CLASS II Drug recall · Reported 23 Sep 2015 · FDA Enforcement Report

Fentanyl 950 mcg/ml + Bupivacaine 5 mg/ml Intrathecal recalled

The Compounding Pharmacy of America is recalling Fentanyl 950 mcg/ml + Bupivacaine 5 mg/ml Intrathecal Solution, Sterile-Preservative Free, distributed nationwide in the US. The recall was initiated on 2 Jun 2015 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesAll lots distributed between November 2014 and May 2015; 02252015@14, 5/26/2015; 04012015@2, 6/30/2015; 04272015@30, 7/26/2015

Quantity recalled129 ml total volume

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-1488-2015
FDA event ID: 71371
Recalling firm: The Compounding Pharmacy of America, Knoxville, TN
Classification: Class II
Status: Terminated
Recall initiated: 2 Jun 2015
FDA classified: 15 Sep 2015
Reported: 23 Sep 2015
Type: Voluntary: Firm initiated
Customers notified by: Telephone
Reason category: Sterility
Drug class: Pain Medication

Timeline

2 Jun 2015	Recall initiated by company
15 Sep 2015	Classified by FDA	+105 days
23 Sep 2015	Published in enforcement report	+8 days

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

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

Fentanyl 950 mcg/ml + Bupivacaine 5 mg/ml Intrathecal Solution, Sterile-Preservative Free,The Compounding Pharmacy of America, Knoxville, TN

Where it was distributed

Nationwide

Questions about this recall

Why was it recalled?

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Which lots are affected?

All lots distributed between November 2014 and May 2015; 02252015@14, 5/26/2015; 04012015@2, 6/30/2015; 04272015@30, 7/26/2015

Where was it sold?

Nationwide

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

100 other products · FDA event 71371

This product is part of a recall event; the main page for the event is HCG 1,100 IU/ml Injection, Multi-Dose Vial, Sterile recalled.

Reported	Class	Recall	Company	Reason	Where
23 Sep 2015	CLASS II	HCG 1,100 IU/ml Injection, Multi-Dose Vial, Sterile recalled	The Compounding Pharmacy of America	Sterility	Nationwide
23 Sep 2015	CLASS II	Testosterone 20 mg, Sterile Pellet recalled	The Compounding Pharmacy of America	Sterility	Nationwide
23 Sep 2015	CLASS II	HCG 1,250 IU/ml Injection, Multi-Dose Vial, Sterile recalled	The Compounding Pharmacy of America	Sterility	Nationwide
23 Sep 2015	CLASS II	Hydromorphone 30 mg/ml Solution, Sterile-Preservative Free recalled	The Compounding Pharmacy of America	Sterility	Nationwide
23 Sep 2015	CLASS II	Morphine 60 mg/ml Solution, Sterile-Preservative Free recalled	The Compounding Pharmacy of America	Sterility	Nationwide
23 Sep 2015	CLASS II	Hyaluronic Acid Sodium 28 mg/ml + Lidocaine HCl 3 mg/ml recalled	The Compounding Pharmacy of America	Sterility	Nationwide
23 Sep 2015	CLASS II	Hydromorphone 50 mg/ml + Fentanyl 3,000 mcg/ml + recalled	The Compounding Pharmacy of America	Sterility	Nationwide
23 Sep 2015	CLASS II	Hydromorphone 80 mg/ml + Bupivacaine 10 mg/ml + Clonidine recalled	The Compounding Pharmacy of America	Sterility	Nationwide
23 Sep 2015	CLASS II	Fentanyl 2,000 mcg/ml + Bupivacaine 20 mg/ml Intrathecal recalled	The Compounding Pharmacy of America	Sterility	Nationwide
23 Sep 2015	CLASS II	Morphine 25 mg/ml + Bupivacaine 30 mg/ml + Clonidine recalled	The Compounding Pharmacy of America	Sterility	Nationwide
23 Sep 2015	CLASS II	Testosterone 12.5 mg, Sterile Pellet recalled	The Compounding Pharmacy of America	Sterility	Nationwide
23 Sep 2015	CLASS II	Hydromorphone 80 mg/ml + Fentanyl 15,000 mcg/ml + recalled	The Compounding Pharmacy of America	Sterility	Nationwide
23 Sep 2015	CLASS II	Tri-Mix AT-6 (60 mg/4 mg/0.3 mg) Injectable recalled	The Compounding Pharmacy of America	Sterility	Nationwide
23 Sep 2015	CLASS II	B-Complex 100 mg/ml Injection, Sterile, Refrigerate recalled	The Compounding Pharmacy of America	Sterility	Nationwide
23 Sep 2015	CLASS II	PGE 2 (Alprostadil) 100 mcg/ml, Sterile, Keep Frozen recalled	The Compounding Pharmacy of America	Sterility	Nationwide
23 Sep 2015	CLASS II	Morphine 25 mg/ml + Bupivacaine 20 mg/ml + Clonidine recalled	The Compounding Pharmacy of America	Sterility	Nationwide
23 Sep 2015	CLASS II	Morphine 12.5 mg/ml Solution recalled by The Compounding Pharmacy of	The Compounding Pharmacy of America	Sterility	Nationwide
23 Sep 2015	CLASS II	Quad-Mix 4 Injectable, Multi-Dose Vial, Sterile recalled	The Compounding Pharmacy of America	Sterility	Nationwide
23 Sep 2015	CLASS II	Phosphatidylcholine 0.1% Sodium Deoxycholate recalled	The Compounding Pharmacy of America	Sterility	Nationwide
23 Sep 2015	CLASS II	L-Arginine 100 mg/ml Injectable, Multi-Dose Vial, Sterile recalled	The Compounding Pharmacy of America	Sterility	Nationwide
23 Sep 2015	CLASS II	Hydromorphone 20 mg/ml Solution, Sterile-Preservative Free recalled	The Compounding Pharmacy of America	Sterility	Nationwide
23 Sep 2015	CLASS II	Morphine 50 mg/ml + Clonidine 200 mcg/ml Solution recalled	The Compounding Pharmacy of America	Sterility	Nationwide
23 Sep 2015	CLASS II	Mitomycin 40 mg/ Sodium Chloride 0.9% Injection recalled	The Compounding Pharmacy of America	Sterility	Nationwide
23 Sep 2015	CLASS II	Acetylcysteine 100 mg/ml Injectable, Multi-Dose Vial recalled	The Compounding Pharmacy of America	Sterility	Nationwide
23 Sep 2015	CLASS II	HCG 1,000 IU/ml Injection, Multi-Dose Vial, Sterile recalled	The Compounding Pharmacy of America	Sterility	Nationwide
23 Sep 2015	CLASS II	Tri-Mix (17.7 mg/0.59 mg/6 mcg) Injectable, Sterile recalled	The Compounding Pharmacy of America	Sterility	Nationwide
23 Sep 2015	CLASS II	Baclofen 2,500 mcg/ml Intrathecal Solution recalled	The Compounding Pharmacy of America	Sterility	Nationwide
23 Sep 2015	CLASS II	Tri-Mix (6.9/0.575/39.375) Injectable recalled	The Compounding Pharmacy of America	Sterility	Nationwide
23 Sep 2015	CLASS II	Tri-Mix Super Injectable, Multi-Dose Vial, Sterile recalled	The Compounding Pharmacy of America	Sterility	Nationwide
23 Sep 2015	CLASS II	Estradiol 25 mg, Sterile Pellet recalled by The Compounding Pharmacy of	The Compounding Pharmacy of America	Sterility	Nationwide
23 Sep 2015	CLASS II	Lipovicine Modified II Injectable, Multi-Dose Vial, Sterile recalled	The Compounding Pharmacy of America	Sterility	Nationwide
23 Sep 2015	CLASS II	Tri-Mix Medium (15 mg/0.5 mg/5 mcg) Injectable recalled	The Compounding Pharmacy of America	Sterility	Nationwide
23 Sep 2015	CLASS II	Estradiol 8 mg, Sterile Pellet recalled by The Compounding Pharmacy of	The Compounding Pharmacy of America	Sterility	Nationwide
23 Sep 2015	CLASS II	Tri-Mix (37.5 mg/1.5 mg/50 mcg) Injectable recalled	The Compounding Pharmacy of America	Sterility	Nationwide
23 Sep 2015	CLASS II	Fentanyl 17,500 mcg/ml + Clonidine 1,000 mcg/ml Intrathecal recalled	The Compounding Pharmacy of America	Sterility	Nationwide
23 Sep 2015	CLASS II	Tri-Mix T-106/PGE 2 0.1/0.14 Injectable recalled	The Compounding Pharmacy of America	Sterility	Nationwide
23 Sep 2015	CLASS II	Methionine 25 mg/ml + Inositol 50 mg/ml + Choline 50 mg/ml recalled	The Compounding Pharmacy of America	Sterility	Nationwide
23 Sep 2015	CLASS II	Morphine 50 mg/ml + Fentanyl 1,500 mcg/ml + Baclofen recalled	The Compounding Pharmacy of America	Sterility	Nationwide
23 Sep 2015	CLASS II	Morphine 50 mg/ml + Fentanyl 3,000 mcg/ml + Baclofen recalled	The Compounding Pharmacy of America	Sterility	Nationwide
23 Sep 2015	CLASS II	Tri-Mix ST3/PGE 2/LIDO 2 0.06/0.2/0.02 Injectable recalled	The Compounding Pharmacy of America	Sterility	Nationwide
23 Sep 2015	CLASS II	Tri-Mix T-50 8.8 mg/0.29 mg/2.9 mcg Injectable recalled	The Compounding Pharmacy of America	Sterility	Nationwide
23 Sep 2015	CLASS II	Sufentanil 50 mcg/ml Solution, Sterile-Preservative Free recalled	The Compounding Pharmacy of America	Sterility	Nationwide
23 Sep 2015	CLASS II	Lipotropic (w/Cyanocobalamin 4000 mcg/ml) Injection recalled	The Compounding Pharmacy of America	Sterility	Nationwide
23 Sep 2015	CLASS II	Tri-Mix (30/0.5/10) Injectable, Sterile, Keep Frozen recalled	The Compounding Pharmacy of America	Sterility	Nationwide
23 Sep 2015	CLASS II	MIC+Methylcobalamin 4000 mcg/ml Injection, Multi-Dose Vial recalled	The Compounding Pharmacy of America	Sterility	Nationwide
23 Sep 2015	CLASS II	Magnesium Sulfate 500 mg/ml Injectable, Multi-Dose Vial recalled	The Compounding Pharmacy of America	Sterility	Nationwide
23 Sep 2015	CLASS II	Hydroxocobalamin 1,000 mcg/ml Injection, Multi-Dose Vial recalled	The Compounding Pharmacy of America	Sterility	Nationwide
23 Sep 2015	CLASS II	Lipo-vite III, Injection Multi-Dose Vial, Sterile recalled	The Compounding Pharmacy of America	Sterility	Nationwide
23 Sep 2015	CLASS II	Hydromorphone 10 mg/ml + Baclofen 2,500 mcg/ml Intrathecal recalled	The Compounding Pharmacy of America	Sterility	Nationwide
23 Sep 2015	CLASS II	Tri-mix (1/1/40) (MFG) Injectable, Multi-Dose Vial, Sterile recalled	The Compounding Pharmacy of America	Sterility	Nationwide
23 Sep 2015	CLASS II	Cyanocobalamin 1,000 mcg/ml, Multi-Dose vial, Sterile recalled	The Compounding Pharmacy of America	Sterility	Nationwide
23 Sep 2015	CLASS II	Tri-Mix (37.5/2/20) Injectable recalled by The Compounding Pharmacy of	The Compounding Pharmacy of America	Sterility	Nationwide
23 Sep 2015	CLASS II	B-Complex Injection, Sterile, Refrigerate recalled	The Compounding Pharmacy of America	Sterility	Nationwide
23 Sep 2015	CLASS II	Lidocaine 1% Injection, The Compounding Pharmacy of America recalled	The Compounding Pharmacy of America	Sterility	Nationwide
23 Sep 2015	CLASS II	Tri-Mix (30/1/22) (MFG) Injectable recalled	The Compounding Pharmacy of America	Sterility	Nationwide
23 Sep 2015	CLASS II	Testosterone 37.5 mg, Sterile Pellet recalled	The Compounding Pharmacy of America	Sterility	Nationwide
23 Sep 2015	CLASS II	Fentanyl 5,000 mcg/ml Intrathecal Solution, Sterile recalled	The Compounding Pharmacy of America	Sterility	Nationwide
23 Sep 2015	CLASS II	5-Methy Tetrahydrofolate 5 mg/ml Injectable recalled	The Compounding Pharmacy of America	Sterility	Nationwide
23 Sep 2015	CLASS II	HCG 2,000 IU/ml Injection, Multi-Dose Vial, Sterile recalled	The Compounding Pharmacy of America	Sterility	Nationwide
23 Sep 2015	CLASS II	Neomycin + Polymyxin B+ Bacitracin Ophthalmic Ointment recalled	The Compounding Pharmacy of America	Sterility	Nationwide
23 Sep 2015	CLASS II	Methylcobalamin 1,000 mcg/ml Injectable, Multi-Dose Vial recalled	The Compounding Pharmacy of America	Sterility	Nationwide
23 Sep 2015	CLASS II	Hyaluronidase/ml Injection, ml, Sterile, Preserved recalled	The Compounding Pharmacy of America	Sterility	Nationwide
23 Sep 2015	CLASS II	Zinc 5 mg/ml Injectable, Multi-Dose Vial, Sterile recalled	The Compounding Pharmacy of America	Sterility	Nationwide
23 Sep 2015	CLASS II	HCG 625 IU/ml Injection, Multi-Dose Vial, Sterile recalled	The Compounding Pharmacy of America	Sterility	Nationwide
23 Sep 2015	CLASS II	Cholecalciferol 600,000 IU/ml Injectable, ml Vial, Sterile recalled	The Compounding Pharmacy of America	Sterility	Nationwide
23 Sep 2015	CLASS II	Tri-Mix (15 mg/0.5 mg/20 mcg) Injectable, Multi-Dose Vial recalled	The Compounding Pharmacy of America	Sterility	Nationwide
23 Sep 2015	CLASS II	Myo-den 25 mg/ml Injection, Multi-Dose Vial, Sterile recalled	The Compounding Pharmacy of America	Sterility	Nationwide
23 Sep 2015	CLASS II	Testosterone 80 mg Pellet, Sterile recalled	The Compounding Pharmacy of America	Sterility	Nationwide
23 Sep 2015	CLASS II	Acetyl-L-Carnitine 500 mg/ml, Injectable recalled	The Compounding Pharmacy of America	Sterility	Nationwide
23 Sep 2015	CLASS II	Hydromorphone 80 mg/ml + Fentanyl 15,000 mcg/ml + recalled	The Compounding Pharmacy of America	Sterility	Nationwide
23 Sep 2015	CLASS II	Tri-Mix T-105 (30 mg/1 mg/10 mcg) Injectable recalled	The Compounding Pharmacy of America	Sterility	Nationwide
23 Sep 2015	CLASS II	Tri-Mix (18 mg/0.6 mg/5.88 mcg) Injectable, Sterile recalled	The Compounding Pharmacy of America	Sterility	Nationwide
23 Sep 2015	CLASS II	HCG 5,000 IU/ml + Methylcobalamin 1,000 mcg/ml Injection recalled	The Compounding Pharmacy of America	Sterility	Nationwide
23 Sep 2015	CLASS II	Hyaluronidase/ml Injection, ml, Sterile, Preservative Free recalled	The Compounding Pharmacy of America	Sterility	Nationwide
23 Sep 2015	CLASS II	HCG 10,000 IU/ml Injection, Multi-Dose Vial, Sterile recalled	The Compounding Pharmacy of America	Sterility	Nationwide
23 Sep 2015	CLASS II	Tri-Mix (25/2.5/10) (MFG) Injectable, Sterile, Keep Frozen recalled	The Compounding Pharmacy of America	Sterility	Nationwide
23 Sep 2015	CLASS II	Testosterone 75 mg Pellet, Sterile recalled	The Compounding Pharmacy of America	Sterility	Nationwide
23 Sep 2015	CLASS II	Testosterone Bi-Blend 50 mg/ml + Estradiol Valerate recalled	The Compounding Pharmacy of America	Sterility	Nationwide
23 Sep 2015	CLASS II	Morphine 30 mg/ml Solution, Sterile-Preservative Free recalled	The Compounding Pharmacy of America	Sterility	Nationwide
23 Sep 2015	CLASS II	Fentanyl 7,500 mcg/ml, + Bupivacaine 20 mg/ml Intrathecal recalled	The Compounding Pharmacy of America	Sterility	Nationwide
23 Sep 2015	CLASS II	Tri-Mix (25/2.5/10) Injectable, Sterile, Keep Frozen recalled	The Compounding Pharmacy of America	Sterility	Nationwide
23 Sep 2015	CLASS II	Sermorelin/GHRP6 1000/1000 mcg/ml Injection recalled	The Compounding Pharmacy of America	Sterility	Nationwide
23 Sep 2015	CLASS II	Folic Acid 5 mg/ml Injection, Multi-Dose Vial, Sterile recalled	The Compounding Pharmacy of America	Sterility	Nationwide
23 Sep 2015	CLASS II	Sermorelin 300 mcg/ml + Ghrp-2 300 mcg/ml Injection recalled	The Compounding Pharmacy of America	Sterility	Nationwide
23 Sep 2015	CLASS II	Lipo-extreme Injectable, Multi-Dose Vial, Sterile recalled	The Compounding Pharmacy of America	Sterility	Nationwide
23 Sep 2015	CLASS II	Nandrolone Decanoate 200 mg/ml Injection recalled	The Compounding Pharmacy of America	Sterility	Nationwide
23 Sep 2015	CLASS II	Oxytocin/ml Injection, Multi-Dose Vial, Sterile recalled	The Compounding Pharmacy of America	Sterility	Nationwide
23 Sep 2015	CLASS II	Sermorelin/GHRP2 1000/1000 mcg/ml Injection recalled	The Compounding Pharmacy of America	Sterility	Nationwide
23 Sep 2015	CLASS II	Morphine 30 mg/ml + Clonidine 250 mcg/ml Solution recalled	The Compounding Pharmacy of America	Sterility	Nationwide
23 Sep 2015	CLASS II	Fentanyl 1,000 mcg/ml Intrathecal Solution recalled	The Compounding Pharmacy of America	Sterility	Nationwide
23 Sep 2015	CLASS II	Buckshot Injectable, Multi-Dose, Sterile, Room Temperature recalled	The Compounding Pharmacy of America	Sterility	Nationwide
23 Sep 2015	CLASS II	Morphine 30 mg/ml + Bupivacaine 5 mg/ml Solution recalled	The Compounding Pharmacy of America	Sterility	Nationwide
23 Sep 2015	CLASS II	Morphine 50 mg/ml + Fentanyl 3,000 mcg/ml + Bupivacaine recalled	The Compounding Pharmacy of America	Sterility	Nationwide
23 Sep 2015	CLASS II	Lipo-Tropic Injectable, Multi-Dose Vial, Sterile recalled	The Compounding Pharmacy of America	Sterility	Nationwide
23 Sep 2015	CLASS II	Tri-Mix (17.7/0.59/6) (MFG) Injectable, Sterile recalled	The Compounding Pharmacy of America	Sterility	Nationwide
23 Sep 2015	CLASS II	Hydroxocobalamin 10 mg/ml Folic Acid 4 mg/ml Injectable recalled	The Compounding Pharmacy of America	Sterility	Nationwide
23 Sep 2015	CLASS II	Tri-Mix ST4/PGE 2/LIDO 2 0.1/0.05/0.05 Injectable recalled	The Compounding Pharmacy of America	Sterility	Nationwide
23 Sep 2015	CLASS II	Morphine 25 mg/ml Solution, Sterile-Preservative Free recalled	The Compounding Pharmacy of America	Sterility	Nationwide
23 Sep 2015	CLASS II	Morphine 40 mg/ml + Bupivacaine 16 mg/ml Solution recalled	The Compounding Pharmacy of America	Sterility	Nationwide
23 Sep 2015	CLASS II	Hydromorphone 60 mg/ml + Bupivacaine 30 mg/ml Solution recalled	The Compounding Pharmacy of America	Sterility	Nationwide

More recalls from The Compounding Pharmacy of America

All 383

Reported	Class	Recall	Company	Reason	Where
21 Feb 2018Drug	CLASS I	HCG 5,000 IU/mL + Methylcobalamin 500 mcg/mL Injection recalled	The Compounding Pharmacy of America	Sterility	SC, TN
23 Sep 2015Drug	CLASS II	Estradiol 4 mg, Sterile Pellet recalled by The Compounding Pharmacy of	The Compounding Pharmacy of America	Sterility	Nationwide
23 Sep 2015Drug	CLASS II	Testosterone 62.5 mg Pellet, Sterile recalled	The Compounding Pharmacy of America	Sterility	Nationwide
23 Sep 2015Drug	CLASS II	Alprostadil 40 mcg/ml Injection, Sterile, Keep Frozen recalled	The Compounding Pharmacy of America	Sterility	Nationwide
23 Sep 2015Drug	CLASS II	Hydroxocobalamin 5,000 mcg/ml Injection, Multi-Dose Vial recalled	The Compounding Pharmacy of America	Sterility	Nationwide

Other Fentanyl recalls

All 247

Reported	Class	Recall	Company	Reason	Where
27 May 2026Drug	CLASS II	fentaNYL Citrate, Sterile CADD for Injection, 2,2500 mcg recalled	IntegraDose Compounding Services	Potency & Assay	Nationwide
6 May 2026Drug	CLASS II	fentaNYL Citrate Injectable Solution recalled by Wells Pharma of Houston	Wells Pharma of Houston	Manufacturing (CGMP) Deviations	Nationwide
6 May 2026Drug	CLASS II	fentaNYL Citrate Injectable Solution, Narcotic, CII recalled	Wells Pharma of Houston	Manufacturing (CGMP) Deviations	Nationwide
6 May 2026Drug	CLASS II	fentaNYL Citrate Injectable Solution, Narcotic, Cii recalled	Wells Pharma of Houston	Manufacturing (CGMP) Deviations	Nationwide
6 May 2026Drug	CLASS II	fentaNYL Citrate injectable Solution recalled by Wells Pharma of Houston	Wells Pharma of Houston	Manufacturing (CGMP) Deviations	Nationwide