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

Labetalol HCl all strengths, all dosage forms and all packaging recalled

Advanced Pharma is recalling Labetalol 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-0836-2017
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

Timeline

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

Labetalol 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.

ReportedClassRecallCompanyReasonWhere
CLASS IISuccinylcholine Chloride all strengths, all dosage forms recalledAdvanced PharmaPackaging DefectsNationwide
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CLASS IIAmiodarone all strengths, all dosage forms and all packaging recalledAdvanced PharmaPackaging DefectsNationwide
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CLASS IIPotassium Phosphate all strengths, all dosage forms recalledAdvanced PharmaPackaging DefectsNationwide
CLASS IIDexmedetomidine HCl all strengths, all dosage forms recalledAdvanced PharmaPackaging DefectsNationwide
CLASS IISodium Citrate all strengths, all dosage forms and all packaging recalledAdvanced PharmaPackaging DefectsNationwide
CLASS IIPenicillin G Potassium all strengths, all dosage forms recalledAdvanced PharmaPackaging DefectsNationwide
CLASS IIEphedrine Sulfate all strengths, all dosage forms and all packaging recalledAdvanced PharmaPackaging DefectsNationwide
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CLASS IIOndansetron HCl all strengths, all dosage forms and all packaging recalledAdvanced PharmaPackaging DefectsNationwide
CLASS IINalbuphine all strengths, all dosage forms and all packaging recalledAdvanced PharmaPackaging DefectsNationwide
CLASS IIRocuronium Bromide all strengths, all dosage forms and all packaging recalledAdvanced PharmaPackaging DefectsNationwide
CLASS IIHeparin sodium all strengths, all dosage forms and all packaging recalledAdvanced PharmaPackaging DefectsNationwide
CLASS IIOfirmev (Acetaminophen) injection all strengths recalledAdvanced PharmaPackaging DefectsNationwide
CLASS IIMethohexital Sodium all strengths, all dosage forms recalledAdvanced PharmaPackaging DefectsNationwide
CLASS IISufentanil Citrate all strengths, all dosage forms and all packaging recalledAdvanced PharmaPackaging DefectsNationwide
CLASS IISodium Phosphate all strengths, all dosage forms and all packaging recalledAdvanced PharmaPackaging DefectsNationwide
CLASS IIGentamicin Sulfate all strengths, all dosage forms and all packaging recalledAdvanced PharmaPackaging DefectsNationwide
CLASS IIEarly TPN (Neonatal) all strengths, all dosage forms recalledAdvanced PharmaPackaging DefectsNationwide
CLASS IIFentanyl Citrate all strengths, all dosage forms and all packaging recalledAdvanced PharmaPackaging DefectsNationwide
CLASS IIDexamethasone Sodium Phosphate all strengths recalled by Advanced PharmaAdvanced PharmaPackaging DefectsNationwide
CLASS IINicu Starter TPN all strengths, all dosage forms and all packaging recalledAdvanced PharmaPackaging DefectsNationwide
CLASS IIBumetadine all strengths, all dosage forms and all packaging recalledAdvanced PharmaPackaging DefectsNationwide
CLASS IICefazolin all strengths, all dosage forms and all packaging recalledAdvanced PharmaPackaging DefectsNationwide
CLASS IIEarly Baby TPN (Neonatal) all strengths recalled by Advanced PharmaAdvanced PharmaPackaging DefectsNationwide
CLASS IIGlycopyrrolate all strengths, all dosage forms and all packaging recalledAdvanced PharmaPackaging DefectsNationwide
CLASS IILorazepam HCl all strengths, all dosage forms and all packaging recalledAdvanced PharmaPackaging DefectsNationwide
CLASS IIPhenylephrine HCl all strengths, all dosage forms and all packaging recalledAdvanced PharmaPackaging DefectsNationwide
CLASS IIVancomycin HCl all strengths, all dosage forms and all packaging recalledAdvanced PharmaPackaging DefectsNationwide
CLASS IINicardipine HCl all strengths, all dosage forms and all packaging recalledAdvanced PharmaPackaging DefectsNationwide
CLASS IIOxytocin all strengths, all dosage forms and all packaging recalledAdvanced PharmaPackaging DefectsNationwide

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