Venlafaxine Hydrochloride Extended-Release Capsules recall
FDA recall D-0617-2024 · initiated Jun 21, 2024
Zydus Pharmaceuticals (USA) Inc recalled Venlafaxine Hydrochloride Extended-Release Capsules in Jun 2024 — an FDA Class II recall (D-0617-2024) because Failed Dissolution Specifications: Out-of-specification results observed for dissolution testing at the 8-hour and 12-hour pull intervals.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Failed Dissolution Specifications: Out-of-specification results observed for dissolution testing at the 8-hour and 12-hour pull intervals.
Wrong strength, or it did not keep
The product did not contain what the label promised, or stopped meeting specification before its expiry date. Under-strength medicine can mean an untreated condition.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: a) 13,128 bottles; b) 252 bottles
Details
- Product
- Venlafaxine Hydrochloride Extended-Release Capsules, USP 37.5mg, packaged in a) 90-count bottles (NDC 68382-034-16) and b)1000-count bottles (NDC 68382-034-10), Rx only, Mfg. by: Zydus Lifesciences Ltd. Ahmedabad, India; Dist. by: Zydus Pharmaceuticals (USA) Inc. Pennington, NJ 08534
- Recalling company
- Zydus Pharms
- Classification
- Class II
- Status
- Terminated
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide within the United States
- Initiated
- Jun 21, 2024
- FDA report date
- Jul 31, 2024
Frequently asked
- Was Venlafaxine Hydrochloride Extended-Release Capsules recalled?
- Zydus Pharmaceuticals (USA) Inc recalled Venlafaxine Hydrochloride Extended-Release Capsules in Jun 2024 — an FDA Class II recall (D-0617-2024) because Failed Dissolution Specifications: Out-of-specification results observed for dissolution testing at the 8-hour and 12-hour pull intervals. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Venlafaxine Hydrochloride Extended-Release Capsules recalled?
- Per the FDA enforcement record, the reason for recall D-0617-2024 was: Failed Dissolution Specifications: Out-of-specification results observed for dissolution testing at the 8-hour and 12-hour pull intervals.
- Is a recalled Venlafaxine Hydrochloride Extended-Release Capsules dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Venlafaxine Hydrochloride Extended-Release Capsules are affected?
- Distributed: Nationwide within the United States. The recall covers these lots — Lot #: a) M213175, Exp. Date 09/2024; b) M213176, Exp. Date 09/2024. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0617-2024.