Doxycycline hyclate tablets recalled after stability testing failed dissolution specifications
Acella Pharmaceuticals is recalling 4,680 five-hundred-count bottles of Doxycycline Hyclate Tablets USP 100 mg after stability testing found the lot did not meet dissolution specifications.
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: Scored 2 as a specification failure: the record states only that dissolution specifications were not met, without describing a health consequence or reporting injury.
Plain-English summary
Doxycycline Hyclate Tablets, USP 100 mg, in 500-count bottles, distributed by Acella Pharmaceuticals of Alpharetta, Georgia, are being recalled for failed dissolution specifications. Stability testing found that the lot did not meet those specifications.
The recall covers 4,680 bottles from lot P24ZLK1, expiring 31 May 2027, carrying NDC 42192-501-05. The product was distributed nationwide in the United States. The FDA has classified the recall as Class II.
The enforcement record states the dissolution failure without describing a health consequence, and reports no injuries.
Doxycycline is a prescription antibiotic, so patients holding the affected lot should contact their pharmacy or prescriber about a replacement rather than stopping treatment on their own.
The recalled product
- Product
- DOXYCYCLINE (DOXYCYCLINE HYCLATE)
- Brand
- DOXYCYCLINE
- Manufacturer
- Acella Pharmaceuticals, LLC
- Category
- Drug — Antibiotic
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 #: P24ZLK1
- Exp 5/31/2027
UPCs (1)
- 0342192501058
Distribution
Distributed nationwide across the United States.
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