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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 · FDADecember 6, 2024Serious

Amerisource Health Services LLC — Duloxetine Delayed-Release Capsules, USP, 60 mg, Rx only, 1,000 count bottles

Prescription medicine · Amerisource Health Services LLC · 1,815 bottles affected

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

Food & drug recall · FDADecember 6, 2024Serious

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

Prescription medicine · Breckenridge Pharmaceutical, Inc · 163,883 bottles affected

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

Food & drug recall · FDADecember 6, 2024Serious

Aurobindo Pharma USA Inc — Nebivolol Tablets, 2.5. mg, 30-count bottles, Rx only

Prescription medicine · Aurobindo Pharma USA Inc

CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso Nebivolol above acceptable intake (AI) limit.

Food & drug recall · FDADecember 5, 2024Serious

FDC Limited — Timolol Maleate Ophthalmic Solution USP, 0.25%, Sterile, 15mL bottles, Rx only

Prescription medicine · FDC Limited · 5184 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 · FDADecember 4, 2024Serious

AvKARE — Nitrofurantoin Capsules, USP, 100 mg, 50 Capsules (5 x 10) Unit Dose per carton, Rx Only

Prescription medicine · AvKARE · 1016 50-count cartons affected

Failed Dissolution Specifications

Food & drug recall · FDADecember 4, 2024Serious

PD-Rx Pharmaceuticals, Inc. — DULoxetine DR USP, 30 mg, 90-count bottle, Rx Only, Packaged by: PD Rx Pharmaceuticals Inc, Oklahoma City, OK 73127, NDC: 43063-877-90

Prescription medicine · PD-Rx Pharmaceuticals, Inc. · 70, 90-count bottles affected

CGMP Deviations: the presence of a Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso-Duloxetine above the interim acceptable intake limit

Food & drug recall · FDADecember 2, 2024Serious

RemedyRepack Inc. — Duloxetine Delayed-Release Capsules, 60 mg, a) 30 count blister cards (NDC 70518-0937-04), b) 30 count bottles (NDC 70518-0937-03), Rx only, Source NDC 57237-0019-99, MFG: Rising Pharma, Inc., Allendale, NJ, Repackaged b

Prescription medicine · RemedyRepack Inc. · a) 1,564 cards, b) 799 bottles affected

CGMP Deviations; presence of N-nitroso-duloxetine impurity above recommended interim limit.

Food & drug recall · FDANovember 27, 2024Serious

AvKARE — Cinacalcet Tablets, 30 mg, 30-count bottle, Rx only

Prescription medicine · AvKARE · 50,304 bottles affected

CGMP deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso-Cinacalcet above acceptable intake limit.

Food & drug recall · FDANovember 27, 2024Serious

AvKARE — Cinacalcet Tablets, 60 mg, 30-count bottle, Rx only

Prescription medicine · AvKARE · 2,396 bottles affected

CGMP deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso-Cinacalcet above acceptable intake limit.

Food & drug recall · FDANovember 27, 2024Serious

AvKARE — Cinacalcet Tablets, 90 mg, 30-count bottle, Rx only

Prescription medicine · AvKARE · 2,796 bottles affected

CGMP deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso-Cinacalcet above acceptable intake limit.

Food & drug recall · FDANovember 26, 2024Serious

Curium US, LLC — Kit for the Preparation of Technetium Tc 99m Sestamibi Injection, Each Kit contains: 30 sterile and non-pyrogenic reaction vials each containing Tetrakis (2-methoxy isobutyl isonitrile) Copper (I) tetratluoroborate - 1 mg

Prescription medicine · Curium US, LLC · 5,160 vials (172 kits 30 vials/kit) affected

Lack of Assurance of Sterility; Improper crimps on vials impacting the integrity of the product

Food & drug recall · FDANovember 25, 2024Serious

Macleods Pharmaceuticals Ltd — Olanzapine Tablets, USP 2.5 mg, 30-count bottle, Rx Only

Prescription medicine · Macleods Pharmaceuticals Ltd · 15,744 30-count bottles affected

Failed Impurities/Degradation Specifications

Food & drug recall · FDANovember 22, 2024Serious

Provepharm Inc. — Dihydroergotamine Mesylate Injection, solution for injection, USP, 1 mg/mL Ampules, Rx Only

Prescription medicine · Provepharm Inc. · 2160 packs/5 ampules per pack = 10,800 ampules affected

Discoloration

Food & drug recall · FDANovember 22, 2024Serious

Jubilant Draximage Inc., dba Jubilant Radiopharma — Kit for the Preparation of Technetium Tc 99m Sulfur Colloid Injection, 10 mL Multi-Dose Reaction Vial, 5 vial Box, Rx Only

Prescription medicine · Jubilant Draximage Inc., dba Jubilant… · 5209 kits affected

Failed Stability Specifications

Food & drug recall · FDANovember 22, 2024Serious

Generitech Corporation — 10 Irregular Pigmentation, Accelerator, Pigment Fading Activator, Only Your Rx, Nature + Science, 1 fl. oz., 30 mL Bottle, For Professional Use Only, Only YourRx Inc., Chatsworth, CA 91311, Made in USA, Onlyyourrx.c

Prescription medicine · Generitech Corporation · 77.5lbs affected

CGMP Deviations: Inconsistency in the water systems.

Food & drug recall · FDANovember 22, 2024Serious

Apothecus Pharmaceutical Corp. — VCF, Vaginal Contraceptive Gel, Birth Control, 10 Pre-filled Applicators, Net Wt. 0.09 oz (2.55g) Each

Prescription medicine · Apothecus Pharmaceutical Corp. · 33,659 retail boxes in US affected

CGMP deviations: out of specifications for assay

Food & drug recall · FDANovember 22, 2024Labelling issue

Dr. Reddy's Laboratories, Inc. — Javygtor (sapropterin dihydrochloride) Tablets 100mg, 120-count bottle, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540 Made in India, NDC 43598-096-04.

Prescription medicine · Dr. Reddy's Laboratories, Inc. · 7,233 bottles affected

Failed Impurities/Degradation Specifications

Food & drug recall · FDANovember 19, 2024Serious

Mylan Institutional, Inc. — Levothyroxine Sodium Tablets, USP, 125 mcg (0.125 mg), 100 Tablets per carton (10 unit dose blister cards of 10 tablets each), Rx only

Prescription medicine · Mylan Institutional, Inc. · 1,664 cartons affected

Subpotent and Superpotent Drug

Food & drug recall · FDANovember 19, 2024Serious

Mylan Institutional, Inc. — Levothyroxine Sodium Tablets, USP, 100 mcg (0.1 mg), 100 Tablets per carton (10 unit dose blister cards of 10 tablets each), Rx only

Prescription medicine · Mylan Institutional, Inc. · 2,835 cartons affected

Subpotent and Superpotent Drug

Food & drug recall · FDANovember 19, 2024Serious

Rising Pharma Holding, Inc. — Duloxetine Delayed-Release Capsules USP, 30 mg, a) 30 count (NDC 57237-018-30), b) 90 count (NDC 57237-018-90) and c) 1000 count (NDC 57237-018-99) bottles, Rx only

Prescription medicine · Rising Pharma Holding, Inc. · 122,925 bottles affected

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

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