CLASS II Drug recall · Reported 21 Mar 2018 · FDA Enforcement Report

Sermorelin Acetate, powder, a) 1 GM-bottle b) 5 GM-bottle recalled

American Pharmaceutical Ingredients is recalling Sermorelin Acetate, powder, a) 1 GM-bottle b) 5 GM-bottle (, distributed nationwide in the US. The recall was initiated on 7 Mar 2018 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLots: 071916-1, Exp. 07/08/2018; 080516-1, 080516-2, Exp. 07/22/2018; 101216-1, 011917C-1, Exp. 09/15/2018;

Quantity recalled1460 GM

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

Recall details

Recall number: D-0592-2018
FDA event ID: 79420
Recalling firm: American Pharmaceutical Ingredients, Waterford, MI
Classification: Class II
Status: Terminated
Recall initiated: 7 Mar 2018
FDA classified: 12 Mar 2018
Reported: 21 Mar 2018
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Potency & Assay

Timeline

7 Mar 2018	Recall initiated by company
12 Mar 2018	Classified by FDA	+5 days
21 Mar 2018	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Stability Data Does Not Support Expiry: Stability data from manufacturer does not support expiration dates listed.

Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.

Product as listed by the FDA

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

Where it was distributed

Nationwide in the USA.

Nationwide

Questions about this recall

Why was it recalled?

Stability Data Does Not Support Expiry: Stability data from manufacturer does not support expiration dates listed.

Which lots are affected?

Lots: 071916-1, Exp. 07/08/2018; 080516-1, 080516-2, Exp. 07/22/2018; 101216-1, 011917C-1, Exp. 09/15/2018;

Where was it sold?

Nationwide in the USA.

What should I do if I have it?

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

1 other product · FDA event 79420

This product is part of a recall event; the main page for the event is Oxytocin USP, powder-bottle, API American Pharmaceutical Ingredients recalled.

Reported	Class	Recall	Company	Reason	Where
21 Mar 2018	CLASS II	Oxytocin USP, powder-bottle, API American Pharmaceutical Ingredients recalled	American Pharmaceutical Ingredients	Potency & Assay	Nationwide

More recalls from American Pharmaceutical Ingredients

All 71

Reported	Class	Recall	Company	Reason	Where
21 Mar 2018Drug	CLASS II	Oxytocin USP, powder-bottle, API American Pharmaceutical Ingredients recalled	American Pharmaceutical Ingredients	Potency & Assay	Nationwide
28 Feb 2018Drug	CLASS II	Levocetirizine Dihydrochloride for prescription compounding recalled	American Pharmaceutical Ingredients	Potency & Assay	Nationwide
28 Feb 2018Drug	CLASS II	Itraconazole USP (Micronized) for prescription compounding recalled	American Pharmaceutical Ingredients	Potency & Assay	Nationwide
28 Feb 2018Drug	CLASS II	Ascorbic Acid USP, for prescription compounding recalled	American Pharmaceutical Ingredients	Potency & Assay	Nationwide
28 Feb 2018Drug	CLASS II	Fluconazole USP for prescription compounding recalled	American Pharmaceutical Ingredients	Potency & Assay	Nationwide

Other Sermorelin recalls

All 74

Reported	Class	Recall	Company	Reason	Where
21 Sep 2022Drug	CLASS II	Sermorelin Acetate 1 MG/ML Injectable syringes recalled	Carolina Infusion	Sterility	Nationwide
20 Jul 2022Drug	CLASS II	Sermorelin/Glycine 2000mcg/5mg/mL-vial, Refrigerate recalled	TMC Acquisition	Sterility	Nationwide
20 Jul 2022Drug	CLASS II	Sermorelin/Glycine 2000mcg/5mg/mL-vial, Refrigerate recalled	TMC Acquisition	Sterility	Nationwide
20 Jul 2022Drug	CLASS II	Sermorelin 2000mcg/mL-vial, Refrigerate, Tailor Made Compounding recalled	TMC Acquisition	Sterility	Nationwide
4 May 2022Drug	CLASS II	Sermorelin Acetate, Lyophilized powder for reconstitution recalled	Olympia Compounding Pharmacy	Manufacturing (CGMP) Deviations	Nationwide