Venlafaxine Hydrochloride extended-release capsules recalled for failed dissolution specifications
Zydus Pharmaceuticals (USA) Inc. is recalling Venlafaxine Hydrochloride Extended-Release Capsules USP 37.5mg due to failed dissolution specifications in lots M213175 and M213176. The recall affects 13,128 and 252 bottles distributed nationwide.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall of prescription psychiatric medication with dissolution failure in extended-release formulation; classified as risk-of-harm product per rubric, though no illnesses or injuries reported.
Plain-English summary
Zydus Pharmaceuticals (USA) Inc. is recalling Venlafaxine Hydrochloride Extended-Release Capsules, USP 37.5mg, packaged in 90-count bottles (NDC 68382-034-16) and 1000-count bottles (NDC 68382-034-10). Affected lots are M213175 and M213176, both with expiration date 09/2024. The recalled product was distributed nationwide in the United States.
The recall was initiated because dissolution testing revealed out-of-specification results at the 8-hour and 12-hour pull intervals. The extended-release formulation did not meet established dissolution specifications at these critical testing points.
Patients currently taking venlafaxine hydrochloride should verify their product's lot number and expiration date. Patients with affected lot numbers should consult their healthcare provider or pharmacist regarding their medication.
The recalled product
- Product
- VENLAFAXINE HYDROCHLORIDE (VENLAFAXINE HYDROCHLORIDE)
- Brand
- VENLAFAXINE HYDROCHLORIDE
- Manufacturer
- Zydus Pharmaceuticals (USA) Inc
- Category
- Drug
- Hazard
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 (3)
- Lot #: a) M213175
- Exp. Date 09/2024
- b) M213176
UPCs (3)
- 0368382034106
- 0368382035103
- 0368382036100
Distribution
Distributed nationwide across the United States.
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