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The Recall Registry is not a government service and does not issue recalls. We gather published recall notices from the U.S. Consumer Product Safety Commission, the U.S. Food and Drug Administration and the National Highway Traffic Safety Administration, and rewrite them in plain language. Always confirm the details with the issuing agency using the link on each recall page.

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Home › All recalls › Prescription medicine

Prescription medicine recalls

Prescription drugs recalled for contamination, potency or labelling.

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Highest riskSeriousWorth checkingLabelling issueTap any recall for the hazard and what to do

1,991 recalls · newest first

Food & drug recall · FDAMay 21, 2026Serious

Keystone Industries — Burkhart topical anesthetic gel, benzocaine 20 %, Strawberry Flavor, 1 oz (30 mL)

Prescription medicine · Keystone Industries · 150 units affected

Defective container:may contain bottles with incomplete seals

Food & drug recall · FDAMay 21, 2026Serious

Keystone Industries — PureLife, TOPICAL ANESTHETIC GEL, BENZOCAINE 20%, 1 oz (30mL), Strawberry Flavor

Prescription medicine · Keystone Industries · 450 units affected

Defective container:may contain bottles with incomplete seals

Food & drug recall · FDAMay 19, 2026Serious

Shimoga Chemicals — Clomiphene Citrate USP Active Pharmaceutical Ingredient (CAS : 50-41-9), Net Weight a)1 KG (NDC 84849-000-01), b) 500 g (NDC 84849-000-02), (c) 100 g (NDC 84849-000-03), Rx Only, Shimoga Chemicals Address -W-57A, MIDC Ku

Prescription medicine · Shimoga Chemicals · N/A affected

cGMP deviations

Food & drug recall · FDAMay 18, 2026Serious

IntegraDose Compounding Services LLC — Vasopressin 2 Units/2 mL in 0.9% Sodium Chloride, syringe, IntegraDose Compounding Services, LLC. 3650 Victoria St N, Suite 900, Shoreview, MN, NDC 71139-0190-1.

Prescription medicine · IntegraDose Compounding Services LLC · 287 units affected

Subpotent Drug

Food & drug recall · FDAMay 18, 2026Labelling issue

Eugia US LLC — Lidocaine HCl Injection, USP 2%, 40 mg/2 mL (20 mg/mL), 2 mL per Single-Dose Vial, Rx Only, Mfd. in India for: Eugia US LLC, E. Windsor, NJ 08520. NDC: 55150-164-02

Prescription medicine · Eugia US LLC · 168,300 vials affected

Labeling: Not Elsewhere Classified: The label wrap covers the barcode, making it hard to scan

Food & drug recall · FDAMay 18, 2026Labelling issue

AbbVie Inc. — PRED MILD, prednisolone acetate ophthalmic suspension, USP, 0.12%, 10 mL, Sterile, Rx only, Allergen, Inc., an AbbVie company, North Chicago, IL 60064, Product of France, NDC 11980-174-10.

Prescription medicine · AbbVie Inc. · 2,736 bottles affected

Failed Stability Specifications

Food & drug recall · FDAMay 14, 2026Labelling issue

Fresenius Kabi USA, LLC — Epinephrine Injection, USP, 1mg/mL, 1 mL single-dose vial, Rx only, Fresenius Kabi, Lake Zurich, IL 60047, NDC 63323-696-02 (vial), NDC 63323-696-25 (carton)

Prescription medicine · Fresenius Kabi USA, LLC · 898,050 vials affected

Failed Impurities/Degradations Specifications

Food & drug recall · FDAMay 14, 2026Labelling issue

AVEVA Drug Delivery Systems, Inc. — Nicotine Transdermal System Patch, 14 mg, 14 patches per box, Aveva

Prescription medicine · AVEVA Drug Delivery Systems, Inc. · 59,808 pouches (4,272 Individual Folding Carton (IFC)) affected

Failed Impurities/Degradation Specifications: Elevated levels of oxidative-related impurities, exceeding shelf-life specifications during stability…

Food & drug recall · FDAMay 14, 2026Serious

Asclemed USA Inc. — Duloxetine DR Capsules, 30 mg, 30 count bottles, Rx, Relabeled by: Enovachem Pharmaceuticals, Torrance, CA 90501, NDC 76420-634-30

Prescription medicine · Asclemed USA Inc. · 50 bottles affected

CGMP Deviations; presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the FDA acceptable intake limit.

Food & drug recall · FDAMay 12, 2026Serious

IntegraDose Compounding Services LLC — fentaNYL Citrate, Sterile CADD for Injection, 2,2500 mcg/50mL in Sterile Water, IntegraDose Compounding Services LLC, 3650 Victorie St N, Suite 900, Shoreview, MN, NDC 71139-6030-1.

Prescription medicine · IntegraDose Compounding Services LLC · 376 cassettes affected

Subpotent Drug

Food & drug recall · FDAMay 12, 2026Highest risk

SUN PHARMACEUTICAL INDUSTRIES INC — DOXOrubin Hydrochloride Liposome injection, 50 mg/25 mL (2mg/mL), 25 mL single-dose vials, Sterile, Rx only

Prescription medicine · SUN PHARMACEUTICAL INDUSTRIES INC · 675 vials affected

Presence of Particulate matter: Particulate matter identified as glass.

Food & drug recall · FDAMay 12, 2026Serious

Spectra Medical Devices, Llc — Lidocaine HCl Injection USP, 25x5 mL, Single-Dose Ampules, Rx Only

Prescription medicine · Spectra Medical Devices, Llc · 210625 ampules affected

Lack of Assurance of Sterility

Food & drug recall · FDAMay 12, 2026Serious

ANI Pharmaceuticals, Inc. — Estradiol Gel, 0.1%, 0.25 mg, 0.25 g per packet, 30 packets per carton, Rx only

Prescription medicine · ANI Pharmaceuticals, Inc. · 3964 Cartons affected

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

Food & drug recall · FDAMay 11, 2026Serious

Haleon US Holdings LLC — Gas-X, Simethicone 125 mg/ ANTIGAS, 120 SoftGels

Prescription medicine · Haleon US Holdings LLC · 285,330 blister cards affected

Labeling: Not Elsewhere Classified- Incomplete inactive ingredient information on the carton labeling.

Food & drug recall · FDAMay 8, 2026Serious

UCB Biosciences Inc. — cimzia (certolizumab pegol), 2x200mg/mL PREFILLED SYRINGES (2 single-dose), Rx ONLY

Prescription medicine · UCB Biosciences Inc. · 141,708 cartons affected

Lack of Assurance of Sterility

Food & drug recall · FDAMay 5, 2026Serious

Ascend Laboratories, LLC — Amlodipine and Olmesartan Medoxomil Tablets, 5mg/40mg, Rx Only, 30-count bottle

Prescription medicine · Ascend Laboratories, LLC · 15,696 x 30's bottles affected

Failed Dissolution Specifications: Olmesartan Medoxomil content below specifications

Food & drug recall · FDAMay 4, 2026Labelling issue

Sagent Pharmaceuticals — Busulfan Injection, 60 mg per 10 mL (6 mg per mL), 8x10 mL Single-Dose Vials, Rx only, Mfd. for Sagent Pharmaceuticals, Schaumburg, IL 60195, Made in Canada, NDC 25021-241-10.

Prescription medicine · Sagent Pharmaceuticals · Lot 656412: 6,200 vials. Lot 659646: 3,328 vials. affected

Failed Impurities/Degradation Specifications

Food & drug recall · FDAMay 1, 2026Labelling issue

Amerisource Health Services LLC — Primidone Tablets, USP, 250 mg, 100 Tablets (10 x 10 unit dose blister) per carton, Rx only

Prescription medicine · Amerisource Health Services LLC · 63,500 tablets affected

Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.

Food & drug recall · FDAMay 1, 2026Labelling issue

Amerisource Health Services LLC — Primidone Tablets, USP, 50 mg, 100 Tablets (10 x 10 unit dose blister) per carton, Rx only

Prescription medicine · Amerisource Health Services LLC · 225,000 tablets affected

Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.

Food & drug recall · FDAApril 30, 2026Serious

Safecor Health, LLC — Atomoxetine Capsules HCL, 10 mg Capsules in unit dose foil strip, strips are packed in cartons of 100, Rx Only, Pkg by: Safecor, Columbus, OH 43204. NDC: 64380-474-01

Prescription medicine · Safecor Health, LLC · 149 capsules affected

Labeling: Label Mix-Up: Atomoxetine HCl 25mg Capsule incorrectly labeled as Atomoxetine HCl 10mg Capsule.

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