Doxycycline Hyclate USP Recalled Due to Misbranding Risk
American Pharmaceutical Ingredients LLC recalls Doxycycline Hyclate USP (NDCs 58597-8082-4 to 58597-8082-8) for misbranding on FDA Import Alert 66-66. Affected items are prescription compounding ingredients.
Lower-risk recall
Labeling: Not Elsewhere Classified. Manufacturer and product were discovered to be on FDA Import Alert 66-66 for misbranding of active pharmaceutical ingredient.
Contact the company
What happened, in plain English
American Pharmaceutical Ingredients LLC is recalling Doxycycline Hyclate USP active pharmaceutical ingredients due to misbranding found on FDA Import Alert 66-66. This affects specific packaging sizes sold for prescription compounding only. Read more at govinfonow.com/recall/41590-doxycycline-hyclate-usp-recalled-due-to-misbranding-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/41590-doxycycline-hyclate-usp-recalled-due-to-misbranding-risk · Updated October 8, 2026 · FDA enforcement record: FDA #D-0927-2017
Cite this page
“Doxycycline Hyclate USP Recalled Due to Misbranding Risk.” GovInfoNow, updated October 8, 2026. https://govinfonow.com/recall/41590-doxycycline-hyclate-usp-recalled-due-to-misbranding-risk. Based on FDA recall #D-0927-2017 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0927-2017%22&limit=1).
Why it’s dangerous
The product was flagged by the FDA for misbranding under Import Alert 66-66, meaning the labeling does not meet regulatory requirements. This affects the product's legal use but does not pose a direct health risk to users.
Who’s affected
Prescription compounding pharmacies and healthcare professionals using the recalled Doxycycline Hyclate USP products. The risk is low as the issue relates to labeling compliance rather than product safety.
How to tell if you have this one
Check for the NDC codes 58597-8082-4 (25g in 500cc), 58597-8082-6 (100g in 16oz), 58597-8082-7 (500g in 2500cc), or 58597-8082-8 (1000g in 1 gallon). These are prescription compounding ingredients sold by American Pharmaceutical Ingredients LLC.
- Brand
American Pharmaceutical Ingredients- Category
Drug
What to do — step by step
Check Product Labels
Look for the NDC codes 58597-8082-4 through 58597-8082-8 on the packaging to identify affected items.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide in the US” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 12 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0927-2017 (June 1, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0927-2017 to see it in context.
- Plain-language summary written by qwen3:4b on October 8, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.