The FDA Desk — 2026-05-18

TITLE: FDA Desk — May 18: Wells Pharma fentanyl/ketamine sweep, three ophthalmic sterility recalls, Hikma alendronate OOS

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Today's enforcement report is dominated by Class II recalls — no Class I actions posted. Two themes carry the day: a multi-lot CGMP sweep against a Houston compounder's controlled-substance injectables, and a cluster of ophthalmic sterility recalls traceable to FDA inspectional findings at upstream manufacturers.

Compounded Injectables — Wells Pharma of Houston (CGMP)

Wells Pharma of Houston LLC has firm-initiated five Class II recalls dated 2026-04-01, all citing unspecified "cGMP deviations" — a pattern consistent with a single underlying inspectional finding rather than discrete product defects.

• D-0507-2026 covers Ketamine Hydrochloride Injectable Solution, 50 mg/mL, 1 mL (NDC 73702-302-31), a Schedule III anesthetic widely used in procedural and emergency settings.
• The remaining four lots are all fentaNYL Citrate Injectable Solution (CII), spanning the compounder's bag and vial portfolio: D-0506-2026 (1000 mcg/50 mL premix bag, NDC 73702-203-65), D-0504-2026 (2500 mcg/250 mL bag, NDC 73702-202-03), D-0503-2026 (1000 mcg/100 mL bag, NDC 73702-202-02), and D-0505-2026 (1250 mcg/25 mL vial, NDC 73702-204-25).

The breadth across concentrations and presentations suggests a facility-level quality system concern; hospital pharmacy buyers relying on Wells Pharma for outsourced sterile compounding should anticipate supply substitution and review CSA recordkeeping for the recalled lots.

Ophthalmic Sterility Cluster

Four eye-drop products were recalled Class II within a 72-hour window in late April for "Lack of Assurance of Sterility" tied to FDA inspectional observations — a continuation of the agency's multi-year scrutiny of ocular product manufacturing.

• D-0501-2026 and D-0500-2026 both cover Similasan/iVIZIA Sterile Lubricant Eye Drops (Povidone 0.5%, 10 mL), distributed by Thea Pharma Inc. (Waltham, MA) under NDCs 59262-700-11 and 82584-700-11; the manufacturer is French, and FDA cited CGMP deviations identified during inspection (2026-04-23).
• D-0499-2026 covers Optase Dry Eye Intense Drops (Glycerin 0.2%, 10 mL) manufactured for Scope Health Inc. of New York under NDC 72972-002-01, recalled 2026-04-20 on the same sterility-assurance basis.
• D-0492-2026 covers GenTeal Tears Lubricant Eye Gel (10 g) distributed by Alcon Laboratories under NDC 0065-8064-01, with Alcon Research LLC citing FDA inspection observations that "may impact product quality" (2026-04-21).

The near-simultaneous timing across unrelated distributors points to a shared contract manufacturer or component supplier; clinicians and retail pharmacy operations should screen OTC ocular inventory against these NDCs.

Oral Solid/Liquid — Hikma

D-0526-2026 is a Class II recall of Hikma Pharmaceuticals USA's Alendronate Sodium Oral Solution 70 mg/75 mL (NDC 0054-0282-59), initiated 2026-04-07 after out-of-specification assay results in a limited number of bottles stored on their side. Unlike the sterility and CGMP actions above, this is a discrete stability/packaging-orientation finding rather than a systemic quality concern, but prescribers should be aware of potential subpotency in dispensed units.