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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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Prescription medicine2,102 Over-the-counter & supplements425 Mobility & home health186

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

2,102 recalls · newest first

Food & drug recall · FDAFebruary 13, 2025Serious

Johnson, S C and Son, Inc — Kids by babyganics SPF 50 totally tropical (titanium dioxide 3/5%, zinc oxide 7.25%) packaged in a) 6 OZ (170 g) spray bottles UPC 813277019954 and UPC 813277019800; and b) Twinpack UPC 813277019930; Dist. by KAS

Prescription medicine · Johnson, S C and Son, Inc · 449,502 units affected

Chemical Contamination

Food & drug recall · FDAFebruary 13, 2025Highest risk

ICU Medical, Inc. — POTASSIUM CHLORIDE Inj., 20 mEq total in 100 mL flexible container 24 x case, 200 mEq/L, Rx Only, ICU Medical, Inc., Lake Forest, Illinois, 60045, USA, NDC# 0990-7075-26; Bar Code Flexible container (01) 00309907075266

Prescription medicine · ICU Medical, Inc. · 67,488 flexible containers affected

Labeling: Label Error on Declared Strength.

Food & drug recall · FDAFebruary 13, 2025Serious

World Perfumes Inc. — Iodo Blanco Iodides, First Aid Antiseptic, Mercury Free, Iodine 2%, First Aid Antiseptic, Contains 1 fl. oz (30 ml) per bottle

Prescription medicine · World Perfumes Inc. · 3,900 bottles affected

Defective Container: broken or leaking bottles.

Food & drug recall · FDAFebruary 12, 2025Serious

Wuxi Medical lnstrument Factory Co., Ltd. — ViaMed Alcohol Prep Pads, For External Use Only, 70% Isopropyl Alcohol, Sterile, 100 pieces per Box, 100 boxes per Carton, Sterile

Prescription medicine · Wuxi Medical lnstrument Factory Co., Ltd. · 37,500 Boxes affected

Lack of assurance of sterility and cGMP deviations observed at the manufacturing site.

Food & drug recall · FDAFebruary 10, 2025Serious

Nephron Sterile Compounding Center LLC — Sodium Chloride Injection 9%, USP, 500 mL, Single-Dose IV Bottle, Rx Only, nephron, 503B outsourcing facility, West Columbia, SC 29172, NDC: 69374-334-50

Prescription medicine · Nephron Sterile Compounding Center LLC · 4,190 bottles affected

Lack of Assurance of Sterility: There is a potential for leakage at the IV bottle port.

Food & drug recall · FDAFebruary 7, 2025Serious

Aspen Biopharma Labs Pvt., Ltd. — Latanoprost NDC# 82187-1002-1 Container Description: Amber colour bottle

Prescription medicine · Aspen Biopharma Labs Pvt., Ltd. · 150.0 gm affected

CGMP Deviations

Food & drug recall · FDAFebruary 7, 2025Serious

Aspen Biopharma Labs Pvt., Ltd. — Alprostadil Container Description: Amber color bottle

Prescription medicine · Aspen Biopharma Labs Pvt., Ltd. · 3.0 gm affected

CGMP Deviations

Food & drug recall · FDAFebruary 7, 2025Serious

Aspen Biopharma Labs Pvt., Ltd. — Finasteride NDC# 82187-1003-1 Container Description: The product packed in white poly bag containing black poly bag and tied each individual finally packed in HDPE container for shipping.

Prescription medicine · Aspen Biopharma Labs Pvt., Ltd. · 120.0 kg affected

CGMP Deviations

Food & drug recall · FDAFebruary 7, 2025Serious

Aspen Biopharma Labs Pvt., Ltd. — Voriconazole Container Description: voriconazole The product packed in white poly bag containing black poly bag and tied each individual finally packed in HDPE container for shipping.

Prescription medicine · Aspen Biopharma Labs Pvt., Ltd. · 4.0 kg affected

CGMP Deviations

Food & drug recall · FDAFebruary 7, 2025Serious

Aspen Biopharma Labs Pvt., Ltd. — Bimatoprost NDC# 82187-1001-1 Container description: The product packed in double self-seal cover and finally packed in Aluminum cover for shipping.

Prescription medicine · Aspen Biopharma Labs Pvt., Ltd. · 400.0 gm affected

CGMP Deviations

Food & drug recall · FDAFebruary 7, 2025Serious

Aspen Biopharma Labs Pvt., Ltd. — Chlorambucil Container Description: The product packed in double self-seal cover and finally packed in Aluminum cover for shipping.

Prescription medicine · Aspen Biopharma Labs Pvt., Ltd. · 5.1 kg affected

CGMP Deviations

Food & drug recall · FDAFebruary 6, 2025Serious

Padagis US LLC — Estradiol Gel, 0.1%, 0.25 mg/g, 30 packets per carton, Rx Only, For Topical Use Only

Prescription medicine · Padagis US LLC · 4944 cartons affected

Defective Container: Some packets may not be fully sealed, potentially allowing for loss of Ethanol from the product.

Food & drug recall · FDAFebruary 6, 2025Serious

SUN PHARMACEUTICAL INDUSTRIES INC — Morphine Sulfate Extended-Release Tablets, 100 mg, 100-count bottles, Rx Only

Prescription medicine · SUN PHARMACEUTICAL INDUSTRIES INC · 9840 bottles affected

Failed Dissolution Specifications

Food & drug recall · FDAFebruary 4, 2025Serious

AvKARE — Silodosin Capsules, 8mg, 90-count bottle, Rx only

Prescription medicine · AvKARE · 1266 bottles affected

Subpotent Drug: Out of Specification (OOS) result for De hydro Impurity (0.654%) for 18 M Stability sample and low assay 94.9% (specification of NLT…

Food & drug recall · FDAJanuary 31, 2025Serious

Fagron Compounding Services — fentaNYL Citrate In Sodium Chloride 1600mcg/100mL (16 mcg per mL) CII, Single use 100mL IV Bag, Fagron Sterile Services, 8710 E 34th St N, Wichita, KS 67726 Bar Code 71266-5060-01

Prescription medicine · Fagron Compounding Services · 1330 bags affected

Lack of Assurance of Sterility

Food & drug recall · FDAJanuary 31, 2025Highest risk

Alvogen, Inc — Fentanyl Transdermal System CII, 25mcg/h, packaged in a pouch, further packaged in 5-count carton, Rx only

Prescription medicine · Alvogen, Inc · 112,128 cartons (5 pouches/carton) affected

Defective delivery system - patches could be multi-stacked, adhered one on top of the other, in a single product pouch.

Food & drug recall · FDAJanuary 31, 2025Serious

Direct Rx — CIPROFLOXACIN OPHTH SOLUTION, 0.3% 5mL bottle, Rx Only, Generic for CILOXAN, Packaged and Distributed by: DIRECT Rx, NDC 61919-795-05.

Prescription medicine · Direct Rx · 477 bottles. affected

Defective Container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle

Food & drug recall · FDAJanuary 30, 2025Serious

The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories — Potassium Chloride Extended-Release Tablets, USP, 10 mEq (750 mg), 100 Tablets per carton (10 x 10 unit dose blisters), Rx Only

Prescription medicine · The Harvard Drug Group LLC dba Major… · 6997 cartons affected

Failed Dissolution Specifications.

Food & drug recall · FDAJanuary 29, 2025Serious

Glenmark Pharmaceuticals Inc., USA — Atomoxetine Capsules, USP, 18 mg, 30 capsule bottles, Rx Only

Prescription medicine · Glenmark Pharmaceuticals Inc., USA · 119,040 bottles affected

CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.

Food & drug recall · FDAJanuary 29, 2025Serious

Glenmark Pharmaceuticals Inc., USA — Atomoxetine Capsules, USP, 40 mg, 30 capsule bottles, Rx Only

Prescription medicine · Glenmark Pharmaceuticals Inc., USA · 233,040 bottles affected

CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.

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