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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

2,003 recalls · newest first

Food & drug recall · FDAJanuary 8, 2024Serious

Teva Pharmaceuticals USA, Inc — Budesonide Extended-Release Tablets 9mg, 30-count bottle, Rx Only

Prescription medicine · Teva Pharmaceuticals USA, Inc · 10,672 30-count bottles affected

Failed Dissolution Specifications

Food & drug recall · FDAJanuary 5, 2024Serious

Lupin Pharmaceuticals Inc. — Rifampin Capsules USP 300mg, 30-count bottle, Rx Only

Prescription medicine · Lupin Pharmaceuticals Inc. · 165,60 bottles affected

Subpotent Drug and Failed Impurities/Degradation Specifications

Food & drug recall · FDAJanuary 5, 2024Serious

Lupin Pharmaceuticals Inc. — Rifampin Capsules USP 150mg, 30-count bottle, Rx Only

Prescription medicine · Lupin Pharmaceuticals Inc. · 15,576 Bottles affected

Subpotent Drug and Failed Impurities/Degradation Specifications

Food & drug recall · FDAJanuary 4, 2024Serious

Glenmark Pharmaceuticals Inc., USA — Fluocinolone Acetonide Oil, 0.01% (Ear Drops), package in 1 Oz. (20 mL fill volume) bottle, Rx only

Prescription medicine · Glenmark Pharmaceuticals Inc., USA · 38,496 bottles affected

Failed Excipient Specifications: OOS for assay of Isopropyl Alcohol

Food & drug recall · FDAJanuary 4, 2024Highest risk

Azurity Pharmaceuticals, Inc. — Zenzedi (Dextroamphetamine Sulfate) CII Tablets, USP, 30 mg, 30-count bottle, Rx only, Mfd. for: Arbor Pharmaceuticals, LLC., Atlanta, Georgia, 30328, NDC 24338-856-03

Prescription medicine · Azurity Pharmaceuticals, Inc. · 4,662 bottles affected

Labeling: Label Mix-up

Food & drug recall · FDAJanuary 3, 2024Serious

Lupin Pharmaceuticals Inc. — Cefixime for Oral Suspension 100mg/5mL, 50 mL bottle, Rx Only

Prescription medicine · Lupin Pharmaceuticals Inc. · 4,608 Bottles affected

Failed Impurities/Degradation Specifications

Food & drug recall · FDAJanuary 2, 2024Serious

Dr. Reddy's Laboratories, Inc. — Tizanidine Tablets, USP 4mg, 150-count bottle, Rx only, Mfd. By: Dr. Reddy's Laboratories Limited, Srikakulam - 532 409 INDIA, NDC 55111-180-15

Prescription medicine · Dr. Reddy's Laboratories, Inc. · 38,952 bottles affected

Presence of Foreign tablets/capsules - identified as tizanidine 2 mg tablets.

Food & drug recall · FDADecember 29, 2023Serious

Strides Pharma Inc. — Methoxsalen Capsules, USP 10mg, 50-count bottle, Rx Only

Prescription medicine · Strides Pharma Inc. · 396 50-count bottles affected

Failed Dissolution Specifications

Food & drug recall · FDADecember 29, 2023Serious

Rising Pharma Holding, Inc. — buPROPion Hydrochloride Extended-Release Tablets, USP (XL) 150mg, 30-count bottles, Rx Only

Prescription medicine · Rising Pharma Holding, Inc. · 47,976 bottles affected

Presence of Foreign Tablets/Capsules

Food & drug recall · FDADecember 28, 2023Highest risk

Denver Solutions, LLC DBA Leiters Health — PHENYLephrine HCl 20 mg per 250 mL 0.9% Sodium Chloride (80 mcg per mL), Item F3360, for IV use only; Leiters 13796 Compark Blvd Englewood, CO 80112; NDC 71449-148-94.

Prescription medicine · Denver Solutions, LLC DBA Leiters Health · 29,016 IV bags affected

Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags.

Food & drug recall · FDADecember 28, 2023Highest risk

Denver Solutions, LLC DBA Leiters Health — FentaNYL citrate PF, 2500 mcg per 250 mL 0.9% Sodium Chloride (10 mcg per mL), Item F3342, for IV use only; Leiters 13796 Compark Blvd Englewood, CO 80112; NDC 71449-072-82.

Prescription medicine · Denver Solutions, LLC DBA Leiters Health · 13,920 IV bags affected

Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags.

Food & drug recall · FDADecember 28, 2023Highest risk

Denver Solutions, LLC DBA Leiters Health — PHENYLephrine HCl 40 mg per 250 mL 0.9% Sodium Chloride (160 mcg per mL), Item F3352, for IV use only; Leiters 13796 Compark Blvd Englewood, CO 80112; NDC 71449-150-82.

Prescription medicine · Denver Solutions, LLC DBA Leiters Health · 12,564 IV bags affected

Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags.

Food & drug recall · FDADecember 28, 2023Serious

Seaway Pharma Inc. — Quality Choice No Drip Severe Congestion Nasal Pump Mist, Oxymetazoline hydrochloride 0.05%, Nasal Decongestant, 12 Hours, 1 fl. oz. bottle

Prescription medicine · Seaway Pharma Inc. · 8,160 bottles affected

CGMP Deviations: Firm reported possible microbial contamination in the purified water used in the manufacturing of the products.

Food & drug recall · FDADecember 28, 2023Highest risk

Denver Solutions, LLC DBA Leiters Health — VANCOmycin HCl PF 1.5g added to 0.9% Sodium Chloride 250 mL IV bag, Item F3208, for IV use only; Leiters 13796 Compark Blvd Englewood, CO 80112; NDC 71449-029-68.

Prescription medicine · Denver Solutions, LLC DBA Leiters Health · 7,548 IV bags affected

Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags.

Food & drug recall · FDADecember 28, 2023Serious

Seaway Pharma Inc. — Premier Value Tussin Cough DM, Dextromethorphan HBr...Cough Suppressant, Guaifenesin...Expectorant, Alcohol Free, 8 FL OZ (237 mL) bottle

Prescription medicine · Seaway Pharma Inc. · 4,176 bottles affected

CGMP Deviations: Firm reported possible microbial contamination in the purified water used in the manufacturing of the products.

Food & drug recall · FDADecember 28, 2023Highest risk

Denver Solutions, LLC DBA Leiters Health — VANCOmycin HCl PF 1.25g added to 0.9% Sodium Chloride 250 mL IV bag, Item F3206, for IV use only; Leiters 13796 Compark Blvd Englewood, CO 80112; NDC 71449-028-68.

Prescription medicine · Denver Solutions, LLC DBA Leiters Health · 10,152 IV bags affected

Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags.

Food & drug recall · FDADecember 28, 2023Serious

Fresenius Medical Care Holdings, Inc. — DELFLEX Peritoneal Dialysis Solution in Biofine container 1.5% Dextrose, packaged in 6000mL bags, Rx only, Fresenius Medical Care NA Waltham, MA 02451, NDC 49230-206-62.

Prescription medicine · Fresenius Medical Care Holdings, Inc. · 69,590 bags affected

Lack of Sterility Assurance

Food & drug recall · FDADecember 28, 2023Highest risk

Denver Solutions, LLC DBA Leiters Health — FentaNYL citrate PF, 1000 mcg per 100 mL 0.9% Sodium Chloride (10 mcg per mL), Item F3355, for IV use only; Leiters 13796 Compark Blvd Englewood, CO 80112; NDC 71449-072-41.

Prescription medicine · Denver Solutions, LLC DBA Leiters Health · 8,976 IV bags affected

Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags.

Food & drug recall · FDADecember 28, 2023Serious

Seaway Pharma Inc. — Quality Choice No Drip Extra Moisturizing Nasal Pump Mist Oxymetazoline hydrochloride 0.05%, 12 Hour Nasal Decongestant, 1 fl oz (30 mL) bottle

Prescription medicine · Seaway Pharma Inc. · 7,992 bottles affected

CGMP Deviations: Firm reported possible microbial contamination in the purified water used in the manufacturing of the products.

Food & drug recall · FDADecember 26, 2023Serious

Amneal Pharmaceuticals of New York, LLC — Divalproex Sodium Extended-release Tablets, USP 250 mg, Rx Only, 100 tablets

Prescription medicine · Amneal Pharmaceuticals of New York, LLC · 21,452/100 count bottles affected

Failed dissolution specifications

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