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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

2,003 recalls · newest first

Food & drug recall · FDAApril 9, 2024Labelling issue

Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd. — Abilify (aripiprazole), 10 mg tablets, packaged in a) 30 count bottles (NDC 59148-008-13) and b) 7 count blister packs (NDC 59148-008-95), RX only, Otsuka America Pharmaceutical, I

Prescription medicine · Second Tokushima Factory, Otsuka… · N/A affected

Cross Contamination with Other Products

Food & drug recall · FDAApril 9, 2024Labelling issue

Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd. — Abilify (aripiprazole), 30 mg tablets, packaged in 30 count bottles, RX only, Otsuka America Pharmaceutical, Inc., NDC 59148-011-13

Prescription medicine · Second Tokushima Factory, Otsuka… · N/A affected

Cross Contamination with Other Products

Food & drug recall · FDAApril 9, 2024Labelling issue

Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd. — Abilify (aripiprazole), 5 mg tablets, packaged in 30 count bottles, RX only, Otsuka America Pharmaceutical, Inc., NDC 59148-007-13

Prescription medicine · Second Tokushima Factory, Otsuka… · 108,192/30 count bottles or 7 count blister packs affected

Cross Contamination with Other Products

Food & drug recall · FDAApril 9, 2024Labelling issue

Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd. — Abilify (aripiprazole), 15 mg tablets, packaged in 30 count bottles, RX only, Otsuka America Pharmaceutical, Inc., NDC 59148-009-13

Prescription medicine · Second Tokushima Factory, Otsuka… · N/A affected

Cross Contamination with Other Products

Food & drug recall · FDAApril 8, 2024Highest risk

Dr. Reddy's Laboratories, Inc. — Javygtor (sapropterin dihydrochloride) Powder for Oral Solution 100mg, 30 individual packets per carton, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540 Made in India, NDC 43598-097

Prescription medicine · Dr. Reddy's Laboratories, Inc. · 17,332 cartons affected

Sub-potent Drug; powder discoloration associated with decreased potency

Food & drug recall · FDAApril 8, 2024Highest risk

Dr. Reddy's Laboratories, Inc. — Sapropterin Dihydrochloride Powder for Oral Solution 100mg, 30 individual packets per carton, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, NDC 43598-477-30.

Prescription medicine · Dr. Reddy's Laboratories, Inc. · 2402 cartons affected

Sub-potent Drug; powder discoloration associated with decreased potency

Food & drug recall · FDAApril 2, 2024Labelling issue

X-Gen Pharmaceuticals Inc. — Cyclophosphamide for Injection, USP, 1g/vial, Lyophilized, Single Dose Vial, Discard unused solution, Cytotoxic Agent, After Reconstitution: For direct intravenous injection or must be further diluted before int

Prescription medicine · X-Gen Pharmaceuticals Inc. · 1332 vials affected

Labeling: Incorrect or missing Package Insert: There is an error on the Package Insert (PI), section 2.3, Preparation, Handling, and Administration.

Food & drug recall · FDAApril 2, 2024Labelling issue

X-Gen Pharmaceuticals Inc. — Cyclophosphamide for Injection, USP, 500mg/vial, Lyophilized, Cytotoxic Agent, Single Dose Vial for Intravenous Use, Rx Only

Prescription medicine · X-Gen Pharmaceuticals Inc. · 1283 vials affected

Labeling: Incorrect or missing Package Insert: There is an error on the Package Insert (PI), section 2.3, Preparation, Handling, and Administration.

Food & drug recall · FDAMarch 29, 2024Serious

HONEYWELL INC — Eyesaline, Saline Eyewash Solution, Cartridge for Fendall 2000, Net contents: 7.9 gal per cartridge, Sperian Eye & Face Protection, Inc., 825 East Highway 151, Platteville, WI 53818. NDC: 0498-0631-37

Prescription medicine · HONEYWELL INC · 10, 605 cartridges affected

CGMP Deviations

Food & drug recall · FDAMarch 28, 2024Serious

Teva Pharmaceuticals USA, Inc — Isotretinoin Capsules, USP 40mg, 30-count 3x10 blister packs per carton, Rx Only

Prescription medicine · Teva Pharmaceuticals USA, Inc · 5,304 3x10-cartons affected

Superpotent Drug: The 3-month stability result for assay was found to be above specification limit

Food & drug recall · FDAMarch 28, 2024Highest risk

AvKARE — Atovaquone Oral Suspension USP, 750 mg per 5 mL sachets, 20 Units x 5 mL cartons, Rx Only

Prescription medicine · AvKARE · 153 cartons affected

Microbial contamination of a non-sterile product: potential Bacillus cereus contamination.

Food & drug recall · FDAMarch 27, 2024Labelling issue

Esperion — NEXLIZET (bempedoic acid and ezetimibe) tablets, 180 mg/10 mg, 30-count bottle, Rx only

Prescription medicine · Esperion · 3,480 30-count bottles affected

Failed dissolution specifications: out-of-specification bempedoic acid dissolution at the 0-month timepoint.

Food & drug recall · FDAMarch 27, 2024Serious

NATCO Pharma Limited — Lansoprazole Delayed-Release Capsules USP, 15 mg, Acid reducer 24 Hour, Treats Frequent Heartburn, 14 capsules per bottle

Prescription medicine · NATCO Pharma Limited · 30 bottles affected

CGMP Deviations

Food & drug recall · FDAMarch 26, 2024Serious

Glenmark Pharmaceuticals Inc., USA — Diltiazem Hydrochloride Extended-Release Capsules, USP 120 mg, Twice-a-Day Dosage, 100 Capsules per bottle, Rx Only

Prescription medicine · Glenmark Pharmaceuticals Inc., USA · 6,528 bottles affected

Failed Dissolution Specifications: Out of Specification (OOS) was reported in test of dissolution at the 12th month time point in long term stability…

Food & drug recall · FDAMarch 26, 2024Serious

Cipla USA, Inc. — Ipratropium Bromide and Albuterol Sulfate Inhalation Solution USP, 0.5 mg & 3mg/3mL unit-dose vials, packaged in carton containing 30 vials ( 6 pouches of 5 - 3 mL vials), Rx only

Prescription medicine · Cipla USA, Inc. · 59244/3ml FFS packs affected

Short fill: Complaints received of less fill volume in respule and few drops of liquid observed in the intact pouch.

Food & drug recall · FDAMarch 25, 2024Labelling issue

Novitium Pharma LLC — Digoxin Tablets, USP 62.5 mcg (0.0625 mg), 100-count bottles, Rx Only

Prescription medicine · Novitium Pharma LLC · 1,003 bottles affected

Failed Impurities/Degradation Specifications

Food & drug recall · FDAMarch 25, 2024Serious

Amneal Pharmaceuticals of New York, LLC — Methylergonovine Maleate Tablets, USP, 0.2mg, 12-count bottle, Rx Only

Prescription medicine · Amneal Pharmaceuticals of New York, LLC · 2784 bottles affected

Failed Dissolution Specifications

Food & drug recall · FDAMarch 22, 2024Serious

B. Braun Medical Inc — Lactated Ringer's Injection USP, 1000mL, EXCEL CONTAINER, Rx only, B.Braun Medical Inc., Bethlehem, PA 18018, NDC 0264-7750-00

Prescription medicine · B. Braun Medical Inc · 7,800 bags affected

Lack of assurance of sterility: bags have the potential to leak..

Food & drug recall · FDAMarch 22, 2024Serious

IntegraDose Compounding Services LLC — fentaNYL Citrate 2,500 mcg/50mL in Sterile Water, 50 mL CADD for Injection, IntegraDose Compounding Services, LLC, 719 Kasota Ave SE, Minneapolis, MN. NDC 71139-6030-1

Prescription medicine · IntegraDose Compounding Services LLC · 187 cassettes affected

Lack of Assurance of Sterility: leaking bags

Food & drug recall · FDAMarch 21, 2024Serious

Apothecus Pharmaceutical Corp. — VCF Vaginal Contraceptive Film (nonoxynol-9, 28%), package in a carton with 9 single films

Prescription medicine · Apothecus Pharmaceutical Corp. · 17,280 paper cartons affected

cGMP Diviations

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