CLASS II Drug recall · Reported 8 Mar 2023 · FDA Enforcement Report

Phenylephrine Hydrochloride Injection, USP 10 mg/mL recalled

Accord Healthcare is recalling Phenylephrine Hydrochloride Injection, USP 10 mg/mL, distributed in Puerto Rico. The recall was initiated on 7 Feb 2023 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesBatches: R2101555, R2101538, R2101564, Exp. Date 11/30/2023;
Quantity recalled9,888 vials

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-0401-2023
FDA event ID
91657
Recalling firm
Accord Healthcare, Durham, NC
Classification
Class II
Status
Terminated
Recall initiated
7 Feb 2023
FDA classified
2 Mar 2023
Reported
8 Mar 2023
Type
Voluntary: Firm initiated
Customers notified by
Letter

Timeline

7 Feb 2023Recall initiated by company
2 Mar 2023Classified by FDA+23 days
8 Mar 2023Published in enforcement report+6 days

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

Reason for recall

CGMP Deviations: recalling drug products following an FDA inspection.

Product as listed by the FDA

Phenylephrine Hydrochloride Injection, USP 10 mg/mL Rx Only, 1 mL Single Dose Vial, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA; Vial NDC 16729-464-63, UPC 3 16729 46463 5; Carton NDC 16729-464-08, UPC 3 16729 46408 6

Where it was distributed

United States including Puerto Rico and Canada

Puerto Rico

Questions about this recall

Why was it recalled?

CGMP Deviations: recalling drug products following an FDA inspection.

Which lots are affected?

Batches: R2101555, R2101538, R2101564, Exp. Date 11/30/2023;

Where was it sold?

United States including Puerto Rico and Canada

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

66 other products · FDA event 91657

This product is part of a recall event; the main page for the event is Dofetilide Capsules 250 mcg (0.25 mg) recalled by Accord Healthcare.

ReportedClassRecallCompanyReasonWhere
CLASS IIDofetilide Capsules 250 mcg (0.25 mg) recalled by Accord HealthcareDofetilideAccord HealthcareManufacturing (CGMP) DeviationsPR
CLASS IIAtorvastatin Calcium Tablets USP 80 mg* recalled by Accord HealthcareAtorvastatin CalciumAccord HealthcareManufacturing (CGMP) DeviationsPR
CLASS IIBusPIRone Hydrochloride Tablets USP 30 mg recalled by Accord HealthcareBuspirone HydrochlorideAccord HealthcareManufacturing (CGMP) DeviationsPR
CLASS IIMontelukast Sodium Tablets, USP, 10 mg* recalled by Accord HealthcareMontelukast SodiumAccord HealthcareManufacturing (CGMP) DeviationsPR
CLASS IIAtorvastatin Calcium Tablets USP 40 mg* recalled by Accord HealthcareAtorvastatin CalciumAccord HealthcareManufacturing (CGMP) DeviationsPR
CLASS IIPirfenidone Tablets 267 mg bottle x3/Carton recalledPirfenidoneAccord HealthcareManufacturing (CGMP) DeviationsPR
CLASS IIrOPINIRole Tablets USP 0.25 mg* recalled by Accord HealthcareRopiniroleAccord HealthcareManufacturing (CGMP) DeviationsPR
CLASS IIBusPIRone Hydrochloride Tablets USP, 5 mg recalled by Accord HealthcareBuspirone HydrochlorideAccord HealthcareManufacturing (CGMP) DeviationsPR
CLASS IIAtorvastatin Calcium Tablets USP, 10 mg* recalled by Accord HealthcareAtorvastatin CalciumAccord HealthcareManufacturing (CGMP) DeviationsPR
CLASS IIPravastatin Sodium Tablets USP, 80 mg recalled by Accord HealthcarePravastatin SodiumAccord HealthcareManufacturing (CGMP) DeviationsPR
CLASS IIGlycopyrrolate Injection, USP 1 mg recalled by Accord HealthcareGlycopyrrolateAccord HealthcareManufacturing (CGMP) DeviationsPR
CLASS IITadalafil Tablets, USP 10 mg recalled by Accord HealthcareTadalafilAccord HealthcareManufacturing (CGMP) DeviationsPR
CLASS IIAripiprazole Tablets, USP 10 mg recalled by Accord HealthcareAripiprazoleAccord HealthcareManufacturing (CGMP) DeviationsPR
CLASS IIGlimepiride Tablets USP, 1 mg recalled by Accord HealthcareGlimepirideAccord HealthcareManufacturing (CGMP) DeviationsPR
CLASS IIAripiprazole Tablets, USP 15 mg recalled by Accord HealthcareAripiprazoleAccord HealthcareManufacturing (CGMP) DeviationsPR
CLASS IISimvastatin Tablets USP 40 mg recalled by Accord HealthcareSimvastatinAccord HealthcareManufacturing (CGMP) DeviationsPR
CLASS IIFinasteride Tablets USP 1 mg, Keeps recalled by Accord HealthcareAccord HealthcareManufacturing (CGMP) DeviationsPR
CLASS IITadalafil Tablets, USP, 2.5 mg recalled by Accord HealthcareTadalafilAccord HealthcareManufacturing (CGMP) DeviationsPR
CLASS IIPravastatin Sodium Tablets USP, 40 mg recalled by Accord HealthcarePravastatin SodiumAccord HealthcareManufacturing (CGMP) DeviationsPR
CLASS IIDoxazosin Tablets USP, 8 mg recalled by Accord HealthcareDoxazosinAccord HealthcareManufacturing (CGMP) DeviationsPR
CLASS IIDoxazosin Tablets USP 1 mg recalled by Accord HealthcareDoxazosinAccord HealthcareManufacturing (CGMP) DeviationsPR
CLASS IIRosuvastatin Tablets, USP 20 mg* recalled by Accord HealthcareRosuvastatinAccord HealthcareManufacturing (CGMP) DeviationsPR
CLASS IIrOPINIRole Tablets USP 2 mg* recalled by Accord HealthcareRopiniroleAccord HealthcareManufacturing (CGMP) DeviationsPR
CLASS IIBusPIRone Hydrochloride Tablets USP, 10 mg recalled by Accord HealthcareBuspirone HydrochlorideAccord HealthcareManufacturing (CGMP) DeviationsPR
CLASS IIrOPINIRole Tablets USP 5 mg* recalled by Accord HealthcareRopiniroleAccord HealthcareManufacturing (CGMP) DeviationsPR
CLASS IIrOPINIRole Tablets USP 3 mg* recalled by Accord HealthcareRopiniroleAccord HealthcareManufacturing (CGMP) DeviationsPR
CLASS IIBusPIRone Hydrochloride Tablets USP 7.5 mg recalled by Accord HealthcareBuspirone HydrochlorideAccord HealthcareManufacturing (CGMP) DeviationsPR
CLASS IIPirfenidone Tablets 801 mg recalled by Accord HealthcarePirfenidoneAccord HealthcareManufacturing (CGMP) DeviationsPR
CLASS IISuccinylcholine Chloride Injection, USP, 200 mg recalledAccord HealthcareManufacturing (CGMP) DeviationsPR
CLASS IIrOPINIRole Tablets USP 1 mg* recalled by Accord HealthcareRopiniroleAccord HealthcareManufacturing (CGMP) DeviationsPR
CLASS IISimvastatin Tablets USP 20 mg recalled by Accord HealthcareSimvastatinAccord HealthcareManufacturing (CGMP) DeviationsPR
CLASS IIPhenylephrine Hydrochloride Injection, USP 100 mg/ (10 mg/mL) recalledAccord HealthcareManufacturing (CGMP) DeviationsPR
CLASS IIDaptomycin for Injection 500 mg per vial, Single-dose vial recalledDaptomycinAccord HealthcareManufacturing (CGMP) DeviationsPR
CLASS IIDaptomycin for Injection 350 mg/vial recalled by Accord HealthcareDaptomycinAccord HealthcareManufacturing (CGMP) DeviationsPR
CLASS IIGlycopyrrolate Injection, USP 4 mg recalled by Accord HealthcareGlycopyrrolateAccord HealthcareManufacturing (CGMP) DeviationsPR
CLASS IISimvastatin Tablets USP 5 mg recalled by Accord HealthcareSimvastatinAccord HealthcareManufacturing (CGMP) DeviationsPR
CLASS IISimvastatin Tablets USP 80 mg recalled by Accord HealthcareSimvastatinAccord HealthcareManufacturing (CGMP) DeviationsPR
CLASS IISimvastatin Tablets, USP, 10 mg recalled by Accord HealthcareSimvastatinAccord HealthcareManufacturing (CGMP) DeviationsPR
CLASS IITadalafil Tablets, USP, 20 mg recalled by Accord HealthcareTadalafilAccord HealthcareManufacturing (CGMP) DeviationsPR
CLASS IIDoxazosin Tablets USP, 2 mg recalled by Accord HealthcareDoxazosinAccord HealthcareManufacturing (CGMP) DeviationsPR
CLASS IIRosuvastatin Tablets, USP 40 mg* recalled by Accord HealthcareRosuvastatinAccord HealthcareManufacturing (CGMP) DeviationsPR
CLASS IIAtorvastatin Calcium Tablets USP 20 mg* recalled by Accord HealthcareAtorvastatin CalciumAccord HealthcareManufacturing (CGMP) DeviationsPR
CLASS IIAripiprazole Tablets, USP 2 mg recalled by Accord HealthcareAripiprazoleAccord HealthcareManufacturing (CGMP) DeviationsPR
CLASS IIGlycopyrrolate Injection, USP, 0.4 mg recalled by Accord HealthcareGlycopyrrolateAccord HealthcareManufacturing (CGMP) DeviationsPR
CLASS IIGlimepiride Tablets USP, 2 mg recalled by Accord HealthcareGlimepirideAccord HealthcareManufacturing (CGMP) DeviationsPR
CLASS IIRosuvastatin Tablets, USP, 10 mg* recalled by Accord HealthcareRosuvastatinAccord HealthcareManufacturing (CGMP) DeviationsPR
CLASS IIRosuvastatin Tablets, USP, 5 mg* recalled by Accord HealthcareRosuvastatinAccord HealthcareManufacturing (CGMP) DeviationsPR
CLASS IIBusPIRone Hydrochloride Tablets USP 15 mg recalled by Accord HealthcareBuspirone HydrochlorideAccord HealthcareManufacturing (CGMP) DeviationsPR
CLASS IIAripiprazole Tablets, USP 20 mg recalled by Accord HealthcareAripiprazoleAccord HealthcareManufacturing (CGMP) DeviationsPR
CLASS IIDofetilide Capsules 500 mcg (0.5 mg) recalled by Accord HealthcareDofetilideAccord HealthcareManufacturing (CGMP) DeviationsPR
CLASS IIDofetilide Capsules, 125 mcg (0.125 mg) recalled by Accord HealthcareDofetilideAccord HealthcareManufacturing (CGMP) DeviationsPR
CLASS IIVigabatrin for Oral Solution, USP, 500 mg recalled by Accord HealthcareAccord HealthcareManufacturing (CGMP) DeviationsPR
CLASS IIPhenylephrine Hydrochloride Injection, USP, 50 mg/ (10 mg/mL) recalledAccord HealthcareManufacturing (CGMP) DeviationsPR
CLASS IIClopidogrel Tablets USP, 75 mg recalled by Accord HealthcareAccord HealthcareManufacturing (CGMP) DeviationsPR
CLASS IITadalafil Tablets, USP, 5 mg recalled by Accord HealthcareTadalafilAccord HealthcareManufacturing (CGMP) DeviationsPR
CLASS IIGlimepiride Tablets USP, 4 mg recalled by Accord HealthcareGlimepirideAccord HealthcareManufacturing (CGMP) DeviationsPR
CLASS IIGlycopyrrolate Injection, USP, 0.2 mg/mL Single Dose Vial x 25 vials recalledGlycopyrrolateAccord HealthcareManufacturing (CGMP) DeviationsPR
CLASS IIAripiprazole Tablets, USP 30 mg recalled by Accord HealthcareAripiprazoleAccord HealthcareManufacturing (CGMP) DeviationsPR
CLASS IIrOPINIRole Tablets USP 4 mg* recalled by Accord HealthcareRopiniroleAccord HealthcareManufacturing (CGMP) DeviationsPR
CLASS IIFinasteride Tablets USP, 5 mg recalled by Accord HealthcareFinasterideAccord HealthcareManufacturing (CGMP) DeviationsPR
CLASS IIAripiprazole Tablets, USP 5 mg recalled by Accord HealthcareAripiprazoleAccord HealthcareManufacturing (CGMP) DeviationsPR
CLASS IIDoxazosin Tablets USP, 4 mg recalled by Accord HealthcareDoxazosinAccord HealthcareManufacturing (CGMP) DeviationsPR
CLASS IIrOPINIRole Tablets USP 0.5 mg* recalled by Accord HealthcareRopiniroleAccord HealthcareManufacturing (CGMP) DeviationsPR
CLASS IIFinasteride Tablets USP, 1 mg recalled by Accord HealthcareFinasterideAccord HealthcareManufacturing (CGMP) DeviationsPR
CLASS IIPravastatin Sodium Tablets USP, 10 mg recalled by Accord HealthcarePravastatin SodiumAccord HealthcareManufacturing (CGMP) DeviationsPR
CLASS IIPravastatin Sodium Tablets USP 20 mg recalled by Accord HealthcarePravastatin SodiumAccord HealthcareManufacturing (CGMP) DeviationsPR

More recalls from Accord Healthcare

All 106
ReportedClassRecallCompanyReasonWhere
DrugCLASS IILevothyroxine Sodium Tablets, USP, 112 mcg (0.112 mg) recalledLevothyroxine SodiumAccord HealthcarePotency & AssayNationwide
DrugCLASS IILevothyroxine Sodium Tablets, USP, 88 mcg (0.088 mg) recalledLevothyroxine SodiumAccord HealthcarePotency & AssayNationwide
DrugCLASS IILevothyroxine Sodium Tablets, USP, 100 mcg (0.1 mg) recalledLevothyroxine SodiumAccord HealthcarePotency & AssayNationwide
DrugCLASS IILevothyroxine Sodium Tablets, USP, 175 mcg (0.175 mg) recalledLevothyroxine SodiumAccord HealthcarePotency & AssayNationwide
DrugCLASS IILevothyroxine Sodium Tablets, USP, 150 mcg (0.15 mg) recalledLevothyroxine SodiumAccord HealthcarePotency & AssayNationwide

Other Phenylephrine recalls

All 122
ReportedClassRecallCompanyReasonWhere
DrugCLASS IIPhenylephrine Hydrochloride Injectable Solution, 40mg recalledWells Pharma of HoustonManufacturing (CGMP) DeviationsNationwide
DrugCLASS IIPHENYLephrine HCl in 0.9% Sodium Chloride, 0.5 mg recalledDenver SolutionsSterilityNationwide
DrugCLASS IPhenylephrine HCl Injection, USP 100 mg/ (10 mg/mL) vials recalledProvepharmParticulate MatterNationwide
DrugCLASS IIphenylephrine in 0.9% Sodium Chloride Inj, 1mg per (100 mcg/mL) recalledHikma Injectables USASterilityNationwide
DrugCLASS IPhenylephrine in 0.9% Sodium Chloride Injection recalledHikma Injectables USALabeling Errors5 states