The FDA Desk — 2026-04-21
TITLE: The FDA Desk — 21 Apr 2026: 10 Recalls Posted, All Class II/III; No Class I
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The FDA Desk — Daily Recall Digest
Run date: 21 April 2026 (UTC)
Items reviewed: 10 FDA recall records
Class I (urgent): None this run.
Class II: 9 · Class III: 1
Status mix: 3 Ongoing · 7 Terminated
No Class I recalls were posted in today's feed. Practitioners and compliance teams should nonetheless note several sterility-assurance and CGMP matters with continuing clinical relevance, particularly the ongoing ProRx semaglutide action.
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Ongoing Recalls — Priority Review
Class II — Semaglutide Injection (ProRx LLC)
Class II, Ongoing. Semaglutide Injection, 10 mg/4 mL (2.5 mg/mL), 4 mL multidose vial, Rx only, manufactured by ProRx LLC, Exton, PA (NDC 84139-225-04) is being recalled for lack of assurance of sterility (Recall ID D-0115-2026, report date 2025-11-05). Given ongoing demand pressure in the GLP-1 market and the subcutaneous, multidose presentation, prescribers and 503B-adjacent purchasers should quarantine affected lots and verify source of supply.
Class II — Assured Instant Hand Sanitizer (Albek de Mexico / Greenbrier Int'l)
Class II, Ongoing. Assured Instant Hand Sanitizer Aloe & Moisturizers, 70% ethyl alcohol, 8 fl oz, distributed by Greenbrier International (Chesapeake, VA), manufactured by Albek de Mexico S.A. de C.V. (UPC 639277928610). Recalled for CGMP deviations; a sister product at the same facility was found below ethanol label claim and contaminated with methanol (Recall ID D-0080-2021). Legacy COVID-era inventory may still be in circulation in dollar-store and institutional channels; destroy rather than redistribute.
Class II — Crampy Belly Rub (Little Moon Essentials LLC)
Class II, Ongoing. Little Moon Essentials "Crampy Belly Rub" (Camphor 1.1%), 4 fl oz and 2 fl oz glass jars (NDCs 70722-260-04 and 70722-260-02), Dania Beach, FL. Recalled for CGMP deviations (Recall ID D-0572-2024, report date 2024-07-10). OTC topical; retailers should confirm removal from e-commerce listings.
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Terminated Recalls — Closed for the Record
These entries appear in today's feed as terminations. They are listed for documentation and traceability; no further field action is required.
- D-321-2016 — Class II, Terminated. Progesterone 100 mg/mL in Corn Oil Injection, 2 mL vials, compounded by Kalman Health & Wellness dba Essential Wellness Pharmacy (Peoria, IL). Recalled for lack of sterility assurance tied to poor sterile production practices across all compounded sterile preparations within expiry.
- D-1285-2020 — Class II, Terminated. Mixed Amphetamine Salts Tablets, 5 mg, 100-ct bottles, Teva Pharmaceuticals USA (North Wales, PA; NDC 0555-0971-02). Recalled because some bottles may have contained mixed strengths — a dispensing-error and DEA Schedule II diversion-risk concern at the time of action.
- D-0623-2022 — Class II, Terminated. No Drip Nasal Spray, Oxymetazoline HCl 0.05%, 1 fl oz, distributed by SUPERVALU Inc. (NDC 41163-703-10), recalled by Perrigo Company PLC. Root cause: contaminated excipient upstream from the excipient supplier (CGMP deviation).
- D-1398-2016 — Class II, Terminated. Fentanyl Citrate 2 mcg/mL + Bupivacaine HCl 0.16% (preservative-free) in 0.9% NaCl, 100 mL Baxter Intravia bag (Service Code 2K8102), compounded by PharMEDium Services, LLC (Memphis, TN; NDC 61553-102-48). Recalled for particulate matter — API contaminated with glass particulate used in sterile injectables.
- D-1443-2014 — Class III, Terminated. VIRACEPT (nelfinavir mesylate) Tablets, 625 mg, 120-ct bottle, Agouron/Pfizer, distributed by ViiV Healthcare (NDC 63010-027-70). Labeling defect: bottles bore incorrect expiry of 11/2016; correct expiry 09/2016. The only Class III in this run.
- D-0194-2019 — Class II, Terminated. 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). Recalled for lack of assurance of sterility — a recurring theme among 503A compounders of intracavernosal injectables.
- D-1066-2013 — Class II, Terminated. Ifosfamide Injection 3 g/60 mL single-dose vial, Pfizer Labs (NDC 0069-4496-22). Recalled for temperature abuse — vials not refrigerated at 2–8 °C at certain AmerisourceBergen distribution centers. Cold-chain failure in oncology distribution; cited here as precedent for current GDP enforcement.
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Editor's Notes
Themes in today's feed
- Sterility assurance at compounders dominates (ProRx, Essential Wellness, Pharm D Solutions, PharMEDium). Four of ten items cite either lack of sterility assurance or particulate contamination in sterile injectables.
- Upstream supplier risk remains a recurring CGMP vector — Perrigo's excipient-sourced contamination and the Albek/Greenbrier methanol case both originate upstream of the distributor named on the label.
- Cold-chain / distributor conduct is represented by the AmerisourceBergen Ifosfamide termination, a reminder that distribution-level deviations are recallable events independent of manufacturer conduct.
Regulatory takeaways
1. The ProRx semaglutide action (D-0115-2026) is the sole new-vintage ongoing sterile-injectable matter in today's feed and warrants active lot verification by buyers.
2. No Class I actions today; absence of Class I does not imply absence of patient risk — Class II sterility findings in injectables remain clinically significant.
3. Terminated status closes the administrative file but does not extinguish product-liability or payer-recoupment exposure for product dispensed during the recall window.
*Prepared by The FDA Desk. Nothing herein constitutes legal or medical advice. Always verify lot-level applicability via the FDA Enforcement Report and the recalling firm's notice before taking field action.*