CLASS II Drug recall · Reported 22 Mar 2017 · FDA Enforcement Report

Metronidazole 1% Gel, Metronidazole 1%/ Niacinamide recalled

Synergy Rx is recalling Metronidazole 1% Gel, Metronidazole 1%/ Niacinamide 4%/ Azelaic Cream 10% Cream, distributed nationwide in the US. The recall was initiated on 10 Feb 2017 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesAll Lots

Quantity recalledN/A

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-0595-2017
FDA event ID: 76472
Recalling firm: Synergy Rx, San Diego, CA
Classification: Class II
Status: Terminated
Recall initiated: 10 Feb 2017
FDA classified: 15 Mar 2017
Reported: 22 Mar 2017
Type: Voluntary: Firm initiated
Customers notified by: Telephone
Reason category: Sterility
Drug class: Antibiotics

Timeline

10 Feb 2017	Recall initiated by company
15 Mar 2017	Classified by FDA	+33 days
22 Mar 2017	Published in enforcement report	+7 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: There are also CGMP Deviations.

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

METRONIDAZOLE 1% GEL, METRONIDAZOLE 1%/ NIACINAMIDE 4%/ AZELAIC CREAM 10% CREAM, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676

Where it was distributed

Nationwide within the United States

Nationwide

Questions about this recall

Why was it recalled?

Lack of Assurance of Sterility: There are also CGMP Deviations.

Which lots are affected?

All Lots

Where was it sold?

Nationwide within the United States

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

80 other products · FDA event 76472

This product is part of a recall event; the main page for the event is Reverse Dml Lotion (Ketoconazole 2%, Metronidazole recalled.

Reported	Class	Recall	Company	Reason	Where
22 Mar 2017	CLASS II	Reverse Dml Lotion (Ketoconazole 2%, Metronidazole recalled	Synergy Rx	Sterility	Nationwide
22 Mar 2017	CLASS II	LP Cream (Lidocaine 15%/Prilocaine 5%) recalled by Synergy Rx	Synergy Rx	Sterility	Nationwide
22 Mar 2017	CLASS II	Custom Lightening/brightening Cream recalled by Synergy Rx	Synergy Rx	Sterility	Nationwide
22 Mar 2017	CLASS II	Tri-bleaching Cream (Retinoic Acid 0.1%, Hydroquinone recalled	Synergy Rx	Sterility	Nationwide
22 Mar 2017	CLASS II	Hydrocortisone 2.5% With Aloe Vera Cream recalled by Synergy Rx	Synergy Rx	Sterility	Nationwide
22 Mar 2017	CLASS II	Clobetasol 0.05% In Olea Base, Clobetasol 0.05% In Orobase recalled	Synergy Rx	Sterility	Nationwide
22 Mar 2017	CLASS II	Intimate Bleaching Cream recalled by Synergy Rx	Synergy Rx	Sterility	Nationwide
22 Mar 2017	CLASS II	Hydroquinone 28% Solution recalled by Synergy Rx	Synergy Rx	Sterility	Nationwide
22 Mar 2017	CLASS II	Kojic Acid 8%/azelaic Acid 15% Cream recalled by Synergy Rx	Synergy Rx	Sterility	Nationwide
22 Mar 2017	CLASS II	Ultra Lite Cream (Hydroquinone 8%) recalled by Synergy Rx	Synergy Rx	Sterility	Nationwide
22 Mar 2017	CLASS II	Clarifying Cream (Retinoic acid 0.025%, Salicylic Acid recalled	Synergy Rx	Sterility	Nationwide
22 Mar 2017	CLASS II	Hydroquinone Cream in all strengths including 4% recalled by Synergy Rx	Synergy Rx	Sterility	Nationwide
22 Mar 2017	CLASS II	Gentle Supreme Bleaching Cream recalled by Synergy Rx	Synergy Rx	Sterility	Nationwide
22 Mar 2017	CLASS II	Hcg in all strength including: 2,400 Powder Vial Drops recalled	Synergy Rx	Sterility	Nationwide
22 Mar 2017	CLASS II	Rosacea Cream ( Metronidazole 1%, Niacinamide 4%) recalled by Synergy Rx	Synergy Rx	Sterility	Nationwide
22 Mar 2017	CLASS II	Enhanced Retin Anti-wrinkle Cream recalled by Synergy Rx	Synergy Rx	Sterility	Nationwide
22 Mar 2017	CLASS II	UREA 40% Cream recalled by Synergy Rx	Synergy Rx	Sterility	Nationwide
22 Mar 2017	CLASS II	Azelaic Acid 15% Cream recalled by Synergy Rx	Synergy Rx	Sterility	Nationwide
22 Mar 2017	CLASS II	Sulfur 5% Cream recalled by Synergy Rx	Synergy Rx	Sterility	Nationwide
22 Mar 2017	CLASS II	Sulfacetamide 10%/hydrocortisone 1% Cream recalled by Synergy Rx	Synergy Rx	Sterility	Nationwide
22 Mar 2017	CLASS II	Vitamin K Oxide 5%, Hq recalled by Synergy Rx	Synergy Rx	Sterility	Nationwide
22 Mar 2017	CLASS II	DUO Cream (Retinoic Acid 0.05%, Hydroquinone recalled by Synergy Rx	Synergy Rx	Sterility	Nationwide
22 Mar 2017	CLASS II	Malek's Magic (retinoic acid 0.05%, hydroquinone recalled by Synergy Rx	Synergy Rx	Sterility	Nationwide
22 Mar 2017	CLASS II	Bleaching Cream 0.1% Cream recalled by Synergy Rx	Synergy Rx	Sterility	Nationwide
22 Mar 2017	CLASS II	Hydroquinone Solution in all strengths including recalled by Synergy Rx	Synergy Rx	Sterility	Nationwide
22 Mar 2017	CLASS II	Trichloroacetic Acid Solution in all strengths including recalled	Synergy Rx	Sterility	Nationwide
22 Mar 2017	CLASS II	LTP (Lidocaine 10%, Tetracaine 2%, Phenylephrine 0.5%) recalled	Synergy Rx	Sterility	Nationwide
22 Mar 2017	CLASS II	Clear 2 (Benzoyl Peroxide 2.5%, Clindamycin 1.2% ) recalled	Synergy Rx	Sterility	Nationwide
22 Mar 2017	CLASS II	Human Chorionic Gonadotropin (HCG) recalled by Synergy Rx	Synergy Rx	Sterility	Nationwide
22 Mar 2017	CLASS II	Cantharadin 0.7% Solution and Cantharidan / Podophyllum recalled	Synergy Rx	Sterility	Nationwide
22 Mar 2017	CLASS II	Enhanced Retin Anti-wrinkle Cream recalled by Synergy Rx	Synergy Rx	Sterility	Nationwide
22 Mar 2017	CLASS II	HCG and HCG with resveratrol Human Chorionic Gonadotropin recalled	Synergy Rx	Sterility	Nationwide
22 Mar 2017	CLASS II	Firm And Fade (Retinoic Acid 0.05%, Hydroquinone recalled by Synergy Rx	Synergy Rx	Sterility	Nationwide
22 Mar 2017	CLASS II	Tretinoin Cream in all strengths including recalled by Synergy Rx	Synergy Rx	Sterility	Nationwide
22 Mar 2017	CLASS II	Supreme Bleaching Cream (Retinoic acid recalled by Synergy Rx	Synergy Rx	Sterility	Nationwide
22 Mar 2017	CLASS II	Generic VI Peel (Sal Acid 2%, Tca 7% Phenol 7%, Retinoic Acid 0.4%) recalled	Synergy Rx	Sterility	Nationwide
22 Mar 2017	CLASS II	Retin-a 0.05% Cream recalled by Synergy Rx	Synergy Rx	Sterility	Nationwide
22 Mar 2017	CLASS II	Betamethasone 0.25%, Rx only, Synergy RX, 4901 Morena Blvd # recalled	Synergy Rx	Sterility	Nationwide
22 Mar 2017	CLASS II	Quad Bleaching Cream (retinoic acid 0.05%, hydroquinone recalled	Synergy Rx	Sterility	Nationwide
22 Mar 2017	CLASS II	Ketoconazole 2%/hydrocortisone 1.5% Cream recalled by Synergy Rx	Synergy Rx	Sterility	Nationwide
22 Mar 2017	CLASS II	Jessners Peel (salicylic Acid 14% rescorcinol 14%, Lactic acid 14%) recalled	Synergy Rx	Sterility	Nationwide
22 Mar 2017	CLASS II	Quad Peel (Sal Acid 2%, Tca 7%, Phenol 7%, Retinoic acid 0.4%) recalled	Synergy Rx	Sterility	Nationwide
22 Mar 2017	CLASS II	Melatonin 1.5mg Spray recalled by Synergy Rx	Synergy Rx	Sterility	Nationwide
22 Mar 2017	CLASS II	Tacrolimus 0.1% Ointment and Tacrolimus 0.1%/Ketoconazole recalled	Synergy Rx	Sterility	Nationwide
22 Mar 2017	CLASS II	Diclofenac 3% and 5% Lip Balm and Diclofenac 5% Spf 30 Lip Balm recalled	Synergy Rx	Sterility	Nationwide
22 Mar 2017	CLASS II	Hydroquinone Cream in all strengths including recalled by Synergy Rx	Synergy Rx	Sterility	Nationwide
22 Mar 2017	CLASS II	Tri-bleaching Cream (Retinoic Acid 0.05%, Hydroquinone recalled	Synergy Rx	Sterility	Nationwide
22 Mar 2017	CLASS II	5-Fluorouracil IN Vanicream, Fluorouracil recalled by Synergy Rx	Synergy Rx	Sterility	Nationwide
22 Mar 2017	CLASS II	VI PEEL (Sal Acid 2%, TCA 17%, Phenol 7%, Retinoic Acid 0.4%) recalled	Synergy Rx	Sterility	Nationwide
22 Mar 2017	CLASS II	Glycolic Acid 15% Lotion recalled by Synergy Rx	Synergy Rx	Sterility	Nationwide
22 Mar 2017	CLASS II	Tretinoin 0.02% In Oil Free Cream recalled by Synergy Rx	Synergy Rx	Sterility	Nationwide
22 Mar 2017	CLASS II	Purified Water recalled by Synergy Rx	Synergy Rx	Sterility	Nationwide
22 Mar 2017	CLASS II	Gentle Bleaching Cream (Retinoic Acid recalled by Synergy Rx	Synergy Rx	Sterility	Nationwide
22 Mar 2017	CLASS II	Tri-bleaching Cream HQ (retinoic Acid recalled by Synergy Rx	Synergy Rx	Sterility	Nationwide
22 Mar 2017	CLASS II	Salicylic Acid Solution in all strengths including recalled	Synergy Rx	Sterility	Nationwide
22 Mar 2017	CLASS II	Acne Solution (Salicylic acid 2%, Hydrocortisone recalled by Synergy Rx	Synergy Rx	Sterility	Nationwide
22 Mar 2017	CLASS II	Fluororacil 0.05% Cream, Fluororacil 5% Cream recalled by Synergy Rx	Synergy Rx	Sterility	Nationwide
22 Mar 2017	CLASS II	Brightening Cream (Retinoic acid 0.1%, Hydroquinone recalled	Synergy Rx	Sterility	Nationwide
22 Mar 2017	CLASS II	Clindamycin 1%, Azelaic Acid 10% Cream recalled by Synergy Rx	Synergy Rx	Sterility	Nationwide
22 Mar 2017	CLASS II	Malek's Magic Plus (retinoic acid 0.1%, hydroquinone recalled	Synergy Rx	Sterility	Nationwide
22 Mar 2017	CLASS II	Benzoyl Peroxide 5% Clindamycin recalled by Synergy Rx	Synergy Rx	Sterility	Nationwide
22 Mar 2017	CLASS II	Erythromycin 2% In Cerave Cream recalled by Synergy Rx	Synergy Rx	Sterility	Nationwide
22 Mar 2017	CLASS II	Lactic Acid Solution in all strengths including 20% recalled	Synergy Rx	Sterility	Nationwide
22 Mar 2017	CLASS II	Bl 20%/4% Cream, Blt 20%/6%/4% Cream, Blt 20%/6%/6% recalled	Synergy Rx	Sterility	Nationwide
22 Mar 2017	CLASS II	Glycolic Acid Solution, all strengths including recalled by Synergy Rx	Synergy Rx	Sterility	Nationwide
22 Mar 2017	CLASS II	Tri-bleaching Cream (Retinoic Acid 0.05%, Hydroquinone recalled	Synergy Rx	Sterility	Nationwide
22 Mar 2017	CLASS II	Fluocinonide 0.05% Solution recalled by Synergy Rx	Synergy Rx	Sterility	Nationwide
22 Mar 2017	CLASS II	Calming Cream (Hydrocortisone 2.5%, Aloe vera powder) recalled	Synergy Rx	Sterility	Nationwide
22 Mar 2017	CLASS II	Minoxadil all strength including recalled by Synergy Rx	Synergy Rx	Sterility	Nationwide
22 Mar 2017	CLASS II	Human Chorionic Gonadotropin in 300IU recalled by Synergy Rx	Synergy Rx	Sterility	Nationwide
22 Mar 2017	CLASS II	Lidocaine Cream in all strengths including recalled by Synergy Rx	Synergy Rx	Sterility	Nationwide
22 Mar 2017	CLASS II	Clear (Benzoyl Peroxide 3.75%, Clindamycin 1.2% Gel) recalled	Synergy Rx	Sterility	Nationwide
22 Mar 2017	CLASS II	Hi-lite Cream (Retinoic Acid 0.05%, Hydroquinone recalled by Synergy Rx	Synergy Rx	Sterility	Nationwide
22 Mar 2017	CLASS II	Modified Jessner Peel (Sal Acid 14%, Lactic Acid 14%, glycolic 14%) recalled	Synergy Rx	Sterility	Nationwide
22 Mar 2017	CLASS II	Supreme Cream (Retinoic acid 0.05%, hydroquinone recalled by Synergy Rx	Synergy Rx	Sterility	Nationwide
22 Mar 2017	CLASS II	Retinoic Acid all strengths including recalled by Synergy Rx	Synergy Rx	Sterility	Nationwide
22 Mar 2017	CLASS II	Bicarbonate 10%, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San recalled	Synergy Rx	Sterility	Nationwide
22 Mar 2017	CLASS II	Adapalene 0.1%, Benzoyl Peroxide 2.5% Gel, Adapelene recalled	Synergy Rx	Sterility	Nationwide
22 Mar 2017	CLASS II	Retinoic Acid Solution in all strengths including recalled by Synergy Rx	Synergy Rx	Sterility	Nationwide
22 Mar 2017	CLASS II	Tca Peel Solution in all strengths including recalled by Synergy Rx	Synergy Rx	Sterility	Nationwide

More recalls from Synergy Rx

All 81

Reported	Class	Recall	Company	Reason	Where
22 Mar 2017Drug	CLASS II	Tca Peel Solution in all strengths including recalled by Synergy Rx	Synergy Rx	Sterility	Nationwide
22 Mar 2017Drug	CLASS II	Retinoic Acid Solution in all strengths including recalled by Synergy Rx	Synergy Rx	Sterility	Nationwide
22 Mar 2017Drug	CLASS II	Adapalene 0.1%, Benzoyl Peroxide 2.5% Gel, Adapelene recalled	Synergy Rx	Sterility	Nationwide
22 Mar 2017Drug	CLASS II	Bicarbonate 10%, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San recalled	Synergy Rx	Sterility	Nationwide
22 Mar 2017Drug	CLASS II	Retinoic Acid all strengths including recalled by Synergy Rx	Synergy Rx	Sterility	Nationwide

Other Metronidazole recalls

All 11

Reported	Class	Recall	Company	Reason	Where
22 Feb 2023Drug	CLASS II	Metronidazole 500MG, antibiotic recalled by Sentara Infusion Services	Sentara Infusion Services	Sterility	Nationwide
15 Jun 2022Drug	CLASS II	Metronidazole Vaginal Gel USP, 0.75% with 5 applicators recalled	Mckesson Medical-Surgical Inc. Corporate Office	Manufacturing (CGMP) Deviations	Nationwide
15 Jun 2022Drug	CLASS II	Metronidazole tablets, USP 250 mg unit dose recalled	Mckesson Medical-Surgical Inc. Corporate Office	Manufacturing (CGMP) Deviations	Nationwide
21 Jun 2017Drug	CLASS II	Metronidazole 500mg Tablet recalled by Safecor Health	Safecor Health	Manufacturing (CGMP) Deviations	MA, NY
5 Apr 2017Drug	CLASS II	Metronidazole Injection, USP, 500 mg recalled by Claris Lifesciences	Claris Lifesciences	Sterility	Nationwide