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 |
|---|---|---|---|---|
| Nov 9, 2018 | Nitrofurantoin Capsules USP (Monohydrate/Macrocrystals), 100 mg, 100-count Un... | Cross contamination with other products: This sub-recall is being initiated in support of the rec... | Class III | AMERICAN HEALTH PACKAGING |
| Nov 8, 2018 | ERBITUX CETUXIMAB Injection, 200 mg/100 mL (2 mg/mL), 100 mL per single-use v... | Labeling: Missing label; potential for missing primary container label on the vial. | Class III | Eli Lilly & Co |
| Nov 7, 2018 | Nitrofurantoin Monohydrate/Macrocrystals capsules,100 mg, packaged in HDPE 60... | Cross contamination with other products: Product is being recalled due to the potential presence ... | Class III | RemedyRepack Inc. |
| Nov 6, 2018 | AMITIZA (lubiprostone) capsules 8 mcg. 60-count bottle, Rx Only. Marketed by:... | Failed Impurities/Degradation Specifications:Elevated levels of a known impurity in the 20-month ... | Class III | Takeda Development Center Americas, Inc. |
| Nov 6, 2018 | Megestrol Acetate Oral Suspension, USP 625 mg/5mL, 150 mL bottle, Rx only, Di... | Failed Stability Specifications: Out-of-Specification results obtained for particle size distribu... | Class III | Breckenridge Pharmaceutical, Inc. |
| Nov 2, 2018 | Nitrofurantoin Capsules, USP (Monohydrate/Macrocrystals) 100 mg, packaged in ... | Cross Contamination with Other Products | Class III | Sandoz Inc |
| Nov 2, 2018 | Nitrofurantoin Capsules, USP (Monohydrate/Macrocrystals) 100 mg, 100-count bo... | Cross Contamination with Other Products | Class III | Sandoz Inc |
| Nov 1, 2018 | Curaplex Epi Safe Kit, Rx Only, contains: 1mL Vial of Epinephrine, 1 Epi-Safe... | Labeling: Incorrect or missing Lot and/or Exp Date:The Kit is incorrectly labeled as expiring May... | Class III | Bound Tree Medical, LLC |
| Oct 29, 2018 | Clindamycin Phosphate Topical Solution USP, 1% (10 mg/mL clindamycin), 60 ple... | Failed Impurities/Degradation Specifications; out of specification results observed for other ind... | Class III | Akorn, Inc. |
| Oct 26, 2018 | Metoprolol Tartrate Injection, USP 5mg/5mL, vials, Rx only, MFG: Claris Lifes... | Failed pH Specifications: High Out-of-Specification results for pH were obtained during stability... | Class III | RemedyRepack Inc. |
| Oct 18, 2018 | Prednisolone and Gatifloxacin Ophthalmic Solution, 1%/0.5%, 3 mL dropper bott... | Presence of precipitate | Class III | Promise Pharmacy LLC |
| Oct 15, 2018 | Metoprolol Tartrate Injection, USP, 5 mg/ 5 mL (1 mg/mL), 5 mL per sterile si... | Failed pH Specifications: Upward shift in the pH of the solution within the shelf life of the imp... | Class III | Baxter Healthcare Corporation |
| Oct 9, 2018 | Testosterone Topical Solution, 30mg/1.5mL, 110mL bottles, Rx only, Manufactur... | Defective Container: Repetitive complaints received indicating pump not working. | Class III | Lupin Pharmaceuticals Inc. |
| Oct 5, 2018 | Temozolomide capsules, 20 mg, packaged in a) 5-count bottle(NCD 43975-253-05)... | Failed dissolution specifications: Out-of-Specification dissolution results obtained during stabi... | Class III | Amerigen Pharmaceuticals Inc. |
| Oct 5, 2018 | Contrave (naltrexone HCl and bupropion HCl). Extended-Release Tablets, 8mg/90... | Container packaging defect. | Class III | Orexigen Therapeutics, Inc. |
| Oct 3, 2018 | Amlodipine Besylate USP 10 mg Tablets, 1000-count bottles, Rx Only, Manufactu... | Subpotent Drug: One lot of product does not meet the product specification for Assay test at 3 mo... | Class III | InvaGen Pharmaceuticals, Inc. |
| Sep 25, 2018 | Progesterone SR 200 mg Capsules, packed in 8,13, 20, 30, 40 or 60 dram screw ... | Labeling Not Elsewhere Classified: Misbranding. | Class III | Right Value Drug Stores, Inc. |
| Sep 25, 2018 | Tadalafil SR 12 mg Capsules packed in 8,13, 20, 30, 40 or 60 dram screw top p... | Labeling Not Elsewhere Classified: Misbranding. | Class III | Right Value Drug Stores, Inc. |
| Sep 25, 2018 | Tadalafil SR 7 mg Capsules packed in 8,13, 20, 30, 40 or 60 dram screw top pi... | Labeling Not Elsewhere Classified: Misbranding. | Class III | Right Value Drug Stores, Inc. |
| Sep 25, 2018 | Levofloxacin Injection in 5% Dextrose, 5 mg/mL, packaged in a) 50 mL (NDC 360... | Superpotent Drug: High out of specification results for levofloxacin resulting in increased conce... | Class III | Baxter Healthcare Corporation |
| Sep 25, 2018 | Progesterone SR 100 mg Capsules, packed in 8,13, 20, 30, 40 or 60 dram screw ... | Labeling Not Elsewhere Classified: Misbranding. | Class III | Right Value Drug Stores, Inc. |
| Sep 18, 2018 | Altavera Levonorgestrel and Ethinyl Estradiol Tablets, USP 0.15 mg and 0.03 m... | Labeling: Not Elsewhere Classified: mislabeling of the Altavera generic name on the packaging com... | Class III | Xiromed LLC |
| 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 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 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 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 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 | 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 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 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 | 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, 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 | 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, 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 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, 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 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 100-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 500-count bottle, Rx only... | Failed Impurities/Degradation Specifications: Out of specification test results obtained during r... | Class III | Mylan Pharmaceuticals Inc. |
| 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 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 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, 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 |
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.