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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 · FDAOctober 20, 2023Serious

ITF PHARMA INC — Tiglutik (riluzole) Oral Suspension 50 mg/10 mL (5 mg/mL), 600 mL (two bottles/300 mL each), RX only

Prescription medicine · ITF PHARMA INC · 1,792 bottles affected

Failed Viscosity Specifications: Out-of-specification test results for viscosity

Food & drug recall · FDAOctober 20, 2023Serious

SUN PHARMACEUTICAL INDUSTRIES INC — Liothyronine Sodium Tablets, USP, 5 mcg, 100-count bottles, Rx only

Prescription medicine · SUN PHARMACEUTICAL INDUSTRIES INC · 7392 Bottles affected

Failed Impurities/Degradation Specifications.

Food & drug recall · FDAOctober 20, 2023Labelling issue

Edenbridge Pharmaceuticals, LLC — Opium Tincture, USP (Deodorized), 10 mg/mL of anhydrous morphine, packaged in 118 mL (4 Fl oz) bottles, Rx only

Prescription medicine · Edenbridge Pharmaceuticals, LLC · 4548 bottles affected

Subpotent Drug

Food & drug recall · FDAOctober 19, 2023Serious

Safecor Health, LLC — Strong Iodine Solution U.S.P. (Lugol's Solution) (Iodine 5%), 14 mL Glass Dropper bottle in box, RX only, Safecor Health, LLC, Woburn, MA 01801. NDC# 48433-230-15

Prescription medicine · Safecor Health, LLC · 166,022 bottles affected

CGMP Deviations: Recall due to the absence of USP CGMP compendial requirements.

Food & drug recall · FDAOctober 19, 2023Serious

Zydus Pharmaceuticals (USA) Inc — Oxybutynin Chloride Extended-Release Tablet USP, 15 mg, 100 count bottles, Rx Only

Prescription medicine · Zydus Pharmaceuticals (USA) Inc

Failed Dissolution Specifications-out-of-specification (OOS) test results observed for dissolution at the 6 month long term time point.

Food & drug recall · FDAOctober 19, 2023Serious

Zydus Pharmaceuticals (USA) Inc — Oxybutynin Chloride Extended-Release Tablet USP, 5 mg, 100 count bottles, Rx Only

Prescription medicine · Zydus Pharmaceuticals (USA) Inc

Failed Dissolution Specifications-out-of-specification (OOS) test results observed for dissolution at the 6 month long term time point.

Food & drug recall · FDAOctober 19, 2023Serious

Zydus Pharmaceuticals (USA) Inc — Oxybutynin Chloride Extended-Release Tablet USP, 10 mg, 100 count bottles Rx Only

Prescription medicine · Zydus Pharmaceuticals (USA) Inc

Failed Dissolution Specifications-out-of-specification (OOS) test results observed for dissolution at the 6 month long term time point.

Food & drug recall · FDAOctober 18, 2023Highest risk

Exela Pharma Sciences LLC — 8.4% Sodium Bicarbonate Injection, USP, 50 mEq/50 mL (1mEq/mL), a) 20x50 mL Single Dose Vials (Vial NDC 51754-5001-1; Carton NDC 51754-5001-5) and b) 25x50 mL Single Dose Vials (Vial NDC 51754-5001-1; Carton NDC

Prescription medicine · Exela Pharma Sciences LLC · 355,220 vials affected

Presence of Particulate Matter: Silicone

Food & drug recall · FDAOctober 18, 2023Highest risk

Exela Pharma Sciences LLC — ELCYS (cysteine hydrochloride injection), USP, 500 mg/10mL (50 mg/mL), 10x10 mL Single Dose Sterile Vials, For Intravenous Infusion Only, Rx Only

Prescription medicine · Exela Pharma Sciences LLC · 38,200 vials affected

Presence of Particulate Matter: Silicone

Food & drug recall · FDAOctober 18, 2023Highest risk

VistaPharm LLC — Sucralfate Oral Suspension, 1g per 10mL, 16 oz (414 mL) PET bottle (12 bottles per case), Rx Only

Prescription medicine · VistaPharm LLC · 180 bottles affected

Microbial Contamination of Non-Sterile Products: identified as Bacillus cereus.

Food & drug recall · FDAOctober 18, 2023Highest risk

Exela Pharma Sciences LLC — Midazolam in 0.8% Sodium Chloride Injection 100 mg/100 mL (1mg/mL), 100 mL Single-Dose Vial, 25 count carton, Ready to Use For Intravenous Infusion Only Preservative Free, Rx Only

Prescription medicine · Exela Pharma Sciences LLC · 23,425 vials affected

Presence of Particulate Matter: Silicone

Food & drug recall · FDAOctober 17, 2023Labelling issue

AbbVie Inc. — Synthroid, Levothyroxine Sodium Tablets, USP 125mcg (0.125mg), 100-count bottle, Rx Only AbbVie Inc. North Chicago, IL 60064, U.S.A. NDC 0074-7068-11

Prescription medicine · AbbVie Inc. · 864 cartons affected

Labeling: Wrong Barcode- One (1) of every forty (40) unit dose blister will contain incorrect barcode information that causes a 125mcg unit dose is…

Food & drug recall · FDAOctober 16, 2023Highest risk

Noah's Wholesale LLC — THE ROCK, Male Sexual Performance Enhancement Capsules, 1200 mg, 1 count blister card

Prescription medicine · Noah's Wholesale LLC · 173 capsules affected

Marketed Without an Approved NDA/ANDA: FDA analysis found the product to be tainted with Sildenafil an ingredient found in an FDA approved product…

Food & drug recall · FDAOctober 13, 2023Serious

Dr. Reddy's Laboratories, Inc. — Montelukast Sodium Tablets, USP 10 mg, Rx Only, 1000 count bottle

Prescription medicine · Dr. Reddy's Laboratories, Inc. · 1,656 bottles affected

Presence of Foreign Tablet(s)/Capsule(s): A foreign tablet was found in a bottle of Montelukast Sodium Tablets, USP 10mg, identified as metoprolol 25…

Food & drug recall · FDAOctober 4, 2023Serious

MEDLINE INDUSTRIES, LP - Northfield — Clinical TREAT Antifungal Powder, Vanilla Scent, 3 OZ (85 g) tube, Active Ingredient: Miconazole Nitrate 2.0% w/w Antifungal

Prescription medicine · MEDLINE INDUSTRIES, LP - Northfield

CGMP deviations: the product was shipped from the Manufacturer to a Medline warehouse and released to stock while it was still under investigation…

Food & drug recall · FDAOctober 4, 2023Labelling issue

Denver Solutions, LLC DBA Leiters Health — VANCOmycin HCI PF, 1.5 g added to 0.9% Sodium Chloride 250 mL IV Bag, Rx only, Leiters Compounding Health, 13796 Compark Blvd, Englewood, CO 80112, NDC 71449-029-68.

Prescription medicine · Denver Solutions, LLC DBA Leiters Health · 25,908 IV bags affected

Labeling: Not Elsewhere Classified

Food & drug recall · FDAOctober 4, 2023Labelling issue

Denver Solutions, LLC DBA Leiters Health — VANCOmycin HCI PF, 1.25 g added to 0.9% Sodium Chloride 250 mL IV Bag, Rx only, Leiters Compounding Health, 13796 Compark Blvd, Englewood, CO 80112, NDC 71449-028-68.

Prescription medicine · Denver Solutions, LLC DBA Leiters Health · 33,480 IV Bags affected

Labeling: Not Elsewhere Classified

Food & drug recall · FDAOctober 4, 2023Labelling issue

SUN PHARMACEUTICAL INDUSTRIES INC — Bupropion Hydrochloride Extended-Release Tablets USP (SR), 150 mg, 60 tablets bottle, Rx Only

Prescription medicine · SUN PHARMACEUTICAL INDUSTRIES INC · 144 bottles affected

Failed Dissolution Specifications

Food & drug recall · FDAOctober 4, 2023Labelling issue

Denver Solutions, LLC DBA Leiters Health — Oxytocin synthetic, 30 Units added to 0.9% Sodium Chloride 500mL IV Bag (0.06 Units per mL), Rx only, Leiter Compounding Health, 13796 Compark Blvd, Englewood, CO 80112, NDC 71449-157-70

Prescription medicine · Denver Solutions, LLC DBA Leiters Health · 6,276 IV bags affected

Labeling: Not Elsewhere Classified

Food & drug recall · FDAOctober 3, 2023Labelling issue

Imprimis NJOF, LLC — Epinephrine-Lidocaine HCl (0.25mg/mL and 7.5mg/mL) 1mL Single Use Intraocular injection Preservative Free NDC 71384-640-01 Not for resale. Office use only. Lot: 23APR018 Date Compounded: 24APR2023 Expires on: 17APR2024.

Prescription medicine · Imprimis NJOF, LLC · 364 bags (1 mL filled in 2 mL glass amber vials; 20 vials shipped in a bag) affected

Subpotent: Failing Test Results for Epinephrine

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