Carbidopa-Levodopa Tablets (Harvard Drug Group) – packaging defect (2023)
Class II: A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Class II recall indicates potential for temporary health effects.
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
Carbidopa and Levodopa Tablets, USP 25 mg/100 mg, 10x10 Unit Dose carton, Rx Only, Manufactured in Czech Republic by: Teva Czech Industries, s.r.o. Opava-Komarov, Czech Republic, Manufactured for: Teva Pharmaceuticals USA, Inc. Parsippany, NJ 07054, Packaged and Distributed by: Major Pharmaceuticals Indianapolis, IN 46268 USA. NDC 0904-7257-61, UPC 3 09047 25761 4
Brand
The Harvard Drug Group
Lot Codes / Batch Numbers
Lot: M04145 Exp. 01/2024
Products Sold
Lot: M04145 Exp. 01/2024
The Harvard Drug Group is recalling Carbidopa and Levodopa Tablets, USP 25 mg/100 mg, 10x10 Unit Dose carton, Rx Only, Manufactured in C due to Packaging defect: observed packaging defect, blister packaging inadequately sealed.. 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
Packaging defect: observed packaging defect, blister packaging inadequately sealed.
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