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Browse Drug Recalls

1,733 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 1,733 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 1,733 FDA drug recalls in 2015.

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DateProductReasonClassFirm
May 15, 2015 Trimix (PGE1;PHENT;PAP) (N), injectable, (100/10/240) 10UG, 5 mL vial, Rx onl... Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection Class II Montana Compounding Pharmacy
May 15, 2015 Alprostadil (PFE1), Solution, 10 mcg/mL, injectable, 5 mL vial, Rx only, comp... Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection Class II Montana Compounding Pharmacy
May 15, 2015 Trimix (A;PH,PA) (N), injectable, 160 UG-1.2 mg-9.6/ mg/mL, 2 mL vial, Rx onl... Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection Class II Montana Compounding Pharmacy
May 15, 2015 MD-Gastroview (Diatrizoate Meglumine and Diatrizoate Sodium Solution USP); 37... Labeling: incorrect or missing lot number and/or expiration date Class II Mallinckrodt, Inc.
May 15, 2015 Trimix (A;PH,PA) (N), injectable, 80 UG-0.6 mg-4.8 mg/mL, 1 mL vial, Rx only,... Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection Class II Montana Compounding Pharmacy
May 15, 2015 Glutathione INHALATION (PF), NASAL solution, 100 mg/mL, 3 mL vial, Rx only, d... Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection Class II Montana Compounding Pharmacy
May 15, 2015 Avastin, solution, 1.25 mg/0.05mL, Injectable, Syringe, Rx only, compounded b... Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection Class II Montana Compounding Pharmacy
May 15, 2015 Trimix (PGE1;PHENT;PAP) (N), injectable, (100/10/297) 10UG, 5 mL vial, Rx onl... Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection Class II Montana Compounding Pharmacy
May 15, 2015 Alprostadil (PFE1), solution, 20 mcg/mL, injectable, 5 mL vial, Rx only, comp... Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection Class II Montana Compounding Pharmacy
May 13, 2015 Fentanyl Citrate Inj., USP, CII, 250 mcg/5 mL (50 mcg/mL) (0.05 mg/mL), Rx On... Failed Impurities/Degradation Specifications; 12 month stability testing (Expansion of RES #70548). Class III West-Ward Pharmaceutical Corp.
May 12, 2015 Famotidine Tablets, USP, 20 mg Tablets, Over the Counter, Made in India and l... CGMP Deviations: Failure of the manufacturer, Wockhardt Ltd, to adequately investigate customer c... Class II Allegiant Health
May 11, 2015 Zebeta¿ (bisoprolol fumarate), tablets, 10mg, 30-count bottle, Rx only, Manuf... Failed Dissolution Specifications: OOS result during stability testing Class II Teva Pharmaceuticals USA
May 7, 2015 QVAR (beclomethasone dipropionate HFA 40 mcg), 40 mcg Inhalation Aerosol, For... Failed Impurities/Degradation Specifications: out of specification test results for an impurity d... Class III Teva Pharmaceuticals USA
May 6, 2015 Amlodipine besylate and Atorvastatin calcium tablets, 5mg/10mg, packaged in a... Subpotent drug Class III Dr. Reddy's Laboratories, Inc.
May 6, 2015 Amlodipine besylate and Atorvastatin calcium tablets, 10mg/10mg, packaged in ... Subpotent drug Class III Dr. Reddy's Laboratories, Inc.
May 6, 2015 Amlodipine besylate and Atorvastatin calcium tablets, 10mg/40mg, 90-count bot... Subpotent drug Class III Dr. Reddy's Laboratories, Inc.
May 6, 2015 Amlodipine besylate and Atorvastatin calcium tablets, 5mg/40mg packaged in a)... Subpotent drug Class III Dr. Reddy's Laboratories, Inc.
May 4, 2015 Loratadine Orally Disintegrating Tablets USP, 10 mg, Antihistamine, Allergy R... Superpotent Drug: Out Of Specification (OOS) result for Assay. Class III Ohm Laboratories, Inc.
Apr 30, 2015 Sodium Sulfacetamide 9% and Sulfur 4.5% Wash Kit, Rx Only, Sodium Sulfacetam... Microbial Contamination of Non-Sterile Products: Product failed USP Microbial Limits Test. Class II Mission Pharmacal Co
Apr 30, 2015 Sodium Sulfacetamide 9% and Sulfur 4.5% Wash Kit with Sunscreen, Rx Only, Sun... Microbial Contamination of Non-Sterile Products: Product failed USP Microbial Limits Test. Class II Mission Pharmacal Co
Apr 29, 2015 Azithromycin Tablets, USP, 250 mg, Rx Only, packaged in a) 2 count and b) 4 c... cGMP Deviations: This recall is a result of the original manufacturer's recall, in which the firm... Class II PD-Rx Pharmaceuticals, Inc.
Apr 29, 2015 Azithromycin 500 mg tablets, Rx Only, packaged in a) 1 count, b) 2 count, c) ... cGMP Deviations: This recall is a result of the original manufacturer's recall, in which the firm... Class II PD-Rx Pharmaceuticals, Inc.
Apr 29, 2015 Ortho-Cept (0.15 mg desogestrel and 0.03 mg ethinyl estradiol) tablets, 28- c... Subpotent Drug Class II Janssen Pharmaceuticals, Inc.
Apr 28, 2015 PHENYLephrine HCl 50 mg in 0.9% Sodium Chloride 250 mL bag (Concentration = 0... Labeling: Label Mix-Up: Product is incorrectly labeled as phenylephrine 50 mg in 0.9% sodium chlo... Class II SCA Pharmaceuticals
Apr 28, 2015 KABIVEN [(3.9%) Lipid Injectable Emulsion with (3.1%) Amino Acids and Electro... Labeling: Label Error on Declared Strength: Labeled 3.1% Amino Acids but contains 3.3% Amino Acids Class II Fresenius Kabi USA, LLC
Apr 28, 2015 Adrucil (fluorouracil injection, USP) Pharmacy Bulk Package Not for Direct In... Presence of Particulate Matter: Black particulate matter was identified as aggregate of silicone ... Class I Teva Pharmaceuticals USA
Apr 24, 2015 Levalbuterol Inhalation Solution, USP, 0.31 mg/ 3 mL, 3 mL Vials, Rx Only. Ma... Failed Impurities/Degradation Specifications: Product is out of specification for a known degradant. Class III Cipla Limited
Apr 24, 2015 Alinia (nitazoxanide), powder for oral suspension, 100mg/5mL, 60 mL/bottle. R... Failed Stability Specifications: Product failed to meet 12 months long term stability specificati... Class II Romark Laboratories, L.C.
Apr 23, 2015 Bi-Est (estriol,estradiol), Progesterone Vaginal Suppository, Rx only, Manufa... Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin. Class II South Coast Specialty Compounding, Inc.
Apr 23, 2015 Estradiol, Estriol capsules, Rx only, Manufactured by Park Compounding, Irvin... Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin. Class II South Coast Specialty Compounding, Inc.
Apr 23, 2015 Bi-Est 80:20 Progesterone (estriol,estradiol, progesterone) capsules, Rx only... Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin. Class II South Coast Specialty Compounding, Inc.
Apr 23, 2015 Bi-Est (estriol,estradiol), Progesterone, Testosterone cream, Rx only, Manufa... Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin. Class II South Coast Specialty Compounding, Inc.
Apr 23, 2015 Meloxicam capsules, 12 mg, Rx Only, Manufactured by Park Compounding, Irving,... Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin. Class II South Coast Specialty Compounding, Inc.
Apr 23, 2015 Chorionic Gonadotropin/ Hydroxocobalamin Lyophilized Powder Injectable, 10,00... Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin. Class II South Coast Specialty Compounding, Inc.
Apr 23, 2015 Methyl Folate Lyophilized Powder for Injection, 20 mg per vial, Rx Only, Manu... Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin. Class II South Coast Specialty Compounding, Inc.
Apr 23, 2015 Cytarabine Injection 100 mg/5 mL (20 mg/mL), 5 mL Single-Dose Vial (NDC 0069-... Presence of Particulate Matter Class I Mylan Institutional LLC
Apr 23, 2015 Bi-Est (estriol,estradiol) Testosterone cream, Rx only, Manufactured by Park ... Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin. Class II South Coast Specialty Compounding, Inc.
Apr 23, 2015 Leucovorin Calcium capsules, 10 mg, Rx only, Manufactured by Park Compounding... Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin. Class II South Coast Specialty Compounding, Inc.
Apr 23, 2015 KETOROLAC TROM 30 MG/ML INJ, 1 mL glass vials repackaged individually inside ... Crystallization Class II RemedyRepack Inc.
Apr 23, 2015 Artesunate Lyophilized Powder for Injection, 60 mg per vial, Rx only, Manufac... Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin. Class II South Coast Specialty Compounding, Inc.
Apr 23, 2015 Estriol,Estradiol cream, Rx only, Manufactured by Park Compounding, Irvine, CA Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin. Class II South Coast Specialty Compounding, Inc.
Apr 23, 2015 Bi-Est (estriol,estradiol), Progesterone, DHEA, Testosterone drops, Rx only, ... Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin. Class II South Coast Specialty Compounding, Inc.
Apr 23, 2015 Tri-Est 80:10:10 Progesterone (estriol, estradiol, estrone, progesterone) cap... Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin. Class II South Coast Specialty Compounding, Inc.
Apr 23, 2015 Bupivacaine Hydrochloride Inj., USP, 0.5% (5 mg/mL), Preservative-Free, 30 mL... Presence of Particulate Matter: Presence of free-floating and embedded iron oxide particles. Class I Hospira Inc.
Apr 23, 2015 Estradiol, Estriol, Progesterone capsules, Rx only, Manufactured by Park Comp... Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin. Class II South Coast Specialty Compounding, Inc.
Apr 23, 2015 Estradiol cream, Rx only, Manufactured by Park Compounding, Irvine, CA Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin. Class II South Coast Specialty Compounding, Inc.
Apr 22, 2015 Famotodine Tablets, USP, 20 mg Tablets, Packaged in A) 30 Count Bottles (NDC... CGMP Deviations: Firm did not adequately investigate customer complaints. Class II Wockhardt Usa Inc.
Apr 22, 2015 Famotodine Tablets, USP, 20 mg Tablets, For Repacking Only, Packaged in 6500 ... CGMP Deviations: Firm did not adequately investigate customer complaints. Class II Wockhardt Usa Inc.
Apr 22, 2015 Clarithromycin Tablets, USP, 500 mg Tablets, 60 Count Bottles, Rx Only. Manuf... CGMP Deviations: Firm did not adequately investigate customer complaints. Class II Wockhardt Usa Inc.
Apr 22, 2015 Famotodine Tablets, USP, 40 mg Tablets, Packaged in A) 30 Count Bottles (NDC... CGMP Deviations: Firm did not adequately investigate customer complaints. Class II Wockhardt Usa Inc.

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.