The FDA Desk — 2026-04-23
TITLE: FDA Desk — Apr 23, 2026: Sterility Compounding Failures Dominate; Semaglutide, Trimix, Progesterone Flagged
---
Executive Summary
No Class I recalls posted in today's FDA enforcement feed. Today's digest is dominated by Class II actions, with a recurring theme of lack of sterility assurance at compounding pharmacies — including an ongoing recall of compounded semaglutide injection (D-0115-2026). One Class III labeling recall (expiry-date error on VIRACEPT) and several CGMP-deviation matters round out the feed. A mix of ongoing and terminated records are included below; counsel and QA teams should note the ongoing entries for active distribution and customer-notification obligations.
---
Ongoing Recalls (Action Items)
Compounded Semaglutide Injection — Sterility Assurance (D-0115-2026)
Class II, Ongoing. Semaglutide Injection, 10 mg/4 mL (2.5 mg/mL) Multidose Vial, NDC 84139-225-04, manufactured by ProRx LLC (Exton, PA). Recall initiated for lack of assurance of sterility. Given the high patient volume associated with compounded GLP-1 products, dispensers and 503A/503B customers should quarantine inventory, notify patients, and document returns. Report date 2025-11-05.
Assured Instant Hand Sanitizer (Aloe & Moisturizers) — Methanol Facility Exposure (D-0080-2021)
Class II, Ongoing. 8 fl oz ethyl alcohol 70% v/v sanitizer (UPC 639277928610), distributed by Greenbrier International, Inc. (Chesapeake, VA), manufactured by Albek De Mexico S.A. de C.V. Recalled as a co-facility product after a sister SKU (Next Advanced Antibacterial Hand Sanitizer) was found below label claim for ethanol and contaminated with methanol. CGMP deviation.
Little Moon Essentials — Crampy Belly Rub (D-0572-2024)
Class II, Ongoing. Camphor 1.1% topical, 4 oz (NDC 70722-260-04) and 2 oz (NDC 70722-260-02) glass jars, Little Moon Essentials LLC (Dania Beach, FL). Recall reason: CGMP deviations. Retailers should confirm removal from shelves.
---
Class II — Terminated (Reference / Closed File)
Progesterone 100 mg/mL Injection — Compounded Sterile Products (D-321-2016)
Progesterone in corn oil, 2 mL vials, compounded by Kalman Health & Wellness dba Essential Wellness Pharmacy (Peoria, IL). Recall covered all in-expiry compounded sterile preparations following observations of poor sterile production practices. Now terminated.
Mixed Amphetamine Salts 5 mg Tablets — Strength Mix-Up (D-1285-2020)
Teva Pharmaceuticals USA, NDC 0555-0971-02, 100-ct bottles. Some bottles may have contained mixed strengths. Terminated.
No Drip Nasal Spray (Oxymetazoline 0.05%) — Contaminated Excipient (D-0623-2022)
Distributed by SUPERVALU INC., manufactured by Perrigo Company PLC, NDC 41163-703-10. CGMP deviation tied to a contaminated excipient recalled upstream. Terminated.
Fentanyl/Bupivacaine in NaCl Bag — Glass Particulate (D-1398-2016)
Compounded by PharMEDium Services, LLC (Memphis, TN), Service Code 2K8102, NDC 61553-102-48. API contaminated with glass particulate used in sterile injectables. Terminated — but remains instructive on API vendor-qualification risk.
Trimix QM10 Injectable — Sterility Assurance (D-0194-2019)
Papaverine 30 mg / Phentolamine 4 mg / Atropine 1 mg / PGE 150 mcg per mL, Pharm D Solutions, LLC (Houston, TX), NDC 69699-1352-05. Compounded sterile product; lack of sterility assurance. Terminated.
Ifosfamide Injection 3 g/60 mL — Temperature Excursion (D-1066-2013)
Pfizer Labs, NDC 0069-4496-22. Vials were not maintained at 2–8 °C at certain AmeriSource Bergen distribution centers. Terminated; noted here as a recurring distributor cold-chain precedent.
---
Class III — Labeling
VIRACEPT (nelfinavir mesylate) 625 mg Tablets — Expiry Mislabel (D-1443-2014)
Pfizer Inc. / Agouron Pharmaceuticals, distributed by ViV Healthcare, NDC 63010-027-70. Bottles labeled with expiry 11/2016 instead of correct 09/2016. Terminated. Included for completeness.
---
Themes to Watch
- Compounded sterile preparations (503A/503B): Three of today's entries (D-0115-2026, D-321-2016, D-0194-2019) and one 503B-adjacent matter (D-1398-2016) involve sterility-assurance or particulate issues. The ongoing ProRx semaglutide action is the most consequential live item.
- Upstream supplier risk: The Perrigo (excipient) and PharMEDium (API glass particulate) files underscore the need for documented supplier-qualification and incoming-material controls under 21 CFR 211.84.
- Distributor handling: The AmeriSource Bergen ifosfamide cold-chain excursion remains a useful reference for 3PL and wholesaler temperature-monitoring SOPs.
---
*Compiled from the FDA Enforcement Report feed. Entries reflect classifications and statuses as published by FDA; consult the official Enforcement Report for authoritative status before acting.*