Hetero Labs, Ltd. - Unit III

Complete recall history across all FDA and CPSC categories — 5 total recalls

Hetero Labs, Ltd. - Unit III 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 (5)

FDA drug safety enforcement actions by Hetero Labs, Ltd. - Unit III

Date Product Reason Class
Sep 12, 2018 Fenofibrate Tablets, USP 145 mg, 90-count bottles, Rx only, Manufactured for:... Presence of Foreign Tablet/Capsule: A foreign identified as Valacyclovir tabl... Class III
Jul 18, 2018 Indomethacin Capsules, USP, 50 mg, 100-count bottles, Rx only, Manufactured f... Failed Tablet/Capsule Specifications: customer complaints of deformed, clumpe... Class II
Jan 10, 2018 Aripiprazole Tablets, USP, 10 mg, 30-count bottles, Rx Only, Manufactured fo... CGMP Deviations: lot made with active pharmaceutical ingredient that did not ... Class II
Dec 22, 2017 Simvastatin Tablets, USP, 40 mg, 1000-count bottle, Rx only, Manufactured for... Presence of foreign substance: metallic razor blade was found in one bottle. Class III
Oct 12, 2017 Levetiracetam Oral Solution, USP, 100 mg/mL, packaged in a 16 fl oz (473 mL) ... Presence of foreign substance (screw) 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.

Explore More Recalls

Search recalls by category, state, reason, or firm across all our databases.