Zydus Recalls Carvedilol Tablets Due to Foreign Tablet Fragments
Zydus Pharmaceuticals is recalling Carvedilol tablets 3.125 mg because a customer complaint identified a fragmented tablet of another drug product mixed in the bottle.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The FDA classified this as a Class III recall, which by definition is unlikely to cause adverse health consequences, fitting the 'Low' severity criteria for minor or documentation issues.
Plain-English summary
Zydus Pharmaceuticals USA Inc. is recalling 7,668 bottles of Carvedilol Tablets, USP, 3.125 mg, 500-count, Rx Only. The product was manufactured by Cadila Healthcare Ltd. in India and distributed by Zydus Pharmaceuticals (USA) Inc. in Pennington, NJ. The specific lot number is Z803518 with an expiration date of 08/2020. The recall is nationwide in the USA.
The recall was initiated due to a customer complaint regarding the presence of a small, solid, light yellow substance in a bottle of Carvedilol tablets. This substance was identified as a fragmented tablet of another drug product. The FDA has classified this recall as Class III, indicating that use of or exposure to the violative product is not likely to cause adverse health consequences.
Patients and healthcare providers should check their inventory for Carvedilol tablets with NDC 68382-092-05, Lot # Z803518, and Exp 08/2020. If this specific lot is found, it should be returned to the pharmacy or distributor for credit. Consumers should not take the medication if they suspect foreign material is present and should consult their healthcare provider for alternative treatment options.
The recalled product
- Product
- CARVEDILOL (CARVEDILOL)
- Brand
- CARVEDILOL
- Manufacturer
- Zydus Pharmaceuticals USA Inc
- Category
- Drug — Prescription Drug
- Affected units
- 7,668
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot #: Z803518
- Exp 08/2020
Distribution
Distributed nationwide across the United States.
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