InvaGen Pharmaceuticals, Inc.
Complete recall history across all FDA and CPSC categories — 11 total recalls
InvaGen Pharmaceuticals, 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 (11)
FDA drug safety enforcement actions by InvaGen Pharmaceuticals, Inc.
| Date | Product | Reason | Class |
|---|---|---|---|
| Nov 17, 2023 | Vigabatrin for Oral Solution, USP 500 mg per packet, 50 packets per box, Rx O... | Defective Container: powder may leak out of the pouch | Class I |
| May 14, 2020 | Gabapentin Tablets USP, 600 mg, Rx Only, 500-count bottle, Manufactured for: ... | Failed Impurities/Degradation Specifications; failure of Impurity A test at t... | Class III |
| Jun 12, 2019 | Testosterone Topical Solution 30mg of testosterone per pump actuation * each ... | Defective Container; actuator may improperly function and affect dose delivery. | Class III |
| Mar 22, 2019 | Testosterone Cypionate Injection, USP, 200 mg/mL, For IM use only, 1 mL Vial,... | Presence of Particulate Matter. | Class II |
| Mar 22, 2019 | Testosterone Cypionate Injection, USP, 2000 mg/10 mL (200 mg/mL), For intramu... | Presence of Particulate Matter. | Class II |
| Mar 22, 2019 | Testosterone Cypionate Injection, USP, 1000 mg/10 mL (100 mg/mL), For intramu... | Presence of Particulate Matter. | Class II |
| Oct 3, 2018 | Amlodipine Besylate USP 10 mg Tablets, 1000-count bottles, Rx Only, Manufactu... | Subpotent Drug: One lot of product does not meet the product specification fo... | Class III |
| Sep 6, 2018 | Bupropion Hydrochloride ER Tablets, USP 150 mg, packaged in a) 90-count bottl... | Failed impurities/ degradation specifications: Out-of-specification results w... | Class III |
| Mar 15, 2018 | buPROPion HCl Extended-Release Tablets, USP (SR), 100 mg, 60 count bottles,... | Failed Dissolution Specifications; during stability testing | Class III |
| Mar 15, 2018 | buPROPion HCl Extended-Release Tablets, USP (SR), 150 mg ,a) 60 count (NDC ... | Failed Dissolution Specifications; during stability testing | Class III |
| Mar 5, 2018 | Decitabine for Injection, 50mg per vial, Rx only, Manufactured by: Cipla Ltd.... | Failed impurities/degradation specifications: Failure to water content and im... | 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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