Lupin Somerset

Complete recall history across all FDA and CPSC categories — 13 total recalls

Lupin Somerset 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 (13)

FDA drug safety enforcement actions by Lupin Somerset

Date Product Reason Class
Apr 10, 2019 Morphine Sulfate Extended-Release Tablets, 30 mg, 100-count bottles, Rx Only,... Failed Impurities/Degradation Specifications Class III
Apr 10, 2019 Morphine Sulfate Extended-Release Tablets, 15 mg, 100-count bottles, Rx Only,... Failed Impurities/Degradation Specifications Class III
Apr 10, 2019 Morphine Sulfate Extended-Release Tablets, 200 mg Rx Only 100 Tablets Manufac... Failed Impurities/Degradation Specifications Class III
Apr 10, 2019 Morphine Sulfate Extended-Release Tablets, 100 mg, 100-count bottles, Rx Only... Failed Impurities/Degradation Specifications Class III
Apr 10, 2019 Morphine Sulfate Extended-Release Tablets, 60 mg, 100-count bottles, Rx Only,... Failed Impurities/Degradation Specifications Class III
Mar 19, 2019 Gavilyte-N, PEG-3350, Sodium chloride, Sodium Bicarbonate and Potassium Chlor... Labeling Not Elsewhere Classified; orange and cherry flavor packets incorrect... Class II
Jan 15, 2019 Fluocinolone Acetonide Topical Solution, USP, 0.01 %, 60 mL bottle, Rx Only, ... Failed Impurities/Degradation Specifications: Expansion of October 2018 recal... Class II
Dec 21, 2018 Nitrofurantoin Oral Suspension, USP, 25mg/5mL, 230 mL bottle, Rx only, Manufa... Subpotent Drug: Expansion of June 2018 recall of lots S700065 and S700619 due... Class II
Oct 5, 2018 Fluocinolone Acetonide Topical Solution, USP 0.01%, 60ml Bottle, Manufactured... Failed Impurities/Degradation Specifications:Out of specification result noti... Class II
Aug 23, 2018 Morphine Sulfate Extended-Release Tablets, 30 mg, 100-count bottle, Rx only, ... Failed Impurities/Degradation Specifications: Morphine Sulfate Extended Relea... Class III
Jun 28, 2018 Nitrofurantoin Oral Suspension USP, 25mg/5mL, 230 mL Bottle, Rx Only, Manufac... Subpotent Drug and Failed Content Uniformity. Class II
Jun 13, 2018 Equate ClearLAX, Polyethylene Glycol 3350 Powder for Solution, OS Osmotic Lax... Labeling: Not Elsewhere Classified - A private label distributor noted unfil... Class III
May 24, 2018 Hydrocodone Bitartrate and Acetaminophen Tablets, USP, 5 mg/325 mg, 1000-coun... Labeling: Missing Label 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.

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