Food, drugs, devices › American Pharmaceutical Ingredients LLC
Drug recall: Oxytocin USP, powder, 1g-bottle, API American Pharmaceutical Ingredients, NDC 58597-7042-3
FDA enforcement event 79420 is a drug recall by American Pharmaceutical Ingredients LLC of Waterford, MI, initiated 7 Mar 2018 and classified Class II, with 2 product records.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 60% of the 367 drug enforcement events initiated in 2018 carry the same class.
Status: Terminated, terminated 2 Dec 2019. Initiation: voluntary: firm initiated. American Pharmaceutical Ingredients LLC has 5 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
American Pharmaceutical Ingredients LLC, Waterford, MI.
Reason for recall
"Stability Data Does Not Support Expiry: Stability data from manufacturer does not support expiration dates listed."
Distribution
"Nationwide in the USA."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| D-0591-2018 | Oxytocin USP, powder, 1g-bottle, API American Pharmaceutical Ingredients, NDC 58597-7042-3 | 21 g | Class II | Terminated | 21 Mar 2018 |
| D-0592-2018 | Sermorelin Acetate, powder, a) 1 GM-bottle (NDC58597-8092-1) b) 5 GM-bottle (NDC 58597-8092-2) c) 10 GM-bottle (NDC 58597-8092-4) API American Pharmaceutical Ingredients | 1460 GM | Class II | Terminated | 21 Mar 2018 |
Context
Other enforcement events for American Pharmaceutical Ingredients LLC
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 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) | Drug | Class II | 66 |
| 1 Jun 2017 | Doxycycline Hyclate USP, active pharmaceutical ingredient, a) 25 g packaged in a 500 cc container (NDC: 58597-8082-4), b | Drug | Class II | 1 |
| 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 | Drug | Class II | 1 |
| 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: 58597-8 | Drug | Class II | 1 |
All 5 events for American Pharmaceutical Ingredients LLC
Questions and answers
Why was this drug recalled?
FDA's record gives the reason for recall as: "Stability Data Does Not Support Expiry: Stability data from manufacturer does not support expiration dates listed."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "Nationwide in the USA."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 2 Dec 2019. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA drug enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.