CLASS II Drug recall · Reported 17 Jan 2018 · FDA Enforcement Report

Benzocaine 20%, Lidocaine 6%, Tetracaine 4% Cream recalled

KRS Global Biotechnology is recalling Benzocaine 20%, Lidocaine 6%, Tetracaine 4% Cream, distributed nationwide in the US. The recall was initiated on 16 Nov 2017 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLots: 06072017@22 BUD: 12/4/2017; 06222017@30 BUD: 12/19/2017; 08032017@31 BUD: 1/30/2018; 09212017@21 BUD: 3/20/2018; 10232017@20 BUD: 11/22/2017

Quantity recalled4,530 jars

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-0165-2018
FDA event ID: 78553
Recalling firm: KRS Global Biotechnology, Boca Raton, FL
Classification: Class II
Status: Terminated
Recall initiated: 16 Nov 2017
FDA classified: 8 Jan 2018
Reported: 17 Jan 2018
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Packaging Defects
Drug class: Pain Medication

Timeline

16 Nov 2017	Recall initiated by company
8 Jan 2018	Classified by FDA	+53 days
17 Jan 2018	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

Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.

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

Benzocaine 20%, Lidocaine 6%, Tetracaine 4% Cream packaged in jars, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.

Where it was distributed

Nationwide in the USA, Bermuda, and New Zealand

Nationwide

Questions about this recall

Why was it recalled?

Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.

Which lots are affected?

Lots: 06072017@22 BUD: 12/4/2017; 06222017@30 BUD: 12/19/2017; 08032017@31 BUD: 1/30/2018; 09212017@21 BUD: 3/20/2018; 10232017@20 BUD: 11/22/2017

Where was it sold?

Nationwide in the USA, Bermuda, and New Zealand

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

46 other products · FDA event 78553

This product is part of a recall event; the main page for the event is Human Chorionic Gonadotropin 6,000 iu/Vial, For SC Use -Lyophilized recalled.

Reported	Class	Recall	Company	Reason	Where
17 Jan 2018	CLASS II	Human Chorionic Gonadotropin 6,000 iu/Vial, For SC Use -Lyophilized recalled	KRS Global Biotechnology	Other	Nationwide
17 Jan 2018	CLASS II	Savinase 100 mcg/mL Topical Solution in a Droptainer recalled	KRS Global Biotechnology	Other	Nationwide
17 Jan 2018	CLASS II	Chloramphenicol 50 mg/ Sulfamethoxazole 50 mg recalled	KRS Global Biotechnology	Other	Nationwide
17 Jan 2018	CLASS II	Progesterone 3% Topical Cream recalled by KRS Global Biotechnology	KRS Global Biotechnology	Packaging Defects	Nationwide
17 Jan 2018	CLASS II	Quadmix #18 Vial recalled by KRS Global Biotechnology	KRS Global Biotechnology	Other	Nationwide
17 Jan 2018	CLASS II	Human Chorionic Gonadotropin, Vial-Lyophilized, For SC Use recalled	KRS Global Biotechnology	Other	Nationwide
17 Jan 2018	CLASS II	Hydroquinone 8%/ Tretinoin 0.1% Topical Ointment recalled	KRS Global Biotechnology	Packaging Defects	Nationwide
17 Jan 2018	CLASS II	Bi-Est (Estriol/Estradiol) (80/20) + Progesterone recalled	KRS Global Biotechnology	Packaging Defects	Nationwide
17 Jan 2018	CLASS II	Benzo/Lido/Tetracaine 20%-8%-8% Topical Cream recalled	KRS Global Biotechnology	Packaging Defects	Nationwide
17 Jan 2018	CLASS II	Methylene Blue (PF) 10 mg/mL (1%) Injectable Vial recalled	KRS Global Biotechnology	Other	Nationwide
17 Jan 2018	CLASS II	Vitamin 9 A/B Lyophilized Vial, For IM Use recalled	KRS Global Biotechnology	Other	Nationwide
17 Jan 2018	CLASS II	Anastrozole 0.5 mg Capsules, Rx Only, KRS Global Biotechnology recalled	KRS Global Biotechnology	Other	Nationwide
17 Jan 2018	CLASS II	Liothyronine SR (T3) recalled by KRS Global Biotechnology	KRS Global Biotechnology	Other	Nationwide
17 Jan 2018	CLASS II	Quadmix #17 Vial recalled by KRS Global Biotechnology	KRS Global Biotechnology	Other	Nationwide
17 Jan 2018	CLASS II	Hydroxocobalamin 0.5 mg/mL For Diluent Purpose Only Vial recalled	KRS Global Biotechnology	Other	Nationwide
17 Jan 2018	CLASS II	Cyclopentolate HCl/ Phenylephrine HCl/ Tropicamide recalled	KRS Global Biotechnology	Other	Nationwide
17 Jan 2018	CLASS II	Trimix #22F (Prostaglandin E1 25 mcg/ Papaverine HCl 30 mg recalled	KRS Global Biotechnology	Other	Nationwide
17 Jan 2018	CLASS II	Arginine 150 mg/ Lysine HCl 50 mg/ Glutamine 200 mg/g Topical Cream recalled	KRS Global Biotechnology	Packaging Defects	Nationwide
17 Jan 2018	CLASS II	Nicotinamide Adenine Dinucleotide 500 mg recalled	KRS Global Biotechnology	Packaging Defects	Nationwide
17 Jan 2018	CLASS II	Vitamin 9 Lyophilized Vial, For IM Use recalled	KRS Global Biotechnology	Other	Nationwide
17 Jan 2018	CLASS II	Sermorelin, 3 mg/ GHRP6, 1.8 mg/ GHRP2, 1.8 mg/mL recalled	KRS Global Biotechnology	Other	Nationwide
17 Jan 2018	CLASS II	Iodochlorhydroxyquin 3%/ Boric Acid 10%/ Amphotericin 5% Otic Powder recalled	KRS Global Biotechnology	Packaging Defects	Nationwide
17 Jan 2018	CLASS II	Chloramphenicol 500 mg Sulfamethoxazole 500 mg Amphotericin recalled	KRS Global Biotechnology	Packaging Defects	Nationwide
17 Jan 2018	CLASS II	Cyclopentolate HCl/ Phenylephrine HCl/ Tropicamide recalled	KRS Global Biotechnology	Other	Nationwide
17 Jan 2018	CLASS II	Estriol 0.1% (1 mg/gm) Cream recalled by KRS Global Biotechnology	KRS Global Biotechnology	Packaging Defects	Nationwide
17 Jan 2018	CLASS II	Oxytocin in 0.9% Sodium Chloride Solution (PF) IV recalled	KRS Global Biotechnology	Other	Nationwide
17 Jan 2018	CLASS II	PrednisoLONE 10 mg Tablet, Rx Only, KRS Global Biotechnology recalled	KRS Global Biotechnology	Other	Nationwide
17 Jan 2018	CLASS II	Sincalide 5 mcg Lyophilized Vials, For IV Use recalled	KRS Global Biotechnology	Other	Nationwide
17 Jan 2018	CLASS II	Amphotericin 60 mg/Chloramphenicol 600 mg/Hydrocortisone recalled	KRS Global Biotechnology	Packaging Defects	Nationwide
17 Jan 2018	CLASS II	Human Chorionic Gonadotropin 11,000 iu/Vial Lyophilized For SC Use recalled	KRS Global Biotechnology	Other	Nationwide
17 Jan 2018	CLASS II	Vitamin 10 B Lyophilized Vial, For IM Use recalled	KRS Global Biotechnology	Other	Nationwide
17 Jan 2018	CLASS II	7-Keto DHEA 25mg Capsule recalled by KRS Global Biotechnology	KRS Global Biotechnology	Other	Nationwide
17 Jan 2018	CLASS II	Sermorelin, 3 mg/ GHRP6, 3 mg/GHRP2, 3 mg, Vial recalled	KRS Global Biotechnology	Other	Nationwide
17 Jan 2018	CLASS II	Human Chorionic Gonadotropin 5,000 iu/ Vial Lyophilized, For SC Use recalled	KRS Global Biotechnology	Other	Nationwide
17 Jan 2018	CLASS II	Human Chorionic Gonadotropin 20,000 iu/Vial, Lyophilized recalled	KRS Global Biotechnology	Other	Nationwide
17 Jan 2018	CLASS II	Human Chorionic Gonadotropin (ODT) recalled by KRS Global Biotechnology	KRS Global Biotechnology	Other	Nationwide
17 Jan 2018	CLASS II	Trimix #23F (Prostaglandin E1 6 mcg/ Papaverine HCl recalled	KRS Global Biotechnology	Other	Nationwide
17 Jan 2018	CLASS II	Sermorelin (ODT) recalled by KRS Global Biotechnology	KRS Global Biotechnology	Other	Nationwide
17 Jan 2018	CLASS II	Benzocaine 20%, Lidocaine 8%, Tetracaine 4% Topical Cream recalled	KRS Global Biotechnology	Packaging Defects	Nationwide
17 Jan 2018	CLASS II	T-105 (Prostaglandin E1, 10 mcg/ Papaverine 30 mg recalled	KRS Global Biotechnology	Other	Nationwide
17 Jan 2018	CLASS II	Chloramphenicol 500 mg Amphotericin 50 mg Otic Powder recalled	KRS Global Biotechnology	Packaging Defects	Nationwide
17 Jan 2018	CLASS II	Quadmix #16 Vial recalled by KRS Global Biotechnology	KRS Global Biotechnology	Other	Nationwide
17 Jan 2018	CLASS II	7-Ketodehydroepiandrosterone (7-Keto DHEA) recalled	KRS Global Biotechnology	Other	Nationwide
17 Jan 2018	CLASS II	Anastrozole SR recalled by KRS Global Biotechnology	KRS Global Biotechnology	Other	Nationwide
17 Jan 2018	CLASS II	Hydroxocobalamin 1 mg/mL Vial For IM Use recalled	KRS Global Biotechnology	Other	Nationwide
17 Jan 2018	CLASS II	Sermorelin Acetate 3 mg/ GHRP6 3 mg, Lyophilized Vial recalled	KRS Global Biotechnology	Other	Nationwide

More recalls from KRS Global Biotechnology

All 129

Reported	Class	Recall	Company	Reason	Where
9 Oct 2019Drug	CLASS II	LIDOcaine HCl 2% (PF) 100 mg/ (20 mg/mL) Fill recalled	KRS Global Biotechnology	Sterility	Nationwide
9 Oct 2019Drug	CLASS II	Norepinephrine added to 5% Dextrose (PF) IV, 8 mg/ (0.032 mg/mL) recalled	KRS Global Biotechnology	Sterility	Nationwide
9 Oct 2019Drug	CLASS II	SUCCinylcholine Chloride (PF), 200 mg/ (20 mg/mL) Fill recalled	KRS Global Biotechnology	Sterility	Nationwide
9 Oct 2019Drug	CLASS II	Human Chorionic Gonadotropins Lyophilized For SC/IM Use recalled	KRS Global Biotechnology	Sterility	Nationwide
9 Oct 2019Drug	CLASS II	Cyclopentolate HCl 1% (5 mg/ / Phenylephrine HCl recalled	KRS Global Biotechnology	Sterility	Nationwide

Other Benzocaine recalls

All 18

Reported	Class	Recall	Company	Reason	Where
24 Jun 2026Drug	CLASS II	Pearson Quality Topical Anesthetic Gel (20% Benzocaine) recalledPearson Topical Anesthetic	Keystone Industries	Packaging Defects	Nationwide
24 Jun 2026Drug	CLASS II	safco SensiCaine-Ultra (20% Benzocaine) recalled by Keystone IndustriesSafco Sensicaine Ultra Topical Anesthetic Gel	Keystone Industries	Packaging Defects	Nationwide
24 Jun 2026Drug	CLASS II	Dental City Topical Anesthetic Gel, Benzocaine recalledDental City Topical Anesthetic	Keystone Industries	Packaging Defects	Nationwide
24 Jun 2026Drug	CLASS II	Burkhart topical anesthetic gel, benzocaine 20 %, Strawberry Flavor recalledBurkhart Topical Anesthetic	Keystone Industries	Packaging Defects	Nationwide
24 Jun 2026Drug	CLASS II	Quala Dental Products, Topical Anesthetic Gel recalledQuala Topical Anesthetic Gel	Keystone Industries	Packaging Defects	Nationwide