Zydus Recalls Venlafaxine ER 150mg Due to Dissolution Failure
Zydus recalls 223,776 bottles of Venlafaxine HCL ER 150mg capsules due to failed dissolution specifications. Check lot numbers and expiration dates for affected units.
Recall notice
Failed Dissolution Specifications: out of specification dissolution results in retained samples
Contact the company
What happened, in plain English
Zydus Pharmaceuticals USA Inc is recalling specific lots of Venlafaxine HCL ER Capsule USP, 150mg, because the medication failed to meet dissolution specifications in retained samples. The product was manufactured by Cadila Healthcare Ltd. in India and distributed nationwide. No remedy or consumer action steps are currently stated in the record. Read more at govinfonow.com/recall/42540-zydus-recalls-venlafaxine-er-150mg-due-to-dissolution-failure.
Source Summary by GovInfoNow · govinfonow.com/recall/42540-zydus-recalls-venlafaxine-er-150mg-due-to-dissolution-failure · Updated October 9, 2026 · FDA enforcement record: FDA #D-1460-2016
Cite this page
“Zydus Recalls Venlafaxine ER 150mg Due to Dissolution Failure.” GovInfoNow, updated October 9, 2026. https://govinfonow.com/recall/42540-zydus-recalls-venlafaxine-er-150mg-due-to-dissolution-failure. Based on FDA recall #D-1460-2016 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1460-2016%22&limit=1).
Why it’s dangerous
The recalled capsules failed dissolution specifications, meaning the drug may not release at the intended rate or amount. This could result in the medication not working as expected for the patient.
Who’s affected
Patients who have been prescribed Venlafaxine HCL ER Capsules, 150mg, from Zydus Pharmaceuticals USA Inc during the relevant time period. The recall affects units distributed nationwide.
How to tell if you have this one
Check your bottle for the following NDC numbers: 68382-036-06 (30-count), 68382-036-16 (90-count), or 68382-036-10 (1000-count). Verify the lot number and expiration date against the record: Lot MR10518 (Exp 9/2017), MR11051-11054 (Exp 10/2017), MR11403 (Exp 11/2017); Lot MR10197, MR10195 (Exp 09/2017), MR11482 (Exp 10/2017), MR11479-11481, MR11483, MR11665 (Exp 11/2017); Lot MR10404, MR10406, MR10521 (Exp 09/2017), MR10744, MR11055, MR11228, MR11285-11289, MR11286 (Exp 10/2017), MR11567 (Exp 11/2017).
- Brand
Zydus Pharmaceuticals- Category
Drug
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Terminated- Distribution
Nationwide- NDC
68382-034-06, 68382-034-16, 68382-034-10, 68382-035-06, 68382-035-16, 68382-035-10, 68382-036-06, 68382-036-16, 68382-036-10
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| D-1460-2016 | Venlafaxine HCL ER Capsule USP, 150mg, packaged in a) 30-count bottles (NDC 68382-036-06), b) 90-count bottles (NDC 68382-036-16), and c) 1000-count bottles, (NDC 68382-036-10), Rx only, Manufactured by : Cadila Healthcare Ltd. Ahmedabad, India, Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534.; Lot #: a) MR10518, Exp. 9/2017; MR11051, MR11052, MR11053, MR11054, Exp. 10/2017; MR11403, Exp. 11/2017. Lot #: b) MR10197, MR10195, Exp. 09/2017; MR11482, Exp.10/2017; MR11479, MR11480, MR11481, MR11483, MR11665 Exp. 11/2017. Lot #: c) MR10404, MR10406, MR10521, Exp. 09/2017; MR10744, MR11055, MR11228, MR11287, MR11285, MR11288, MR11289, MR11286, Exp.10/2017; MR11567, Exp.11/2017. | 223,776 bottles |
| D-1461-2016 | Venlafaxine HCL ER Capsule USP, 75mg, packaged in a) 30-count bottles (NDC 68382-035-06), b) 90-count bottles (NDC 68382-035-16), and c) 1000-count bottles, (NDC 68382-035-10), Rx only, Manufactured by : Cadila Healthcare Ltd. Ahmedabad, India, Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534.; Lot #: a) MS1217, MS1218 , Exp.12/2017. Lot #: b) MS1215, Exp.12/2017 Lot #: c) MR11150, MR11151, MR11854, Exp. 10/2017; MR11798, MR11799, MS1214, Exp.11/2017 | N/A |
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 4.2 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Questions people ask
How many bottles are affected by this recall?
A total of 223,776 bottles are included in the recall.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-1460-2016 (July 19, 2016) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1460-2016 to see it in context.
- Plain-language summary written by qwen3.6:35b-a3b on October 9, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.