Fresh Recalls

ANI Pharmaceuticals recalls

2 recent recalls on record for ANI Pharmaceuticals in connected official government data as of September 7, 2026 at 6:00 AM UTC.

Models with recalls

Estradiol Gel (1)hydrOXYzine Hydrochloride Oral Solution (1)

All ANI Pharmaceuticals recalls

FDA Class III · Drug · July 1, 2026

hydrOXYzine Hydrochloride Oral Solution recall — ANI Pharmaceuticals, Inc.

Presence of foreign substance

Official ID D-0619-2026 · Official record ↗

FDA Class II · Drug · May 27, 2026

Estradiol Gel recall — ANI Pharmaceuticals, Inc.

Defective Container; packets were found to be either empty or partially full.

Official ID D-0543-2026 · Official record ↗

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Compiled from official public-domain government data. Last checked September 7, 2026 at 6:00 AM UTC.