Stat Rx USA Recalls Venlafaxine ER Due to Labeling Error
Stat Rx USA is recalling 5 bottles of Venlafaxine ER 150mg because the label incorrectly identifies the dosage form as 'Tabs' instead of 'Capsules.'
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which by definition is unlikely to cause adverse health consequences, and the issue is a minor labeling error regarding dosage form.
Plain-English summary
Stat Rx USA, LLC is recalling 5 bottles of Venlafaxine ER 150mg, 30 Tabs bottle, which is a generic for Effexor. The product was packaged and distributed by Stat Rx USA, LLC in Gainesville, GA. The specific lot number is A00984 with an expiration date of 01/14, and the NDC is 42549-684-30.
The recall was initiated due to a labeling error. The product was incorrectly labeled as 'Tabs' instead of 'Capsules.' This is a Class III recall, which indicates that the use of or exposure to the violative product is not likely to cause adverse health consequences.
The affected product was distributed in Georgia and Tennessee. Consumers who have this product should contact their pharmacist or healthcare provider for guidance on how to proceed.
The recalled product
- Product
- Venlafaxine ER 150mg, 30 Tabs bottle, Generic for: Effexor, Packaged and Distributed by: Stat Rx USA, LLC, Gainesville, GA 30501 NDC 42549-684-30
- Manufacturer
- Stat Rx USA
- Category
- Drug — Antidepressant
- Hazard
- Affected units
- 5
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot # A00984 Exp. 01/14
Distribution
Related recalls
Same manufacturer · Stat Rx USA
See all →- LowStat Rx USA Recalls Methocarbamol Tablets Due to Incorrect Expiration Date
FDA (Drugs) · 2013-02-13
- LowStat Rx USA Recalls Tobramycin Ophthalmic Ointment Due to Labeling Error
FDA (Drugs) · 2012-11-21
- LowStat Rx USA Recalls Tizanidine Tablets Due to Labeling Error
FDA (Drugs) · 2012-08-01
Same hazard · mis labeling
See all →- SevereImperio Distribution Recalls Beef Jerky Produced Without Federal Inspection
USDA FSIS · 2026-10-24
- ModerateHalyard Laparoscopy Comprehensive Pack II Recalled for Latex Content
FDA (Devices) · 2026-10-14
- HighFreshPoint Recalls Cranberry Chicken Salad Wedges for Undeclared Egg Allergen
FDA (Food) · 2026-10-14
- HighJ K Patisserie & Bakery LLC Recalls Croissants for Undeclared Egg
FDA (Food) · 2026-10-14
- SevereBetter Bakehouse Recalls Donutful Chocolate Dipped Vanilla Cake Donuts for Undeclared Milk
FDA (Food) · 2026-10-14
Similar recalls
- LowStat Rx USA Recalls Tizanidine Tablets Due to Labeling Error
FDA (Drugs) · 2012-08-01
- ModerateVenlafaxine 50 mg Tablets Recalled for Wrong Strength
FDA (Drugs) · 2021-08-18
- ModerateVenlafaxine HCL ER Capsules Recalled for Potential Label Mixup
FDA (Drugs) · 2014-01-29
- LowStat Rx USA Recalls Methocarbamol Tablets Due to Incorrect Expiration Date
FDA (Drugs) · 2013-02-13
- CriticalPfizer Recalls Effexor XR Capsules Due to Foreign Tablet Contamination
FDA (Drugs) · 2014-05-28
- ModerateBryant Ranch Recalls Venlafaxine Tablets Due to Labeling Error
FDA (Drugs) · 2016-05-11