The FDA Desk — 2026-05-01
TITLE: The FDA Desk — May 1, 2026: Sterility failures, nitrosamine in cinacalcet, benzene in OTC acne lotion
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Top of the Docket
No Class I recalls were posted today. The day's enforcement actions are dominated by Class II events involving sterility, nitrosamine, and chemical contamination concerns, plus a notable cluster of cough-drop recalls tied to a single Chinese manufacturer.
Sterile Injectables — Sterility Assurance Failures
- D-0483-2026: International Medication Systems Ltd. (Amphastar) initiated a Class II recall of Epinephrine Injection USP, 1 mg/10 mL (0.1 mg/mL) prefilled syringes (NDC 76329-3318-1) on 2026-04-01 for lack of assurance of sterility — a particularly consequential defect given the product's use in anaphylaxis and cardiac emergencies.
- D-0471-2026: Payless Compounders, LLC pulled compounded semaglutide–glycine–cyanocobalamin injectable (2.5 mg / 5 mg / 1 mg-mL, 0.5 mL vials) distributed via Northwest Compounders, Beaverton, OR, also for lack of assurance of sterility (Class II, 2026-03-06) — adding to the ongoing regulatory scrutiny of compounded GLP-1 products.
Nitrosamine and Chemical Contamination
- D-0449-2026: Cipla USA recalled Cinacalcet Hydrochloride Tablets 30 mg (NDC 69097-410-02), manufactured at Cipla Ltd.'s Patalganga, India site, after detection of N-nitroso-cinacalcet above the acceptable daily intake limit alongside cited CGMP deviations (Class II, 2026-03-16). This continues the agency's multi-year nitrosamine enforcement arc into calcimimetics used for secondary hyperparathyroidism.
- D-0452-2026: Owen Biosciences Inc. recalled FarmHouse Fresh "Midnight Clearing" 2.5% benzoyl peroxide acne night lotion (0.5 and 1 fl oz tubes) for benzene contamination (Class II, 2026-03-03) — the latest in the expanding benzoyl-peroxide/benzene problem affecting OTC acne products.
Cough Drops — Single-Source Cluster
A coordinated Class II recall traces back to FDA observations during an August 15, 2025 inspection of Xiamen Kang Zhongyuan Biotechnology Co., Ltd. (China). Four downstream U.S. distributions, all initiated 2026-03-20, are affected:
- D-0462-2026 and D-0461-2026: MGC Health menthol cough drops (Honey Lemon 30-ct and Sugar Free Honey Lemon 25-ct), distributed by Medical Group Care, LLC (Naples, FL).
- D-0460-2026: Discount Drug Mart Food Market menthol cough drops (30-ct), distributed by Drug Mart-Food Fair (Medina, OH).
- D-0456-2026: exchange select Honey Lemon menthol cough drops (30-ct), manufactured for U.S. Military Exchanges via Medical Group Care — extending the recall's reach onto military installations.
FDA has not publicly detailed the underlying inspectional finding beyond the cited "certain observations," but the common manufacturer and synchronized firm-initiated dates indicate a single root cause across private-label SKUs.
Topical and Other Recalls
- D-0476-2026: Sun Pharmaceutical Industries Inc. (product manufactured by Taro, Brampton, ON; distributed by Taro USA) recalled Fluocinonide USP 0.05% Cream, 30 g (NDC 51672-1386-2) for out-of-specification viscosity above the upper limit, identified during stability testing (Class II, 2026-03-25).
- D-0480-2026: Island Kinetics dba CoValence Laboratories recalled glo Skin Beauty Remedy Gel, hydrocortisone 1%, 30 mL (NDCs 66915-531-12/-13) as Class III for subpotency — the only Class III action on today's docket and the lowest-risk classification of the day.
Editor's Note
Today's docket is thematically coherent: two sterility-assurance failures in injectables (one of which is emergency-use epinephrine), a continuing nitrosamine signal in a generic small-molecule, a benzene hit in OTC cosmetics, and a foreign-inspection-driven cluster of cough-drop recalls reaching the military supply chain. Healthcare providers stocking the IMS epinephrine and dialysis programs using Cipla cinacalcet should review lot-level exposure first.