Browse Drug Recalls

2,029 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 2,029 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 2,029 FDA drug recalls.

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DateProductReasonClassFirm
Oct 19, 2016 Invokamet (canagliflozin and metformin HCl) tablets, 150 mg/1,000 mg, 60-coun... Labeling: Incorrect or Missing Package Insert - Xarelto prescribing information outserts may be a... Class III Janssen Ortho L.L.C.
Oct 18, 2016 Zeasorb AF (miconazole nitrate), 2%, cures most athlete's foot, Net wt. 2.5 O... Labeling Not Elsewhere Classified: front labels have the incorrect NDC or 0145-1506-01 instead of... Class III GSK Consumer Healthcare
Oct 12, 2016 HCG-Vitamin B12 5000 IU-8 mg in 10 mL vial, Rx only, For Sub-Q & IM Injection... Labeling; Error on Declared Strength; product description incorrectly states HCG 7500 units inste... Class III Pharm D Solutions, LLC
Sep 16, 2016 Marcaine 0.25% (bupivacaine HCl) injection, USP, 125 mg/50 mL (2.5 mg/mL), 50... Lack of Assurance of Sterility and Subpotent Drug: defect in glass vial prevented stopper from fo... Class II Hospira Inc., A Pfizer Company
Sep 16, 2016 Marcaine 0.5% (bupivacaine HCl) injection, USP, 250 mg/50 mL (5 mg/mL), 50 mL... Lack of Assurance of Sterility and Subpotent Drug: defect in glass vial prevented stopper from fo... Class II Hospira Inc., A Pfizer Company
Sep 15, 2016 Xanax (Alprazolam) USP, CIV, 0.5 mg tablets , 10 x 10 blister cards per carto... Labeling: Missing Label-Primary packaging label (i.e. blister card) is blank and contains no prod... Class III Mckesson Packaging Services
Sep 15, 2016 PREMARIN (conjugated estrogen tablets, USP) 1.25 mg, 1000- count bottle, Rx o... Labeling: Incorrect or Missing Lot and/or Exp Date: Bottles were incorrectly labeled with an expi... Class III Pfizer Inc.
Sep 8, 2016 Lansoprazole Delayed-Release Capsules, USP, 30 mg, packaged in 100-count cart... Labeling: Label mix-up. The inner packaging was properly labeled Omeprazole DR 40mg Capsules, but... Class III Mckesson Packaging Services
Sep 1, 2016 Mozobil (plerixafor injection) 24mg/1.2mL (20mg/mL), For Single Use Only, Rx ... Labeling: Incorrect or Missing Package Insert Class III Sanofi-Aventis U.S. LLC
Aug 30, 2016 Ramipril Capsules, USP, 1.25 mg, 30-count bottle, Rx only, Manufactured by: A... Labeling: Incorrect or Missing Lot And/or Exp Date: Bottles labeled with the incorrect expiration... Class III Actavis Laboratories, FL, Inc.
Aug 19, 2016 Lamotrigine Orally Disintegrating Tablets (ODT), 200 mg, 30 Tablets 3 blister... Labeling; Label Mixup; box labeled to contain 200 mg blister packs but actually contain 100 mg bl... Class I Impax Laboratories, Inc.
Aug 18, 2016 Amoxicillin For Oral Suspension, USP - Dye Free, 400 mg/5 mL, 100 mL (when re... Labeling: Label Error on Declared Strength- bottles missing colored coded panel where strength of... Class III West-Ward Pharmaceuticals Corp.
Aug 4, 2016 Mozobil (plerixafor injection) 24 mg/1.2 mL (20 mg/mL) per vial, Rx Only, For... Labeling: Incorrect or Missing Lot and/or Exp. Date Class III Genzyme Corporation / Genzyme Biosurgery
Aug 3, 2016 Mucinex Sinus-Max Day Night, 60 caplets, Dist. by Reckitt Benckiser, Parsippa... Labeling: Label Error on Declared Strength; label on outer carton incorrectly states Diphenhydram... Class III Reckitt Benckiser LLC
Jul 29, 2016 2% Chlorhexidine Gluconate* Cloth, 2 disposable cloths per package, further p... CGMP Deviations: potential contamination of products manufactured on the same equipment and lines... Class II Sage Products LLC
Jun 28, 2016 DULOXETINE Delayed-Release Capsules, USP, 60 mg, 1000 count bottles, Rx only,... Labeling; Incorrect or Missing Lot and/or Exp Date; incorrect expiration date on container label ... Class III Golden State Medical Supply Inc.
Jun 13, 2016 Methylprednisolone Tablets, USP, 16 mg, 50-count bottles, Rx only, Manufactur... Labeling: Incorrect or Missing Lot and/or Exp Date: incorrect expiration date of 02/0218 is print... Class III Jubilant Cadista Pharmaceuticals, Inc.
Jun 10, 2016 SECONAL SODIUM (secobarbital sodium) Capsules, USP, 100 mg, 100 Ct. Bottles, ... Labeling: Incorrect or Missing Package Insert: Package insert is missing warning regarding anaphy... Class III Valeant Pharmaceuticals North America LLC
May 30, 2016 Irbesartan and Hydrochlorothiazide Tablets, USP, 300/12.5 mg, Rx only, Manufa... Labeling: Incorrect or Missing Lot and/or Exp Date: Incorrect lot number, 327B160012, appears on ... Class III Prinston Pharmaceutical Inc
May 25, 2016 Lisinopril Tablets USP, 30 mg, 100-count bottle, Rx Only, Manufactured by Sa... Labeling: Incorrect or Missing Package Insert Class III Sandoz Inc
May 23, 2016 Lodrane D (Brompheniramine maleate 4 mg and Pseudoephedrine HCl 60 mg) Capsul... Labeling: Not Elsewhere Classified: correctly labeled bottles were packaged in cartons that were ... Class III Valeant Pharmaceuticals North America LLC
May 19, 2016 Doxycycline, USP Capsules 40 mg, Packaged in 30 ct Bottles, Rx Only. Markete... Labeling: Incorrect Or Missing Lot and/or Exp Date: Some expiries and lot numbers are missing. Class III Galderma Laboratories, L.P.
May 16, 2016 Potassium CHLORide added to 5% Dextrose Injection, 20 mEq 250 mL Bag, PharMED... Labeling: Not Elsewhere Classified: Potassium Chloride was printed on Potassium Phosphate label s... Class II Pharmedium Services, LLC
May 10, 2016 Coppertone SUNSCREEN LOTION, CLEARLY SHEER, BROAD SPECTRUM SPF 50, 5 FL OZ (1... Labeling; Product Contains Undeclared API (Oxybenzone) Class II Bayer Health Care LLC
Apr 29, 2016 BLACK LABEL X capsules, 60-count bottles, Manufactured for: Making it A Lifes... Marketed without an approved NDA/ANDA - presence of undeclared sildenafil. Class I Making It a Lifestyle
Apr 27, 2016 Hectorol (doxercalciferol injection) 2 mcg/1mL, Rx only, Manufactured by: Ge... Labeling: Wrong barcode. An incorrect bar code was noted on the vial label of Hectorol 2 mcg/1mL ... Class III Genzyme Corporation / Genzyme Biosurgery
Apr 22, 2016 Acetaminophen & Codeine Phosphate Tablets, 300 mg/30 mg, 15-count plastic bot... Labeling: Not elsewhere classified - count on the label was incorrect. Class III A-S Medication Solutions LLC.
Apr 20, 2016 FARSER KAI YEUNG PILL, packaged in a bottle within a box, Made in The People... Marketed Without An Approved NDA/ANDA: Products marked as dietary supplements have labeling that ... Class II Murray International Trading Co., Inc.
Apr 20, 2016 FUCONPO CAPSULE, packaged in a 30-count bottle within a box, remaining labeli... Marketed Without An Approved NDA/ANDA: Products marked as dietary supplements have labeling that ... Class II Murray International Trading Co., Inc.
Apr 20, 2016 FUQINGSONG RELIEF CREAM (Flucinonide Ointment), packaged in 50-count individu... Marketed Without An Approved NDA/ANDA: Products marked as dietary supplements have labeling that ... Class II Murray International Trading Co., Inc.
Apr 20, 2016 GASTRODIA CAPSULES, packaged in 30-count bottles within a box, LANZHOU MANUFA... Marketed Without An Approved NDA/ANDA: Products marked as dietary supplements have labeling that ... Class II Murray International Trading Co., Inc.
Apr 20, 2016 CROCODILE BILE PILL FOR ASTHMA, packaged in 100-count bottles within a box, r... Marketed Without An Approved NDA/ANDA: Products marked as dietary supplements have labeling that ... Class II Murray International Trading Co., Inc.
Apr 20, 2016 Tien Ma Tou Tong Wan (Condensed pills), packaged in 100-count bottles within ... Marketed Without An Approved NDA/ANDA: Products marked as dietary supplements have labeling that ... Class II Murray International Trading Co., Inc.
Apr 20, 2016 PEKING NIU-HUANG CHIEH-TU-PIEN Tablets (Sugar Coated), packaged in 50-count b... Marketed Without An Approved NDA/ANDA: Products marked as dietary supplements have labeling that ... Class II Murray International Trading Co., Inc.
Apr 20, 2016 PATCH-REMOUING PILL (For Facial Pigmentation), packaged in a bottle within a ... Marketed Without An Approved NDA/ANDA: Products marked as dietary supplements have labeling that ... Class II Murray International Trading Co., Inc.
Apr 20, 2016 ChingChunBao ANTI-AGING TABLETS, packaged in 80-count bottles within a box, U... Marketed Without An Approved NDA/ANDA: Products marked as dietary supplements have labeling that ... Class II Murray International Trading Co., Inc.
Apr 20, 2016 LARYNGITIS PILLS Herbal Supplement, packaged in 10-count packets containing 3... Marketed Without An Approved NDA/ANDA: Products marked as dietary supplements have labeling that ... Class II Murray International Trading Co., Inc.
Apr 20, 2016 WUPOOSER KAI YEUNG PILL, packaged in a bottle within a box, Made in The Peopl... Marketed Without An Approved NDA/ANDA: Products marked as dietary supplements have labeling that ... Class II Murray International Trading Co., Inc.
Apr 20, 2016 PING ON OINTMENT RELIEF FOR MUSCULAR PAIN, packaged in a packet of 12-count 8... Marketed Without An Approved NDA/ANDA: Products marked as dietary supplements have labeling that ... Class II Murray International Trading Co., Inc.
Apr 20, 2016 Te Xiao BaiNeiTing Herbal Supplement (Naphazoline HCl Solution 0.1%) liquid, ... Marketed Without An Approved NDA/ANDA: Products marked as dietary supplements have labeling that ... Class II Murray International Trading Co., Inc.
Apr 20, 2016 SCIATICA PILLS, packaged in 120-count bottles within a box, Made in the Peopl... Marketed Without An Approved NDA/ANDA: Products marked as dietary supplements have labeling that ... Class II Murray International Trading Co., Inc.
Apr 12, 2016 SKY Aspirin Chewable Tablets, 81 mg, Unit Dose 750 tablets (25 x 30) box, OTC... Labeling: Label mix-up -outer carton incorrectly labeled as aspirin chewable tablets. Class III Mckesson Packaging Services
Apr 7, 2016 Good Neighbor Pharmacy PEG-Phen Lubricant Eye Drops (Polyethylene Glycol 400 ... Presence of Particulate Matter Class II Akorn, Inc.
Apr 5, 2016 Cisatracurium Besylate Injection, 20 mg per 10 mL (2 mg per mL), For intraven... Incorrect/ Undeclared Excipient: Firm is recalling product due to an incorrect statement of Pres... Class II Fresenius Kabi USA, LLC
Mar 31, 2016 Fenofibrate Capsules (Micronized), 134 mg Capsules, 20-count Unit Dose Bliste... Labeling: Incorrect or Missing Lot and/or Exp Date Class III Amerisource Health Services
Mar 31, 2016 Fenofibrate Capsules (Micronized), 200 mg , 30-count Unit Dose Blister Packs ... Labeling: Incorrect or Missing Lot and/or Exp Date Class III Amerisource Health Services
Mar 30, 2016 PHENYLephrine 1 mg/10 mL (100 mcg/mL) in 0.9% Sodium Chloride, 10 mL syringe,... Labeling: Label Error on Declared Strength. Product has correct label on the syringe and the case... Class I QuVa Pharma, Inc.
Mar 25, 2016 CAP-BIOTIN 100 MG, Rx Only, Compounded by RELIABLE COMPOUNDING PHARMACY, 801 ... Labeling: Label Mix-Up: Products labeled Biotin 100 mg found to contain 4-aminopyridine Class I Reliable Rexall-A Compounding Pharmacy
Mar 25, 2016 Venlafaxine 75 mg Tablet, Compare to Effexor 75 mg Tablet, a) 30-count bottle... Labeling: Label Mix-Up: Bryant Ranch received Tevas venlafaxine hydrochloride extended-release ta... Class III Bryant Ranch Prepack Inc.
Mar 24, 2016 Escitalopram Tablets USP 20 mg, 100-count bottles, Rx Only, Manufactured for:... Labeling: Incorrect or Missing Lot and/or Expiration Date Class III Lupin Limited

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.