Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Doxycycline Hyclate USP Recalled by American Pharmaceutical Ingredients LLC Due to Labeling: Not Elsewhere Classified. Manufacturer and product were...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact American Pharmaceutical Ingredients LLC directly.
Affected Products
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 container (NDC: 58597-8082-8). For Prescription Compounding RX Only. Packed under cGMP conditions by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
Quantity: 23.5kg
Why Was This Recalled?
Labeling: Not Elsewhere Classified. Manufacturer and product were discovered to be on FDA Import Alert 66-66 for misbranding of active pharmaceutical ingredient.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About American Pharmaceutical Ingredients LLC
American Pharmaceutical Ingredients LLC has 71 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report