Osmotica Pharmaceutical Corp
Osmotica Pharmaceutical Corp has 3 FDA enforcement events on this register (4 product records) between 2013 and 2018: 3 drug; the busiest year was 2013 with 1.
0% of its events are Class I; the most common class is Class III (3). 0 events are listed as ongoing; the recalling firm's address is in GA.
Recall classification reflects the relative degree of health hazard. Event counts depend on a firm's size and product range; they are not a comparison of one firm with another.
Enforcement events
| Initiated | Product (first record) | Type | Class | Records | Status |
|---|---|---|---|---|---|
| 28 Feb 2018 | Methylphenidate Hydrochloride Extended-release Tablets, USP, 36 mg, 100-count bottle, Rx only, Trigen Laboratories, LLC Bridgewater, NJ 08807. NDC 13811-708-10 | Drug | Class III | 1 | Terminated |
| 18 Dec 2017 | Methylphenidate Hydrochloride Extended-release Tablets, USP 27 mg, 100-count bottles, Rx Only, Trigen Laboratories, LLC. Bridgewater, NJ 08807, NDC 13811-707-10 | Drug | Class III | 2 | Terminated |
| 16 Sep 2013 | Venlafaxine (Venlafaxine Hydrochloride) extended release Tablets, 225 mg, packaged in a) 30- count bottle (NDC 0131-3268-32) and b) 90-count bottle (NDC: 0131-3268-46), Rx only, Manufactured by: Kremers Urban Pharmaceuticals Inc. For: Osmotica Pharmaceutical Corp., Wilmington, NC 28405, USA. | Drug | Class III | 1 | Terminated |
By type and class
Class I: 0% of this firm's events; 18% of all events on the register.
Events by year
Questions and answers
How many FDA recalls has Osmotica Pharmaceutical Corp had?
3 enforcement events (4 product records) on this register, 2013–2018: 3 drug.
Are any Osmotica Pharmaceutical Corp recalls ongoing?
0 events are listed as ongoing in the current openFDA export.
What class are Osmotica Pharmaceutical Corp recalls?
3 Class III. 0% are Class I against 18% of all events on the register. Class reflects the relative degree of health hazard of the product, not the firm.
Where does this data come from?
openFDA food, drug and device enforcement reports (CC0), export dated 28 Sep 2026.
Provenance
Source: openFDA enforcement reports (CC0), export dated 28 Sep 2026. Firm names are grouped exactly as FDA spells them; the same company can appear under several spellings. Only organisations are shown. See the methodology.