Doxycycline Hyclate API Recalled for Misbranding Under FDA Import Alert
American Pharmaceutical Ingredients LLC is recalling Doxycycline Hyclate USP active pharmaceutical ingredient due to misbranding. The product is subject to FDA Import Alert 66-66.
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 and involves a labeling/misbranding issue (Import Alert 66-66) without reported illnesses or injuries, fitting the criteria for moderate severity.
Plain-English summary
American Pharmaceutical Ingredients LLC is recalling Doxycycline Hyclate USP, an active pharmaceutical ingredient intended for prescription compounding. The recall involves specific lot numbers and container sizes, including 25 g, 100 g, 500 g, and 1,000 g packages. The total quantity recalled is 23.5 kg.
The recall was initiated because the manufacturer and product were discovered to be on FDA Import Alert 66-66 for the misbranding of the active pharmaceutical ingredient. This classification indicates a labeling or regulatory compliance issue rather than a direct contamination or safety defect in the chemical substance itself.
The product was distributed nationwide in the US. Healthcare professionals and compounding pharmacies should verify their inventory against the specific lot number 082815-1 and expiration date 06/04/2019. Consumers should not use this product for self-medication, as it is an active ingredient for professional compounding only.
The recalled product
- Product
- Doxycycline Hyclate USP, active pharmaceutical ingredient, a) 25 g packaged in a 500 cc container (NDC: 58597-8082-4), b) 100 g packaged in 16 oz container (NDC: 58597-8082-6), c) 500 g packaged in a 2500 cc container (NDC: 58597-8082-7) and a 1,000 g packaged in 1 gallon contai
- Manufacturer
- American Pharmaceutical Ingredients LLC
- Hazard
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: 082815-1
- EXP 06/04/2019
Distribution
Distributed nationwide across the United States.
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