The FDA Desk — 2026-04-20
TITLE: The FDA Desk — 20 Apr 2026: Ten Class II/III Recalls; No Class I Actions Reported
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The FDA Desk — Daily Recall Digest
Report date: 20 April 2026 (UTC)
Items reviewed: 10 (9 Class II, 1 Class III)
Class I recalls: None reported this run.
No Class I (reasonable probability of serious adverse health consequences or death) actions appear in today's dataset. Counsel and compliance teams should nonetheless note two ongoing sterility-assurance matters involving compounded/injectable drugs, which historically drive patient-harm litigation exposure.
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Ongoing Class II Recalls — Priority Review
Sterility Assurance — Injectables
Class II — Semaglutide Injection, 10 mg/4 mL Multidose Vial (ProRx LLC) — *Ongoing.* ProRx LLC (Exton, PA) is recalling Semaglutide Injection 2.5 mg/mL, 4 mL multidose vials (NDC 84139-225-04) for Lack of Assurance of Sterility. Given the high patient volume associated with GLP-1 compounded products, dispensers should immediately quarantine stock and document return/destruction. *(Recall ID: D-0115-2026; report date 2025-11-05.)*
CGMP Deviations — Consumer Products
Class II — Assured Instant Hand Sanitizer Aloe & Moisturizers, 8 fl oz (Albek De Mexico S.A. De C.V.) — *Ongoing.* Distributed by Greenbrier International (Chesapeake, VA); UPC 639277928610. Recalled under a broader action tied to a facility where product was found below ethanol label claim and containing methanol. Methanol exposure remains a toxicity concern; retailers should confirm removal from shelves and reverse-logistics reconciliation. *(Recall ID: D-0080-2021.)*
Class II — Little Moon Essentials "Crampy Belly Rub" (Camphor 1.1%) — *Ongoing.* 4 fl oz (NDC 70722-260-04) and 2 fl oz (NDC 70722-260-02) glass jars, Little Moon Essentials LLC (Dania Beach, FL). Recall predicated on CGMP deviations. *(Recall ID: D-0572-2024; report date 2024-07-10.)*
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Terminated Class II Recalls — For the Record
The following actions have been formally terminated by FDA and are included for audit-trail and historical-reference purposes:
- Progesterone 100 mg/mL in Corn Oil Injection, 2 mL vials — Kalman Health & Wellness dba Essential Wellness Pharmacy (Peoria, IL). Recall of all in-date compounded sterile preparations for Lack of Assurance of Sterility stemming from poor sterile production practices. *(D-321-2016.)*
- Mixed Amphetamine Salts Tablets, 5 mg, 100-ct (Teva Pharmaceuticals USA) — North Wales, PA; NDC 0555-0971-02. Some bottles may have contained mixed strengths — a notable dose-integrity failure with pediatric/ADHD implications. *(D-1285-2020.)*
- No Drip Nasal Spray, Oxymetazoline HCl 0.05% — Perrigo Company PLC, distributed by SUPERVALU Inc.; NDC 41163-703-10. CGMP deviations tied to upstream contaminated excipient. *(D-0623-2022.)*
- Fentanyl Citrate 2 mcg/mL + Bupivacaine HCl 0.16% in 0.9% NaCl, 100 mL Intravia bags — PharMEDium Services, LLC (Memphis, TN); NDC 61553-102-48. Particulate matter (glass) from contaminated API used in sterile injectables. *(D-1398-2016.)*
- VIRACEPT (nelfinavir mesylate) Tablets, 625 mg, 120-ct — Agouron Pharmaceuticals / Pfizer, distributed by ViV Healthcare; NDC 63010-027-70. Class III; labeling error — bottles bore an incorrect expiry of 11/2016 (correct: 09/2016). *(D-1443-2014.)*
- Trimix QM10 (Papaverine 30 mg / Phentolamine 4 mg / Atropine 1 mg / PGE 150 mcg/mL) Injectable — Pharm D Solutions, LLC (Houston, TX); NDC 69699-1352-05. Lack of Assurance of Sterility. *(D-0194-2019.)*
- Ifosfamide Injection 3 g/60 mL single-dose vials — Pfizer Labs, distribution via AmeriSource Bergen; NDC 0069-4496-22. Temperature abuse — failure to maintain 2–8 °C refrigeration at certain AmerisourceBergen distribution centers. *(D-1066-2013.)*
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Editor's Notes
- Dominant failure mode today: Sterility assurance in compounded and small-batch injectables (4 of 10 items across active and terminated status). Outsourcing facilities (503B) and traditional compounders should treat this as a continuing FDA enforcement priority.
- Active watch items: ProRx semaglutide (D-0115-2026) and the Albek/Greenbrier hand sanitizer (D-0080-2021) remain *Ongoing*; confirm your wholesaler/3PL have executed retrieval.
- Classification reminder: Class II denotes a situation in which use may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse consequences is remote (21 C.F.R. § 7.3(m)).
*Nothing in this digest constitutes legal advice. Verify lot-level scope directly against the FDA Enforcement Report before acting.*