Clindamycin Hydrochloride Capsules Recalled for Manufacturing Practice Deviations
Glenmark Pharmaceuticals Inc. USA is recalling Clindamycin Hydrochloride Capsules, USP 300mg due to CGMP deviations. The product has been distributed nationwide.
The agency’s classification
FDA (Drugs): Class II
Class II is 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.
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: This is a Class II recall with no reported illnesses, injuries, or hospitalizations. The hazard is a manufacturing process deviation rather than a specifically identified safety risk, making this a low-risk, voluntary precautionary recall.
Plain-English summary
Glenmark Pharmaceuticals Inc. USA is recalling Clindamycin Hydrochloride Capsules, USP, 300mg in 100-count bottles. The recall was initiated on March 13, 2025 and remains ongoing.
The reason for the recall is CGMP (Current Good Manufacturing Practice) deviations identified during the manufacturing process. The firm initiated the recall voluntarily.
The affected lot numbers are 17241278, 17241297, 17241304, 17241315, and 17241327, all with expiration dates of July 2026. The product was distributed nationwide in the United States.
Consumers with bottles from these lot numbers should contact their pharmacy or healthcare provider for guidance.
The recalled product
- Product
- CLINDAMYCIN HYDROCHLORIDE (CLINDAMYCIN HYDROCHLORIDE)
- Brand
- CLINDAMYCIN HYDROCHLORIDE
- Manufacturer
- Glenmark Pharmaceuticals Inc., USA
- Category
- Drug
- Hazard
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 (6)
- Lot # 17241278
- exp. date Jul-26 17241297
- exp. date Jul-26 17241304
- exp. date Jul-26 17241315
- exp. date Jul-26 17241327
- exp. date Jul-26
UPCs (3)
- 0368462142011
- 0368462143018
- 0368462144015
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 39 recalled by Glenmark Pharmaceuticals Inc., USA under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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