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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jun 18, 2013 | Methylphenidate Hydrochloride Extended-Release Capsules (LA), 30 mg, 100 coun... | Failed Dissolution Specifications: Product is being recalled due to out of specification dissolut... | Class II | Teva Pharmaceuticals USA, Inc. |
| Jun 18, 2013 | NeoCitran Extra Strength Non-Drowsy Cold & Sinus (acetaminophen 650 mg and ph... | Presence of Foreign Substance: The products are being recalled because they may contain foreign s... | Class II | Novartis Consumer Health |
| Jun 18, 2013 | Theraflu Flu & Chest Congestion (acetaminophen 1000 mg and guaifenesin 400 mg... | Presence of Foreign Substance: The products are being recalled because they may contain foreign s... | Class II | Novartis Consumer Health |
| Jun 18, 2013 | Theraflu Nighttime Severe Cold & Cough (acetaminophen 650 mg, diphenhydramine... | Presence of Foreign Substance: The products are being recalled because they may contain foreign s... | Class II | Novartis Consumer Health |
| Jun 18, 2013 | Amoxicillin for Oral Suspension, USP 200 mg/5 mL, a) 75 mL bottle NDC 0093-41... | Discoloration: This recall is being carried out due to an orange to brown discolored Amoxicillin... | Class III | Teva Pharmaceuticals USA, Inc. |
| Jun 18, 2013 | Theraflu Exte (dextromethorphan hydrobromide 20 mg, phenylephrine hydrochlori... | Presence of Foreign Substance: The products are being recalled because they may contain foreign s... | Class II | Novartis Consumer Health |
| Jun 18, 2013 | Theraflu Flu & Sore Throat (acetaminophen 650 mg, pheniramine maleate 20 mg, ... | Presence of Foreign Substance: The products are being recalled because they may contain foreign s... | Class II | Novartis Consumer Health |
| Jun 17, 2013 | Belladonna Alkaloids/PB (Belladonna Alkaloids / Phenobarbital) Tablets Phenob... | Presence of Foriegn Substance:The manufacturer, West-ward Pharmaceutical, recalled product becaus... | Class II | Physicians Total Care, Inc. |
| Jun 17, 2013 | ENTERIC COATED ASPIRIN (NSAID), 81 mg, 120-count tablets per bottle, distribu... | Labeling: Label Mix-Up: A complaint from a pharmacist was received that the entire contents of 1 ... | Class I | Advance Pharmaceutical Inc |
| Jun 14, 2013 | Prednisone Tablet USP, 20 mg tablets, packaged in blisters of ten (10) tablet... | Labeling: Missing Label; missing label on blister card | Class III | Boehringer Ingelheim Roxane Inc |
| Jun 13, 2013 | ChloraPrep With Tint, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopr... | Lack of Assurance of Sterility; Immediate product pouches may not be properly sealed. | Class II | CareFusion 213, LLC |
| Jun 13, 2013 | Medroxyprogesterone acetate, micronized (EP, USP) active pharmaceutical ingre... | Failed Stability Specifications: Out of specification results for particle size were obtained at ... | Class III | Bayer HealthCare Pharmaceuticals Inc. |
| Jun 11, 2013 | Sodium Bicarbonate Powder, CAS-144-55-8, Arm & Hammer, Sodium Bicarbonate U.S... | Presence of Foreign Substance: raw material recalled due to stainless steel and other contamination. | Class II | Church & Dwight Inc |
| Jun 11, 2013 | Sodium Bicarbonate Powder, CAS-144-55-8, Arm & Hammer, labeled as a) USP1 Gra... | Presence of Foreign Substance: raw material recalled due to stainless steel and other contamination. | Class II | Church & Dwight Inc |
| Jun 11, 2013 | Bethel 30 capsules, packaged in 30 count bottles, Distributed by BETHEL INC. ... | Marketed Without An Approved NDA/ANDA: FDA analysis found this product contained undeclared sibut... | Class I | Bethel Nutritional Consulting, Inc |
| Jun 11, 2013 | Sodium Bicarbonate Powder, CAS-144-55-8, Arm & Hammer, labeled as a) USP5 Gra... | Presence of Foreign Substance: raw material recalled due to stainless steel and other contamination. | Class II | Church & Dwight Inc |
| Jun 11, 2013 | Sodium Bicarbonate Powder, CAS-144-55-8, Arm & Hammer, labeled as a) USP3 Gra... | Presence of Foreign Substance: raw material recalled due to stainless steel and other contamination. | Class II | Church & Dwight Inc |
| Jun 11, 2013 | Sodium Bicarbonate Powder, CAS-144-55-8, Arm & Hammer, labeled as a) USP2 Gra... | Presence of Foreign Substance: raw material recalled due to stainless steel and other contamination. | Class II | Church & Dwight Inc |
| Jun 7, 2013 | VECURONIUM Bromide for Injection, 10 mg* per vial, *1 mg per mL when reconsti... | CGMP Deviations: product was not manufactured under current good manufacturing practices which co... | Class II | Sagent Pharmaceuticals Inc |
| Jun 6, 2013 | Excedrin Migraine (Acetaminophen 250 mg, Aspirin (NSAID) 250 mg and Caffeine ... | Defective container: products are packaged in pouches which may not have been fully sealed | Class II | Novartis Consumer Health |
| Jun 6, 2013 | Parsel Plus (reference US product: Excedrin Tension Headache) (Acetaminophen... | Defective container: products are packaged in pouches which may not have been fully sealed | Class II | Novartis Consumer Health |
| Jun 6, 2013 | 0.9% Sodium Chloride Injection, USP, 250 mL single dose Flexible Plastic Cont... | Lack of Assurance of Sterility: The product has the potential for solution to leak at or near the... | Class II | Hospira Inc. |
| Jun 6, 2013 | No Doz, Max Strength (200 mg caffeine) caplets, 2-count caplets per pouch, Di... | Defective container: products are packaged in pouches which may not have been fully sealed | Class II | Novartis Consumer Health |
| Jun 6, 2013 | Excedrin Extra Strength (Acetaminophen 250 mg, Aspirin (NSAID) 250 mg and Caf... | Defective container: products are packaged in pouches which may not have been fully sealed | Class II | Novartis Consumer Health |
| Jun 4, 2013 | Cleocin Phosphate (clindamycin Injection), USP, a) 600 mg/4mL (150 mg/mL) ADD... | Presence of Particulate Matter: Firm is recalling a small number of vials with very small reflect... | Class II | Pharmacia & Upjohn LLC |
| Jun 4, 2013 | VersaPharm Incorporated, Ethambutol Hydrochloride Tablets, USP 400 mg 60 tabl... | Discoloration: Ethambutol HCl Tablets 400 mg is being recalled due to a Out of Specification resu... | Class II | West-Ward Pharmaceutical Corp. |
| Jun 3, 2013 | Fentanyl Transdermal System, 50 mcg/h, 1 system per pouch (NDC 0591-3212-54),... | Failed Impurities/Degradation Specifications | Class III | Actavis |
| May 31, 2013 | Prempro (Conjugated Estrogen/Medroxyprogesterone Acetate) tablets 0.625 mg/2.... | Failed Dissolution Specifications: Pfizer Inc. is recalling PREMPRO (conjugated estrogens/medroxy... | Class III | Pfizer Inc. |
| May 31, 2013 | Prempro (Conjugated Estrogen/Medroxyprogesterone Acetate) tablets 0.625 mg/5.... | Failed Dissolution Specifications: Pfizer Inc. (Pfizer) is recalling PREMPRO (conjugated estrogen... | Class III | Pfizer Inc. |
| May 31, 2013 | Calcium Chloride Preservative Free Sterile injection, 100 mg/ml, 10 ml vial, ... | Non-Sterility: The firm's contract testing laboratory found sterility failures. | Class I | Abrams Royal Pharmacy |
| May 31, 2013 | Norpace CR (disopyramide phosphate) extended-release capsules USP,150 mg, pac... | Failed Dissolution Specification | Class III | Pfizer Inc |
| May 30, 2013 | Cefazolin, injection, 1 gram per vial, 25 vials per box, sterile, Rx only, si... | Lack of Assurance of Sterility: Sandoz Inc is recalling Cefazolin for Injection, USP 1 gm vials, ... | Class II | Sandoz Incorporated |
| May 30, 2013 | Pharmalucence Kit for the Preparation of Technetium Tc 99m Sestamibi Injectio... | Presence of Particulate Matter; particulate found in retain samples | Class III | Pharmalucence, Inc. |
| May 29, 2013 | Diclazuril 10 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... | Class II | Lowlite Investments, Inc. D/B/A Olympia Pharmacy |
| May 29, 2013 | Ketamine 100 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... | Class II | Lowlite Investments, Inc. D/B/A Olympia Pharmacy |
| May 29, 2013 | Metabolase Injection, compounded by Olympia Pharmacy, Orlando, FL | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... | Class II | Lowlite Investments, Inc. D/B/A Olympia Pharmacy |
| May 29, 2013 | Acetyl-D-Glucosamine w/Chondroitin 200 mg/ml, compounded by Olympia Pharmacy,... | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... | Class II | Lowlite Investments, Inc. D/B/A Olympia Pharmacy |
| May 29, 2013 | Dexpanthenol 250 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... | Class II | Lowlite Investments, Inc. D/B/A Olympia Pharmacy |
| May 29, 2013 | Atropine Sulfate 50 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... | Class II | Lowlite Investments, Inc. D/B/A Olympia Pharmacy |
| May 29, 2013 | Glutathione 200 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... | Class II | Lowlite Investments, Inc. D/B/A Olympia Pharmacy |
| May 29, 2013 | Acepromazine 25 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... | Class II | Lowlite Investments, Inc. D/B/A Olympia Pharmacy |
| May 29, 2013 | Oxytocin 20 units/ml Injection, compounded by Olympia Pharmacy, Orlando, FL | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... | Class II | Lowlite Investments, Inc. D/B/A Olympia Pharmacy |
| May 29, 2013 | Medroxyprogesterone 150 mg/ml Injection, compounded by Olympia Pharmacy, Orla... | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... | Class II | Lowlite Investments, Inc. D/B/A Olympia Pharmacy |
| May 29, 2013 | Estradiol Cypionate 10 mg/ml Injection, compounded by Olympia Pharmacy, Orlan... | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... | Class II | Lowlite Investments, Inc. D/B/A Olympia Pharmacy |
| May 29, 2013 | Detomidine 10 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... | Class II | Lowlite Investments, Inc. D/B/A Olympia Pharmacy |
| May 29, 2013 | Diphenhydramine 50 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... | Class II | Lowlite Investments, Inc. D/B/A Olympia Pharmacy |
| May 29, 2013 | Phentolamine 20 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... | Class II | Lowlite Investments, Inc. D/B/A Olympia Pharmacy |
| May 29, 2013 | Cal-Phos 1000 Injection, compounded by Olympia Pharmacy, Orlando, FL | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... | Class II | Lowlite Investments, Inc. D/B/A Olympia Pharmacy |
| May 29, 2013 | Adenosine-Mono-Phosphate Injection, 200 mg/ml, compounded by Olympia Pharmacy... | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... | Class II | Lowlite Investments, Inc. D/B/A Olympia Pharmacy |
| May 29, 2013 | Guanabenz 8 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... | Class II | Lowlite Investments, Inc. D/B/A Olympia Pharmacy |
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.