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Data / FDA warning letters / Drug compounding

FDA warning letters on drug compounding: 24 since Nov 2024

The full list. FDA warning letters: drug compounding: 24 rows for $5, FDA warning letters issued November 12, 2024 to October 30, 2026.

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For agents and scripts: this list is ordered at https://specstream.ai/data/fda-warning-letters/subject/compounding, and every list with its row count and price is at https://specstream.ai/data/lists.json.

Updated August 7, 2026. Source: FDA warning letters (U.S. Food and Drug Administration).

FDA issued 24 warning letters on drug compounding from December 17, 2024 to August 7, 2026, to 24 companies; 4 have a closeout letter. The newest, issued August 7, 2026 by the Center for Drug Evaluation and Research, went to Pine Pharmaceuticals, LLC (Compounding Pharmacy/Adulterated Drug Products).

The request: Every new FDA warning letter on drug compounding, with the company, the office and the letter. $10 of credit on sign-up, no card.

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  • 24Letters
  • 4With closeout
  • August 7, 2026Latest issued

Newest letters

The newest 24 of 24 by issue date, each linked to the letter on fda.gov.

IssuedCompanyIssuing officeSubjectPostedSource
August 7, 2026Pine Pharmaceuticals, LLCCenter for Drug Evaluation and ResearchCompounding Pharmacy/Adulterated Drug ProductsOctober 6, 2026fda.gov
May 12, 2026Fagron BVCenter for Drug Evaluation and ResearchCompounding Pharmacy/Adulterated Drug ProductsJune 9, 2026fda.gov
April 7, 2026ProRx LLCCenter for Drug Evaluation and ResearchCompounding Pharmacy/Adulterated Drug ProductsMay 12, 2026fda.gov
March 20, 2026RC Outsourcing, LLCCenter for Drug Evaluation and ResearchCompounding Pharmacy/Adulterated Drug ProductsApril 21, 2026fda.gov
February 9, 2026Thrive Health and Wellness, LLC dba Thrive Health SolutionsCenter for Drug Evaluation and ResearchCompounding Pharmacy/Adulterated Drug ProductsApril 21, 2026fda.gov
February 2, 2026Apollo Care, LLCCenter for Drug Evaluation and ResearchCompounding Pharmacy/Adulterated Drug ProductsApril 21, 2026fda.gov
January 20, 2026GenoGenix LLCCenter for Drug Evaluation and ResearchCompounding Pharmacy/Adulterated Drug ProductsMarch 3, 2026fda.gov
January 16, 2026Boothwyn Pharmacy, LLCCenter for Drug Evaluation and ResearchCompounding Pharmacy/Adulterated Drug ProductsFebruary 10, 2026fda.gov
December 12, 2025MedisourceRxCenter for Drug Evaluation and ResearchCompounding Pharmacy/Adulterated Drug ProductsFebruary 24, 2026fda.gov
December 1, 2025Apothecary Pharma, LLCCenter for Drug Evaluation and ResearchCompounding Pharmacy/Adulterated Drug ProductsMarch 17, 2026fda.gov
November 7, 2025Wells Pharma of Houston, LLCCenter for Drug Evaluation and ResearchCompounding Pharmacy/Adulterated Drug ProductsNovember 25, 2025fda.gov
October 10, 2025PQ Pharmacy, LLCCenter for Drug Evaluation and ResearchCompounding Pharmacy/Adulterated Drug ProductsDecember 2, 2025fda.gov
September 22, 2025Revive Rx LLC dba Revive Rx PharmacyCenter for Drug Evaluation and ResearchCompounding Pharmacy/Adulterated Drug ProductsDecember 23, 2025fda.gov
September 16, 2025Turbare ManufacturingCenter for Drug Evaluation and ResearchCompounding Pharmacy/Adulterated Drug ProductsDecember 2, 2025fda.gov
May 5, 2025Staska Pharmaceuticals, Inc.Center for Drug Evaluation and ResearchCompounding Pharmacy/Adulterated Drug ProductsJuly 1, 2025fda.gov
April 23, 2025OSRX, Inc.Center for Drug Evaluation and ResearchCompounding Pharmacy/Adulterated Drug ProductsMay 13, 2025fda.gov
April 8, 2025Tailstorm Health Inc. dba Medivant HealthCenter for Drug Evaluation and ResearchCompounding Pharmacy/Adulterated Drug ProductsMay 13, 2025fda.gov
April 2, 2025Empower Clinic Services, LLC dba Empower PharmacyCenter for Drug Evaluation and ResearchCompounding Pharmacy/Adulterated Drug ProductsApril 29, 2025fda.gov
April 2, 2025Empower Clinic Services, LLC dba Empower PharmaCenter for Drug Evaluation and ResearchCompounding Pharmacy/Adulterated Drug ProductsApril 22, 2025fda.gov
March 5, 2025Annovex Pharma, Inc.Center for Drug Evaluation and ResearchCompounding Pharmacy/Adulterated Drug ProductsMarch 25, 2025fda.gov
March 4, 2025ProRx, LLCCenter for Drug Evaluation and ResearchCompounding Pharmacy/Adulterated Drug ProductsMarch 4, 2025fda.gov
January 22, 2025Nubratori, Inc. dba Nubratori RxCenter for Drug Evaluation and ResearchCompounding Pharmacy/Adulterated Drug ProductsApril 15, 2025fda.gov
December 19, 2024Fagron Compounding Services, LLC dba Fagron Sterile ServiceCenter for Drug Evaluation and ResearchCompounding Pharmacy/Adulterated Drug ProductsFebruary 4, 2025fda.gov
December 17, 2024Right Value Drug Stores, LLC dba Carie Boyd PharmaceuticalsCenter for Drug Evaluation and ResearchCompounding Pharmacy/Adulterated Drug ProductsMarch 11, 2025fda.gov

Subjects as FDA words them

SubjectLettersLatest
Compounding Pharmacy/Adulterated Drug Products24August 7, 2026

By issuing office

Issuing officeLettersLatest
Center for Drug Evaluation and Research24August 7, 2026

By year issued

YearLettersLatest
202514December 12, 2025
20268August 7, 2026
20242December 19, 2024

Where FDA publishes its warning letters

Public domain (U.S. government work). Letters are as FDA lists them in its warning letters table: the company, the issue and posting dates, the issuing office and FDA's subject line. Subject groups are SpecStream's, read from the words of that subject line. FDA posts a letter some weeks after it issues it, so the newest weeks fill in later. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.