CLASS II Drug recall · Reported 3 Dec 2014 · FDA Enforcement Report

Phenylephrine HCl (100 mcg/mL syr) recalled by Perry Drug

Perry Drug is recalling Phenylephrine HCl (100 mcg/mL syr) in 0.9% NaCl 1 mg / Syringes, Compounded Rx, Perry, distributed in Kansas, Missouri. The recall was initiated on 7 Nov 2014 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codes141008AA, 11/8/14; 141017E, 11/17/14; 141030EE, 11/30/14

Quantity recalled8 prefilled syringes

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-0263-2015
FDA event ID: 69674
Recalling firm: Perry Drug, Overland Park, KS
Classification: Class II
Status: Terminated
Recall initiated: 7 Nov 2014
FDA classified: 24 Nov 2014
Reported: 3 Dec 2014
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Drug class: Cold & Cough Medicine

Timeline

7 Nov 2014	Recall initiated by company
24 Nov 2014	Classified by FDA	+17 days
3 Dec 2014	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

Lack of sterility assurance;All lots of sterile products compounded by the pharmacy that are within expiry were recalled due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.

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

Phenylephrine HCl (100 mcg/mL syr) in 0.9% NaCl 1 mg / 10 mL, 3Ml Syringes, Compounded Rx, Perry Drug Compounding Pharmacy, Overland Park, KS --- NDC 88888-5230-12

Where it was distributed

Kansas and Missouri

Kansas Missouri

Questions about this recall

Why was it recalled?

Which lots are affected?

141008AA, 11/8/14; 141017E, 11/17/14; 141030EE, 11/30/14

Where was it sold?

Kansas and Missouri

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

16 other products · FDA event 69674

This product is part of a recall event; the main page for the event is HCG-20,000 U/ Vial, Compounded Rx recalled by Perry Drug.

Reported	Class	Recall	Company	Reason	Where
3 Dec 2014	CLASS II	HCG-20,000 U/ Vial, Compounded Rx recalled by Perry Drug	Perry Drug	Sterility	KS, MO
3 Dec 2014	CLASS II	Methyl B12 25 mg/mL Inj., 10 Syringes, Compounded Rx recalled	Perry Drug	Sterility	KS, MO
3 Dec 2014	CLASS II	Leuprolide 50 mcg/ Micro Lupron Kit, Compounded Rx recalled	Perry Drug	Sterility	KS, MO
3 Dec 2014	CLASS II	HCG - PF Inject Syringe, Compounded Rx recalled by Perry Drug	Perry Drug	Sterility	KS, MO
3 Dec 2014	CLASS II	HCG 200 IU/mL Injection vials, Compounded Rx recalled by Perry Drug	Perry Drug	Sterility	KS, MO
3 Dec 2014	CLASS II	HCG Low Dose 10 IU / vials, Compounded Rx recalled by Perry Drug	Perry Drug	Sterility	KS, MO
3 Dec 2014	CLASS II	Testosterone Cyp 200 mg/mL Sesame Inj recalled by Perry Drug	Perry Drug	Sterility	KS, MO
3 Dec 2014	CLASS II	HCG Low Dose 30 IU/ vial, Compounded Rx recalled by Perry Drug	Perry Drug	Sterility	KS, MO
3 Dec 2014	CLASS II	Tri-Mix (Pge-10MCG/Pap-30MG/PT vials, Compounded Rx recalled	Perry Drug	Sterility	KS, MO
3 Dec 2014	CLASS II	Sodium Tetradecyl SO4 0.3% Inj recalled by Perry Drug	Perry Drug	Sterility	KS, MO
3 Dec 2014	CLASS II	HCG 10,000 U/ PF Inj vials, Compounded Rx recalled by Perry Drug	Perry Drug	Sterility	KS, MO
3 Dec 2014	CLASS II	Tri Mix PF SYR Inj., Compounded Rx, 10 each, Compounded Rx recalled	Perry Drug	Sterility	KS, MO
3 Dec 2014	CLASS II	Tri-mix Antidote 10 each Syringes, Compounded Rx recalled by Perry Drug	Perry Drug	Sterility	KS, MO
3 Dec 2014	CLASS II	Testosterone Cyp-250/Prop-20 mg Syringe, Compounded Rx recalled	Perry Drug	Sterility	KS, MO
3 Dec 2014	CLASS II	HCG 10,000 U/ MB12 - 12,000 MCG/ Inj (250IU), Rx recalled by Perry Drug	Perry Drug	Sterility	KS, MO
3 Dec 2014	CLASS II	Cyclosporine 0.045 % Sol PF, Rx recalled by Perry Drug	Perry Drug	Sterility	KS, MO

More recalls from Perry Drug

All 17

Reported	Class	Recall	Company	Reason	Where
3 Dec 2014Drug	CLASS II	Cyclosporine 0.045 % Sol PF, Rx recalled by Perry Drug	Perry Drug	Sterility	KS, MO
3 Dec 2014Drug	CLASS II	HCG 10,000 U/ MB12 - 12,000 MCG/ Inj (250IU), Rx recalled by Perry Drug	Perry Drug	Sterility	KS, MO
3 Dec 2014Drug	CLASS II	Testosterone Cyp-250/Prop-20 mg Syringe, Compounded Rx recalled	Perry Drug	Sterility	KS, MO
3 Dec 2014Drug	CLASS II	Tri-mix Antidote 10 each Syringes, Compounded Rx recalled by Perry Drug	Perry Drug	Sterility	KS, MO
3 Dec 2014Drug	CLASS II	Tri Mix PF SYR Inj., Compounded Rx, 10 each, Compounded Rx recalled	Perry Drug	Sterility	KS, MO

Other Phenylephrine recalls

All 122

Reported	Class	Recall	Company	Reason	Where
6 May 2026Drug	CLASS II	Phenylephrine Hydrochloride Injectable Solution, 40mg recalled	Wells Pharma of Houston	Manufacturing (CGMP) Deviations	Nationwide
30 Apr 2025Drug	CLASS II	PHENYLephrine HCl in 0.9% Sodium Chloride, 0.5 mg recalled	Denver Solutions	Sterility	Nationwide
26 Feb 2025Drug	CLASS I	Phenylephrine HCl Injection, USP 100 mg/ (10 mg/mL) vials recalled	Provepharm	Particulate Matter	Nationwide
8 Jan 2025Drug	CLASS II	phenylephrine in 0.9% Sodium Chloride Inj, 1mg per (100 mcg/mL) recalled	Hikma Injectables USA	Sterility	Nationwide
29 May 2024Drug	CLASS I	Phenylephrine in 0.9% Sodium Chloride Injection recalled	Hikma Injectables USA	Labeling Errors	5 states