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Browse Drug Recalls

1,309 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 1,309 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 1,309 FDA drug recalls in 2014.

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DateProductReasonClassFirm
May 12, 2014 Papaverine HCl 30 mg, Phentolamine Mesylate 1 mg, Alprostadil 10 mcg, a) 5 mL... Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled inje... Class II John W Hollis Inc
May 12, 2014 LIPOTROPIC GOLD, Each mL contains: Levocarnitine 5 mg, Thiamine 50 mg, Ribofl... Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled inje... Class II John W Hollis Inc
May 12, 2014 Papaverine HCl 30 mg, Phentolamine Mesylate 0.5 mg, Alprostadil 10 mcg, a) 5 ... Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled inje... Class II John W Hollis Inc
May 12, 2014 Polidocanol 5% Solution for Injection, each mL contains Polidocanol (Laureth ... Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled inje... Class II John W Hollis Inc
May 12, 2014 B-Complex/Adenosine Inj sol, Adenosine-5-Monophosphate 0.03g, Choline Chlorid... Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled inje... Class II John W Hollis Inc
May 12, 2014 METHYLCOBALAMIN FOR INTRAMUSCULAR OR SUBCUTANEOUS USE ONLY, Methylcobalamin 1... Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled inje... Class II John W Hollis Inc
May 12, 2014 Testosterone Cypionate for Injection, each mL contains Testosterone Cypionate... Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled inje... Class II John W Hollis Inc
May 12, 2014 Papaverine HCl 30 mg, Phentolamine Mesylate 1 mg, a) 5 mL and b) 10 mL, JOHN ... Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled inje... Class II John W Hollis Inc
May 12, 2014 0.9 % Sodium Chloride Injection, USP, 1000 mL in VIAFLEX Plastic Container, B... Presence of Particulate Matter; blue polyisoprene shavings found inside the bag port tubes Class I Baxter Healthcare Corp.
May 12, 2014 MIC PLUS B12, Adenosine, L-Carnitine, Contains: Methionine 15mg, Choline 100... Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled inje... Class II John W Hollis Inc
May 12, 2014 CYANOCOBALAMIN FOR INTRAMUSCULAR OR SUBCUTANEOUS USE ONLY, Each mL contains: ... Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled inje... Class II John W Hollis Inc
May 8, 2014 PROMETHAZINE HYDROCHLORIDE Tablets, USP, 25 mg, 100 Tablet Bottles, Rx Only. ... Presence of Foreign Tablets: Presence of atenolol 25 mg tablet mixed into promethazine 25 mg tabl... Class II Zydus Pharmaceuticals USA Inc
May 5, 2014 AFRICAN BLACK ANT, 2800 mg, 6 capsules per box, produced by: Qinghan Hongwei ... Marketed Without an Approved NDA/ANDA: Eugene FDA laboratory analyses determined they contain und... Class I Eugene Oregon, Inc.
May 5, 2014 Hemo-Stat Solution, Aluminum chloride 25%, in 37.2 g glass bottles, distribut... Marketed without an Approved NDA/ANDA; product is being manufactured and distributed without a ND... Class II Axcentria Pharmaceuticals, LLC
May 5, 2014 MOJO RISEN, 650 mg, 2 capsule per pouch, Distributed by: Mojo Risen, LLC, Spr... Marketed Without an Approved NDA/ANDA: Eugene FDA laboratory analyses determined they contain und... Class I Eugene Oregon, Inc.
May 5, 2014 Black Ant, 2800 mg, four capsules per box, Manufacturer Qinghai Baojiantang P... Marketed Without an Approved NDA/ANDA: Eugene FDA laboratory analyses determined they contain und... Class I Eugene Oregon, Inc.
May 2, 2014 Fosphenytoin Sodium Injection, USP, 100 mg PE/2 mL (50 mg PE/mL) (PE= phenyto... Presence of Particular Matter: Potential glass delamination and consistent with glass particulate... Class II Fresenius Kabi USA, LLC
May 2, 2014 Fosphenytoin Sodium Injection, USP, 500 mg PE/10 mL (50 mg PE/mL), (PE= pheny... Presence of Particular Matter: Potential glass delamination and consistent with glass particulate... Class II Fresenius Kabi USA, LLC
May 1, 2014 Calcitriol Oral Solution 1 mcg/mL, 15mL bottle, Rx only, Roxane Laboratories,... Failed Impurity/Degradation Specification; out of specification for trans-calcitriol degradant at... Class II Boehringer Ingelheim Roxane Inc
May 1, 2014 Dextroamphetamine Sulfate Tablets, USP, 10 mg, 100-count bottles, Rx only, Ba... Failed Impurities/Degradation Specifications: this product is being recalled due to an out of spe... Class II Teva Pharmaceuticals USA
Apr 30, 2014 Lite Fit USA, For Men & Women, Extreme Fat Burner, Suppresses Appetite, Boost... Marketed Without an Approved NDA/ANDA: Bacai, Inc. DBA Ky Duyen House is voluntarily recalling Li... Class I Bacai Inc. Dba Ky Duyen House
Apr 29, 2014 Red Yeast Rice High Potency Dietary Supplement, 600 mg, packaged in a) 120-co... Marketed Without An Approved NDA/ANDA: Product is being recalled due to excessive levels of lovas... Class II Independent Nutrition Center, Inc.
Apr 29, 2014 Tatiomax (reduced glutathione/hydrolyzed collagen) powder for injection vials... Marketed Without An Approved NDA/ANDA: Product is sold over the counter whose labeling includes d... Class II Flawless Beauty LLC
Apr 29, 2014 Sterile Water for Injection, 5 mL ampoules, packaged in 50-count ampoules per... Marketed Without An Approved NDA/ANDA: Product is sold over the counter whose labeling indicates ... Class II Flawless Beauty LLC
Apr 29, 2014 Relumins Advanced Glutathione (lyophilized glutathione/vitamin C) injectable ... Marketed Without An Approved NDA/ANDA: Product is sold over the counter whose labeling indicates ... Class II Flawless Beauty LLC
Apr 29, 2014 Laroscorbine Platinium (vitamin C/collagen) injectable I.V. solution, 1 gm/0.... Marketed Without An Approved NDA/ANDA: Product is sold over the counter whose labeling includes d... Class II Flawless Beauty LLC
Apr 29, 2014 Saluta (reduced glutathione) Powder for Injection, 600 mg/vial, packaged in 1... Marketed Without An Approved NDA/ANDA: Parenteral product is labeled for use as an antidote. Class II Flawless Beauty LLC
Apr 29, 2014 Vitamin C (ascorbic acid) Injection, USP, 500 mg per 2 mL, 50 x 2 mL ampoules... Marketed Without An Approved NDA/ANDA: Parenteral product is sold over the counter whose labeling... Class II Flawless Beauty LLC
Apr 28, 2014 TEV-TROPIN [somatropin (rDNA origin) for injection] 5 mg (15 IU) 1-count bott... Chemical Contamination: TEV-TROPIN [somatropin (rDNA origin) for injection] may contain silicone ... Class II Ferring Pharmaceuticals Inc
Apr 25, 2014 PediaCare brand NIGHTTIME MULTI-SYMPTOM Cold, (diphenhydramine HCl 6.25 mg an... Presence of Precipitate; small amounts of diphenhydramine precipitated out of solution Class III Prestige Brands Holdings
Apr 25, 2014 PediaCare brand DAY & NIGHT Value Pack DAYTIME MULTI-SYMPTOM Cold (dextrometh... Presence of Precipitate; small amounts of diphenhydramine precipitated out of solution Class III Prestige Brands Holdings
Apr 24, 2014 Diclofenac Sodium and Misoprostol Delayed-Release Tablets, 75 mg/0.2 mg, 60-c... Failed Tablet/Capsule Specifications: Recall due to complaints of split or broken tablets. Class II Actavis Laboratories, FL, Inc.
Apr 24, 2014 Famotidine Injection 20 mg, Rx Only, GALAXY Single Dose Container, Code 2G342... Presence of Particulate Matter: Baxter Healthcare Corporation has received a complaint reporting ... Class II Baxter Healthcare Corp.
Apr 24, 2014 Diclofenac Sodium and Misoprostol Delayed-Release Tablets, 50 mg/0.2 mg, 60-c... Failed Tablet/Capsule Specifications: Recall due to complaints of split or broken tablets. Class II Actavis Laboratories, FL, Inc.
Apr 23, 2014 QVAR¿ (beclomethasone dipropionate HFA), 80mcg Inhalation Aerosol, 50 metered... Defective Delivery System; defective valve Class II Teva Pharmaceuticals USA
Apr 22, 2014 Liothyronine Sodium Tablets, USP 5 mcg, Rx Only, a) 100-count bottle NDC 4279... Cross Contamination with Other Products: Four lots of Liothyronine Sodium Tablets, USP 5 mcg are ... Class II SigmaPharm Laboratories LLC
Apr 21, 2014 Marcaine (bupivacaine HCl) injection, USP, 0.25%, Preservative-Free, 10 mL (2... Presence of Particulate Matter: Confirmed customer complaint of discolored solution with visible ... Class I Hospira Inc.
Apr 21, 2014 Glycopyrrolate 0.2 mg/ml, 5 mL pre-filled syringe, Rx Only. Pharmakon Pharma... Incorrect/ Undeclared Excipient: Contains undeclared benzyl alcohol. Class II Pharmakon Pharmaceuticals
Apr 21, 2014 Midazolam HCl 2 mg/ml in 0.9% Sodium Chloride in 30 mL PVC Vial, Rx Only. Ph... Incorrect/ Undeclared Excipient: Contains undeclared benzyl alcohol. Class I Pharmakon Pharmaceuticals
Apr 21, 2014 Midazolam HCl 1 mg/ml in 0.9% Sodium Chloride in 50 mL and 100 mL IV bag, Rx ... Incorrect/ Undeclared Excipient: Contains undeclared benzyl alcohol. Class I Pharmakon Pharmaceuticals
Apr 21, 2014 Atropine Sulfate 0.4 mg/ml Injection, USP, Total Dosage 0.8 mg per 2 mL, 3 mL... Incorrect/ Undeclared Excipient: Contains undeclared benzyl alcohol. Class I Pharmakon Pharmaceuticals
Apr 21, 2014 0.9% Sodium Chloride Irrigation, USP, 1000 mL,Not for Injection, Manufacture... Presence of Particulate Matter: Nylon fibers found in a bottle of 0.9% sodium chloride for irriga... Class II Baxter Healthcare Corp.
Apr 18, 2014 Olanzapine Orally Disintegrating Tablets 5 mg, 30-count Bottle, Rx only, Manu... Subpotent Drug: Out of specification (OOS) results at the 9 month temperature point. Class III Apotex Corp.
Apr 18, 2014 1% LIDOCAINE HCl Injection, USP, Preservative-Free, 10 mg/mL, 30 mL Single-do... Presence of Particulate Matter: Confirmed customer complaint that orange and black particulates, ... Class I Hospira Inc.
Apr 17, 2014 CUBICIN (daptomycin for injection), 500 mg single-use vial, Rx only, Manufact... Presence of Particulate Matter: Customer complaint stating that one vial contained a glass shard. Class I Cubist Pharmaceuticals, Inc.
Apr 17, 2014 Wockhardt Metoprolol Succinate, Extended-Release Tablets USP, 50 mg, a)100-... Failed Dissolution Specifications: Product was out of specification (OOS) at the 12 month long te... Class III Wockhardt Usa Inc.
Apr 17, 2014 Triveen - PRx RNF Capsules, 30-count bottles, Rx only; Manufactured for: Trig... Labeling: Not Elsewhere Classified: Label indicates that the product contains Vitamin B12 (12 mic... Class III Trigen Laboratories, Inc.
Apr 16, 2014 Pristiq (desvenlafaxine) Extended-Release Tablets 50 mg, 30 count bottle, Rx ... Presence of Foreign Tablets/Capsules: Pfizer is recalling 50 mg Pristiq (desvenlafaxine) extended... Class II Pfizer Us Pharmaceutical Group
Apr 15, 2014 Children's Triacting Night Time Cold & Cough with PE (diphenhydramine hcl an... Presence of Precipitate: Small amounts of diphenydramine and mannitol precipitated out of solution. Class III P&L Developments, LLC
Apr 15, 2014 Super ARTHGOLD 500mg, 120 Capsule Bottle, Dietary Supplement. Manufactured f... Marketed Without an Approved NDA/ANDA; Product contains undeclared indomethacin, diclofenac, and ... Class I Sung Soo Kim

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.