Unichem Pharmaceuticals Usa Inc

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

Unichem Pharmaceuticals Usa 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 Unichem Pharmaceuticals Usa Inc

Date Product Reason Class
Sep 19, 2022 Clonidine Hydrochloride Tablets, USP, 0.3 mg, 100-count bottle, Rx Only, Manu... Product mix-up:0.2 mg strength Clonidine Hydrochloride Tablets, USP in a 100-... Class III
Oct 25, 2021 Topiramate Tablets, USP 50 mg, 500-count bottles, Rx Only, Manufactured by: U... Discoloration Class III
May 26, 2020 Clonidine Hydrochloride Tablets, USP 0.1 mg 100-count bottles, Rx only, Manuf... Failed Impurities/Degradation Specifications: potential migration of benzophe... Class III
Jan 29, 2020 Clonidine Hydrochloride Tablets, USP 0.1mg, Rx Only, 100-count bottle, Manufa... Failed Impurities/Degredation Specifications: This recall is initiated as a p... Class III
Dec 19, 2017 Divalproex Sodium Delayed Release Tablets USP, 500 mg, 100-count bottle, RX O... Cross Contamination With Other Products: metronidazole powder was found in on... Class II
Oct 2, 2017 Bisoprolol Fumarate tablets, 5 mg, 30-count bottles, Rx only, Manufactured ... Failed Impurities/Degradation Specifications: Out of Specification for an unk... Class II
Aug 19, 2016 Lamotrigine Tablets, USP, 150 mg, 500-count Tablets per bottle, Rx only, Man... Tablets/Capsules Imprinted With Wrong ID: incorrect imprint debossed on the t... Class III
Jul 30, 2015 Hydrochlorothiazide Tablet USP 25 mg,1000- count bottle, Rx Only, Manufactur... Presence of Foreign Tablet: A pharmacist found a clopidogrel tablet in the 1... 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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