The FDA Desk — 2026-04-19
TITLE: The FDA Desk — Apr 19, 2026: 9 Class II Drug Recalls, Incl. Ongoing Semaglutide Sterility Action
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Executive Summary
Today's enforcement report covers 10 drug recalls posted to the FDA database: 9 Class II and 1 Class III. No Class I (life-threatening) recalls are present in this run. Three actions remain Ongoing — most notably a sterility-based recall of compounded semaglutide injection (D-0115-2026) — while the remainder are Terminated. Sterility assurance and CGMP deviations dominate the root-cause profile.
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Ongoing Recalls — Active Market Risk
Class II — Semaglutide Injection (ProRx LLC)
D-0115-2026. Semaglutide Injection, 10 mg/4 mL (2.5 mg/mL), 4 mL multidose vial, Rx only, NDC 84139-225-04, manufactured by ProRx LLC (Exton, PA), is under ongoing Class II recall for lack of assurance of sterility. Given the ongoing national demand for compounded GLP-1 products and the subcutaneous route of administration, dispensers and prescribers should verify lot disposition and quarantine affected inventory. Report date: 2025-11-05.
Class II — Assured Instant Hand Sanitizer (Albek De Mexico)
D-0080-2021. Assured Instant Hand Sanitizer Aloe & Moisturizers (Ethyl Alcohol 70% v/v), 8 fl oz, UPC 639277928610, distributed by Greenbrier International, Inc. (Chesapeake, VA), remains on ongoing recall. Root cause: CGMP deviations tied to a sister-product contamination event in which Next Advanced Antibacterial Hand Sanitizer was sub-potent for ethanol and contained methanol. Co-facility products are captured under the same action.
Class II — Little Moon Essentials Crampy Belly Rub
D-0572-2024. Crampy Belly Rub (Camphor 1.1%) in 4 oz (NDC 70722-260-04) and 2 oz (NDC 70722-260-02) glass jars, Little Moon Essentials LLC (Dania Beach, FL), remains under ongoing Class II recall for CGMP deviations. Retail-channel OTC topical; consumer-facing risk.
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Terminated Recalls — For the Record
Class II — Compounded Progesterone 100 mg/mL
D-321-2016. Progesterone in Corn Oil Injection, 2 mL vials, Rx only, compounded by Kalman Health & Wellness dba Essential Wellness Pharmacy (Peoria, IL). Recalled for lack of sterility assurance arising from deficient sterile production practices; all in-date compounded sterile preparations were captured. Status: Terminated.
Class II — Mixed Amphetamine Salts 5 mg (Teva)
D-1285-2020. Dextroamphetamine/amphetamine mixed salts tablets 5 mg, 100-count bottles, NDC 0555-0971-02, Teva Pharmaceuticals USA (North Wales, PA). Recalled because certain bottles may have contained mixed strengths — a dose-integrity concern for a Schedule II stimulant. Status: Terminated.
Class II — Oxymetazoline No Drip Nasal Spray
D-0623-2022. Oxymetazoline HCl 0.05% Nasal Spray, 30 mL, NDC 41163-703-10, distributed by SUPERVALU INC., manufactured by Perrigo Company PLC. Recall driven by CGMP deviations — product manufactured with a contaminated excipient recalled upstream by the excipient supplier. Status: Terminated.
Class II — Fentanyl/Bupivacaine Compounded Infusion Bag
D-1398-2016. Fentanyl Citrate 2 mcg/mL and Bupivacaine HCl 0.16% (preservative-free) in 0.9% NaCl, 100 mL, Service Code 2K8102, compounded by PharMEDium Services, LLC (Memphis, TN), NDC 61553-102-48. Recalled for particulate matter — API contaminated with glass particulate was used to produce sterile injectables. Status: Terminated.
Class II — Trimix QM10 Injectable
D-0194-2019. Trimix QM10 (papaverine 30 mg / phentolamine 4 mg / atropine 1 mg / PGE 150 mcg per mL), NDC 69699-1352-05, Pharm D Solutions, LLC (Houston, TX). Compounded intracavernosal injectable recalled for lack of sterility assurance. Status: Terminated.
Class II — Ifosfamide Injection 3 g/60 mL (Pfizer/AmerisourceBergen)
D-1066-2013. Ifosfamide Injection 3 g/60 mL single-dose vial, NDC 0069-4496-22, distributed by Pfizer Labs. Recalled for temperature abuse — vials were not held at the labeled 2–8 °C at certain AmerisourceBergen distribution centers, implicating cold-chain integrity of an oncology sterile injectable. Status: Terminated.
Class III — Viracept (Nelfinavir Mesylate) 625 mg
D-1443-2014. Viracept (nelfinavir mesylate) Tablets 625 mg, 120-count bottle, NDC 63010-027-70, Agouron Pharmaceuticals (a Pfizer company) / ViV Healthcare. Recalled for a labeling error: bottles labeled with expiry 11/2016 when the correct expiry was 09/2016. Class III — low likelihood of adverse health consequence. Status: Terminated.
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Thematic Observations
- Sterility assurance failures continue to drive Class II compounded-drug recalls (D-0115-2026, D-321-2016, D-0194-2019, D-1398-2016). The ongoing ProRx semaglutide action is the most clinically salient item today.
- CGMP deviations — whether in-house (D-0080-2021, D-0572-2024) or upstream excipient contamination (D-0623-2022) — remain a recurring classification basis.
- Distribution and labeling controls (D-1066-2013 cold chain; D-1443-2014 expiry mislabel) round out the causal mix.
Recommended Actions
- Pharmacies and clinics dispensing compounded GLP-1s should confirm whether any inventory traces to ProRx LLC NDC 84139-225-04 and sequester per recall instructions.
- Retailers and 340B contract distributors should verify that Greenbrier/Assured hand sanitizer (UPC 639277928610) and Little Moon Crampy Belly Rub lots have been purged from active shelves.
- Document recall acknowledgment and destruction/return in the quality system in accordance with 21 CFR Part 7 recordkeeping expectations.
*— The FDA Desk*