The FDA Desk — 2026-04-22
TITLE: The FDA Desk — 22 Apr 2026: 10 Recalls, No Class I; Sterility and CGMP Themes Dominate
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Executive Summary
Ten FDA recall entries reviewed this cycle. No Class I recalls are present. Nine items are classified Class II and one Class III. Three matters remain Ongoing (D-0115-2026, D-0080-2021, D-0572-2024); the remainder are Terminated. Dominant themes: lack of sterility assurance in compounded injectables, CGMP deviations, and labeling/handling failures in distributed finished drugs.
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Ongoing Matters (Active Risk)
Sterile Injectables — Compounded Semaglutide
Class II — Ongoing. Semaglutide Injection, 10 mg/4 mL multidose vials (NDC 84139-225-04), compounded by ProRx LLC (Exton, PA), is under recall for Lack of Assurance of Sterility (D-0115-2026, report date 2025-11-05). Given multidose subcutaneous administration and expanding GLP-1 demand, dispensers should confirm NDC-level quarantine and document patient notifications consistent with state board sterile-compounding obligations.
Hand Sanitizer — Methanol Cross-Contamination
Class II — Ongoing. Assured Instant Hand Sanitizer Aloe & Moisturizers, 8 fl oz (UPC 639277928610), distributed by Greenbrier International and manufactured by Albek De Mexico S.A. De C.V., was recalled for CGMP deviations; companion products were manufactured in a facility where methanol contamination was identified in a related SKU (D-0080-2021). Retail and institutional holders should verify removal from inventory; methanol exposure via dermal/ingestion routes carries documented toxicity.
OTC Topical — CGMP Deviations
Class II — Ongoing. Little Moon Essentials Crampy Belly Rub (Camphor 1.1%), 4 oz (NDC 70722-260-04) and 2 oz (NDC 70722-260-02) glass jars, recalled by Little Moon Essentials LLC (Dania Beach, FL) for CGMP deviations (D-0572-2024).
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Terminated Matters (Closed, for Reference)
Sterile Compounding Failures
- D-321-2016 (Class II): Progesterone 100 mg/mL in Corn Oil Injection, 2 mL vials, Essential Wellness Pharmacy (Peoria, IL). All in-date compounded sterile preparations recalled for lack of sterility assurance tied to deficient sterile production practices.
- D-0194-2019 (Class II): Trimix QM10 (Papaverine/Phentolamine/Atropine/PGE) Injectable, Pharm D Solutions, LLC (Houston, TX), NDC 69699-1352-05 — lack of sterility assurance.
- D-1398-2016 (Class II): Fentanyl Citrate 2 mcg/mL + Bupivacaine 0.16% PF in 0.9% NaCl, 100 mL Intravia bags (Service Code 2K8102), PharMEDium Services, LLC (Memphis, TN), NDC 61553-102-48 — particulate matter (glass-contaminated API).
CGMP / Excipient Contamination
- D-0623-2022 (Class II): No Drip Nasal Spray, Oxymetazoline HCl 0.05%, distributed by SUPERVALU (NDC 41163-703-10), manufactured by Perrigo Company PLC — contaminated excipient sourced from an upstream supplier recall.
Finished Drug Mix-Ups and Labeling
- D-1285-2020 (Class II): Mixed Amphetamine Salts 5 mg tablets, 100-count bottles, Teva Pharmaceuticals USA (NDC 0555-0971-02) — bottles may contain mixed strengths. Material dispensing risk in the ADHD population; termination does not eliminate historical adverse-event exposure.
- D-1443-2014 (Class III): VIRACEPT (nelfinavir mesylate) 625 mg tablets, 120-count, Pfizer/ViV Healthcare (NDC 63010-027-70) — incorrect expiry labeling (labeled 11/2016; true expiry 09/2016).
Distribution / Cold-Chain
- D-1066-2013 (Class II): Ifosfamide Injection 3 g/60 mL single-dose vials, distributed by Pfizer Labs (NDC 0069-4496-22) — temperature abuse at AmeriSourceBergen distribution centers (failure to maintain 2–8 °C).
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Editor's Notes
- Classification skew: The sterility-assurance cluster (D-0115-2026, D-321-2016, D-0194-2019) continues to reflect recurring compounding-pharmacy risk. Institutions sourcing compounded injectables should reassess vendor qualification files and 503A/503B status.
- Compounded GLP-1 exposure: D-0115-2026 is the only ongoing sterile-injectable matter this cycle and warrants priority attention given prescribing volume.
- No Class I actions were reported in this batch; no life-threatening or serious-injury classifications triggered.
*Prepared from FDA enforcement report data retrieved 2026-04-22. Item identifiers shown inline for audit.*