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Par Pharmaceutical Inc.

Complete recall history across all FDA and CPSC categories — 8 total recalls

Par Pharmaceutical 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 (8)

FDA drug safety enforcement actions by Par Pharmaceutical Inc.

Date Product Reason Class
Aug 10, 2020 BusPIRone Hydrochloride Tablets, USP 7.5 mg NDC# 49884-725-01 Failed Impurity /Degradation Specifications Class II
Mar 30, 2020 Glycopyrrolate Tablets, USP 1 mg, 100-count bottle, Rx only, Dist. by: Par Ph... Failed Impurities/Degradation Specification: Presence of unknown impurity obs... Class II
Mar 4, 2020 PrediniSONE Tablets, USP 5 mg, 48-count bottle, Rx only, Distributed by: Par... Labeling: Incorrect or Missing Exp Date - An incorrect expiration date has be... Class III
Feb 10, 2020 Frovatriptan Succinate Tablets, 2.5mg, packaged in 1 blister card of 9 tablet... Labeling: Incorrect or Missing Lot and/or Exp Date: Product incorrectly label... Class III
Oct 26, 2015 Meclizine Hydrochloride Tablets, USP, 12.5 mg Tablets, Packaged in a) 100 Ct ... Failed Impurities/Degradation Specifications: Out of specification for impuri... Class III
Oct 26, 2015 Meclizine Hydrochloride Tablets USP, 25 mg Tablets, Packaged in a) 100 Ct Bot... Failed Impurities/Degradation Specifications: Out of specification for impuri... Class III
Feb 12, 2015 Mafenide Acetate, USP, For 5% Topical Solution, STERILE, Net Wt. 50 grams ste... Presence of Foreign Substance; oxidized steel, organic material and shredded ... Class II
Nov 24, 2014 HydrALAZINE Hydrochloride Tablets, USP 25 mg, 100 count bottle Rx only, Distr... Presence of Foreign Substance: Par Pharmaceutical, Inc. is recalling one lot ... 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.

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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