM INCORPORATED Ethambutol Hydrochloride Tablets, USP, 100 mg, 100-co... Subpotency: Out of Specification (OOS) result at the 36 month routine stabili... Class II
May 20, 2014 Isoniazid Tablets, USP, 300 mg, Rx only, packaged in a) 100-count bottles, ND... Failed Dissolution Specifications: Stability lots cannot support dissolution ... Class II
Nov 7, 2013 Carisoprodol Tablets, USP 350 mg, Rx Only, 1000 tablets. Dist by: West-ward ... Presence of Foreign Substance; heavy metals (chromium, titanium etc) and inac... Class II
Sep 23, 2013 Irinotecan Hydrochloride Injection, 40 mg/2 mL (20 mg/mL), 1 x 2 mL Single Do... Superpotent Drug: a recent review of the USP revealed that an incorrect calcu... Class II
Sep 23, 2013 Irinotecan Hydrochloride Injection, 100 mg/5 mL (20 mg/mL), 1 x 5 mL Single D... Superpotent Drug: a recent review of the USP revealed that an incorrect calcu... Class II
Jul 30, 2013 Lisinopril Tablets, USP, 2.5 mg, Rx only, packaged in a) 100-count bottles (N... Failed Impurities/Degradation Specifications: Out of Specification results fo... Class II
Jul 30, 2013 Belladonna Alkaloids with Phenobarbital Tablets, 1000 count (NDC 0143-1140-10... Presence of Foreign Substance: black specks comprised of degraded organic mat... Class II
Jun 4, 2013 VersaPharm Incorporated, Ethambutol Hydrochloride Tablets, USP 400 mg 60 tabl... Discoloration: Ethambutol HCl Tablets 400 mg is being recalled due to a Out o... Class II
May 16, 2013 West-ward Belladonna Alkaloids with Phenobarbital Tablets, a) 1000-count bott... Cross contamination with other products: Belladonna Alkaloids with Phenobarbi... Class II
May 16, 2013 West-ward Belladonna Alkaloids with Phenobarbital Tablets, a) 1000-count bott... Presence of Foreign Substance: Belladonna Alkaloids with Phenobarbital Tablet... Class II
May 13, 2013 Nicardipine Hydrochloride Injection 25 mg/10 mL (2.5 mg/mL), 10 mL single-use... Failed Impurity/Degradation Specifications; out of specification value for im... Class III
Mar 18, 2013 Donnatal Extentabs, 0.3888mg/46.8mg, 100-count bottle (NDC # 66213-421-10), R... Labeling: Incorrect or Missing Lot and/or Exp Date: Bottled product is labele... Class II
Mar 18, 2013 Ethambutol Hydrochloride Tablets, USP, 100 mg, 100-count tablets per bottle, ... Subpotent Drug: Out Of Specification results for assay at the stability time-... Class II
Feb 6, 2013 Ciprofloxacin Tablets USP, 500 mg, 100-count bottle, Rx only, Manufactured fo... Presence of Foreign Substance(s): A complaint was received for a rubber-like ... Class II
Jan 7, 2013 Belladonna Alkaloids (hyoscyamine sulfate, USP 0.1037 mg; atropine sulfate, U... Presence of Foreign Substance: Uncharacteristic blacks spots were found in ta... Class II
Jan 7, 2013 Glycopyrrolate Tablets, USP, 1 mg, Rx Only, 100 tablets per bottle, Manufactu... Subpotent Drug Class III
Dec 7, 2012 Carisoprodol Tablets, USP, 350 mg, packaged in a) 500-count tablets per bottl... Presence of Foreign Substance: Uncharacteristic blacks spots on tablets. Class II
Dec 7, 2012 Propylthiouracil Tablets, USP, 50 mg, packaged in a) 100-count tablets per bo... Presence of Foreign Substance: Uncharacteristic spots identified as steel cor... Class II
Dec 7, 2012 Lisinopril Tablets, USP 40 mg, packaged in a) 100-count tablets per bottle (N... Presence of Foreign Substance: Uncharacteristic black spots identified as a f... Class II
Dec 5, 2012 PredniSONE Tablets, USP, 10 mg, packaged in a) 100-count tablets per bottle (... Presence of Foreign Substance: Tablets are being recalled due to gray defects... Class II
Dec 5, 2012 PredniSONE Tablets, USP, 20 mg, packaged in a) 100-count tablets per bottle (... Presence of Foreign Substance: A complaint was received for black specks iden... Class II
Dec 4, 2012 Isoniazid Tablets 300 mg tablets USP, Rx Only, a) 30 tablets - NDC 61748-013-... Failed Dissolution Specifications; 36 month stability timepoint Class II
Nov 30, 2012 Lisinopril and Hydrochlorothiazide Tablets, 20 mg/25 mg, packaged in a) 100-c... Presence of Foreign Substance: Reports of gray smudges identified as minute s... Class II
Nov 30, 2012 VERSAPHARM Ethambutol Tablets, USP,400 mg, Rx Only a)60 tablets, NDC 617... Discoloration: Ethambutol Tablets USP 400 mg have tablets cores that may be d... Class II
Nov 30, 2012 Carisoprodol Tablets, USP, 350 mg Rx Only, 100 tablets per bottle, Rx Only, M... Labeling: Not elsewhere classified: On 12/12/11, DEA published a final rule i... Class III
Apr 13, 2012 Fosphenytoin Sodium Injection, USP, 100 mg PE per 2 mL (50 mg PE per mL), 2 m... Presence of Particulate Matter: This product is being recalled due to the dis... Class II
Apr 13, 2012 Fosphenytoin Sodium Injection, USP, 500 mg PE per 10 mL (50 mg PE per mL), 10... Presence of Particulate Matter: This product is being recalled due to the dis... Class II

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

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