Carvedilol Tablets (Zydus Pharmaceuticals) – Foreign Tablet Contamination (2019)
Class III: A situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences
Class III recall indicates unlikely adverse health consequences.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Carvedilol Tablets, USP, 3.125 mg, 500-count bottle, Rx Only, Manufactured by: Cadila Healthcare Ltd., India; Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534; NDC 68382-092-05
Brand
Zydus Pharmaceuticals USA Inc
Lot Codes / Batch Numbers
Lot #: Z803518, Exp 08/2020
Products Sold
Lot #: Z803518, Exp 08/2020
Zydus Pharmaceuticals USA Inc is recalling Carvedilol Tablets, USP, 3.125 mg, 500-count bottle, Rx Only, Manufactured by: Cadila Healthcare Ltd due to Presence of Foreign Tablets/Capsules: Customer complaint for a small, solid, light yellow substance, identified as a fragmented tablet of another drug. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Presence of Foreign Tablets/Capsules: Customer complaint for a small, solid, light yellow substance, identified as a fragmented tablet of another drug product, found mixed with tablets in a bottle of Carvedilol tablets 3.125mg.
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 7, 2026