CLASS III Drug recall · Reported 9 Oct 2013 · FDA Enforcement Report
Venlafaxine (Venlafaxine Hydrochloride) extended release recalled
Osmotica Pharmaceutical is recalling Venlafaxine (Venlafaxine Hydrochloride) extended release Tablets, 225 mg, distributed nationwide in the US. The recall was initiated on 16 Sep 2013 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1067-2013
- FDA event ID
- 66226
- Recalling firm
- Osmotica Pharmaceutical, Marietta, GA
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 16 Sep 2013
- FDA classified
- 27 Sep 2013
- Reported
- 9 Oct 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Antidepressants
Timeline
| 16 Sep 2013 | Recall initiated by company | |
| 27 Sep 2013 | Classified by FDA | +11 days |
| 9 Oct 2013 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Dissolution Specification:12 hour time point at 18 months of product shelf life.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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.
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Failed Dissolution Specification:12 hour time point at 18 months of product shelf life.
Which lots are affected?
Lot #: a) 58975, 58976, 58977, 65165 , Exp 01/14; b) 58973, 58974, 65131, Exp: 01/14
Where was it sold?
Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Osmotica Pharmaceutical
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Methylphenidate Hydrochloride Extended-release Tablets, USP, 36 mg recalledMethylphenidate Hydrochloride | Osmotica Pharmaceutical | Potency & Assay | Nationwide |
| Drug | CLASS III | Methylphenidate Hydrochloride Extended-release Tablets, USP 54 mg recalledMethylphenidate Hydrochloride | Osmotica Pharmaceutical | Potency & Assay | Nationwide |
| Drug | CLASS III | Methylphenidate Hydrochloride Extended-release Tablets, USP 27 mg recalledMethylphenidate Hydrochloride | Osmotica Pharmaceutical | Potency & Assay | Nationwide |