Browse Drug Recalls
1,680 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 1,680 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 1,680 FDA drug recalls — Class III.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Sep 17, 2018 | treatNOW ABILIFY (aripiprazole) and ABILIFY MAINTENA (aripiprazole) 400MG for... | Labeling Not Elsewhere Classified: Physician sample kits/cartons of treatNOW Abilify are mislabel... | Class III | Otsuka Pharmaceutical Development & Commerciali... |
| Sep 17, 2018 | treatNOW ABILIFY (aripiprazole) / ABILIFY MAINTENA 400-mg (aripiprazole) for ... | Labeling Not Elsewhere Classified: Physician sample kits/cartons of treatNOW Abilify are mislabel... | Class III | Otsuka Pharmaceutical Development & Commerciali... |
| Sep 12, 2018 | Zoledronic Acid Injection, 5 mg/100 mL (0.05 mg/mL) One 100ml Single-Dose Bot... | Failed Impurities/Degradation Specifications: OOS for unknown impurities. | Class III | Dr. Reddy's Laboratories, Inc. |
| Sep 12, 2018 | Fenofibrate Tablets, USP 145 mg, 90-count bottles, Rx only, Manufactured for:... | Presence of Foreign Tablet/Capsule: A foreign identified as Valacyclovir tablet 500 mg was co-min... | Class III | Hetero Labs, Ltd. - Unit III |
| Sep 12, 2018 | Zoledronic Acid Injection, 5mg/100 mL (0.05 mg/mL) 100ml vial, Rx Only. Mfd B... | Failed Impurities/Degradation Specifications: OOS for unknown impurities. | Class III | Dr. Reddy's Laboratories, Inc. |
| Sep 10, 2018 | Calcium Gluconate 2.5% a) 250 mL 25 mg/mL NDC 69699-0908-25; b) Nasal Spray 2... | Lack of Assurance of Sterility | Class III | Pharm D Solutions, LLC |
| Sep 6, 2018 | Bupropion Hydrochloride ER Tablets, USP 150 mg, packaged in a) 90-count bottl... | Failed impurities/ degradation specifications: Out-of-specification results were observed in the ... | Class III | InvaGen Pharmaceuticals, Inc. |
| Sep 6, 2018 | Pramipexole dihydrochloride extended release tablets, 0.75 mg, packaged in 30... | Failed impurities/degradation specifications: Finished product contain a known product impurity a... | Class III | Par Pharmaceutical, Inc. |
| Aug 28, 2018 | Argatroban Injection, 250 mg/2.5 mL (100 mg/mL), 2.5 mL Single-use Vial, Rx o... | Failed Impurities/Degradation Specifications; Out of specification stability testing results at t... | Class III | Pfizer Inc. |
| Aug 27, 2018 | Levonorgestrel and Ethinyl Estradiol Tablets, USP 0.15 mg/0.03 mg, Rx Only, 3... | Labeling: Not Elsewhere Classified-Incorrect NDC and product name identified on blister packs. | Class III | Mylan Pharmaceuticals Inc. |
| Aug 27, 2018 | MethylPREDNISolone Tablets, USP, 4 mg, 21-count blister pack. Rx Only. Jubil... | Failed Stability Specifications: An out-of-specification result was obtained during 18-month stab... | Class III | Jubilant Cadista Pharmaceuticals, Inc. |
| Aug 23, 2018 | Morphine Sulfate Extended-Release Tablets, 30 mg, 100-count bottle, Rx only, ... | Failed Impurities/Degradation Specifications: Morphine Sulfate Extended Release Tablets are being... | Class III | LUPIN SOMERSET |
| Aug 21, 2018 | Oxycodone and Acetaminophen Tablets, USP, 5 mg*/325 mg, 100-count bottle, Rx ... | Labeling: Incorrect or Missing Lot and/or Exp Date: Lot FG10517 is mislabeled on the primary cont... | Class III | Mayne Pharma Inc |
| Aug 14, 2018 | Diltiazem HCl Extended-release Capsules, USP 120 mg, 80 capsules, 8 blister c... | Failed Impurities/Degradation Specifications; out of specification results for related compound p... | Class III | Mylan Institutional, Inc. (d.b.a. UDL Laborator... |
| Aug 14, 2018 | Valsartan Tablets USP, 40 mg, 30-count bottle, Rx only, Manufactured by: Jubi... | Incorrect/Undeclared Excipient: There is a potential an incorrect grade of excipient was used dur... | Class III | Jubilant Cadista Pharmaceuticals, Inc. |
| Aug 14, 2018 | Valsartan Tablets USP, 320 mg, 90-count bottle, Rx only, Manufactured by: Jub... | Incorrect/Undeclared Excipient: There is a potential an incorrect grade of excipient was used dur... | Class III | Jubilant Cadista Pharmaceuticals, Inc. |
| Aug 14, 2018 | Tyvaso Inhalation System Patient a) Starter Kit with TYVASO (treprostinil) I... | Defective Delivery System: Water ingress through the lower water cup sensor of the device. | Class III | United Therapeutics Corp. |
| Aug 14, 2018 | Valsartan Tablets USP, 160 mg, 90-count bottle, Rx only, Manufactured by: Jub... | Incorrect/Undeclared Excipient: There is a potential an incorrect grade of excipient was used dur... | Class III | Jubilant Cadista Pharmaceuticals, Inc. |
| Aug 14, 2018 | Valsartan Tablets USP, 80 mg, 90-count bottle, Rx only, Manufactured by: Jubi... | Incorrect/Undeclared Excipient: There is a potential an incorrect grade of excipient was used dur... | Class III | Jubilant Cadista Pharmaceuticals, Inc. |
| Aug 9, 2018 | Contrave (naltrexone HCl and bupropion HCl) Extended-Release Tablets, 8 mg/90... | Defective Container: Customer complaints of punctures in the bottle. | Class III | Orexigen Therapeutics, Inc. |
| Aug 8, 2018 | Azelastine HCl Ophthalmic Solution 0.05%, 6 mL in 10 mL HDPE bottle, 1 bottle... | Failed Impurities/Degradation Specifications:out-of-specification (OOS) results for Azelastine N-... | Class III | Akorn, Inc. |
| Aug 7, 2018 | Diltiazem HCl Extended-Release Capsules, USP 120 mg 500-count bottle, Rx only... | Failed Impurities/Degradation Specifications: Out of specification test results obtained during r... | Class III | Mylan Pharmaceuticals Inc. |
| Aug 7, 2018 | Diltiazem HCl Extended-Release Capsules, USP 120 mg 100-count bottle, Rx only... | Failed Impurities/Degradation Specifications: Out of specification test results obtained during r... | Class III | Mylan Pharmaceuticals Inc. |
| Aug 3, 2018 | Well at Walgreens, Scar Cream with SPF 30, (Avobenzone 3%, Octocrylene 10%, O... | Subpotent Drug: low out of specification assay results for the octocrylene and avobenzone ingredi... | Class III | Product Quest Manufacturing LLC |
| Aug 3, 2018 | Acne Treatment Pads (2% salicylic acid), packaged in a 50-count jar, OTC, Dis... | Subpotent drug: The product active ingredient level not matching the exact levels indicated on th... | Class III | Huijing (Shanghai) Bio-tech Co., Ltd. |
| Aug 3, 2018 | Cicatricure, Scar Cream + Sunscreen SPF 30 (avobenzone 3%, octocrylene 10%, o... | Subpotent Drug: low out of specification assay results for the octocrylene and avobenzone ingredi... | Class III | Product Quest Manufacturing LLC |
| Aug 2, 2018 | Atorvastatin Calcium tablets, 40 mg, 500-count bottle, Rx only, Mfd By: Dr. R... | Failed Impurities/Degradation Specifications - OOS was observed for ATV Cyclo FP Impurity and Tot... | Class III | Dr. Reddy's Laboratories, Inc. |
| Aug 1, 2018 | Levofloxacin Injection in 5% Dextrose, 500 mg (5 mg/mL), 500 mg in 100 mL 5% ... | Superpotent Drug: High out of specification results for levofloxacin resulting in increased conce... | Class III | Baxter Healthcare Corporation |
| Aug 1, 2018 | Levofloxacin Injection in 5% Dextrose, 250 mg (5 mg/mL), 250 mg in 50 mL 5% D... | Superpotent Drug: High out of specification results for levofloxacin resulting in increased conce... | Class III | Baxter Healthcare Corporation |
| Aug 1, 2018 | Levofloxacin Injection in 5% Dextrose, 750 mg (5 mg/mL), 750 mg in 150 mL 5% ... | Superpotent Drug: High out of specification results for levofloxacin resulting in increased conce... | Class III | Baxter Healthcare Corporation |
| Jul 26, 2018 | Moxifloxacin Ophthalmic Solution USP, 0.5%, 5 mL bottle, Rx only, Manufactur... | Failed Impurities/Degradation Specifications: An out-of-specification result in the related subst... | Class III | Lupin Pharmaceuticals Inc. |
| Jul 26, 2018 | Testosterone 200 mg Pellet, Rx only, Carie Boyd's Prescription Shop 122 Grape... | Labeling: Incorrect or Missing Lot and/or Exp Date: Incorrect expiration date on label | Class III | Right Value Drug Stores, Inc. |
| Jul 11, 2018 | Fluconazole Injection, USP, Iso-Osmotic Sodium Chloride Diluent, 200 mg in 10... | Superpotent Drug: lots out of specification for elevated sodium chloride and fluconazole assay. | Class III | Renaissance Lakewood, LLC |
| Jul 11, 2018 | Fluconazole Injection, USP, Iso-Osmotic Sodium Chloride Diluent, 200 mg in 10... | Failed Stability Specifications: lot out of specification for elevated water vapor. | Class III | Renaissance Lakewood, LLC |
| Jul 11, 2018 | Fluconazole Injection, USP, Iso-Osmotic Sodium Chloride Diluent, 400 mg in 20... | Superpotent Drug and Failed Stability Specifications: lot out of specification for elevated sodiu... | Class III | Renaissance Lakewood, LLC |
| Jul 10, 2018 | Diazepam Rectal Gel, 2.5 mg, TWIN PACK that Contains two pre-filled, unit-dos... | Labeling: Incorrect or Missing Lot and/or Exp Date: Product distributed without a lot number or e... | Class III | Valeant Pharmaceuticals North America LLC |
| Jul 9, 2018 | Triamterene and Hydrochlorothiazide Tablets, USP 37.5 mg/25 mg, 100-count bot... | Subpotent Drug | Class III | Mylan Pharmaceuticals Inc. |
| Jun 27, 2018 | Enalapril Maleate, USP 5MG, 30-count bottle, RX only. Packaged By: Aidarex Ph... | Out-of-specification results for the Enalapril Diketopiperazine degradation product during commer... | Class III | Aidarex Pharmaceuticals LLC |
| Jun 27, 2018 | Enalapril Maleate, USP 2.5MG, 90-count bottle, RX only. Packaged By: Aidarex ... | Out-of-specification results for the Enalapril Diketopiperazine degradation product during commer... | Class III | Aidarex Pharmaceuticals LLC |
| Jun 27, 2018 | Enalapril Maleate, USP 5MG, 90-count bottle, RX only. Packaged By: Aidarex Ph... | Out-of-specification results for the Enalapril Diketopiperazine degradation product during commer... | Class III | Aidarex Pharmaceuticals LLC |
| Jun 26, 2018 | Enalapril Maleate Tablets, USP, 2.5 mg, 100 Tablets (10 x 10) Unit Dose per c... | Failed Impurities/Degradation Specifications: Sub-recall because this repackaged product was reca... | Class III | MAJOR PHARMACEUTICALS |
| Jun 26, 2018 | Enalapril Maleate Tablets, USP, 5 mg, 100 Tablets (10 x 10) Unit Dose per car... | Failed Impurities/Degradation Specifications: Sub-recall because this repackaged product was reca... | Class III | MAJOR PHARMACEUTICALS |
| Jun 25, 2018 | Enalapril Maleate Tablets USP, 5 mg, 100 Tablets (10X10) blister cards, 12 ca... | Failed Impurities/Degradation Specification; out-of-specification results for the Enalapril DKT d... | Class III | AMERICAN HEALTH PACKAGING |
| Jun 19, 2018 | Enalapril Maleate Tablets USP; 2.5 mg NDC code 64679-923-03. 1000 Tablets HDP... | Failed Impurities/Degradation Specifications | Class III | Wockhardt Limited |
| Jun 19, 2018 | Enalapril Maleate Tablets USP; 5 mg NDC code 64679-924-03. 1000 Tablets HDPE ... | Failed Impurities/Degradation Specifications | Class III | Wockhardt Limited |
| Jun 15, 2018 | Calcitriol Oral Solution, 1 mcg/mL, 15 mL bottle, Rx Only, Distributed by: Ra... | Subpotency: lower than expected potency result was obtained at the 18 month stability time point. | Class III | Validus Pharmaceuticals, Inc. |
| Jun 15, 2018 | Rocaltrol (calcitriol) Oral Solution, 1 mcg/mL, 15 mL bottle, Rx only, Distri... | Subpotency: lower than expected potency result was obtained at the 18 month stability time point. | Class III | Validus Pharmaceuticals, Inc. |
| Jun 13, 2018 | Equate ClearLAX, Polyethylene Glycol 3350 Powder for Solution, OS Osmotic Lax... | Labeling: Not Elsewhere Classified - A private label distributor noted unfiled NDC numbers on EQ... | Class III | LUPIN SOMERSET |
| Jun 12, 2018 | Atorvastatin Calcium Tablets, 20 mg*, 90-count bottle, Rx Only, Mfd. By: Dr. ... | Failed Impurities/Degradation Specifications | Class III | Dr. Reddy's Laboratories, Inc. |
| Jun 12, 2018 | Atorvastatin Calcium Tablets, 40 mg*, packaged as a) 90-count bottle (NDC 551... | Failed Impurities/Degradation Specifications | Class III | Dr. Reddy's Laboratories, 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.