Minocycline extended-release tablets failed dissolution testing during stability analysis
Minocycline Hydrochloride Extended-Release Tablets, USP, 115 mg, are being recalled after an out-of-specification dissolution result at the ninth month of testing. 360 bottles affected.
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: FDA Class II recall for an out-of-specification dissolution result with no clinical consequence described in the source, which fits the Moderate band.
Plain-English summary
Minocycline Hydrochloride Extended-Release Tablets, USP, 115 mg, 30-count bottle, prescription only, manufactured by Alkem Laboratories Ltd. in India and distributed by Ascend Laboratories, LLC of Parsippany, New Jersey, NDC 67877-644-30, are being recalled. The action covers 360 bottles.
The stated reason is failed dissolution specifications: an out-of-specification result was observed during the ninth month of dissolution test analysis. The FDA classified the action as Class II. The source does not describe a resulting clinical consequence.
The affected lot is 25141635, expiring 4/30/2028. Distribution was nationwide in the USA.
Patients should not stop taking a prescribed medicine without advice. Anyone holding the affected lot should speak to their pharmacist or prescriber and follow the instructions issued by the firm.
The recalled product
- Product
- MINOCYCLINE HYDROCHLORIDE (MINOCYCLINE HYDROCHLORIDE)
- Brand
- MINOCYCLINE HYDROCHLORIDE
- Manufacturer
- Ascend Laboratories, LLC
- Category
- Drug — Extended-release tablet
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 (2)
- Lot# 25141635
- Exp 4/30/2028
Distribution
Distributed nationwide across the United States.
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