CLASS II Drug recall · Reported 11 Dec 2013 · FDA Enforcement Report

Sermorelin 3mg, Main Street Compounding Pharmacy recalled

Main Street Family Pharmacy is recalling Sermorelin 3mg, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, distributed nationwide in the US. The recall was initiated on 28 May 2013 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesall codes distributed prior to and including 05/23/2013

Quantity recalled71 units

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-265-2014
FDA event ID: 65479
Recalling firm: Main Street Family Pharmacy, Newbern, TN
Classification: Class II
Status: Terminated
Recall initiated: 28 May 2013
FDA classified: 3 Dec 2013
Reported: 11 Dec 2013
Type: Voluntary: Firm initiated
Customers notified by: Telephone
Reason category: Other Reasons
Drug class: Compounded Drugs

Timeline

28 May 2013	Recall initiated by company
3 Dec 2013	Classified by FDA	+189 days
11 Dec 2013	Published 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

The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials.

Product as listed by the FDA

Sermorelin 3mg, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200

Where it was distributed

nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV

Nationwide Alaska Alabama Arizona California Colorado Connecticut District of Columbia Florida Georgia Hawaii Illinois Indiana Kansas Kentucky Louisiana Massachusetts Maryland Minnesota Missouri Mississippi

Questions about this recall

Why was it recalled?

The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials.

Which lots are affected?

all codes distributed prior to and including 05/23/2013

Where was it sold?

nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV

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

100 other products · FDA event 65479

This product is part of a recall event; the main page for the event is Mic Ultra-Sulfur Free, Main Street Compounding Pharmacy recalled.

Reported	Class	Recall	Company	Reason	Where
11 Dec 2013	CLASS II	Mic Ultra-Sulfur Free, Main Street Compounding Pharmacy recalled	Main Street Family Pharmacy	Other	Nationwide
11 Dec 2013	CLASS II	Depo-Testadiiol, Main Street Compounding Pharmacy recalled	Main Street Family Pharmacy	Other	Nationwide
11 Dec 2013	CLASS II	Lipotropic PFS, Main Street Compounding Pharmacy recalled	Main Street Family Pharmacy	Other	Nationwide
11 Dec 2013	CLASS II	Double Strength PGE1 40mcg/ml recalled by Main Street Family Pharmacy	Main Street Family Pharmacy	Other	Nationwide
11 Dec 2013	CLASS II	Minoxidil 10%, Main Street Compounding Pharmacy recalled	Main Street Family Pharmacy	Other	Nationwide
11 Dec 2013	CLASS II	HCG 11000u w/B-12, Main Street Compounding Pharmacy recalled	Main Street Family Pharmacy	Other	Nationwide
11 Dec 2013	CLASS II	Alphahydroxyprogesterone, 250mg recalled by Main Street Family Pharmacy	Main Street Family Pharmacy	Other	Nationwide
11 Dec 2013	CLASS II	Medroxyprogesterone 150mg w/lid Main Street Compounding recalled	Main Street Family Pharmacy	Other	Nationwide
11 Dec 2013	CLASS II	Medroxyprogesterone (PF) 150mg recalled by Main Street Family Pharmacy	Main Street Family Pharmacy	Other	Nationwide
11 Dec 2013	CLASS II	Testosterone Cypionate 250mg recalled by Main Street Family Pharmacy	Main Street Family Pharmacy	Other	Nationwide
11 Dec 2013	CLASS II	Methylprednisolone 40mg w/lidocaine recalled	Main Street Family Pharmacy	Other	Nationwide
11 Dec 2013	CLASS II	Mic . syrin, Main Street Compounding Pharmacy recalled	Main Street Family Pharmacy	Other	Nationwide
11 Dec 2013	CLASS II	Dexamethasone 8mg, Main Street Compounding Pharmacy recalled	Main Street Family Pharmacy	Other	Nationwide
11 Dec 2013	CLASS II	Dexamethasone LA 16mg, Main Street Compounding Pharmacy recalled	Main Street Family Pharmacy	Other	Nationwide
11 Dec 2013	CLASS II	HCG 10000u, Main Street Compounding Pharmacy recalled	Main Street Family Pharmacy	Other	Nationwide
11 Dec 2013	CLASS II	HCG 370iu prefilled syringes recalled by Main Street Family Pharmacy	Main Street Family Pharmacy	Other	Nationwide
11 Dec 2013	CLASS II	Methylprednisolone 40mg, Main Street Compounding Pharmacy recalled	Main Street Family Pharmacy	Other	Nationwide
11 Dec 2013	CLASS II	Sermorelin 6mg, Main Street Compounding Pharmacy recalled	Main Street Family Pharmacy	Other	Nationwide
11 Dec 2013	CLASS II	Estradiol Pellets 15mg, Main Street Compounding Pharmacy recalled	Main Street Family Pharmacy	Other	Nationwide
11 Dec 2013	CLASS II	Medroxyprogesterone 150mg, Main Street Compounding Pharmacy recalled	Main Street Family Pharmacy	Other	Nationwide
11 Dec 2013	CLASS II	Single Strength PGE1 20mcg, Main Street Compounding recalled	Main Street Family Pharmacy	Other	Nationwide
11 Dec 2013	CLASS II	Methylprednisolone 40mg PF, Main Street Compounding recalled	Main Street Family Pharmacy	Other	Nationwide
11 Dec 2013	CLASS II	HCG 2000IU, Main Street Compounding Pharmacy recalled	Main Street Family Pharmacy	Other	Nationwide
11 Dec 2013	CLASS II	HCG 390iu prefilled syringes recalled by Main Street Family Pharmacy	Main Street Family Pharmacy	Other	Nationwide
11 Dec 2013	CLASS II	Test Cypionate 20mg/ml, Main Street Compounding Pharmacy recalled	Main Street Family Pharmacy	Other	Nationwide
11 Dec 2013	CLASS II	Methylprednisolone 80mg, Main Street Compounding Pharmacy recalled	Main Street Family Pharmacy	Other	Nationwide
11 Dec 2013	CLASS II	HCG 2500u, Main Street Compounding Pharmacy recalled	Main Street Family Pharmacy	Other	Nationwide
11 Dec 2013	CLASS II	HCG 270 iu prefilled syringes recalled by Main Street Family Pharmacy	Main Street Family Pharmacy	Other	Nationwide
11 Dec 2013	CLASS II	Cyclosporine Drops (compounded) recalled by Main Street Family Pharmacy	Main Street Family Pharmacy	Other	Nationwide
11 Dec 2013	CLASS II	Brompheniramine, Main Street Compounding Pharmacy recalled	Main Street Family Pharmacy	Other	Nationwide
11 Dec 2013	CLASS II	Dexamethasone sodium phosphate recalled by Main Street Family Pharmacy	Main Street Family Pharmacy	Other	Nationwide
11 Dec 2013	CLASS II	Lidocaine 2%, Main Street Compounding Pharmacy recalled	Main Street Family Pharmacy	Other	Nationwide
11 Dec 2013	CLASS II	Alprostadil 100mcg/ml, Main Street Compounding Pharmacy recalled	Main Street Family Pharmacy	Other	Nationwide
11 Dec 2013	CLASS II	Testosterone Pellets 50mg, Main Street Compounding Pharmacy recalled	Main Street Family Pharmacy	Other	Nationwide
11 Dec 2013	CLASS II	Lipo C, Methionine 12.5mg, Inositol 50mg, Choline 100mg recalled	Main Street Family Pharmacy	Other	Nationwide
11 Dec 2013	CLASS II	Sodium Hyaluronate., Main Street Compounding Pharmacy recalled	Main Street Family Pharmacy	Other	Nationwide
11 Dec 2013	CLASS II	Carnitine 250mg/ml, Main Street Compounding Pharmacy recalled	Main Street Family Pharmacy	Other	Nationwide
11 Dec 2013	CLASS II	Betamethasone Na phosphate 4mg/ml recalled	Main Street Family Pharmacy	Other	Nationwide
11 Dec 2013	CLASS II	B-Complex 100 (PF), Main Street Compounding Pharmacy recalled	Main Street Family Pharmacy	Other	Nationwide
11 Dec 2013	CLASS II	Methylprednisolone 20mg PF, Main Street Compounding recalled	Main Street Family Pharmacy	Other	Nationwide
11 Dec 2013	CLASS II	HCG 140 iu prefilled syringes recalled by Main Street Family Pharmacy	Main Street Family Pharmacy	Other	Nationwide
11 Dec 2013	CLASS II	TCA 30% - 0.8PH vial, Main Street Compounding Pharmacy recalled	Main Street Family Pharmacy	Other	Nationwide
11 Dec 2013	CLASS II	Glutathione "Reduced" 200mg/ml recalled by Main Street Family Pharmacy	Main Street Family Pharmacy	Other	Nationwide
11 Dec 2013	CLASS II	Marcaine .2% NS, Main Street Compounding Pharmacy recalled	Main Street Family Pharmacy	Other	Nationwide
11 Dec 2013	CLASS II	B-12/Adenosine, Main Street Compounding Pharmacy recalled	Main Street Family Pharmacy	Other	Nationwide
11 Dec 2013	CLASS II	HCG 275 iu prefilled syringes recalled by Main Street Family Pharmacy	Main Street Family Pharmacy	Other	Nationwide
11 Dec 2013	CLASS II	Oral B-12--cotton candy, Main Street Compounding Pharmacy recalled	Main Street Family Pharmacy	Other	Nationwide
11 Dec 2013	CLASS II	Amic-12 w/out lido10ml , Main Street Compounding Pharmacy recalled	Main Street Family Pharmacy	Other	Nationwide
11 Dec 2013	CLASS II	Tri-Mix SS Pap 30mg, Phen 1mg, PGE1 10mcg recalled	Main Street Family Pharmacy	Other	Nationwide
11 Dec 2013	CLASS II	Methylcobalamin, Main Street Compounding Pharmacy recalled	Main Street Family Pharmacy	Other	Nationwide
11 Dec 2013	CLASS II	HCG 360iu PFS, Main Street Compounding Pharmacy recalled	Main Street Family Pharmacy	Other	Nationwide
11 Dec 2013	CLASS II	Mic B w/Amp Mix Main Street Compounding Pharmacy recalled	Main Street Family Pharmacy	Other	Nationwide
11 Dec 2013	CLASS II	Pre-Menopausal Pack 3rd Month recalled by Main Street Family Pharmacy	Main Street Family Pharmacy	Other	Nationwide
11 Dec 2013	CLASS II	Dexamethasone LA 16mg/ml, Main Street Compounding Pharmacy recalled	Main Street Family Pharmacy	Other	Nationwide
11 Dec 2013	CLASS II	B-12 PFS, Main Street Compounding Pharmacy recalled	Main Street Family Pharmacy	Other	Nationwide
11 Dec 2013	CLASS II	Taper Pack C, Main Street Compounding Pharmacy recalled	Main Street Family Pharmacy	Other	Nationwide
11 Dec 2013	CLASS II	Gomenol, Main Street Compounding Pharmacy recalled	Main Street Family Pharmacy	Other	Nationwide
11 Dec 2013	CLASS II	Sodium Hyaluronate, Main Street Compounding Pharmacy recalled	Main Street Family Pharmacy	Other	Nationwide
11 Dec 2013	CLASS II	Methylprednisolone 40mg PF, Main Street Compounding recalled	Main Street Family Pharmacy	Other	Nationwide
11 Dec 2013	CLASS II	HCG 340 iu prefilled syringes recalled by Main Street Family Pharmacy	Main Street Family Pharmacy	Other	Nationwide
11 Dec 2013	CLASS II	Dexamethasone LA 16mg, Main Street Compounding Pharmacy recalled	Main Street Family Pharmacy	Other	Nationwide
11 Dec 2013	CLASS II	B-Complex 206 mg/ml, Main Street Compounding Pharmacy recalled	Main Street Family Pharmacy	Other	Nationwide
11 Dec 2013	CLASS II	Medroxyprogesterone 150mg, Main Street Compounding Pharmacy recalled	Main Street Family Pharmacy	Other	Nationwide
11 Dec 2013	CLASS II	17-P, Main Street Compounding Pharmacy recalled	Main Street Family Pharmacy	Other	Nationwide
11 Dec 2013	CLASS II	Wydase, Main Street Compounding Pharmacy recalled	Main Street Family Pharmacy	Sterility	Nationwide
11 Dec 2013	CLASS II	Post-menopausal HCG pack, Main Street Compounding Pharmacy recalled	Main Street Family Pharmacy	Other	Nationwide
11 Dec 2013	CLASS II	Betamethasone 10mg, Main Street Compounding Pharmacy recalled	Main Street Family Pharmacy	Other	Nationwide
11 Dec 2013	CLASS II	Testosterone Pellet 112mg, Main Street Compounding Pharmacy recalled	Main Street Family Pharmacy	Other	Nationwide
11 Dec 2013	CLASS II	Mitomycin 0.02% Main Street Compounding Pharmacy recalled	Main Street Family Pharmacy	Other	Nationwide
11 Dec 2013	CLASS II	Glycerin 72%, Lido1%, w/Epi 2;1 recalled by Main Street Family Pharmacy	Main Street Family Pharmacy	Other	Nationwide
11 Dec 2013	CLASS II	Testosterone Pellets 75mg, Main Street Compounding Pharmacy recalled	Main Street Family Pharmacy	Other	Nationwide
11 Dec 2013	CLASS II	Pontocaine 2%, Main Street Compounding Pharmacy recalled	Main Street Family Pharmacy	Other	Nationwide
11 Dec 2013	CLASS II	HCG 5000iu, Main Street Compounding Pharmacy recalled	Main Street Family Pharmacy	Other	Nationwide
11 Dec 2013	CLASS II	Mic 25/50/50, Main Street Compounding Pharmacy recalled	Main Street Family Pharmacy	Other	Nationwide
11 Dec 2013	CLASS II	Mitomycin 40mg Compounded, Main Street Compounding Pharmacy recalled	Main Street Family Pharmacy	Other	Nationwide
11 Dec 2013	CLASS II	HCG 380 iu prefilled syringes recalled by Main Street Family Pharmacy	Main Street Family Pharmacy	Other	Nationwide
11 Dec 2013	CLASS II	Triamcinolone Diacetate 40mg recalled by Main Street Family Pharmacy	Main Street Family Pharmacy	Other	Nationwide
11 Dec 2013	CLASS II	Mic Ultra, Main Street Compounding Pharmacy recalled	Main Street Family Pharmacy	Other	Nationwide
11 Dec 2013	CLASS II	Methylprednisolone 40mg, Main Street Compounding Pharmacy recalled	Main Street Family Pharmacy	Other	Nationwide
11 Dec 2013	CLASS II	Sermorelin GHRP 9mg/3mg/3mg recalled by Main Street Family Pharmacy	Main Street Family Pharmacy	Other	Nationwide
11 Dec 2013	CLASS II	Estradiol Pellets 12mg, Main Street Compounding Pharmacy recalled	Main Street Family Pharmacy	Other	Nationwide
11 Dec 2013	CLASS II	HCG 450 iu prefilled syringes recalled by Main Street Family Pharmacy	Main Street Family Pharmacy	Other	Nationwide
11 Dec 2013	CLASS II	Lipotropic (Getwell), Main Street Compounding Pharmacy recalled	Main Street Family Pharmacy	Other	Nationwide
11 Dec 2013	CLASS II	HCG 230 iu prefilled syringes recalled by Main Street Family Pharmacy	Main Street Family Pharmacy	Other	Nationwide
11 Dec 2013	CLASS II	Mic B-Complex, Main Street Compounding Pharmacy recalled	Main Street Family Pharmacy	Other	Nationwide
11 Dec 2013	CLASS II	Calcium Gluconate 2.5% Gel, Main Street Compounding recalled	Main Street Family Pharmacy	Other	Nationwide
11 Dec 2013	CLASS II	Testosterone Propionate recalled by Main Street Family Pharmacy	Main Street Family Pharmacy	Other	Nationwide
11 Dec 2013	CLASS II	Estradiol Pellet 20mg, Main Street Compounding Pharmacy recalled	Main Street Family Pharmacy	Other	Nationwide
11 Dec 2013	CLASS II	B-12 prefilled syringe, Main Street Compounding Pharmacy recalled	Main Street Family Pharmacy	Other	Nationwide
11 Dec 2013	CLASS II	HCG 12000u, Main Street Compounding Pharmacy recalled	Main Street Family Pharmacy	Other	Nationwide
11 Dec 2013	CLASS II	Mitomycin (full Strength), Main Street Compounding Pharmacy recalled	Main Street Family Pharmacy	Other	Nationwide
11 Dec 2013	CLASS II	HCG 260 iu prefilled syringes recalled by Main Street Family Pharmacy	Main Street Family Pharmacy	Other	Nationwide
11 Dec 2013	CLASS II	Lipotonix Plus, Main Street Compounding Pharmacy recalled	Main Street Family Pharmacy	Other	Nationwide
11 Dec 2013	CLASS II	Pre-menopausal HCG PK 2nd month recalled by Main Street Family Pharmacy	Main Street Family Pharmacy	Other	Nationwide
11 Dec 2013	CLASS I	Methylprednisolone 80mg/ml (PF) recalled by Main Street Family Pharmacy	Main Street Family Pharmacy	Other	Nationwide
11 Dec 2013	CLASS II	Lipoden, Main Street Compounding Pharmacy recalled	Main Street Family Pharmacy	Other	Nationwide
11 Dec 2013	CLASS II	HCG 15000u w/b-12, Main Street Compounding Pharmacy recalled	Main Street Family Pharmacy	Other	Nationwide
11 Dec 2013	CLASS II	Mic, Main Street Compounding Pharmacy, 126 East Main Street recalled	Main Street Family Pharmacy	Other	Nationwide
11 Dec 2013	CLASS II	Testosterone 210mg (compounded) recalled by Main Street Family Pharmacy	Main Street Family Pharmacy	Other	Nationwide
11 Dec 2013	CLASS II	Marcaine .1%/NS, Main Street Compounding Pharmacy recalled	Main Street Family Pharmacy	Other	Nationwide

More recalls from Main Street Family Pharmacy

All 299

Reported	Class	Recall	Company	Reason	Where
11 Dec 2013Drug	CLASS II	Mitomycin 40mg, Main Street Compounding Pharmacy recalled	Main Street Family Pharmacy	Other	Nationwide
11 Dec 2013Drug	CLASS II	HCG 5000iu kit, Main Street Compounding Pharmacy recalled	Main Street Family Pharmacy	Other	Nationwide
11 Dec 2013Drug	CLASS II	HCG 5,000U, Main Street Compounding Pharmacy recalled	Main Street Family Pharmacy	Other	Nationwide
11 Dec 2013Drug	CLASS II	HCG 3000IU, Main Street Compounding Pharmacy recalled	Main Street Family Pharmacy	Other	Nationwide
11 Dec 2013Drug	CLASS II	Amikacin 500mg, Main Street Compounding Pharmacy recalled	Main Street Family Pharmacy	Other	Nationwide

Other Sermorelin recalls

All 74

Reported	Class	Recall	Company	Reason	Where
21 Sep 2022Drug	CLASS II	Sermorelin Acetate 1 MG/ML Injectable syringes recalled	Carolina Infusion	Sterility	Nationwide
20 Jul 2022Drug	CLASS II	Sermorelin/Glycine 2000mcg/5mg/mL-vial, Refrigerate recalled	TMC Acquisition	Sterility	Nationwide
20 Jul 2022Drug	CLASS II	Sermorelin/Glycine 2000mcg/5mg/mL-vial, Refrigerate recalled	TMC Acquisition	Sterility	Nationwide
20 Jul 2022Drug	CLASS II	Sermorelin 2000mcg/mL-vial, Refrigerate, Tailor Made Compounding recalled	TMC Acquisition	Sterility	Nationwide
4 May 2022Drug	CLASS II	Sermorelin Acetate, Lyophilized powder for reconstitution recalled	Olympia Compounding Pharmacy	Manufacturing (CGMP) Deviations	Nationwide