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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Dec 4, 2014 | Eye Drops A.C. (Tetrahydrozoline HCl 0.05%, Zinc sulfate 0.25%), 0.5 FL OZ (1... | CGMP Deviations: Active Pharmaceutical Ingredient (API) used for manufacture was stored in a non-... | Class III | K C Pharmaceuticals Inc |
| Dec 4, 2014 | Eye Drops Advanced Relief (Dextran 70 0.1%, Polyethylene glycol 400 1%, Povid... | CGMP Deviations: Active Pharmaceutical Ingredient (API) used for manufacture was stored in a non-... | Class III | K C Pharmaceuticals Inc |
| Dec 4, 2014 | Eye Drops (Tetrahydrozoline HCl 0.05%), 0.5 FL OZ (15 mL) Bottles, Over the C... | CGMP Deviations: Active Pharmaceutical Ingredient (API) used for manufacture was stored in a non-... | Class III | K C Pharmaceuticals Inc |
| Dec 4, 2014 | Eye Drops Industrial Strength (Polyethylene glycol 400 1%, Tetrahydrozoline H... | CGMP Deviations: Active Pharmaceutical Ingredient (API) used for manufacture was stored in a non-... | Class III | K C Pharmaceuticals Inc |
| Nov 25, 2014 | Dacarbazine, Injection, USP, 200mg, vials packaged in individual cartons, Rx... | Discoloration: Reconstituted solution may appear pink instead of colorless to pale yellow when st... | Class III | Hospira Inc. |
| Nov 10, 2014 | Potassium Chloride Injection, 10mEq per 100mL, 100 mL Sterile single dose con... | Labeling: Label Error On Declared Strength: Bags of Potassium Chloride 10 mEq per 100 mL were inc... | Class II | Baxter Healthcare Corp. |
| Nov 7, 2014 | Sterile powder Vancomycin Hydrochloride for Injection, USP, Equivalent to 1 g... | Correct Labeled Product Mispack: Product tray containing vials was mislabeled to contain another ... | Class III | Hospira Inc. |
| Oct 17, 2014 | Obagi Nu-Derm Clear, AM PM 3, Skin Bleaching and Corrector Cream, Hydroquinon... | Labeling: Label Mix-Up; Containers of the Obagi Nu-Derm Clear pre-labeled bottles were inadverten... | Class II | Obagi Medical Products |
| Oct 10, 2014 | Assured Naproxen Sodium Tablets, USP 220 mg., 15 count bottle, Repackaged by ... | Correct Labeled Product Mispacked; correct labeled bottles of Assured Ibuprofen softgels were pac... | Class II | Contract Packaging Resources Inc. |
| Oct 7, 2014 | ZEE Aspirin 325mg - 24 tablets in single dose packets, OTC, Manufactured for ... | Incorrect/Undeclared Excipients: ZEE Medical is recalling ZEE Aspirin due to the incorrect listin... | Class II | Zee Medical Products Inc |
| Oct 3, 2014 | Ketorolac Tromethamine INJECTION, USP, 30 mg per mL, a) 1 mL vial (NDC 25021-... | Incorrect or Missing Lot and/or Exp Date: Ketorolac Tromethamine Injection, is being recalled as... | Class II | Sagent Pharmaceuticals Inc |
| Sep 12, 2014 | Amiodarone HCl Injection, 450 mg/9 mL (50 mg per mL), 9 mL Single-Use Vial, R... | Temperature Abuse: One shipment was inadvertantly stored refrigerated rather than the labeled roo... | Class II | Mckesson |
| Sep 8, 2014 | Potassium Chloride Injection, 10 mEq per 100 mL, Highly Concentrated (100 mEq... | Correct Labeled Product Mispack: Shipping cartons labeled as containing Potassium Chloride inject... | Class II | Baxter Healthcare Corp |
| Aug 28, 2014 | Dermatend Ultra, mole, wart and skin tag remover, For external use only, Ingr... | Labeling: Labeling Bears Unapproved Claims; Dermatend is not FDA approved and therefore has not b... | Class II | Solace International Inc |
| Aug 28, 2014 | Dermatend Original, mole, wart and skin tag remover, For external use only, I... | Labeling: Labeling Bears Unapproved Claims; Dermatend is not FDA approved and therefore has not b... | Class II | Solace International Inc |
| Aug 19, 2014 | Nicotine Polacrilex Lozenge, 2 mg Mint Mini. 27 Ct Tubes, Over the Counter. ... | Failed Dissolution Specifications and Failed Tablet Specifications: High 30 minute dissolution te... | Class III | Perrigo Holland Inc |
| Aug 7, 2014 | MUSTARCREME, Net Contents: 60g (21 oz) Country of Origin Guyana. | Does Not Meet Monograph: NEW GPC INC. has recalled multiple Over-the-Counter Drug Products due to... | Class II | New Gpc Inc. |
| Aug 7, 2014 | alcosulph Astringent Lotion, Net Contents: 1) 60 mL and 2) 120 mL. Product p... | Does Not Meet Monograph: NEW GPC INC. has recalled multiple Over-the-Counter Drug Products due to... | Class II | New Gpc Inc. |
| Aug 7, 2014 | alcosulph Moisturizing Cream, Net Contents: 60g. Product packaged within a p... | Does Not Meet Monograph: NEW GPC INC. has recalled multiple Over-the-Counter Drug Products due to... | Class II | New Gpc Inc. |
| Aug 7, 2014 | Whitfield's OINTMENT B.P., Net Contents: 15g. Manufactured by: NEW GPC INC. ... | Does Not Meet Monograph: NEW GPC INC. has recalled multiple Over-the-Counter Drug Products due to... | Class II | New Gpc Inc. |
| Aug 7, 2014 | Rector's Remedy OINTMENT, Net Contents: 15g. Manufactured by: NEW GPC INC. A... | Does Not Meet Monograph: NEW GPC INC. has recalled multiple Over-the-Counter Drug Products due t... | Class II | New Gpc Inc. |
| Aug 7, 2014 | WHITFIELD LOTION, Net Contents: 60 mL. Manufactured by: NEW GPC INC. A1 Farm... | Does Not Meet Monograph: NEW GPC INC. has recalled multiple Over-the-Counter Drug Products due to... | Class II | New Gpc Inc. |
| Aug 7, 2014 | Ferrol EXPECTORANT, Net Contents: 100 mL. Product packaged within a plastic ... | Does Not Meet Monograph: NEW GPC INC. has recalled multiple Over-the-Counter Drug Products due to... | Class II | New Gpc Inc. |
| Aug 6, 2014 | Alcohol-Free Hand Sanitizer, 1. fl. oz. (30 ml) bottles capped with white spr... | Microbial Contamination of Non-Sterile Product | Class II | HLI dba Humphreyline Inc |
| Jul 17, 2014 | Clonidine HCl Injection, 1000 mcg/10 mL (100 mcg/mL),10 mL Single Dose Vial, ... | Labeling: Label Error On Declared Strength: The side label description incorrectly states "Each m... | Class III | X-Gen Pharmaceuticals Inc. |
| Jul 8, 2014 | VIRACEPT (R) (nelfinavir mesylate) Tablets, 625 mg, 120-count bottle, Rx only... | Labeling: Incorrect or missing lot and or Exp Date: The bottles were labeled with an incorrect ex... | Class III | Pfizer Inc. |
| Jul 1, 2014 | Ibuprofen Tablets, USP, 600 mg, 100 tablets per carton (10 x 10), Rx Only, Pa... | Labeling: Label Mix-Up: Some cartons of AHP Ibuprofen Tablets, USP, 600mg, lot #142588 that conta... | Class I | American Health Packaging |
| Jul 1, 2014 | Oxcarbazepine Tablets, 300 mg, 100 tablets per carton (10 x 10), Rx Only, Pac... | Labeling: Label Mix-Up: Some cartons of AHP Ibuprofen Tablets, USP, 600mg, lot #142588 that conta... | Class I | American Health Packaging |
| Jun 26, 2014 | LORTUSS EX, Each 5 mL (1 teaspoonful) contains: Codeine Phosphate 10 mg, Guai... | Does Not Meet Monograph: Phenylephrine and pseudoephedrine are below monograph specifications, an... | Class III | Poly Pharmaceuticals, Inc |
| Jun 26, 2014 | POLY-TUSSIN AC LIQUID, Each 5 mL (1 teaspoonful) contains: Brompheniramine Ma... | Does Not Meet Monograph: Phenylephrine and pseudoephedrine are below monograph specifications, an... | Class III | Poly Pharmaceuticals, Inc |
| Jun 12, 2014 | Captomer-250 [succinic acid (from 250 mg DMSA)] capsules, 162 mg, 45-count bo... | Marketed Without An Approved NDA/ANDA: Captomer and Captomer-250 are marketed as dietary suppleme... | Class II | Thorne Research Inc |
| Jun 12, 2014 | Captomer [succinic acid (from 100 mg DMSA)] capsules, 65 mg, 45-count bottles... | Marketed Without An Approved NDA/ANDA: Captomer and Captomer-250 are marketed as dietary suppleme... | Class II | Thorne Research Inc |
| Jun 5, 2014 | APLENZIN¿ (bupropion hydrobromide), extended-release tablets, 522 mg, a) 7-co... | Labeling: Incorrect or Missing Package Insert | Class III | Valeant Pharmaceuticals North America LLC |
| Jun 5, 2014 | APLENZIN¿ (bupropion hydrobromide), extended-release tablets, 348 mg, a) 7-co... | Labeling: Incorrect or Missing Package Insert | Class III | Valeant Pharmaceuticals North America LLC |
| Jun 5, 2014 | APLENZIN¿ (bupropion hydrobromide), extended-release tablets, 174 mg, 7-count... | Labeling: Incorrect or Missing Package Insert | Class III | Valeant Pharmaceuticals North America LLC |
| Jun 2, 2014 | Atorvastatin Calcium 40 MG Tablet, MFG: Apotex NDC# 6050525808 | Presence of Foreign Tablets/Capsules:179 doses of Valacyclovir HCl 500 mg tablets were repacked i... | Class II | Unit Dose Solutions Inc |
| Jun 2, 2014 | Soliris (eculizumab), 300 mg/30 mL (10 mg/mL), 30 mL Single-Use Vial, Rx only... | Presence of Particulate Matter: Product failed the appearance for the presence of visible particl... | Class I | Alexion Pharmaceuticals, Inc. |
| May 21, 2014 | Vaseretic (enalapril maleate/hydrochlorothiazide) 10/25 mg Tablets, NDC 0187-... | Labeling: Incorrect or Missing Package Insert: Product is packaged with the incorrect version of ... | Class III | Valeant Pharmaceuticals North America LLC |
| May 21, 2014 | Vasotec (enalapril maleate) tablets, RX only, Manufactured by Valeant Pharmac... | Labeling: Incorrect or Missing Package Insert: Product is packaged with the incorrect version of ... | Class III | Valeant Pharmaceuticals North America LLC |
| May 16, 2014 | ePHEDrine Sulfate Injection, USP 25 mg/5 mL (5 mg/mL) Single Use 5 mL Syring... | Labeling: Label Error on Declared Strength; The outer light protective bags, where the ephedrine ... | Class II | US Compounding Inc |
| May 14, 2014 | Oasis TEARS, Lubricant Eye Drops, 10mL/0.3 fl. oz. Bottle, OTC Only. Distribu... | Labeling: Missing Label; The label on the immediate bottle is missing. | Class III | Oasis Medical 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 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 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 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 |
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.