The FDA Desk — 2026-04-29

TITLE: FDA Desk — April 29: Sterility failures hit epinephrine and compounded semaglutide; benzene in OTC acne lotion

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Today's Posture

No Class I recalls posted today. The docket is dominated by Class II actions — sterility failures in injectables, a nitrosamine impurity in a generic calcimimetic, benzene contamination in an OTC acne lotion, and a multi-distributor cough drop sweep tied to an FDA inspection of a Chinese manufacturer. One Class III subpotency recall closes the file.

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 (NDC 76329-3318-1) on 2026-04-01 for lack of assurance of sterility — a serious concern given epinephrine's emergency-use profile in code carts and anaphylaxis kits.
• D-0471-2026: Payless Compounders, LLC (distributing as Northwest Compounders, Beaverton, OR) recalled compounded Semaglutide-Glycine-Cyanocobalamin injectable in 2.5 mg and 5 mg presentations for lack of assurance of sterility (Class II, 2026-03-06) — the latest sterility action against a GLP-1 compounder amid ongoing FDA scrutiny of the segment.

Nitrosamine and Chemical Contamination

• D-0449-2026: Cipla USA recalled Cinacalcet Hydrochloride Tablets, 30 mg (NDC 69097-410-02), manufactured at Cipla's Patalganga, India site, for CGMP deviations and N-Nitroso Cinacalcet above the acceptable daily intake limit (Class II, 2026-03-16). Continues the multi-year pattern of nitrosamine impurities driving recalls of chronic-use generics.
• D-0452-2026: Owen Biosciences Inc. recalled FarmHouse Fresh "Midnight Clearing" 2.5% benzoyl peroxide night lotion (0.5 oz and 1 oz tubes) for benzene contamination (Class II, 2026-03-03) — consistent with the broader benzoyl peroxide/benzene degradation issue that has dogged OTC acne products since the Valisure citizen petition.

Cough Drops — Single Manufacturer, Multiple Labels

Xiamen Kang Zhongyuan Biotechnology Co. (China) is the manufacturer of record on four Class II recalls dated 2026-03-20, all triggered by FDA observations during an August 15, 2025 facility inspection. The contract manufacturing pattern means multiple private-label brands are implicated:

• 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 cough drops, 30-ct, manufactured for the military exchanges via Medical Group Care.

Buyers and pharmacy operations should treat these as a single manufacturing-origin event and audit any other private-label inventory sourced from the same facility.

Topical Rx and OTC

• D-0476-2026: Sun Pharmaceutical Industries (distributing Taro-manufactured product) recalled Fluocinonide USP 0.05% Cream, 30 g (NDC 51672-1386-2) for out-of-specification viscosity results above the limit during stability testing (Class II, 2026-03-25). A formulation/stability issue rather than a safety-critical failure, but pulls Rx topical corticosteroid supply.
• D-0480-2026: Island Kinetics / CoValence Laboratories recalled Remedy Gel hydrocortisone 1%, 30 mL (distributed by glo Skin Beauty, NDC 66915-531-12/13) as Class III for subpotency (2026-03-18) — lowest-tier risk, efficacy concern only.

Editor's Note

Two themes worth tracking: (1) sterility-assurance failures continue to cluster around compounded GLP-1 products, and the epinephrine recall is a reminder that small-volume injectable manufacturers remain a fragile node in emergency drug supply; (2) today's cough-drop docket illustrates how a single foreign contract manufacturer's inspection findings cascade across unrelated U.S. retail and military-exchange brands.