Browse Drug Recalls
1,702 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 1,702 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 1,702 FDA drug recalls, Class III.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jun 28, 2013 | Duet DHA Balanced, 1) 30 count tablet blister cards and 5 count softgels blis... | Subpotent; Beta carotene (Vitamin A) | Class III | Stayma Consulting Service, LLC. |
| Jun 28, 2013 | Duet DHA 400 ec, containing one 30-count bottle of multi-vitamin tablets (imp... | Subpotent; Beta carotene (Vitamin A) | Class III | Stayma Consulting Service, LLC. |
| Jun 27, 2013 | LA MER the spf 18 fluid tint , broad spectrum spf 18, 1.7 fl.oz. liq./50 ml, ... | Subpotent Drug: Avobenzone 3%, one of the active sunscreen ingredients may be subpotent and sunsc... | Class III | Max Huber Research Labs, Inc. |
| Jun 27, 2013 | LA MER the spf 18 fluid tint , broad spectrum spf 18, 1.7 fl.oz. liq./50 ml, ... | Subpotent Drug: Avobenzone 3%, one of the active sunscreen ingredients may be subpotent and sunsc... | Class III | Max Huber Research Labs, Inc. |
| Jun 27, 2013 | LA MER the spf 18 fluid tint , broad spectrum spf 18, 1.7 fl.oz. liq./50 ml, ... | Subpotent drug: Avobenzone 3%, one of the active sunscreen ingredients may be subpotent and sunsc... | Class III | Max Huber Research Labs, Inc. |
| Jun 21, 2013 | FOLLOW YOUR DREAMS! Justice, Chocolate anti bac, Ethyl Alcohol, Net Wt. 1 fl ... | Labeling: Label Error on Declared Strength; the label states that the product contains 62% ethyl ... | Class III | Tween Brands Inc |
| Jun 21, 2013 | I LOVE BACON Justice, VANILLA scent anti bac, Ethyl Alcohol, Net Wt. 1 fl oz... | Labeling: Label Error on Declared Strength; the label states that the product contains 62% ethyl ... | Class III | Tween Brands Inc |
| Jun 21, 2013 | Believe in Yourself Strawberry Anti bac Justice, Ethyl Alcohol, Net Wt 1 fl o... | Labeling: Label Error on Declared Strength; the label states that the product contains 62% ethyl ... | Class III | Tween Brands Inc |
| Jun 21, 2013 | yum yum bubble gum Justice, BUBBLEGUM SCENT ANTI BAC, Ethyl Alcohol, Net Wt. ... | Labeling: Label Error on Declared Strength; the label states that the product contains 62% ethyl ... | Class III | Tween Brands Inc |
| Jun 21, 2013 | Grapefruit anti bac Justice, Ethyl Alcohol, Net Wt. 1 fl oz, Tocopheryl Aceta... | Labeling: Label Error on Declared Strength; the label states that the product contains 62% ethyl ... | Class III | Tween Brands Inc |
| Jun 21, 2013 | TODAY IS AWESOME! Justice, Cotton Candy anti bac, Ethyl Alcohol, Net Wt. 1 fl... | Labeling: Label Error on Declared Strength; the label states that the product contains 62% ethyl ... | Class III | Tween Brands Inc |
| Jun 21, 2013 | LIFE IS SWEET! Justice, Vanilla Scent anti bac, Ethyl Alcohol, Net Wt. 1 fl ... | Labeling: Label Error on Declared Strength; the label states that the product contains 62% ethyl ... | Class III | Tween Brands Inc |
| Jun 21, 2013 | Lemon anti bac Justice, Ethyl Alcohol, Net Wt. 1 fl oz, Distr by Tween Brands... | Labeling: Label Error on Declared Strength; the label states that the product contains 62% ethyl ... | Class III | Tween Brands Inc |
| Jun 21, 2013 | Girls can change the World, Green Apple Anti bac Justice, Ethyl Alcohol, Net ... | Labeling: Label Error on Declared Strength; the label states that the product contains 62% ethyl ... | Class III | Tween Brands Inc |
| Jun 21, 2013 | Shine from within blueberry Anti bac Justice, Ethyl Alcohol, Net Wt 1 fl oz, ... | Labeling: Label Error on Declared Strength; the label states that the product contains 62% ethyl ... | Class III | Tween Brands Inc |
| Jun 21, 2013 | I love to shop Justice, Peach anti bac, Ethyl Alcohol, Net Wt. 1 fl oz, Distr... | Labeling: Label Error on Declared Strength; the label states that the product contains 62% ethyl ... | Class III | Tween Brands Inc |
| Jun 21, 2013 | YOU CANT HANDLE THIS Justice, GRAPE SCENT ANTI BAC, Ethyl Alcohol Net Wt. 1 f... | Labeling: Label Error on Declared Strength; the label states that the product contains 62% ethyl ... | Class III | Tween Brands Inc |
| Jun 21, 2013 | I love my BFF Justice, Watermelon anti bac, Ethyl Alcohol, Net Wt. 1 fl oz, D... | Labeling: Label Error on Declared Strength; the label states that the product contains 62% ethyl ... | Class III | Tween Brands Inc |
| Jun 21, 2013 | Share a Smile Mixed berry Anti bac Justice, Ethyl Alcohol, Net Wt. 1 fl oz, ... | Labeling: Label Error on Declared Strength; the label states that the product contains 62% ethyl ... | Class III | Tween Brands Inc |
| Jun 21, 2013 | GIRLS ROCK Justice, VANILLA scent anti bac, Ethyl Alcohol, Net Wt. 1 fl oz, D... | Labeling: Label Error on Declared Strength; the label states that the product contains 62% ethyl ... | Class III | Tween Brands Inc |
| Jun 21, 2013 | BFF's are COOL! Justice, CHERRY SCENT ANTI BAC, Ethyl Alcohol, Net Wt. 1 fl o... | Labeling: Label Error on Declared Strength; the label states that the product contains 62% ethyl ... | Class III | Tween Brands Inc |
| Jun 21, 2013 | I love sleep overs Justice, Grape anti bac, Ethyl Alcohol, Net Wt. 1 fl oz, D... | Labeling: Label Error on Declared Strength; the label states that the product contains 62% ethyl ... | Class III | Tween Brands Inc |
| Jun 21, 2013 | I MUSTACHE YOU TO BE MY BFF Justice, COTTON CANDY scent anti bac, Ethyl Alcoh... | Labeling: Label Error on Declared Strength; the label states that the product contains 62% ethyl ... | Class III | Tween Brands Inc |
| 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 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 | 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 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 | Norpace CR (disopyramide phosphate) extended-release capsules USP,150 mg, pac... | Failed Dissolution Specification | Class III | Pfizer Inc |
| 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 28, 2013 | Dr. Sheffield's Triple Antibiotic Ointment Bacitracin 400 units, Neomycin Sul... | Failed Stability Specifications: Unable to meet shelf life expiry. | Class III | Faria Limited LLC dba Sheffield Pharmaceuticals |
| May 21, 2013 | Folic Acid Injection, USP, 5 mg/mL, For IM, IV or SC Use, 10 mL, Multiple Dos... | Failed Impurities/Degradation Specification | Class III | Fresenius Kabi USA, LLC |
| May 15, 2013 | Theraflu Nighttime Warming Relief Nighttime Multi-Symptom Cold, Acetaminophen... | Failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing. | Class III | Novartis Consumer Health |
| May 15, 2013 | Maximum Strength Comtrex Day/Night Cold & Cough, Acetaminophen 325mg, Chlorph... | Failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing. | Class III | Novartis Consumer Health |
| May 15, 2013 | Excedrin, Sinus Headache, Acetaminophen 325mg, Phenylephrine HCL 5mg , 2 cap... | Failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing | Class III | Novartis Consumer Health |
| May 15, 2013 | Theraflu Warming Relief, Multi-Symptom Cold, Acetaminophen 325mg, Dextrometho... | Failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing | Class III | Novartis Consumer Health |
| May 15, 2013 | Budesonide Capsules, 3 mg, Enteric Coated, packaged in 30-count capsules unit... | Failed Dissolution Specifications: Routine stability testing at the 12-month interval yielded an ... | Class III | Mylan Institutional, Inc. (d.b.a. UDL Laborator... |
| May 15, 2013 | Maximum Strength Comtrex Nighttime Cold & Cough, Acetaminophen 325mg ,Chlorph... | Failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing. | Class III | Novartis Consumer Health |
| May 15, 2013 | Maximum Strength Comtrex , Day/Night Flu Therapy , Acetaminophen 325mg, Chlor... | Failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing. | Class III | Novartis Consumer Health |
| May 15, 2013 | Maximum Strength Comtrex ,Severe Cold & Sinus Acetaminophen 325mg, Chlorphen... | Failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing. | Class III | Novartis Consumer Health |
| May 13, 2013 | Nicardipine Hydrochloride Injection 25 mg/10 mL (2.5 mg/mL), 10 mL single-use... | Failed Impurity/Degradation Specifications; out of specification value for impurity Nitrophenylpu... | Class III | West-ward Pharmaceutical Corp. |
| May 7, 2013 | Derma-Smoothe/FS (fluocinolone acetonide) Topical Oil (SCALP OIL), 0.01 %, 11... | Subpotent Drug: the active ingredient, fluocinolone acetonide, was found to be subpotent during t... | Class III | Hill Dermaceuticals, Inc. |
| Apr 30, 2013 | HydrOXYzine Hydrochloride Oral Solution, USP, 10 mg/5 mL, 16 fl. oz. (473 mL)... | Subpotent; 24 month stability test station | Class III | Hi-Tech Pharmacal Co., Inc. |
| Apr 26, 2013 | Amoxicillin for Oral Suspension, USP 400mg/5mL, NDC 0093-4161-78 (75ml) and 0... | Discoloration: This recall is being carried out due to a yellow to brown discolored Amoxicillin p... | Class III | Teva Pharmaceuticals USA, Inc. |
| Apr 19, 2013 | Lamisil AT (terbinafine hydrochloride cream 1% antifungal), 24 g (.85 oz) tub... | Labeling: Incorrect or Missing Lot and/or Expiration date; The Lot and/or Expiration date on the ... | Class III | Novartis Consumer Health |
| Apr 9, 2013 | Lisinopril Tablets, USP, 30 mg, Rx only, 100 tablets, NDC 65862-041-01 Manufa... | Labeling: Label Error on Declared Strength: Incorrect strength on side display panel of label | Class III | Aurobindo Pharma USA Inc |
| Apr 8, 2013 | BUCALSEP (R) ORAL SOLUTION, (Benzocaine, 600 mg, Cetylpyridinum Chloride 30 m... | Subpotent; Cetylpyridinum Chloride | Class III | Hi-Tech Pharmacal Co., Inc. |
| Apr 5, 2013 | Glenmark Gabapentin Tablets, a) 600mg, 500- count bottle (NDC 68462-126-05)... | Chemical Contamination: Gabapentin Sodium tablets is recalled due to complaints related to an off... | Class III | Glenmark Generics Inc., USA |
| Apr 5, 2013 | Glenmark Pravastatin Sodium Tablets ,40 mg, 90-count bottle (NDC 68462-197-90... | Chemical Contamination: Pravastatin Sodium Tablets isbeing recalled due to complaints related to ... | Class III | Glenmark Generics Inc., USA |
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.