Aspirin-Dipyridamole Capsules Recalled for Capsule Breakage Defect
Glenmark Pharmaceuticals is recalling Aspirin and Extended-Release Dipyridamole Capsules due to capsule breakage defects. Approximately 168,936 bottles were distributed nationwide.
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 2/5 (Moderate).
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: FDA Class III recall for a manufacturing defect. Capsule breakage is a functional defect affecting drug delivery, not a cosmetic issue, justifying moderate rather than low severity. No safety incidents are mentioned in the source.
Plain-English summary
Glenmark Pharmaceuticals Inc., USA is recalling Aspirin and Extended-Release Dipyridamole Capsules, 25mg/200mg, in 60-count bottles (NDC 68462-405-60), due to capsule breakage resulting from failed capsule specifications during manufacturing.
The recall affects approximately 168,936 bottles of this prescription medication that were distributed nationwide in the United States. The product was manufactured in India.
The following lot numbers are affected with their respective expiration dates: 17201639 (08/2022), 17201759 (09/2022), 17202067 (10/2022), 17210696 (02/2023), 17210092 (11/2022), 17210145 (12/2022), 17210732 (02/2023), 17211062 (04/2023), 17211441 (05/2023), 17211670 (06/2023), 17211810 (07/2023), 17211862 (08/2023), 17212020 (08/2023), 17212068 (08/2023), 17212438 (10/2023), 17220172 (12/2023), and 17220251 (12/2023).
Patients with affected medication should contact their healthcare provider or pharmacy for guidance. This is a prescription medication, and treatment decisions should be made in consultation with a qualified healthcare professional.
The recalled product
- Product
- ASPRIN AND EXTENDED-RELEASE DIPYRIDAMOLE (ASPRIN AND EXTENDED-RELEASE DIPYRIDAMOLE)
- Brand
- ASPRIN AND EXTENDED-RELEASE DIPYRIDAMOLE
- Manufacturer
- Glenmark Pharmaceuticals Inc., USA
- Category
- Drug
- Hazard
- Affected units
- 168,936
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 (20)
- Lot#: 17201639
- Exp 08/2022
- 17201759
- Exp 09/2022
- 17202067
- Exp 10/2022
- 17210696
- Exp 02/2023
- 17210092
- Exp 11/2022
- 17210145
- Exp 12/2022
- 17210732
- 17211062
- Exp 04/2023
- 17211441
- Exp 05/2023
- 17211670
- Exp 06/2023
- 17211810
UPCs (1)
- 0368462405604
Distribution
Distributed nationwide across the United States.
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