Zydus Pharmaceuticals USA Inc recalls Venlafaxine HCL ER Capsule USP, 150mg, packaged in a) 30-count bottles (NDC 68382-036-06), b) 90-count bottles (NDC
Failed Dissolution Specifications: out of specification dissolution results in retained samples
Recall notice
Failed Dissolution Specifications: out of specification dissolution results in retained samples
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Source Page by GovInfoNow · govinfonow.com/recall/42540-zydus-pharmaceuticals-usa-inc-recalls-venlafaxine-hcl-er-capsule-usp · Recall date July 19, 2016 · FDA enforcement record: FDA #D-1460-2016
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“Zydus Pharmaceuticals USA Inc recalls Venlafaxine HCL ER Capsule USP, 150mg, packaged in a) 30-count bottles (NDC 68382-036-06), b) 90-count bottles (NDC.” GovInfoNow, recall dated July 19, 2016. https://govinfonow.com/recall/42540-zydus-pharmaceuticals-usa-inc-recalls-venlafaxine-hcl-er-capsule-usp. Based on FDA recall #D-1460-2016 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1460-2016%22&limit=1).
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- Brand
Zydus Pharmaceuticals (USA) Inc- 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 |
Contact Zydus Pharmaceuticals (USA) Inc
We’ve drafted a message you can send Zydus Pharmaceuticals (USA) Inc to request your refund or repair — edit it as you like.
Subject: Recall D-1460-2016 — Zydus Pharmaceuticals (USA) Inc Zydus Pharmaceuticals USA Inc recalls Venlafaxine HCL ER Capsule US Hello, I own a Zydus Pharmaceuticals USA Inc recalls Venlafaxine HCL ER Capsule USP, 150mg, packaged in a) 30-count bottles (NDC 68382-036-06), b) 90-count bottles (NDC that is covered by recall D-1460-2016 from Zydus Pharmaceuticals (USA) Inc. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
- 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.
