Browse Drug Recalls

2,085 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 2,085 FDA drug recall enforcement actions. Each entry includes the product description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.

Drug Safety Recalls

Browse 2,085 FDA drug recalls in 2013.

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Date	Product	Reason	Class	Firm
Jul 19, 2013	Oxycodone and Acetaminophen Capsules, USP 5mg/500 mg, packaged in a)100-count...	Subpotent drug: Two lots of Oxycodone and Acetaminophen Capsules, USP 5/500 mg are being recalled...	Class III	Watson Laboratories Inc
Jul 18, 2013	TUMS, Antacid/Calcium Supplement, ULTRA Strength 1000, Assorted Berries, 72 C...	Presence of Foreign Tablets/Capsules: Product labeled TUMS Ultra Assorted Berries 1000mg Chewable...	Class III	GlaxoSmithKline, LLC.
Jul 18, 2013	ALCOHOL FREE ANTISEPTIC (cetylpyridinium chloride) Mouth Rinse, 0.07%, mint, ...	Microbial Contamination of Non-Sterile Products: This product is being recalled because a stabili...	Class III	Vi-Jon, Inc.
Jul 17, 2013	Acyclovir Tablets USP 800 mg ,(NDC 60505-5307-1), Rx only, Manufactured by A...	Presence of Particulate Matter: Product from lot KF2199, may contain tablets with pieces of nitri...	Class II	Apotex Inc.
Jul 15, 2013	Braintree HalfLytely and Bisacodyl Tablet Bowel Prep Kit (Rx) NDC 52268-523-02	Defective Container; Small micro fracture observed in the 2-Liter bottle at the fill line resulti...	Class III	Braintree Laboratories Inc.
Jul 12, 2013	0.75% Bupivacaine HCl Injection, USP, 7.5 mg/mL, 30 mL, Single-dose, Hospira ...	Presence of particulate matter: visible free floating and partially embedded particulate matter i...	Class I	Hospira Inc.
Jul 12, 2013	0.25% Bupivacaine HCl Injection, USP, 2.5 mg/mL, 30 mL, Single-dose, Hospira ...	Presence of particulate matter: visible free floating and partially embedded particulate matter i...	Class I	Hospira Inc.
Jul 4, 2013	Nystatin Oral Suspension, USP 500,000 units/ 5 mL (NDC 66689-037-01 ) Rx Onl...	Failed Impurites/Degradation Specifications: Test failure of single largest peak at 18 months.	Class II	VistaPharm, Inc.
Jul 3, 2013	DayQuil Sinex DayTime Sinus Relief (acetaminophen 325 mg and phenylephrine HC...	Unit Dose Mispackaging: Product packaging defect which could result in code date smearing, incomp...	Class II	Procter & Gamble Co
Jul 2, 2013	MERCapsuleTOPURINE, Tablet, 50 mg, Rx only, Distributed by: AidaPak Service, ...	Labeling: Label Mixup: MERCapsuleTOPURINE, Tablet, 50 mg may have potentially been mislabeled as ...	Class II	Aidapak Services, LLC
Jul 2, 2013	SELENIUM, Tablet, 50 mcg, Over The Counter, Distributed by: AidaPak Service, ...	Labeling: Label Mixup :SELENIUM, Tablet, 50 mcg may have potentially been mislabeled as the follo...	Class II	Aidapak Services, LLC
Jul 2, 2013	CHOLECALCIFEROL, Capsule, 5000 units, Over The Counter, Distributed by: AidaP...	Labeling: Label Mixup; CHOLECALCIFEROL, Capsule, 5000 units may be potentially mislabeled as ...	Class II	Aidapak Services, LLC
Jul 2, 2013	VENLAFAXINE HCL, Tablet, 100 mg, Rx only, Distributed by: AidaPak Service, LL...	Labeling: Label Mixup: VENLAFAXINE HCL, Tablet, 100 mg may have potentially was mislabeled as tiZ...	Class II	Aidapak Services, LLC
Jul 2, 2013	hydrALAZINE HCl Tablet, 100 mg, Rx only, Distributed by: AidaPak Service, LLC...	Labeling: Label Mixup; hydrALAZINE HCl Tablet, 100 mg may be potentially mislabeled as DOXEPIN...	Class II	Aidapak Services, LLC
Jul 2, 2013	ASCORBIC ACID, Tablet, 500 mg, Over The Counter, Distributed by: AidaPak Serv...	Labeling: Label Mixup: ASCORBIC ACID, Tablet, 500 mg may have potentially been mislabeled as the ...	Class II	Aidapak Services, LLC
Jul 2, 2013	CALCITRIOL, Capsule, 0.25 mcg, Rx only, Distributed by: AidaPak Service, LLC,...	Labeling: Label Mixup: CALCITRIOL, Capsule, 0.25 mcg may be potentially as one of the following d...	Class II	Aidapak Services, LLC
Jul 2, 2013	POTASSIUM ACID PHOSPHATE, Tablet, 500 mg, Rx only, Distributed by: AidaPak Se...	Labeling: Label Mixup: POTASSIUM ACID PHOSPHATE, Tablet, 500 mg may have potentially been mislabe...	Class II	Aidapak Services, LLC
Jul 2, 2013	CHOLECALCIFEROL/ CALCIUM/ PHOSPHORUS Tablet, 120 units/105 mg/81 mg, Over The...	Labeling: Label Mixup; CHOLECALCIFEROL/CALCIUM/PHOSPHORUS Tablet, 120 units/105 mg/81 mg may be p...	Class II	Aidapak Services, LLC
Jul 2, 2013	OMEPRAZOLE/SODIUM BICARBONATE, Capsule, 20 mg/110 mg, Rx only, Distributed by...	Labeling: Label Mixup; OMEPRAZOLE/SODIUM BICARBONATE, Capsule, 20 mg/110 mg may be potentially mi...	Class II	Aidapak Services, LLC
Jul 2, 2013	LORazepam, Tablet, 0.25 mg (1/2 of 0.5 mg), Rx only, Distributed by: AidaPak ...	Labeling: Label Mixup: LORazepam, Tablet, 0.25 mg (1/2 of 0.5 mg) may have potentially been misla...	Class II	Aidapak Services, LLC
Jul 2, 2013	NIACIN TR, Tablet, 1000 mg, Rx only, Distributed by: AidaPak Service, LLC, ND...	Labeling: Label Mixup: NIACIN TR, Tablet, 1000 mg may have potentially been mislabeled as the fol...	Class II	Aidapak Services, LLC
Jul 2, 2013	ACARBOSE, Tablet 25 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 23...	Labeling: Label Mixup; ACARBOSE Tablet, 25 mg may be potentially mislabeled as LACTOBACILLUS G...	Class II	Aidapak Services, LLC
Jul 2, 2013	VITAMIN B COMPLEX W/C, Tablet, 0 mg, Over The Counter, Distributed by: AidaPa...	Labeling: Label Mixup: VITAMIN B COMPLEX W/C, Tablet, 0 mg may have potentially been mislabeled a...	Class II	Aidapak Services, LLC
Jul 2, 2013	VERAPAMIL HCL ER, Tablet, 240 mg, Rx only, Distributed by: AidaPak Service, L...	Labeling:Label Mixup; VERAPAMIL HCL ER, Tablet, 240 mg may be potentially mislabeled as TRIFLU...	Class II	Aidapak Services, LLC
Jul 2, 2013	RAMIPRIL, Capsule, 2.5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC...	Labeling:Label Mixup; RAMIPRIL, Capsule, 2.5 mg, Rx only may be potentially mislabeled as PROP...	Class II	Aidapak Services, LLC
Jul 2, 2013	RILUZOLE, Tablet, 50 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 0...	Labeling: Label Mixup: RILUZOLE, Tablet, 50 mg may have potentially been mislabeled as the follow...	Class II	Aidapak Services, LLC
Jul 2, 2013	MYCOPHENOLATE MOFETIL, Capsule, 250 mg, Rx only, Distributed by: AidaPak Serv...	Labeling: Label Mixup: MYCOPHENOLATE MOFETIL, Capsule, 250 mg may be potentially mis-labeled as t...	Class II	Aidapak Services, LLC
Jul 2, 2013	ASCORBIC ACID, Tablet, 250 mg, Over The Counter, Distributed by: AidaPak Serv...	Labeling: Label Mixup: ASCORBIC ACID, Tablet, 250 mg may have potentially been mislabeled as one ...	Class II	Aidapak Services, LLC
Jul 2, 2013	PSEUDOEPHEDRINE HCL, Tablet, 60 mg, Rx in Oregon, Distributed by: AidaPak Ser...	Labeling: Label Mixup; PSEUDOEPHEDRINE HCL, Tablet, 60 mg may be potentially mislabeled as RE...	Class II	Aidapak Services, LLC
Jul 2, 2013	NIACIN TR, Tablet, 750 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC...	Labeling: Label Mixup: NIACIN TR, Tablet, 750 mg may have potentially been mislabeled as the foll...	Class II	Aidapak Services, LLC
Jul 2, 2013	PIOGLITAZONE, Tablet, 15 mg, Rx only, Distributed by: AidaPak Service, LLC, N...	Labeling: Label Mixup: PIOGLITAZONE, Tablet, 15 mg may have potentially been mislabeled as one of...	Class II	Aidapak Services, LLC
Jul 2, 2013	TRIFLUOPERAZINE HCL, Tablet, 1 mg, Rx only, Distributed by: AidaPak Service, ...	Labeling: Label Mixup: TRIFLUOPERAZINE HCL, Tablet, 1 mg may have potentially been mislabeled as ...	Class II	Aidapak Services, LLC
Jul 2, 2013	ASPIRIN/ER DIPYRIDAMOLE, Capsule, 25 mg/200 mg, Rx only, Distributed by: Aida...	Labeling: Label Mixup: ASPIRIN/ER DIPYRIDAMOLE, Capsule, 25 mg/200 mg may have potentially been m...	Class II	Aidapak Services, LLC
Jul 2, 2013	TEMAZEPAM, Capsule, 7.5 mg, Rx only, Distributed by: AidaPak Service, LLC, ND...	Labeling: Label Mixup: TEMAZEPAM, Capsule, 7.5 mg may have potentially been mislabeled as one of ...	Class II	Aidapak Services, LLC
Jul 2, 2013	CapsuleTOPRIL, Tablet, 12.5 mg, Rx only, Distributed by: AidaPak Service, LLC...	Labeling: Label Mixup: CapsuleTOPRIL, Tablet, 12.5 mg may have potentially been mislabeled as the...	Class II	Aidapak Services, LLC
Jul 2, 2013	GLUCOSAMINE/CHONDROITIN DS, Tablet, 500 mg/400 mg, Over The Counter, Distribu...	Labeling: Label Mixup; GLUCOSAMINE/CHONDROITIN DS, Tablet, 500 mg/400 mg may be potentially misla...	Class II	Aidapak Services, LLC
Jul 2, 2013	SENNOSIDES, Tablet, 8.6 mg, Over The Counter, Distributed by: AidaPak Service...	Labeling: Label Mixup: SENNOSIDES, Tablet, 8.6 mg may have potentially been mislabeled as one of ...	Class II	Aidapak Services, LLC
Jul 2, 2013	LIOTHYRONINE SODIUM, Tablet, 25 mcg, Rx only, Distributed by: AidaPak Service...	Labeling: Label Mixup: LIOTHYRONINE SODIUM, Tablet, 25 mcg may have potentially been mislabeled a...	Class II	Aidapak Services, LLC
Jul 2, 2013	MIRTAZAPINE Tablet, 7.5 mg, Rx only, Distributed by: AidaPak Service, LLC, N...	Labeling:Label Mixup; MIRTAZAPINE Tablet, 7.5 mg may be potentially mislabeled as ISONIAZID, T...	Class II	Aidapak Services, LLC
Jul 2, 2013	MINOCYCLINE HCL, Capsule, 50 mg, Rx only, Distributed by: AidaPak Service, LL...	Labeling: Label Mixup: MINOCYCLINE HCL, Capsule, 50 mg may have potentially been mislabeled as th...	Class II	Aidapak Services, LLC
Jul 2, 2013	tiZANidine HCl Tablet, 2 mg, Rx only, Distributed by: AidaPak Service, LLC, ...	Labeling:Label Mixup; tiZANidine HCl Tablet, 2 mg may be potentially mislabeled as RIBAVIRIN, ...	Class II	Aidapak Services, LLC
Jul 2, 2013	TACROLIMUS, Capsule, 0.5 mg, Rx only, Distributed by: AidaPak Service, LLC, N...	Labeling: Label Mixup: TACROLIMUS, Capsule, 0.5 mg may have potentially been mislabeled as one of...	Class II	Aidapak Services, LLC
Jul 2, 2013	VITAMIN B COMPLEX, Capsule, 0 mg, Over The Counter, Distributed by: AidaPak S...	Labeling: Label Mixup: VITAMIN B COMPLEX, Capsule, 0 mg may have potentially been mislabeled as t...	Class II	Aidapak Services, LLC
Jul 2, 2013	SIROLIMUS, Tablet, 1 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 0...	Labeling: Label Mixup: SIROLIMUS, Tablet, 1 mg may be potentially mislabeled as one of the follow...	Class II	Aidapak Services, LLC
Jul 2, 2013	RALOXIFENE HCL, Tablet, 60 mg, Rx only, Distributed by: AidaPak Service, LLC,...	Labeling: Label Mixup: RALOXIFENE HCL, Tablet, 60 mg may be potentially mis-labeled as following ...	Class II	Aidapak Services, LLC
Jul 2, 2013	MULTIVITAMIN/MULTIMINERAL W/IRON, CHEW Tablet, 0 mg, Over The Counter, Distri...	Labeling: Label Mixup: MULTIVITAMIN/MULTIMINERAL W/IRON, CHEW Tablet, 0 mg may have potentially b...	Class II	Aidapak Services, LLC
Jul 2, 2013	carBAMazepine ER, Tablet, 100 mg, Rx only, Distributed by: AidaPak Service, L...	Labeling: Label Mixup: carBAMazepine ER, Tablet, 100 mg may have potentially been mislabeled as o...	Class II	Aidapak Services, LLC
Jul 2, 2013	NIACIN TR, Tablet, 500 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC...	Labeling: Label Mixup; NIACIN TR, Tablet, 500 mg may be potentially mislabeled as LACTOBACILLU...	Class II	Aidapak Services, LLC
Jul 2, 2013	PROPRANOLOL HCL Tablet, 10 mg, Rx only, Distributed by: AidaPak Service, LLC,...	Labeling: Label Mixup; PROPRANOLOL HCL Tablet, 10 mg may be potentially mislabeled as LACTOBAC...	Class II	Aidapak Services, LLC
Jul 2, 2013	CINACALCET HCL Tablet, 30 mg, Rx only, Distributed by: AidaPak Service, LLC, ...	Labeling:Label Mixup; CINACALCET HCL, Tablet, 30 mg may be potentially mislabeled as ACETAMINO...	Class II	Aidapak Services, LLC

Frequently Asked Questions

When a drug safety issue is identified — through FDA inspections, laboratory testing, adverse event reports, or manufacturer quality checks — the responsible company issues a recall to remove the affected products from the market. Pharmacies pull the product from shelves, and consumers are advised to contact their healthcare provider for alternatives.

The leading causes include cGMP deviations, impurity contamination (including nitrosamines like NDMA), failed dissolution or stability testing, sterility issues, potency problems, labeling errors, and foreign particle contamination.

Use the search and filter tools on this page to look up specific medications, active ingredients, or manufacturers. Each recall entry includes the product description, lot numbers, and distribution details.