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 |
|---|---|---|---|---|
| Mar 29, 2019 | Clonidine HCL Injection, 1000 mcg/10mL (100 mcg/mL), 10 ML Single Dose Vial, ... | Labeling: Label Error on Declared Strength: Side carton panel incorrectly lists the concentration... | Class III | X-Gen Pharmaceuticals Inc. |
| Mar 28, 2019 | Nystatin Oral Suspension, USP, 100,000 units per mL, 473 mL per bottle, Rx on... | Failed Impurities/Degradation Specifications: Out of Specification for an unknown impurity was ob... | Class III | Akorn, Inc. |
| Mar 26, 2019 | Thallous Chloride TI 201 Injection, Specific Concentration: 37 MBq/mL (1 mCi/... | Chemical Contamination: Trace amounts of an impurity was detected in the reagent used to manufact... | Class III | Medi-Physics Inc. dba GE Healthcare |
| Mar 22, 2019 | Biotin 10 mg/mL Injection, 30 mL vial, Rx only, 511 S. Harbor Blvd., Building... | Failed pH Specification: product does not meet pH label claim. | Class III | Auro Pharmacies Inc. DBA Central Drugs |
| Mar 18, 2019 | Diclofenac Sodium Topical Solution, 1.5% w/w, 5 FL. OZ. (150 mL) bottle, Rx O... | Defective Container: firm discovered samples stored horizontally as well as product quality compl... | Class III | Ingenus Pharmaceuticals Llc |
| Mar 15, 2019 | Cleocin Phosphate, clindamycin injection, USP, 900 mg/ 6 mL (150 mg/mL), 6 mL... | Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demons... | Class III | Pfizer Inc. |
| Mar 15, 2019 | Repairwear Laser Focus Line Smoothing Cream Broad Spectrum SPF 15, packaged i... | Defective container: Ineffective seal between the cap and jar of the affected product. | Class III | Estee Lauder Inc |
| Mar 15, 2019 | Clindamycin Injection, USP, 900 mg/6 mL (150 mg/mL), 6 mL vial, Rx only, Dist... | Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demons... | Class III | Pfizer Inc. |
| Mar 15, 2019 | Clindamycin Injection, USP, 300 mg/ 2 mL (150 mg/mL), 2 mL vials, Rx only, Di... | Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demons... | Class III | Pfizer Inc. |
| Mar 15, 2019 | Clindamycin Injection, USP, 600 mg/ 4 mL (150 mg/mL), 4 mL vials, Rx only, Di... | Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demons... | Class III | Pfizer Inc. |
| Mar 15, 2019 | Cleocin Phosphate, clindamycin injection, USP, 600 mg/ 4 mL (150 mg/mL), 4 mL... | Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demons... | Class III | Pfizer Inc. |
| Mar 15, 2019 | Cleocin Phosphate (clindamycin injection), USP, 300 mg/ 2 mL (150 mg/mL), 2 m... | Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demons... | Class III | Pfizer Inc. |
| Mar 13, 2019 | 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. |
| Mar 11, 2019 | Lansoprazole Delayed-Release Orally Disintegrating Tablets, 15 mg, 100 tablet... | Subpotent Drug. | Class III | Teva Pharmaceuticals USA |
| Mar 7, 2019 | Mirapex (pramipexole dihydrochloride) Tablets, 1 mg, 100-count unit-dose tabl... | Failed Tablet/Capsule Specifications: identification of low weight tablets during routine stabili... | Class III | Boehringer Ingelheim Pharmaceuticals, Inc. |
| Mar 4, 2019 | ATHLETICARE Anti-Bacterial Hand Soap AC 550 (triclosan), 0.25%, 4 litres/1.1 ... | Does Not Meet Monograph: product contains, triclosan, an ingredient that can no longer be contain... | Class III | Petra Hygienic Systems Int Ltd |
| Mar 1, 2019 | Oxybutynin Chloride Extended-Release Tablets USP 10 mg, a) 100 tablets (NDC 4... | Failed Dissolution Specifications | Class III | AVKARE Inc. |
| Feb 28, 2019 | BuPROPion Hydrochloride Extended-Release Tablets, USP (XL) 150 mg, a) 30 coun... | Failed Dissolution Specifications; 9-monthstability timepoint | Class III | Jubilant Cadista Pharmaceuticals, Inc. |
| Feb 26, 2019 | Moxifloxacin Ophthalmic Solution USP, 0.5%, 3 mL bottle, Rx only, Manufacture... | Failed Impurities/Degradation Specifications: Expansion of July 2018 and February 2019 recall due... | Class III | Lupin Pharmaceuticals Inc. |
| Feb 21, 2019 | Oxybutynin Chloride, Extended-Release Tablets USP, 10 mg, 100 Tablet, Rx Only... | Failed Dissolution Specifications | Class III | Lannett Company Inc. |
| Feb 19, 2019 | Temozolomide Capsules, 5 mg, packaged in a) 5-count bottle (NDC 43975-252-05)... | Failed dissolution specifications | Class III | Amerigen Pharmaceuticals Inc. |
| Feb 19, 2019 | Lovastatin Tablets USP, 40 mg, packaged in a) 100-count bottles (NDC 68001-31... | CGMP Deviations: Finished product made with lovastatin drug substance that was out of specificati... | Class III | American Health Packaging |
| Feb 13, 2019 | Ciclopirox shampoo 1%,120 mL bottle, Rx only, Manufactured By Perrigo Bronx, ... | Failed Degradation/Impurities Specifications: Out of specification related substance results duri... | Class III | Perrigo New York, Inc. |
| Feb 13, 2019 | Lovastatin Tablets USP, 40 mg, packaged in a) 60-count (NDC 68180-469-07 and ... | CGMP Deviations: Finished product made with lovastatin drug substance that was out of specificati... | Class III | Lupin Pharmaceuticals Inc. |
| Feb 13, 2019 | Diltiazem HCl Extended-Release Capsules, USP 180mg, Packaged in a) 100-count ... | Failed Impurities/Degradation Specifications: High out of specification results obtained during r... | Class III | Mylan Pharmaceuticals Inc. |
| Feb 7, 2019 | Mometasone Furoate Cream, 0.1%, 45 g tube, Rx Only, Manufactured by: G&W Labo... | Labeling: Not Elsewhere Classified. Mometasone Furoate Cream has an NDC typographical error. | Class III | ACP Nimble Buyer, Inc. |
| Feb 6, 2019 | Oxytocin 10 Units added to NS 1000 mL (oxytocin and 0.9% Sodium Chloride) Inj... | Superpotent Drug: product may contain concentrations of oxytocin higher than what is represented ... | Class III | Advanced Pharma Inc. |
| Feb 6, 2019 | Oxytocin 30 Units added to NS 500 mL (oxytocin and 0.9% Sodium Chloride) Inje... | Superpotent Drug: product may contain concentrations of oxytocin higher than what is represented ... | Class III | Advanced Pharma Inc. |
| Feb 6, 2019 | Oxytocin 20 Units added to NS 1000 mL (oxytocin and 0.9% Sodium Chloride) Inj... | Superpotent Drug: product may contain concentrations of oxytocin higher than what is represented ... | Class III | Advanced Pharma Inc. |
| Feb 6, 2019 | Esomeprazole Magnesium Delayed-Release Capsules USP, 40mg*, a) 90-count bottl... | Discoloration: Esomeprazole Magnesium DR Capsules (40mg) may contain brown pellets. | Class III | Dr. Reddy's Laboratories, Inc. |
| Feb 1, 2019 | Moxifloxacin Ophthalmic Solution USP, 0.5%, 3 mL dropper bottle, Rx Only, Man... | Failed Impurities/Degradation Specifications: Out of specification test results in related substa... | Class III | Lupin Pharmaceuticals Inc. |
| Jan 30, 2019 | Cardizem CD (diltiazem HCl) capsules, 240 mg, packaged in a) 30-count bottles... | Failed Dissolution Specifications: high out of specification results for dissolution when measuri... | Class III | Valeant Pharmaceuticals North America LLC |
| Jan 30, 2019 | Diltiazem HCl CD capsules, 360 mg, 90-count bottles, Rx Only, Manufactured fo... | Failed Dissolution Specifications: high out of specification results for dissolution when measuri... | Class III | Valeant Pharmaceuticals North America LLC |
| Jan 30, 2019 | Cardizem CD (diltiazem HCl) capsules, 120 mg, packaged in a) 30-count bottles... | Failed Dissolution Specifications: high out of specification results for dissolution when measuri... | Class III | Valeant Pharmaceuticals North America LLC |
| Jan 30, 2019 | Cardizem CD (diltiazem HCl) capsules, 180 mg, packaged in a) 30-count bottles... | Failed Dissolution Specifications: high out of specification results for dissolution when measuri... | Class III | Valeant Pharmaceuticals North America LLC |
| Jan 30, 2019 | Cardizem CD (diltiazem HCl) capsules, 300 mg, packaged in a) 30-count bottles... | Failed Dissolution Specifications: high out of specification results for dissolution when measuri... | Class III | Valeant Pharmaceuticals North America LLC |
| Jan 28, 2019 | Bimatoprost Ophthalmic Solution 0.03%, packaged in a) 5 mL (NDC 68180-429-02)... | Failed Impurities/Degradation Specifications: OOS results observed in any other individual impuri... | Class III | Lupin Pharmaceuticals Inc. |
| Jan 25, 2019 | Clobetasol Propionate Emollient Cream 0.05%, a) 30 gram (NDC 50383-270-30) an... | Failed Stability Specification; out of specification (OOS) results for a preservative at 9 month ... | Class III | Akorn Inc |
| Jan 11, 2019 | Clobetasol Propionate Topical Solution USP, 0.05% w/w, 50 mL bottle, Manufact... | Defective Container; complaints of leakage. | Class III | Oxalis Labs |
| Dec 26, 2018 | LOPERAMIDE HCL TABLETS USP, 2 mg, ANTI-DIARRHEAL, 24 caplets per carton, OTC... | Labeling Not Elsewhere Classified: The front panel indicates 24 caplets whereas the side panel i... | Class III | Sun Pharmaceutical Industries, Inc. |
| Dec 20, 2018 | Temozolomide Capsules, 20 mg, packaged in a a) 5-count (NDC 43975-253-05) and... | Failed Dissolution Specifications | Class III | Amerigen Pharmaceuticals Inc. |
| Dec 20, 2018 | Temozolomide Capsules, 180 mg, packaged in a 14 count bottles, Rx only, Mfd, ... | Failed Dissolution Specifications | Class III | Amerigen Pharmaceuticals Inc. |
| Dec 20, 2018 | COSOPT Ophthalmic Solution, USP, (2% Dorzolamide Hydrochloride, 0.5% Timolol ... | Failed Stability Specifications: out of specification results for opalescence at 7 month stabilit... | Class III | Akorn Inc |
| Dec 10, 2018 | Advanced Protection Sunscreen spf 30 (Octinoxate 7.5%, Octisalate 5%, Oxybenz... | Subpotent Drug:Out of specification for percentage of active pharmaceutical ingredients. | Class III | CBI Laboratories, Inc. |
| Dec 10, 2018 | Options Rx Anti-Oxidant Oil-Free Sunscreeen (Octinoxate 7.5%, Octisalate 5%, ... | Subpotent Drug:Out of specification for percentage of active pharmaceutical ingredients. | Class III | CBI Laboratories, Inc. |
| Dec 7, 2018 | Absorica (Isotretinoin) Capsules 30 mg USP, 30 capsules (3x10 Prescription Pa... | Subpotent Drug: Isotretinoin content results were lower than the specification limit obtained dur... | Class III | Sun Pharmaceutical Industries, Inc. |
| Nov 30, 2018 | Amlodipine and Olmesartan Medoxomil Tablets, 5 mg/40 mg, Rx only, 30-count bo... | Discoloration: This product is being recalled due to a confirmed pharmacist report that tablets f... | Class III | Aurobindo Pharma USA Inc. |
| Nov 30, 2018 | NYSTATIN Oral Suspension, USP 500,000 Units/5mL, unit dose 5ml cups, packaged... | Failed Impurities/Degradation Specifications:Out of specification for impurities. | Class III | VistaPharm, Inc. |
| Nov 27, 2018 | Aprepitant Capsules, USP 40 mg, 1 capsule Unit Blister Pack, Rx Only, Manufa... | Shortfill: Aprepitant capsules 40 mg is being recalled due to customer reports of missing capsule... | Class III | Glenmark Pharmaceuticals Inc., USA |
| Nov 21, 2018 | Norepinephrine 8 mg (32 mcg/mL) added to 0.9% Sodium Chloride Injection 250 m... | Incorrect excipient: Product was compounded in 250 mL 5% Dextrose instead of 250 mL 0.9% Sodium C... | Class III | QuVa Pharma, 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.