# FDA recall D-0927-2017

> **American Pharmaceutical Ingredients LLC** · Class II · drug recall initiated 2017-06-01.

## 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.

## Distribution

Nationwide in the US

## Key facts

- **Recall number:** D-0927-2017
- **Recalling firm:** American Pharmaceutical Ingredients LLC
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2017-06-01
- **Report date:** 2017-07-05
- **Termination date:** 2018-05-31

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Waterford, MI, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0927-2017

## Citation

> AI Analytics. FDA recall D-0927-2017. Retrieved 2026-07-08 from https://api.ai-analytics.org/recall/D-0927-2017. Source: US FDA. Licensed CC0.

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