CLASS II Drug recall · Reported 31 May 2017 · FDA Enforcement Report

Fentanyl Citrate and Bupivacaine HCl all strengths recalled

Advanced Pharma is recalling Fentanyl Citrate and Bupivacaine HCl all strengths, all dosage forms and all packaging, distributed nationwide in the US. The recall was initiated on 22 Feb 2017 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesall lots within expiry.

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-0853-2017
FDA event ID: 76561
Recalling firm: Advanced Pharma, Houston, TX
Classification: Class II
Status: Terminated
Recall initiated: 22 Feb 2017
FDA classified: 23 May 2017
Reported: 31 May 2017
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Packaging Defects
Drug class: Pain Medication

Timeline

22 Feb 2017	Recall initiated by company
23 May 2017	Classified by FDA	+90 days
31 May 2017	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

Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

Fentanyl Citrate and Bupivacaine HCl all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054

Where it was distributed

U.S. Nationwide

Nationwide

Questions about this recall

Why was it recalled?

Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.

Which lots are affected?

all lots within expiry.

Where was it sold?

U.S. 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

59 other products · FDA event 76561

This product is part of a recall event; the main page for the event is Succinylcholine Chloride all strengths, all dosage forms recalled.

Reported	Class	Recall	Company	Reason	Where
31 May 2017	CLASS II	Succinylcholine Chloride all strengths, all dosage forms recalled	Advanced Pharma	Packaging Defects	Nationwide
31 May 2017	CLASS II	Epinephrine HCl all strengths, all dosage forms and all packaging recalled	Advanced Pharma	Packaging Defects	Nationwide
31 May 2017	CLASS II	Nitroglycerin all strengths, all dosage forms and all packaging recalled	Advanced Pharma	Packaging Defects	Nationwide
31 May 2017	CLASS II	Ropivacaine HCl in 0.9% Sodium Chloride all strengths recalled	Advanced Pharma	Packaging Defects	Nationwide
31 May 2017	CLASS II	Calcium Gluconate all strengths, all dosage forms and all packaging recalled	Advanced Pharma	Packaging Defects	Nationwide
31 May 2017	CLASS II	Ropi/ Epi/ Clon PeriCapsular injection all strengths recalled	Advanced Pharma	Packaging Defects	Nationwide
31 May 2017	CLASS II	RECK PeriCapsular injection all strengths recalled by Advanced Pharma	Advanced Pharma	Packaging Defects	Nationwide
31 May 2017	CLASS II	Atropine Sulfate all strengths, all dosage forms and all packaging recalled	Advanced Pharma	Packaging Defects	Nationwide
31 May 2017	CLASS II	Esmolol HCl all strengths, all dosage forms and all packaging recalled	Advanced Pharma	Packaging Defects	Nationwide
31 May 2017	CLASS II	Neostigmine Methylsulfate all strengths recalled by Advanced Pharma	Advanced Pharma	Packaging Defects	Nationwide
31 May 2017	CLASS II	Meperidine HCl all strengths, all dosage forms and all packaging recalled	Advanced Pharma	Packaging Defects	Nationwide
31 May 2017	CLASS II	Ketamine HCl all strengths, all dosage forms and all packaging recalled	Advanced Pharma	Packaging Defects	Nationwide
31 May 2017	CLASS II	Morphine Sulfate all strengths, all dosage forms and all packaging recalled	Advanced Pharma	Packaging Defects	Nationwide
31 May 2017	CLASS II	NOVA PeriCapsular injection all strengths recalled by Advanced Pharma	Advanced Pharma	Packaging Defects	Nationwide
31 May 2017	CLASS II	Fentanyl Citrate with Ropivacaine HCl all strengths recalled	Advanced Pharma	Packaging Defects	Nationwide
31 May 2017	CLASS II	Hydromorphone HCl all strengths, all dosage forms and all packaging recalled	Advanced Pharma	Packaging Defects	Nationwide
31 May 2017	CLASS II	Magnesium Sulfate all strengths, all dosage forms and all packaging recalled	Advanced Pharma	Packaging Defects	Nationwide
31 May 2017	CLASS II	Add Heparin PF Only TO TPN all strengths recalled by Advanced Pharma	Advanced Pharma	Packaging Defects	Nationwide
31 May 2017	CLASS II	Norepinephrine Bitartrate all strengths recalled by Advanced Pharma	Advanced Pharma	Packaging Defects	Nationwide
31 May 2017	CLASS II	Bupivacaine HCl in 0.9% Sodium Chloride all strengths recalled	Advanced Pharma	Packaging Defects	Nationwide
31 May 2017	CLASS II	Lidocaine all strengths, all dosage forms and all packaging recalled	Advanced Pharma	Packaging Defects	Nationwide
31 May 2017	CLASS II	Famotidine HCl all strengths, all dosage forms and all packaging recalled	Advanced Pharma	Packaging Defects	Nationwide
31 May 2017	CLASS II	TPN Neonatal all strengths, all dosage forms and all packaging recalled	Advanced Pharma	Packaging Defects	Nationwide
31 May 2017	CLASS II	Diltiazem HCl all strengths, all dosage forms and all packaging recalled	Advanced Pharma	Packaging Defects	Nationwide
31 May 2017	CLASS II	Betamethasone Sodium Phosphate & Betamethasone Acetate all recalled	Advanced Pharma	Packaging Defects	Nationwide
31 May 2017	CLASS II	Adenosine all strengths, all dosage forms and all packaging recalled	Advanced Pharma	Packaging Defects	Nationwide
31 May 2017	CLASS II	0.9% Sodium Chloride Slip Tip all strengths recalled by Advanced Pharma	Advanced Pharma	Packaging Defects	Nationwide
31 May 2017	CLASS II	Amiodarone all strengths, all dosage forms and all packaging recalled	Advanced Pharma	Packaging Defects	Nationwide
31 May 2017	CLASS II	Standard Starter TPN all strengths, all dosage forms recalled	Advanced Pharma	Packaging Defects	Nationwide
31 May 2017	CLASS II	Cardioplegic Solution Maintenance all strengths recalled	Advanced Pharma	Packaging Defects	Nationwide
31 May 2017	CLASS II	Midazolam HCl all strengths, all dosage forms and all packaging recalled	Advanced Pharma	Packaging Defects	Nationwide
31 May 2017	CLASS II	Potassium Phosphate all strengths, all dosage forms recalled	Advanced Pharma	Packaging Defects	Nationwide
31 May 2017	CLASS II	Dexmedetomidine HCl all strengths, all dosage forms recalled	Advanced Pharma	Packaging Defects	Nationwide
31 May 2017	CLASS II	Sodium Citrate all strengths, all dosage forms and all packaging recalled	Advanced Pharma	Packaging Defects	Nationwide
31 May 2017	CLASS II	Penicillin G Potassium all strengths, all dosage forms recalled	Advanced Pharma	Packaging Defects	Nationwide
31 May 2017	CLASS II	Ephedrine Sulfate all strengths, all dosage forms and all packaging recalled	Advanced Pharma	Packaging Defects	Nationwide
31 May 2017	CLASS II	Ondansetron HCl all strengths, all dosage forms and all packaging recalled	Advanced Pharma	Packaging Defects	Nationwide
31 May 2017	CLASS II	Nalbuphine all strengths, all dosage forms and all packaging recalled	Advanced Pharma	Packaging Defects	Nationwide
31 May 2017	CLASS II	Rocuronium Bromide all strengths, all dosage forms and all packaging recalled	Advanced Pharma	Packaging Defects	Nationwide
31 May 2017	CLASS II	Labetalol HCl all strengths, all dosage forms and all packaging recalled	Advanced Pharma	Packaging Defects	Nationwide
31 May 2017	CLASS II	Heparin sodium all strengths, all dosage forms and all packaging recalled	Advanced Pharma	Packaging Defects	Nationwide
31 May 2017	CLASS II	Ofirmev (Acetaminophen) injection all strengths recalled	Advanced Pharma	Packaging Defects	Nationwide
31 May 2017	CLASS II	Methohexital Sodium all strengths, all dosage forms recalled	Advanced Pharma	Packaging Defects	Nationwide
31 May 2017	CLASS II	Sufentanil Citrate all strengths, all dosage forms and all packaging recalled	Advanced Pharma	Packaging Defects	Nationwide
31 May 2017	CLASS II	Sodium Phosphate all strengths, all dosage forms and all packaging recalled	Advanced Pharma	Packaging Defects	Nationwide
31 May 2017	CLASS II	Gentamicin Sulfate all strengths, all dosage forms and all packaging recalled	Advanced Pharma	Packaging Defects	Nationwide
31 May 2017	CLASS II	Early TPN (Neonatal) all strengths, all dosage forms recalled	Advanced Pharma	Packaging Defects	Nationwide
31 May 2017	CLASS II	Fentanyl Citrate all strengths, all dosage forms and all packaging recalled	Advanced Pharma	Packaging Defects	Nationwide
31 May 2017	CLASS II	Dexamethasone Sodium Phosphate all strengths recalled by Advanced Pharma	Advanced Pharma	Packaging Defects	Nationwide
31 May 2017	CLASS II	Nicu Starter TPN all strengths, all dosage forms and all packaging recalled	Advanced Pharma	Packaging Defects	Nationwide
31 May 2017	CLASS II	Bumetadine all strengths, all dosage forms and all packaging recalled	Advanced Pharma	Packaging Defects	Nationwide
31 May 2017	CLASS II	Cefazolin all strengths, all dosage forms and all packaging recalled	Advanced Pharma	Packaging Defects	Nationwide
31 May 2017	CLASS II	Early Baby TPN (Neonatal) all strengths recalled by Advanced Pharma	Advanced Pharma	Packaging Defects	Nationwide
31 May 2017	CLASS II	Glycopyrrolate all strengths, all dosage forms and all packaging recalled	Advanced Pharma	Packaging Defects	Nationwide
31 May 2017	CLASS II	Lorazepam HCl all strengths, all dosage forms and all packaging recalled	Advanced Pharma	Packaging Defects	Nationwide
31 May 2017	CLASS II	Phenylephrine HCl all strengths, all dosage forms and all packaging recalled	Advanced Pharma	Packaging Defects	Nationwide
31 May 2017	CLASS II	Vancomycin HCl all strengths, all dosage forms and all packaging recalled	Advanced Pharma	Packaging Defects	Nationwide
31 May 2017	CLASS II	Nicardipine HCl all strengths, all dosage forms and all packaging recalled	Advanced Pharma	Packaging Defects	Nationwide
31 May 2017	CLASS II	Oxytocin all strengths, all dosage forms and all packaging recalled	Advanced Pharma	Packaging Defects	Nationwide

More recalls from Advanced Pharma

All 99

Reported	Class	Recall	Company	Reason	Where
8 May 2019Drug	CLASS II	HYDROmorphone 20 mg/ Injectable Solution recalled by Advanced Pharma	Advanced Pharma	Potency & Assay	Nationwide
27 Mar 2019Drug	CLASS II	Neostigmine Methylsulfate Injection Solution 5 mg recalled	Advanced Pharma	Sterility	Nationwide
27 Mar 2019Drug	CLASS II	Phenylephrine HCl, 1,200 mcg in 0.9% Sodium Chloride recalled	Advanced Pharma	Sterility	Nationwide
27 Mar 2019Drug	CLASS II	HYDROmorphone HCl 1 mg in 0.9% Sodium Chloride recalled	Advanced Pharma	Sterility	Nationwide
27 Mar 2019Drug	CLASS II	Heparin in 0.45% Sodium Chloride, QS, Injectable Solution recalled	Advanced Pharma	Sterility	Nationwide

Other Fentanyl recalls

All 246

Reported	Class	Recall	Company	Reason	Where
16 Sep 2026Drug	CLASS II	fentaNYL Citrate, 1,000 mcg recalled by OurPharma	OurPharma	Other	Nationwide
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