Main Street Compounding Pharmacy Recalls Dexamethasone 4/8 Due to Adverse Reactions
Main Street Compounding Pharmacy is recalling Dexamethasone 4/8 after receiving reports of skin abscesses potentially linked to the product.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is FDA Class II, and the source text reports adverse reactions (skin abscesses), which aligns with the rubric criteria for Severe (FDA Class II with hospitalization reports or significant injury reports).
Plain-English summary
Main Street Family Pharmacy, LLC is recalling 311 units of Dexamethasone 4/8. The product was distributed nationwide to specific states including 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. All codes distributed prior to and including 05/23/2013 are affected.
The recall was initiated after the firm received seven reports of adverse reactions in the form of skin abscesses. These reactions were potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. The source text does not specify if the Dexamethasone 4/8 product itself contained methylprednisolone or if the adverse reactions were directly caused by the Dexamethasone 4/8 units, but the recall is associated with these reports.
Consumers who have this product should stop using it and contact the recalling firm, Main Street Family Pharmacy, LLC, at 888-658-6200 for further instructions.
The recalled product
- Product
- Dexamethasone 4/8, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200
- Manufacturer
- Main Street Family Pharmacy, LLC
- Category
- Drug — Compounded Steroid
- Affected units
- 311
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- all codes distributed prior to and including 05/23/2013
Distribution
Part of a larger recall action
This product is one of 299 recalled by Main Street Family Pharmacy, LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 299 products in this recall →Related recalls
Same manufacturer · Main Street Family Pharmacy, LLC
See all →- SevereMain Street Compounding Pharmacy Recalls Acetylcystein 10% Vials
FDA (Drugs) · 2013-12-11
- SevereMain Street Compounding Pharmacy Recalls Minoxidil 10% Due to Adverse Reactions
FDA (Drugs) · 2013-12-11
- SevereMain Street Compounding Pharmacy Recalls HCG 11000u w/B-12
FDA (Drugs) · 2013-12-11
- SevereMain Street Compounding Pharmacy Recalls Brompheniramine Due to Adverse Reactions
FDA (Drugs) · 2013-12-11
- SevereMain Street Compounding Pharmacy Recalls Methylcobalamin Due to Adverse Reaction Reports
FDA (Drugs) · 2013-12-11
Same hazard · infection
See all →- HighArrowhead DE LLC Recalls Arrow-LOK Implants Due to Sterility Assurance Concerns
FDA (Devices) · 2026-08-26
- SevereRegeneron Recalls Libtayo Injection Due to Sterility Assurance Concerns
FDA (Drugs) · 2026-08-26
- HighSurgipro Sutures Recalled for Potential Sterile Barrier Perforation
FDA (Devices) · 2026-08-19
- SevereSpectra Medical Devices Recalls Sodium Chloride Injection Ampules Due to Sterility Concerns
FDA (Devices) · 2026-08-19
- HighV-Loc 90 Absorbable Wound Closure Devices Recalled for Packaging Defects
FDA (Devices) · 2026-08-19