John Howell
Executive Vice President
Boothwyn Pharmacy, LLC
221 Gale Lane
Kennett Square , PA 19348
United StatesFEI 1000076625Issued Jan 16, 2026Center for Drug Evaluation and Research (CDER)
Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy. To check it, open FDA's record for this establishment, listed under FEI 1000076625.
Violations4
Issue DateJan 16, 2026
Product TypeDrugs
StatusOpen
Letter Details
Firm
Boothwyn Pharmacy, LLC
Location
John Howell
Executive Vice President
Boothwyn Pharmacy, LLC
221 Gale Lane
Kennett Square , PA 19348
United States
FEI Number
1000076625
Country
United States
Issue Date
January 16, 2026
Issuing Office
Center for Drug Evaluation and Research (CDER)
Product Type
Drugs
Status
Open
Summary
Boothwyn Pharmacy, LLC was cited for producing adulterated drug products, specifically sterile GLP-1 injectables compounded under insanitary conditions that created contamination and health risks in violation of federal manufacturing standards. During a May-June 2025 inspection, FDA investigators identified serious deficiencies in the pharmacy's drug production practices, including failure to maintain adequate sterility assurances and quality controls. The company voluntarily recalled all affected drug products with out-of-specification results in July 2025 and ceased GLP-1 sterile product production, though it notified FDA of plans to resume such manufacturing in August 2025.
Boothwyn Pharmacy, LLC FDA Warning Letter, January 16, 2026