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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 · FDAApril 29, 2024Serious

Breckenridge Pharmaceutical, Inc — Duloxetine Delayed-Release Capsules, USP, 60 mg, 90-count bottles, Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley

Prescription medicine · Breckenridge Pharmaceutical, Inc · 281,554/90 count bottles affected

CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit

Why this is here: It was found to contain a drug or chemical that is not on the label. That is different from an allergen or a contamination scare: anyone taking it has been taking a substance nobody prescribed, in an unknown dose, and it can interact with medication they are already on. Follow the agency notice rather than judging it by how the product looks.

Food & drug recall · FDAApril 29, 2024Serious

Breckenridge Pharmaceutical, Inc — Duloxetine Delayed-Release Capsules, USP, 20 mg, , 500-count bottles, Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berke

Prescription medicine · Breckenridge Pharmaceutical, Inc · 7,188/ 500 count bottles affected

CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit

Food & drug recall · FDAApril 29, 2024Serious

Breckenridge Pharmaceutical, Inc — Duloxetine Delayed-Release Capsules, USP, 30mg, Rx Only, (a) 90-count bottles (NDC 51991-747-90), (b) 1000-count bottles (NDC 51991-747-10), Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelon

Prescription medicine · Breckenridge Pharmaceutical, Inc · 281,554/90 & 1000 count bottles affected

CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit

Food & drug recall · FDAApril 29, 2024Highest risk

Hikma Injectables USA Inc — Phenylephrine in 0.9% Sodium Chloride Injection Preservative Free, 100mcg/mL, 5mL syringe, Rx only, Hikma Injectables USA Inc, 36 Stults Road, Dayton, NJ 08810, NDC 63037-123-25

Prescription medicine · Hikma Injectables USA Inc

Labeling: Label mix-up - ephedrine syringes mislabeled as phenylephrine.

Food & drug recall · FDAApril 26, 2024Serious

Rubicon Research Private Limited — traMADol Hydrochloride Tablets, USP 50 mg, 1000-count bottle, Rx Only

Prescription medicine · Rubicon Research Private Limited · 2,592 1000-count Bottles affected

Presence of Foreign Tablets: Pharmacist reported a tablet of baclofen in a bottle of 1000-count tramadol

Food & drug recall · FDAApril 25, 2024Serious

Sagent Pharmaceuticals — MethylPREDNISolone Acetate Injectable Suspension, USP, 400 mg per 10 mL (40 mg per mL), 1 x 10 mL Multi-Dose Vial, Rx only, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195, Made in India. NDC: 25021-820-10

Prescription medicine · Sagent Pharmaceuticals · 14,360 vials affected

Presence of Particulate Matter: Potential for black particulates in the drug product.

Food & drug recall · FDAApril 25, 2024Serious

FDC Limited — Timolol Maleate Ophthalmic Solution, USP, 0.5%, packaged in a) 5mL bottles (NDC 64980-514-05), and b) 15 mL bottles (NDC 64980-514-15), Rx only

Prescription medicine · FDC Limited · 382,104 units affected

Defective Container: yellow-colored spike from cap lodged in the nozzle.

Food & drug recall · FDAApril 25, 2024Labelling issue

Viatris Inc — Valacyclovir Tablets USP, 500 mg, 90 count bottles, Rx Only

Prescription medicine · Viatris Inc · 143,230 bottles affected

Failed Tablet/Capsule Specifications: There is a potential for the imprint, M 122, to be missing on some tablets.

Food & drug recall · FDAApril 24, 2024Serious

Lupin Pharmaceuticals Inc. — Cefdinir for Oral Suspension USP 250 mg/5 mL (60 mL when reconstituted), 60 mL bottle, Rx only

Prescription medicine · Lupin Pharmaceuticals Inc. · 17,070 bottles affected

Presence of foreign substance: Product complaint of foreign material in reconstituted bottle.

Food & drug recall · FDAApril 24, 2024Serious

Coast Quality Pharmacy, LLC dba Anazao Health — Progesterone 200 mg, Compounded, 90-count bottle, Rx, Dissolve One Sublingual Tablet After Dinner Nightly, AnazaoHealth, 5710 Hoover Blvd, Tampa, Fl 33643, (800)-995-4363. Beyond Use Date: 09/

Prescription medicine · Coast Quality Pharmacy, LLC dba Anazao… · 9896 tablets affected

Presence of Foreign Substance; Broken metal piece found embedded in tablet.

Food & drug recall · FDAApril 24, 2024Serious

SOMERSET THERAPEUTICS LLC — Haloperidol decanoate Injection 50mg/mL, packaged in a) 1 mL Single-Dose Vials (NDC 70069-381-01) and b) 10 1mL Single-Dose Vials (NDC 70069-381-10), Rx only

Prescription medicine · SOMERSET THERAPEUTICS LLC · 5,578 units affected

Presence of Foreign Substance: This oil based product may contain trace amounts of water for injection (WFI).

Food & drug recall · FDAApril 24, 2024Serious

Aurobindo Pharma USA Inc. — Clorazepate Dipotassium Tablets, USP, 3.75 mg, a) 100 tablets per bottle, NDC 13107-282-01 b) 500 tablets per bottle, NDC 13107-282-05, Rx Only

Prescription medicine · Aurobindo Pharma USA Inc. · 6696 bottles affected

Discoloration: Dotted and yellow spots on tablets

Food & drug recall · FDAApril 24, 2024Labelling issue

Acella Pharmaceuticals, LLC — Sodium Sulfacetamide 10% - Sulfur 5% Cleanser, Rx Only, 6 oz (170.3 g) Bottle

Prescription medicine · Acella Pharmaceuticals, LLC · 7104 Bottles affected

Subpotent drug

Food & drug recall · FDAApril 24, 2024Serious

Lupin Pharmaceuticals Inc. — Cefdinir for Oral Suspension USP 125 mg/5 mL (60 mL when reconstituted), 60 mL bottle, Rx only

Prescription medicine · Lupin Pharmaceuticals Inc. · 17,040 bottles affected

Presence of foreign substance: Product complaint of foreign material in reconstituted bottle.

Food & drug recall · FDAApril 24, 2024Serious

Aurobindo Pharma USA Inc. — Clorazepate Dipotassium Tablets, USP, 7.5 mg, a) 100 tablets per bottle, NDC 13107-283-01, b) 500 tablets per bottle, NDC 13107-283-05, Rx Only

Prescription medicine · Aurobindo Pharma USA Inc. · 6909 bottles affected

Discoloration: Dotted and yellow spots on tablets

Food & drug recall · FDAApril 23, 2024Serious

EPI Health, LLC — Cloderm (clocortolone pivalate) Cream, 0.1%, Rx Only, For Topical Use Only, Net Wt 45g

Prescription medicine · EPI Health, LLC · 18645 tubes affected

CGMP Deviation: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity…

Food & drug recall · FDAApril 23, 2024Serious

Regeneron Pharmaceuticals Inc — EYLEA, (aflibercept) Injection, 2 mg (0.05mL of a 40mg/mL solution), Single-dose Pre-filled Syringe, Rx only

Prescription medicine · Regeneron Pharmaceuticals Inc · 251,504 syringes affected

Lack of Assurance of Sterility: Complaints of syringe breakage

Food & drug recall · FDAApril 23, 2024Serious

EPI Health, LLC — minolira (minocycline hydrochloride) extended-release tablets, 105mg 30-count Bottle, Rx Only, Mfg by: Dr Reddy's Laboratories Limited, INDIA

Prescription medicine · EPI Health, LLC · 12808 bottles affected

CGMP Deviation: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity…

Food & drug recall · FDAApril 23, 2024Serious

EPI Health, LLC — minolira (minocycline hydrochloride) extended-release tablets, 135mg 30-count Bottle, Rx Only, Mfg by: Dr Reddy's Laboratories Limited, INDIA

Prescription medicine · EPI Health, LLC · 5664 bottles affected

CGMP Deviation: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity…

Food & drug recall · FDAApril 22, 2024Labelling issue

SUN PHARMACEUTICAL INDUSTRIES INC — Xelpros (latanoprost ophthalmic emulsion) 0.005%, 125mcg/2.5mL, 2.5 mL bottle, Rx only

Prescription medicine · SUN PHARMACEUTICAL INDUSTRIES INC · 35,069 bottles affected

Failed Release Testing: Out of specification for particulate matter test.

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