Doxycycline Hyclate USP — Class II drug recall D-0927-2017
Terminated recall by American Pharmaceutical Ingredients LLC, reported 2017-07-05, distributed nationwide. Labeling: Not Elsewhere Classified. Manufacturer and product were discovered to be on FDA Import Alert 66-66 f
| Recall number | D-0927-2017 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | American Pharmaceutical Ingredients LLC, Waterford, MI, United States |
| Recall initiated | 2017-06-01 |
| Classified | 2017-06-29 |
| Reported by FDA | 2017-07-05 |
| Terminated | 2018-05-31 |
| Distributed | Nationwide (US) |
| Quantity | 23.5 kilograms |
| Reason classes | labeling |
| NDC | 58597-8082-04, 58597-8082-06, 58597-8082-07, 58597-8082-08 |
| Lot numbers | 082815-1 |
| Expiration dates | 2019-06-04 |
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 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
Reason for recall
Labeling: Not Elsewhere Classified. Manufacturer and product were discovered to be on FDA Import Alert 66-66 for misbranding of active pharmaceutical ingredient.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0927-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.