FDA Recalls Doxycycline Hyclate Due to Missing Stability Data
American Pharmaceutical Ingredients LLC is recalling Doxycycline Hyclate USP for prescription compounding because it lacks stability data to support its expiration dates.
What this means for you
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: The recall is classified as FDA Class II, which the rubric associates with moderate severity when no specific injuries or illnesses are reported, representing a reasonable probability of temporary or medically reversible health consequences.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a recall for Doxycycline Hyclate USP for prescription compounding, packed by American Pharmaceutical Ingredients LLC. The affected product is available in 25g, 100g, 500g, and 1000g packages and is distributed nationwide within the United States. The recall involves approximately 75,000 units.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. Specifically, the manufacturer lacked the necessary stability data and controls to support the assigned retest or expiration dates for the product in its current container/closure system. This deficiency means the product's quality and safety over time cannot be fully verified.
Healthcare providers and pharmacies should stop using the affected lots and return them to the manufacturer. Consumers who have purchased this prescription-only product should contact their healthcare provider or pharmacist for guidance on whether to continue using it or seek a replacement.
The recalled product
- Product
- Doxycycline Hyclate USP for prescription compounding, packaged in a) 25g (NDC 58597-8082-4); b) 100g (NDC 58597-8082-6); c) 500g (NDC 58597-8082-7); d) 1000g (NDC 58597-8082-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
- Manufacturer
- American Pharmaceutical Ingredients LLC
- Category
- Drug — Antibiotic
- Affected units
- 75,000
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 (7)
- Lot #: a) 082815-1
- Exp. 06/04/2019
- b) 082417-1
- Exp. 03/04/2020
- 082815-1
- c) 082815-1
- d) 082815-1
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 66 recalled by American Pharmaceutical Ingredients LLC 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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