Reported Apr 16, 2025 · Ongoing
Solifenacin Succinate Tablets 5mg, a.) 30-count bottle (NDC# 68462-386-30) b.) 90-count bottle (NDC# 68462-386-90), Rx…
Glenmark Pharmaceuticals Inc., USA
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Glenmark Pharmaceuticals Inc., USA · 750 Corporate Dr · Mahwah, NJ · 07430-2009
Is this the product you have?
- Solifenacin Succinate Tablets 5mg, a.) 30-count bottle (NDC# 68462-386-30) b.) 90-count bottle (NDC# 68462-386-90), Rx Only
- Manufactured byGlenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India
- Manufactured forGlenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430
- Lot codes and dates
- 30
- count bottle
17232395exp. date Nov-25 17232400exp
- date Nov-25 90-count bottle
17232395exp. date Nov-25
- Amount recalled
- N/A
This recall covers 39 products
The agency filed one notice per product. You are reading one of them; the other 38 are below.
26 more are in the archive.
Where it was sold
- Nationwide
Why it was recalled
CGMP Deviations
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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