Doxycycline antibiotic tablets recalled for failed dissolution specifications
Acella Pharmaceuticals recalls Doxycycline Hyclate Tablets, USP 100 mg due to failed dissolution specifications discovered during stability testing. Lot P24ZLK1 with expiration 5/31/2027 is affected nationwide.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II FDA recall where stability testing identified that the affected lot does not meet dissolution specifications. No illnesses or injuries have been reported. Failed dissolution represents a risk-of-harm condition since tablets that do not dissolve properly cannot deliver medication as intended.
Plain-English summary
Acella Pharmaceuticals, LLC is recalling Doxycycline Hyclate Tablets, USP 100 mg due to failed dissolution specifications. The recall affects Lot P24ZLK1 (expiration 5/31/2027) distributed nationwide in the USA. This recall includes approximately 4,680 500-count bottles.
Stability testing found that the affected lot does not meet dissolution specifications. The product is distributed under NDC 42192-501-05 and is manufactured by Acella Pharmaceuticals, LLC in Alpharetta, Georgia.
Consumers who have bottles from Lot P24ZLK1 should contact their healthcare provider or pharmacist. This is a Class II FDA recall.
The recalled product
- Product
- DOXYCYCLINE (DOXYCYCLINE HYCLATE)
- Brand
- DOXYCYCLINE
- Manufacturer
- Acella Pharmaceuticals, LLC
- Category
- Drug — Antibiotic
- Hazard
- dissolution-failure
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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