Carvedilol Tablets Recalled Due to CGMP Manufacturing Deviations
Glenmark Pharmaceuticals Inc., USA is voluntarily recalling Carvedilol Tablets, USP 12.5 mg due to CGMP (Current Good Manufacturing Practice) deviations. The recall affects specific lots distributed nationwide.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The source states FDA Class II classification. No illnesses, injuries, or adverse health reports are documented in the source text. The recall is based on manufacturing process deviations (CGMP) rather than a detected product quality failure or actual harm, placing it at the lower end of Class II—a voluntary precautionary recall.
Plain-English summary
Glenmark Pharmaceuticals Inc., USA is voluntarily recalling Carvedilol Tablets, USP 12.5 mg in 500-count bottles (NDC# 68462-164-05) due to deviations from Current Good Manufacturing Practice (CGMP) standards. The recall affects four lots: 17240238, 17240243, 17240245, and 17240248, all with January 2026 expiration dates.
The recalled product was manufactured by Glenmark Pharmaceuticals Limited in Pithampur, Madhya Pradesh, India and distributed nationwide in the United States. This is a Class II recall, which the FDA issues when a product defect may cause adverse health consequences or serious adverse effects.
Patients should not stop taking carvedilol without consulting their healthcare provider, as abrupt discontinuation of this heart medication can be harmful. Patients should contact their pharmacy to determine if their supply is affected and speak with their doctor about next steps. Healthcare providers and consumers with questions can contact the FDA or the recalling firm.
The recalled product
- Product
- CARVEDILOL (CARVEDILOL)
- Brand
- CARVEDILOL
- Manufacturer
- Glenmark Pharmaceuticals Inc., USA
- Hazard
- cgmp-deviation
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 (5)
- Lot # 17240238
- exp. date Jan-26 17240243
- exp. date Jan-26 17240245
- exp. date Jan-26 17240248
- exp. date Jan-26
UPCs (4)
- 0368462162019
- 0368462163016
- 0368462164013
- 0368462165010
Distribution
Distributed nationwide across the United States.
Related recalls
Same brand · CARVEDILOL
- SevereCarvedilol Tablets Recalled Due to N-Nitroso Impurity
FDA (Drugs) · 2025-06-04
- SevereCarvedilol Tablets 6.25 mg Recalled for N-Nitroso Impurity
FDA (Drugs) · 2025-06-04
- SevereCarvedilol Tablets 12.5 mg Recalled for Impurity Above Limit
FDA (Drugs) · 2025-06-04
- SevereCarvedilol Tablets 25 mg Recalled Due to Impurity Above Acceptable Limit
FDA (Drugs) · 2025-06-04
- HighCarvedilol Tablets Recalled for Carcinogenic N-Nitroso Impurity Manufacturing Defect
FDA (Drugs) · 2025-02-12
Same category
- ModerateQuality Choice Earwax Removal Kit Carbamide Peroxide Subpotent Drug Recall
FDA (Drugs) · 2026-07-22
- ModerateLeader Carbamide Peroxide Earwax Removal Kit Recalled for Subpotency
FDA (Drugs) · 2026-07-22
- SevereCleviprex Injectable Emulsion Recall Due to Sterility Assurance Concerns
FDA (Drugs) · 2026-07-22
- ModerateFamily Wellness Carbamide Peroxide Earwax Removal Kit Subpotent Drug
FDA (Drugs) · 2026-07-22
- ModerateClinere Ear Wax Remover Recalled for Subpotent Carbamide Peroxide
FDA (Drugs) · 2026-07-22