The FDA Desk — 2026-04-30

TITLE: FDA Desk — April 30, 2026: Sterility failures hit epinephrine and compounded semaglutide; benzene found in OTC acne lotion

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Today's Docket

No Class I recalls were posted today. The day's action is a cluster of Class II events spanning sterile injectables, contaminated topicals, nitrosamine-laden generics, and a multi-distributor cough drop withdrawal traceable to a single Chinese manufacturer.

Sterile Injectables — Assurance-of-Sterility Failures

• D-0483-2026: International Medication Systems Ltd. (an Amphastar company, So. El Monte, CA) initiated a Class II recall of Epinephrine Injection, USP, 1 mg/10 mL (NDC 76329-3318-1) on 2026-04-01 for lack of assurance of sterility — a notable supply concern given epinephrine's emergency-use profile.
• D-0471-2026: Payless Compounders, LLC pulled Semaglutide-Glycine-Cyanocobalamin Injectable (2.5 mg, 5 mg; 0.5 mL vials) distributed by Northwest Compounders (Beaverton, OR) as Class II on 2026-03-06, also for lack of assurance of sterility — the latest sterility hit on the booming compounded-GLP-1 channel.

Nitrosamine and CGMP Issues in Oral Solids

• D-0449-2026: Cipla USA recalled Cinacalcet Hydrochloride 30 mg tablets (NDC 69097-410-02), manufactured at Cipla Ltd.'s Patalganga, India site, as Class II on 2026-03-16. The recall cites CGMP deviations and N-Nitroso Cinacalcet above the acceptable daily intake limit, extending the long-running nitrosamine impurity saga into the calcimimetic class used in secondary hyperparathyroidism.
• D-0476-2026: Sun Pharmaceutical (via Taro Pharmaceuticals, Brampton, ON) recalled Fluocinonide 0.05% Cream, 30 g (NDC 51672-1386-2) as Class II on 2026-03-25 after stability testing returned out-of-specification viscosity results above the upper limit — a formulation defect rather than a contamination event.

Topical OTC — Benzene and Subpotency

• D-0452-2026: Owen Biosciences Inc. recalled FarmHouse Fresh "Midnight Clearing" Night Lotion (2.5% benzoyl peroxide) in 0.5 oz and 1 oz tubes as Class II on 2026-03-03 for benzene contamination. The finding continues the pattern of benzene detections in benzoyl peroxide acne products that has prompted multiple voluntary withdrawals across the category.
• D-0480-2026: Island Kinetics / CoValence Laboratories recalled Remedy Gel hydrocortisone 1%, 30 mL distributed by glo Skin Beauty (Denver, CO; NDC 66915-531-12 and -531-13) as Class III on 2026-03-18 for subpotency — a lower-tier event but a reminder that OTC hydrocortisone potency drift can mislead self-treating consumers.

Cough Drops — One Chinese Manufacturer, Four Brands

Xiamen Kang Zhongyuan Biotechnology Co., Ltd. is the common manufacturer behind a coordinated Class II recall (all dated 2026-03-20) of menthol cough-suppressant/oral-anesthetic drops sold under multiple US distributor labels, initiated on FDA's recommendation following observations from an August 15, 2025 inspection of the manufacturing site:

• D-0462-2026: MGC Health Honey Lemon, 30-count (Medical Group Care, LLC; NDC 83698-114-30).
• D-0461-2026: MGC Health Sugar-Free Honey Lemon, 25-count (NDC 83698-125-25).
• D-0460-2026: Discount Drug Mart Food Market menthol cough drops, 30-count (Drug Mart-Food Fair, Medina, OH; NDC 83698-102-30).
• D-0456-2026: Exchange Select Honey Lemon, 30-count, manufactured for the military exchanges (NDC under the same 83698 labeler).

The shared root cause and identical recall date suggest FDA treated the contract-manufacturer inspection findings as a site-level deficiency, with private-label distributors following the agency's lead rather than each conducting an independent root-cause analysis.

Editor's Note

Two themes dominate today's posting: continued sterility-assurance failures at compounders and small sterile-injectable shops (the epinephrine and compounded semaglutide entries), and the cascading distributor impact when a single offshore contract manufacturer falls short of CGMP — visible in four separately-numbered cough drop recalls that are, operationally, one event.