Clindamycin Hydrochloride Capsules Recalled for cGMP Deviations
Preferred Pharmaceuticals, Inc. is voluntarily recalling Clindamycin Hydrochloride Capsules USP 300mg due to manufacturing process deviations. The recall affects 1190 bottles 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 an FDA Class II recall for manufacturing process deviations without reported illnesses or injuries. cGMP deviations represent a quality and control concern that could potentially lead to adverse health consequences, but the source text contains no evidence of actual harm, making this a precautionary recall classified as Moderate.
Plain-English summary
Preferred Pharmaceuticals, Inc. is voluntarily recalling Clindamycin Hydrochloride Capsules, USP, 300mg, 30-count bottles, manufactured by Glenmark Pharmaceuticals Limited. The recall was initiated on April 18, 2025, due to Current Good Manufacturing Practice (cGMP) deviations.
The affected product is identified by NDC 68788-8685-03 and includes the following lot numbers: L0224T, K1824M, K0124N, J1624V, J0824O, I2424E, I1024O, A0925F, and L2324L, all with an expiration date of July 31, 2026. A total of 1190 bottles have been distributed nationwide in the United States.
Consumers who have purchased this medication should stop using it and contact their healthcare provider or pharmacist for guidance. The product should be returned to the pharmacy where it was dispensed or to the manufacturer for proper handling.
The recalled product
- Product
- Clindamycin Hydrochloride Capsules, USP, 300mg, 30-count bottles, Manufactured by: Glenmark Pharmaceuticals Limited, NDC 68788-8685-03.
- Manufacturer
- Preferred Pharmaceuticals, Inc.
- Category
- Drug — Antibiotic
- Affected units
- 1,190
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 (10)
- Lot #: L0224T
- K1824M
- K0124N
- J1624V
- J0824O
- I2424E
- I1024O
- A0925F
- L2324L
- Exp: 7/31/2026.
Distribution
Distributed nationwide across the United States.
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