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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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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

1,993 recalls · newest first

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, 100 mg, 30 capsule bottles, Rx Only

Prescription medicine · Glenmark Pharmaceuticals Inc., USA · 58,368 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, 100 mg, 30 capsule bottles, Rx Only

Prescription medicine · Glenmark Pharmaceuticals Inc., USA · 39,168 bottles affected

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

Food & drug recall · FDAJanuary 28, 2025Highest risk

Ascent Consumer Products Inc. — SinuCleanse Soft Tip Squeeze Bottle Nasal Wash System (sodium bicarbonate USP 700 mg and sodium chloride USP 2300 mg), 30-count All Natural USP Grade Saline Packets and 1 Soft tip Squeeze Bottle, Net WT 0.1OZ

Prescription medicine · Ascent Consumer Products Inc. · 4,176 cartons affected

Microbial Contamination of Non-Sterile Products: Bacterial contamination with Staphylococcus aureus

Food & drug recall · FDAJanuary 28, 2025Highest risk

Ascent Consumer Products Inc. — SinuCleanse Premixed SALINE PACKETS (sodium bicarbonate USP 700 mg and sodium chloride USP 2300 mg) for Nasal Wash System, 60-count All Natural USP Grade Saline Packets, Net WT 0.1OZ (3g) each

Prescription medicine · Ascent Consumer Products Inc. · unknown affected

Microbial Contamination of Non-Sterile Products: Bacterial contamination with Staphylococcus aureus

Food & drug recall · FDAJanuary 28, 2025Highest risk

Ascent Consumer Products Inc. — SinuCleanse Soft Tip NETI POT Nasal Wash System (sodium bicarbonate USP 700 mg and sodium chloride USP 2300 mg), 30-count All Natural USP Grade Saline Packets and 1 kettle style Neti Pot, Net WT 0.1OZ (3g) ea

Prescription medicine · Ascent Consumer Products Inc. · unknown affected

Microbial Contamination of Non-Sterile Products: Bacterial contamination with Staphylococcus aureus

Food & drug recall · FDAJanuary 24, 2025Serious

SKY PACKAGING — HydrALAZINE Hydrochloride, 100 Tablets (10x10), USP, 50mg, Rx only

Prescription medicine · SKY PACKAGING

Failed Impurities/Degradation Specifications

Food & drug recall · FDAJanuary 24, 2025Serious

RemedyRepack Inc. — Carvedilol 25 mg Tablet, QTY: 30 Tablets per Blister Pack (3 x 10 blister cards), Rx Only, MFG by: Glenmark, Mahwah, NJ 07430, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC: 70518-3945-00.

Prescription medicine · RemedyRepack Inc. · 247 blister packs affected

CGMP deviations: presence of N-Nitroso Carvedilol Impurity-1 (NNC 1), above the FDA recommended acceptable intake limit.

Food & drug recall · FDAJanuary 24, 2025Serious

SKY PACKAGING — HydrALAZINE Hydrochloride, 25 mg, 100 Unit Dose Tablets (10x10), USP, Rx only

Prescription medicine · SKY PACKAGING

Failed Impurities/Degradation Specifications

Food & drug recall · FDAJanuary 23, 2025Serious

FDC Limited — Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 5mL bottles, Rx only

Prescription medicine · FDC Limited · 118104 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 22, 2025Serious

Glenmark Pharmaceuticals Inc., USA — Carvedilol Tablets, USP, 12.5 mg, Rx only, a)500 Tablets, NDC 68462-164-05; b) 100 Tablets, NDC 68462-164-01

Prescription medicine · Glenmark Pharmaceuticals Inc., USA

CGMP Deviations:N-Nitroso Carvedilol I impurity (NNCI-I) were found to be failing per current FDA recommended limit.

Food & drug recall · FDAJanuary 22, 2025Serious

Glenmark Pharmaceuticals Inc., USA — Carvedilol Tablets, USP, 25 mg, Rx only, a)500 Tablets, NDC 68462-165-05; b) 100 Tablets, NDC 68462-165-01

Prescription medicine · Glenmark Pharmaceuticals Inc., USA

CGMP Deviations:N-Nitroso Carvedilol I impurity (NNCI-I) were found to be failing per current FDA recommended limit.

Food & drug recall · FDAJanuary 21, 2025Serious

The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories — Lorazepam Tablets, USP, 1mg, Unit Dose, 100 tablets per carton (10 x 10 blister packs), Rx only, The drug product contained in this package is from NDC # 69315-90

Prescription medicine · The Harvard Drug Group LLC dba Major… · 94,349 cartons affected

Failed impurities/degradation specifications and Sub-potent Drug: Out-of-specification results were obtained during routine stability testing for…

Food & drug recall · FDAJanuary 21, 2025Serious

AvKARE — Irbesartan Tablets USP, 300 mg, 50 Tablets (5 x 10) Unit Dose per carton

Prescription medicine · AvKARE · 341 cartons affected

Out of Specification for Dissolution

Food & drug recall · FDAJanuary 21, 2025Serious

The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories — Lorazepam Tablets, USP, 2mg, Unit Dose, 100 tablets per carton (10 x 10 blister packs), Rx only, The drug product contained in this package is from NDC # 69315-90

Prescription medicine · The Harvard Drug Group LLC dba Major… · 27,525 cartons affected

Failed impurities/degradation specifications and Sub-potent Drug: Out-of-specification results were obtained during routine stability testing for…

Food & drug recall · FDAJanuary 21, 2025Serious

The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories — Lorazepam Tablets, USP, 0.5mg, Unit Dose, 100 tablets per carton (10 x 10 blister packs), Rx only, The drug product contained in this package is from NDC # 69315

Prescription medicine · The Harvard Drug Group LLC dba Major… · 82,281 cartons affected

Failed impurities/degradation specifications and Sub-potent Drug: Out-of-specification results were obtained during routine stability testing for…

Food & drug recall · FDAJanuary 21, 2025Highest risk

Provepharm Inc. — Phenylephrine HCl Injection, USP 100 mg/10 mL (10 mg/mL) vials, Rx only, Pharmacy Bulk Package (supplied as a single unit), Dist. by: Provepharm, Inc., Collegeville, PA 19426

Prescription medicine · Provepharm Inc. · 24640 vials affected

Presence of Particulate Matter.

Food & drug recall · FDAJanuary 17, 2025Serious

McKesson — Inflectra (infliximab-dyyb), For injection, 100mg per vial, packaged in 10 mL single-dose vial, Rx only, Mfd by: CELLTRION, INC, Dist. by: Pfizer Labs, Division of Pfizer Inc., New York, NY 10001, NDC 0069-0809-01

Prescription medicine · McKesson · 192 vials affected

cGMP Deviations: Product intended for quarantine was inadvertently distributed.

Food & drug recall · FDAJanuary 16, 2025Labelling issue

Appco Pharma LLC — Venlafaxine Extended-Release Tablets, 150mg, Rx only, 90 Tablets

Prescription medicine · Appco Pharma LLC · 1380 bottles affected

Failed Tablet/Capsule Specifications: Missing tab ID on either side of the tablet

Food & drug recall · FDAJanuary 13, 2025Serious

The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories — Duloxetine Delayed-Release Capsules USP, 20 mg, packaged in a) 30 Unit Doses (3x10 blister packs) NDC 0904-7043-04 and b) 100 Unit Doses (10x10 blister packs) NDC

Prescription medicine · The Harvard Drug Group LLC dba Major… · a) 6408 boxes and b)1488 boxes affected

CGMP Deviations: presence of Nitrosamine Drug Substances Related Impurity (NDSRI), N-Nitroso-Duloxetine above the FDA recommended acceptable intake…

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