American Pharmaceutical Ingredients LLC

FDA recalling firm · 5 enforcement events · 71 product records · 2017–2018 · MI

American Pharmaceutical Ingredients LLC has 5 FDA enforcement events on this register (71 product records) between 2017 and 2018: 5 drug; the busiest year was 2017 with 3.

0% of its events are Class I; the most common class is Class II (5). 0 events are listed as ongoing; the recalling firm's address is in MI.

Recall classification reflects the relative degree of health hazard. Event counts depend on a firm's size and product range; they are not a comparison of one firm with another.

Enforcement events

Initiated	Product (first record)	Type	Class	Records	Status
7 Mar 2018	Oxytocin USP, powder, 1g-bottle, API American Pharmaceutical Ingredients, NDC 58597-7042-3	Drug	Class II	2	Terminated
9 Feb 2018	Amitriptyline HCl USP for prescription compounding , packaged in a) 25 g (NDC 58597-8003-4); b) 100 g (NDC 58597-8003-6); c) 500 g (NDC 58597-8003-7), d) 1000 g (NDC 58597-8003-8), RX only, packed by American Pharmaceutical Ingredients, 6650 Highland Road, Waterford, MI 48327.	Drug	Class II	66	Terminated
1 Jun 2017	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…	Drug	Class II	1	Terminated
26 May 2017	Methocarbamol, USP, packaged in a) 100 g container (NDC: 58597-8023-6, b) 500 g container (NDC: 58597-8023-7), c) 1,000 g container (NDC: 58597-8023-8). For Prescription Compounding RX Only. Packed under cGMP conditions by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327	Drug	Class II	1	Terminated
17 Apr 2017	ESTRONE USP, packaged in a) 1g bottle (NDC: 58597-8049-2), c) 5g bottle (NDC: 58597-8049-3), d) 25g bottle (NDC: 58597-8049-4), For Prescription Compounding, RX Only, Packed under cGMP conditions by American Pharmaceutical Ingredients, LLC, 6650 Highland Road, Waterford, MI 48327	Drug	Class II	1	Terminated

By type and class

Drug5

Class II5

Class I: 0% of this firm's events; 18% of all events on the register.

Events by year

Enforcement events for American Pharmaceutical Ingredients LLC by year initiated.

Questions and answers

How many FDA recalls has American Pharmaceutical Ingredients LLC had?

5 enforcement events (71 product records) on this register, 2017–2018: 5 drug.

Are any American Pharmaceutical Ingredients LLC recalls ongoing?

0 events are listed as ongoing in the current openFDA export.

What class are American Pharmaceutical Ingredients LLC recalls?

5 Class II. 0% are Class I against 18% of all events on the register. Class reflects the relative degree of health hazard of the product, not the firm.

Where does this data come from?

openFDA food, drug and device enforcement reports (CC0), export dated 28 Sep 2026.

Provenance

Source: openFDA enforcement reports (CC0), export dated 28 Sep 2026. Firm names are grouped exactly as FDA spells them; the same company can appear under several spellings. Only organisations are shown. See the methodology.