The FDA Desk — 2026-04-24

TITLE: FDA Desk — April 24, 2026: Sterility failures dominate today's recall docket; no Class I actions

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Overview

Today's FDA recall postings contain no Class I actions. The docket is dominated by Class II recalls, with a recurring theme of sterility assurance failures in compounded injectables and CGMP deviations in OTC and Rx manufacturing. One Class III labeling recall rounds out the day. Several entries are historical terminations being formally closed out; one — a 2025 ProRx semaglutide injection recall — remains active.

Sterility failures in compounded and sterile injectables

• D-0115-2026 — ProRx LLC (Exton, PA) has initiated a Class II voluntary recall of Semaglutide Injection 10 mg/4 mL multidose vials (NDC 84139-225-04), citing lack of assurance of sterility; recall dated 2025-10-15 and remains open on today's posting, notable given the continued GLP-1 compounding scrutiny.
• D-321-2016 — Essential Wellness Pharmacy (Kalman Health & Wellness, Peoria, IL) Class II recall of compounded Progesterone 100 mg/mL in Corn Oil Injection for lack of sterility assurance; covered all in-date compounded sterile preparations and is now terminated.
• D-0194-2019 — Pharm D Solutions (Houston, TX) Class II recall of compounded Trimix QM10 (papaverine/phentolamine/atropine/PGE) injectable for lack of sterility assurance; terminated.
• D-1398-2016 — PharMEDium Services (Memphis, TN) Class II recall of fentanyl citrate/bupivacaine HCl in 0.9% sodium chloride IV bags after API contaminated with glass particulate was used to produce sterile injectables; terminated.

Taken together, three of four sterility-linked actions involve outsourcing facilities or 503A/503B-style compounders, consistent with FDA's continuing enforcement posture on compounded sterile preparations.

CGMP and manufacturing deviations

• D-0080-2021 — Greenbrier International's Assured Instant Hand Sanitizer (8 fl oz), manufactured by Albek De Mexico, Class II recalled after related Next Advanced product was found subpotent for ethanol and contaminated with methanol; this sits within the broader 2020–2021 methanol-in-sanitizer enforcement wave.
• D-0623-2022 — Perrigo Company PLC Class II recall of SUPERVALU-distributed No Drip Nasal Spray (oxymetazoline 0.05%) after a contaminated excipient — itself recalled upstream — was used in manufacturing; terminated.
• D-0572-2024 — Little Moon Essentials LLC Class II recall of Crampy Belly Rub (camphor 1.1%) in 2 oz and 4 oz glass jars for CGMP deviations; remains a cautionary data point for small topical OTC manufacturers.

Distribution, labeling, and mix-up recalls

• D-1285-2020 — Teva Pharmaceuticals USA Class II recall of mixed amphetamine salts 5 mg tablets (100-count) after bottles were found to potentially contain mixed strengths — a dosing-error risk for a Schedule II stimulant; terminated.
• D-1066-2013 — AmeriSource Bergen Class II recall of Pfizer-distributed Ifosfamide Injection 3g/60 mL after temperature-abuse findings at distribution centers where vials were not held at the required 2–8 °C; terminated.
• D-1443-2014 — Pfizer Inc. Class III recall of Viracept (nelfinavir mesylate) 625 mg tablets, 120-count bottles, for a labeling error showing an incorrect expiry date of 11/2016 rather than the correct 09/2016; terminated.

Editor's note

No new Class I hazards appeared on today's docket. The operative signal for compliance and clinical readers is the continued concentration of Class II actions around sterility assurance in compounded injectables (including a live 2025 semaglutide recall) and excipient/CGMP integrity across OTC and Rx supply chains. Counsel advising 503A/503B compounders should treat the ProRx posting as the item of active relevance; the remainder are closeouts useful primarily for recall-history diligence.