Food, drugs, devices › Osmotica Pharmaceutical Corp
Drug recall: Venlafaxine (Venlafaxine Hydrochloride) extended release Tablets, 225 mg, packaged in a) 30- count bottle (NDC 0131-3268
FDA enforcement event 66226 is a drug recall by Osmotica Pharmaceutical Corp of Marietta, GA, initiated 16 Sep 2013 and classified Class III, with 1 product record.
FDA defines Class III as a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences. 26% of the 370 drug enforcement events initiated in 2013 carry the same class.
Status: Terminated, terminated 9 May 2014. Initiation: voluntary: firm initiated. Osmotica Pharmaceutical Corp has 3 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Osmotica Pharmaceutical Corp, Marietta, GA.
Reason for recall
"Failed Dissolution Specification:12 hour time point at 18 months of product shelf life."
Distribution
"Nationwide"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| D-1067-2013 | 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. | 57857 bottles | Class III | Terminated | 9 Oct 2013 |
Context
Other enforcement events for Osmotica Pharmaceutical Corp
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 28 Feb 2018 | Methylphenidate Hydrochloride Extended-release Tablets, USP, 36 mg, 100-count bottle, Rx only, Trigen Laboratories, LLC | Drug | Class III | 1 |
| 18 Dec 2017 | Methylphenidate Hydrochloride Extended-release Tablets, USP 27 mg, 100-count bottles, Rx Only, Trigen Laboratories, LLC. | Drug | Class III | 2 |
All 3 events for Osmotica Pharmaceutical Corp
Questions and answers
Why was this drug recalled?
FDA's record gives the reason for recall as: "Failed Dissolution Specification:12 hour time point at 18 months of product shelf life."
What does Class III mean?
FDA classifies recalls by relative degree of health hazard. Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
Where was the product distributed?
FDA's distribution pattern field reads: "Nationwide"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 9 May 2014. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA drug enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.