VistaPharm, Inc.

Complete recall history across all FDA and CPSC categories — 32 total recalls

VistaPharm, Inc. 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 (32)

FDA drug safety enforcement actions by VistaPharm, Inc.

Date Product Reason Class
Sep 30, 2022 Pyridostigmine Bromide Oral Solution, USP 60 mg/5 mL Delivers 5 mL, packaged ... cGMP Deviations: Out of specification for assay of one of the preservative in... Class II
Jan 7, 2022 Clobazam Oral Suspension 2.5 mg/mL, 120 mL bottles, Rx only, Manufactured by... Failed Stability Specifications Class II
Sep 25, 2020 NYSTATIN ORAL SUSPENSION, USP 100,000 units per mL Contains: Alcohol 0.5% v/v... Failed Impurties/Degradation Specifications: out of specification results for... Class III
Jun 23, 2020 Nystatin Oral Suspension, USP 100,000 units per mL, Bubblegum Flavored, 16 fl... Failed impurities/degradation products; Presence of an impurity peak that exc... Class III
Jun 23, 2020 Nystatin Oral Suspension, USP 500,000 units/5mL Cup, Delivers 5 mL, Rx Only,... Failed impurities/degradation products; Presence of an impurity peak that exc... Class III
Nov 30, 2018 NYSTATIN Oral Suspension, USP 500,000 Units/5mL, unit dose 5ml cups, packaged... Failed Impurities/Degradation Specifications:Out of specification for impurit... Class III
Aug 17, 2017 Hydrocodone Bitartrate and Acetaminophen Oral Solution 7.5 mg/325 mg per 15 m... Labeling: Not Elsewhere Classified; product is incorrectly labeled as Class I... Class III
Jun 26, 2017 Lactulose Solution, USP, 20 g/30 mL, dose cups delivers 30 mL packaged 50-uni... Microbial contamination of non-sterile product: product failed Total Yeast/Mo... Class II
Jun 26, 2017 Lactulose Solution, USP, 10 g/15 mL, dose cups delivers 15 mL packaged in 50-... Microbial contamination of non-sterile product: product failed Total Yeast/Mo... Class II
May 17, 2017 Nystatin Oral Suspension, USP, 100,000 units/mL, packaged in a) 2 fl.oz. (60m... Failed Impurities/Degradation Specifications: Presence of an impurity peak th... Class III
Jan 18, 2017 Nystatin Oral Suspension, USP 100,000 units per mL, a) 2 fl. oz. (60 mL), 24 ... CGMP Deviations: Purified water used to manufacture the drug products may hav... Class II
Jan 18, 2017 Methadone Hydrochloride Oral Concentrate, USP 10 mg/mL C-II, a.) 1 fl. oz. (3... CGMP Deviations: Purified water used to manufacture the drug products may hav... Class II
Jan 18, 2017 Methadone Hydrochloride Oral Concentrate, USP 10 mg/mL C-II (Sugar Free), 1 l... CGMP Deviations: Purified water used to manufacture the drug products may hav... Class II
Jan 18, 2017 Oxycodone Hydrochloride Oral Solution, USP 5 mg/5 mL, a). 5 mL, 50 unit dose ... CGMP Deviations: Purified water used to manufacture the drug products may hav... Class II
Jan 18, 2017 Potassium Chloride Oral Solution, USP, 10%, 20 mEq per 15 mL, packaged in 15... Defective Container: Leakage of unit dose cups that may occur at the seal. Class II
Jan 18, 2017 Phenytoin Oral Suspension, USP 100 mg/ 4 mL, 50 unit dose cups of 4 mL per ca... CGMP Deviations: Purified water used to manufacture the drug products may hav... Class II
Jan 18, 2017 Methadone Hydrochloride Oral Concentrate, USP 5 mg/5 mL C-II, 500 mL, 6 bottl... CGMP Deviations: Purified water used to manufacture the drug products may hav... Class II
Jan 18, 2017 Hydrocodone Bitartrate and Acetaminophen Oral Solution, 7.5 mg/325 mg per 15... CGMP Deviations: Purified water used to manufacture the drug products may hav... Class II
Jan 18, 2017 Nystatin Oral Suspension, USP 500,000 Units/5 mL, a). 50 unit dose cups of 5 ... CGMP Deviations: Purified water used to manufacture the drug products may hav... Class II
Jan 18, 2017 Lactulose Solution, USP 20 g/30 mL, 50 unit dose cups of 30 mL per case, Rx o... CGMP Deviations: Purified water used to manufacture the drug products may hav... Class II
Jan 18, 2017 Lactulose Solution, USP 10 g/15 mL, 50 unit dose cups of 15 mL per case, Rx o... CGMP Deviations: Purified water used to manufacture the drug products may hav... Class II
Jan 18, 2017 Metoclopramide Oral Solution, USP 10 mg/ 10 mL, 50 unit dose cups of 10 mL pe... CGMP Deviations: Purified water used to manufacture the drug products may hav... Class II
Nov 9, 2016 Lactulose Solution, USP, 10 g/15 mL, 15 mL unit dose cups (NDC 66689-039-01),... Microbial Contamination of Non-Sterile Products: bulk solution tested positiv... Class II
Apr 18, 2016 Oxycodone Hydrochloride Oral Solution, USP 5 mg/5 mL (1mg/ml) (NDC 66689-401-... Defective Container: Excess lidding material accumulation between the seal an... Class II
Jun 26, 2015 METOCLOPRAMIDE ORAL SOLUTION, USP 10 mg/10 mL, 10 mL cups, Rx only. Manufactu... Defective Container: Lids on unit dose cups are not fully qualified. Class III
Aug 13, 2014 METOCLOPRAMIDE ORAL SOLUTION, USP 5 mg/5 mL, (present as the hydrochloride), ... Defective Container: Product leaks when inverted. Class II
Oct 15, 2013 Phenytoin Oral Suspension USP 125mg/5mL, 50 cups per case, For Oral Administ... Defective Container: A lidding deformity allowed for the product to have out ... Class II
Jul 4, 2013 Nystatin Oral Suspension, USP 500,000 units/ 5 mL (NDC 66689-037-01 ) Rx Onl... Failed Impurites/Degradation Specifications: Test failure of single largest p... Class II
May 30, 2012 Hydrocodone Bitartrate & Acetaminophen Oral Solution 7.5 mg/325 mg per 15 mL,... Impurities/Degradation Products: exceeded specification at 3 month stability ... Class II
Sep 30, 2011 Xactdose Phenytoin Oral Suspension, USP 125 mg/5mL, supplied in 5 mL unit dos... Defective container; lidding deformity allows the contained product to transp... Class II
Apr 6, 2011 Xactdose Phenytoin Oral Suspension, USP, 125mg/ 5 mL, supplied in 5 mL unit d... Defective container; lidding deformity allows the contained product to transp... Class II
Jan 19, 2011 METOCLOPRAMIDE ORAL SOLUTION, USP 5 mg/5 mL, This cup delivers 10 mL, Rx Only... Labeling: Correct Labeled Product Miscart/Mispack: The shipper label displaye... Class III

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.

Yes. You can search for any company using the firm/manufacturer pages for each category: Food Firms, Drug Firms, Device Firms, or Product Manufacturers. You can also use the search functionality on any browse page to find recalls by company name.

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