Osmotica Pharmaceutical Corp
Complete recall history across all FDA and CPSC categories — 4 total recalls
Osmotica Pharmaceutical Corp 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 (4)
FDA drug safety enforcement actions by Osmotica Pharmaceutical Corp
| Date | Product | Reason | Class |
|---|---|---|---|
| Feb 28, 2018 | Methylphenidate Hydrochloride Extended-release Tablets, USP, 36 mg, 100-count... | Subpotent Drug:100-count product bottle labeled as Methylphenidate HCL ER Tab... | Class III |
| Dec 18, 2017 | Methylphenidate Hydrochloride Extended-release Tablets, USP 54 mg, 100-count ... | Subpotent Drug | Class III |
| Dec 18, 2017 | Methylphenidate Hydrochloride Extended-release Tablets, USP 27 mg, 100-count ... | Subpotent Drug | Class III |
| Sep 16, 2013 | Venlafaxine (Venlafaxine Hydrochloride) extended release Tablets, 225 mg, pac... | Failed Dissolution Specification:12 hour time point at 18 months of product s... | 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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