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, 2020 | Homeopathic Energy Catalyst, 1 fl oz (30 mL) Distributed by: Deseret Biologic... | Labeling: Product Contains Undeclared API; Incorrect formulation | Class III | Grato Holdings, Inc. |
| Sep 16, 2020 | Nymalize (nimodipine) oral solution, 60 mg/20 mL, 12 Unit-Dose Cups and 12 Or... | Subpotent Drug | Class III | Arbor Pharmaceuticals Inc. |
| Sep 9, 2020 | Citalopram Oral Solution, USP 20 mg/10 mL, 10 mL unit dose cups, Rx Only, Mfg... | Failed Impurities/Degradation Specifications; high out of specification results obtained at the 9... | Class III | PAI Holdings, LLC. dba Pharmaceutical Associate... |
| Sep 9, 2020 | Nicotine Gum, Nicotine Polacrilex Gum USP, 2 mg (nicotine), 110-count pieces ... | Labeling: Incorrect or Missing Package Insert: The package insert included in the finished produc... | Class III | P & L Developments, LLC |
| Aug 3, 2020 | Extra Strength Headache Relief (Acetaminophen 250 mg/aspirin 250 mg/Caffeine ... | Failed Stability Specifications: Out-of-Specification (OOS) results for the Aspirin related compo... | Class III | Ultra Seal Corporation |
| Aug 3, 2020 | Pain Relief Maximum Strength (Acetaminophen 250 mg/aspirin 250 mg/Caffeine 65... | Failed Stability Specifications: Out-of-Specification (OOS) results for the Aspirin related compo... | Class III | Ultra Seal Corporation |
| Jul 31, 2020 | Red Cross Oral Pain (Oral Anesthetic benzocaine 20%), Maximum Strength, 1/8 F... | Labeling; Not Elsewhere Classified: The Mentholatum Company is initiating a voluntary recall due ... | Class III | The Mentholatum Company |
| Jul 24, 2020 | Clobetasol Propionate Cream, USP, 0.05%, packaged in a)15g Tubes (NDC 60429-9... | Failed Content Uniformity: bulk lot used to make these two lots was found to have failed content ... | Class III | Golden State Medical Supply Inc. |
| Jul 22, 2020 | Leucovorin Calcium Tablets USP, 10 mg, Rx only, 24 Tablets per bottle, Distr.... | Failed Tablet/Capsule Specifications: Tablets are imprinted with the incorrect identification code. | Class III | West-Ward Columbus Inc |
| Jul 20, 2020 | Clobetasol Propionate Cream USP, 0.05%, a) 15 g tube, NDC: 60429-902-15; b) ... | Failed Content Uniformity: bulk lot used to make these two lots was found to have failed content ... | Class III | Taro Pharmaceuticals U.S.A., Inc. |
| Jul 13, 2020 | Fosaprepitant for Injection, 150 mg / vial in a 10 mL Single-Dose vial, Rx on... | Labeling Error: Label Error on Declared Strength: Carton label and product insert incorrectly sta... | Class III | Fresenius Kabi USA, LLC |
| Jul 6, 2020 | Skin Medica Acne System, Contains: Purifying Foaming Wash (Salicylic Acid 2.0... | SUBPOTENT DRUG: Products failed assay results at the 12 and 24 month timepoints. | Class III | Allergan PLC |
| Jul 6, 2020 | Skin Medica Acne Treatment Lotion (Benzoyl Peroxide 2.5%), 2 Oz bottle, Distr... | SUBPOTENT DRUG: Products failed assay results at the 12 and 24 month timepoints. | Class III | Allergan PLC |
| Jul 6, 2020 | Clonazepam Orally Disintegrating Tablets, USP, 0.125 mg, 60-count bottle, Rx ... | Cross contamination with other products - OOS discovered during routine stability testing for hig... | Class III | SUN PHARMACEUTICAL INDUSTRIES INC |
| Jun 23, 2020 | Nystatin Oral Suspension, USP 500,000 units/5mL Cup, Delivers 5 mL, Rx Only,... | Failed impurities/degradation products; Presence of an impurity peak that exceeds the approved sp... | Class III | VistaPharm, Inc. |
| Jun 23, 2020 | Tecfidera (dimethyl fumarate) delayed-release capsules, 240 mg, 60-count bott... | cGMP deviations: one lot of the product was distributed to US Markets despite being rejected duri... | Class III | Biogen MA Inc. |
| Jun 23, 2020 | Nystatin Oral Suspension, USP 100,000 units per mL, Bubblegum Flavored, 16 fl... | Failed impurities/degradation products; Presence of an impurity peak that exceeds the approved sp... | Class III | VistaPharm, Inc. |
| Jun 17, 2020 | Famotidine Injection, USP, 20 mg/2mL, 2 mL vial, Rx only, Single Dose Vial, F... | TEMPERATURE ABUSE: Complaint received from customer that product was received in a non-refrigerat... | Class III | HF Acquisition Co. LLC |
| Jun 10, 2020 | Nabumetone Tablets, USP, 500 mg, 100 Tablets per carton (10 tablets x 10 blis... | Labeling Not Elsewhere Classified: The statement Pharmacist: Dispense with the accompanying Medi... | Class III | American Health Packaging |
| Jun 5, 2020 | Prednisolone Sodium Phosphate Oral Solution, 5 mg/5 mL, 120 mL Bottle, Rx onl... | Discoloration: Out of Specification (OOS) result for APHA Color Test. | Class III | Akorn, Inc. |
| Jun 4, 2020 | Brimonidine Tartrate Opthalmic Solution 0.2%, 5 mL bottle, Rx only, Manufactu... | Failed Impurities/Degradation Specification: There is a slow leaching process from the product l... | Class III | SOMERSET THERAPEUTICS LLC |
| Jun 4, 2020 | Brimonidine Tartrate Opthalmic Solution 0.2%, 10 mL bottle, Rx only, Manufact... | Failed Impurities/Degradation Specification: There is a slow leaching process from the product l... | Class III | SOMERSET THERAPEUTICS LLC |
| Jun 4, 2020 | Brimonidine Tartrate Opthalmic Solution 0.2%, 15 mL bottle, Rx only, Manufact... | Failed Impurities/Degradation Specification: There is a slow leaching process from the product l... | Class III | SOMERSET THERAPEUTICS LLC |
| May 28, 2020 | Lamotrigine Tablets, USP, 150 mg, Rx Only, a) 60 count Bottle, NDC 42291-368-... | Presence of Foreign Substance consistent with granules from desiccant packs used during storage | Class III | AVKARE Inc. |
| May 27, 2020 | Duavee (conjugated estrogens/bazedoxifene) tablets 0.45/20 mg, packaged in 2 ... | Failed Dissolution Specifications | Class III | Pfizer Inc. |
| May 26, 2020 | Olanzapine Tablets, USP 7.5 mg, 30-count bottle, Rx only, Manufactured for: P... | Failed Impurities/ Degradation Specifications | Class III | Aurobindo Pharma USA Inc. |
| May 26, 2020 | Clonidine Hydrochloride Tablets, USP 0.1 mg 100-count bottles, Rx only, Manuf... | Failed Impurities/Degradation Specifications: potential migration of benzophenone at very low lev... | Class III | UNICHEM PHARMACEUTICALS USA INC |
| May 26, 2020 | Lamotrigine Tablets, USP, 150 mg, 20,000-count bulk container, Manufactured b... | Presence of Foreign Substance visually consistent with the silica granules present in the desicca... | Class III | Jubilant Cadista Pharmaceuticals, Inc. |
| May 26, 2020 | Olanzapine Tablets, USP 2.5 mg, 30-count bottle, Rx only, Manufactured for: P... | Failed Impurities/ Degradation Specifications | Class III | Aurobindo Pharma USA Inc. |
| May 19, 2020 | Zilretta (triamcinolone acetonide extended-release injectable suspension), 32... | Temperature Abuse: Product was stored at room temperature longer than 6 weeks and was inadvertent... | Class III | Flexion Therapeutics, Inc. |
| May 14, 2020 | Gabapentin Tablets USP, 600 mg, Rx Only, 500-count bottle, Manufactured for: ... | Failed Impurities/Degradation Specifications; failure of Impurity A test at the 12-month long-ter... | Class III | InvaGen Pharmaceuticals, Inc. |
| May 13, 2020 | Ethacrynic Acid Tablets USP, 25 mg, 100 Tablets per Bottle, Rx only, Distr. b... | Failed Impurities/Degradation Specifications: Out of Specification for impurity 6 and total degra... | Class III | West-Ward Columbus Inc |
| May 5, 2020 | Potassium Acetate Injection, USP 40 mEq/20 mL (2 mEq/mL) Single Dose Vials, R... | Short Fill | Class III | Exela Pharma Sciences LLC |
| Apr 24, 2020 | Esomeprazole Magnesium Delayed Release Capsules USP, 40 mg*, 1000-count bott... | Discoloration: product contains brown pellets | Class III | Dr. Reddy's Laboratories, Inc. |
| Apr 24, 2020 | Memantine Hydrochloride Extended-Release Capsules, 28 mg, 100 capsules per un... | Failed dissolution specifications: Low stage 3 results obtained for dissolution during routine st... | Class III | The Harvard Drug Group |
| Apr 23, 2020 | R.E.C.K. (Ropivacaine, Epinephrine, Clonidine, Ketorolac) in Sodium Chloride ... | Presence of Particulate Matter: Fresenius Kabi recalling vials of Ketorolac | Class III | QuVa Pharma, Inc. |
| Apr 20, 2020 | ChapStick Total Hydration Moisture + Tint + SPF15 Peachy Keen Net Wt. 0.08 OZ... | Labeling: Not elsewhere classified: Observed separation in the secondary packaging in the blister... | Class III | Glaxosmithkline Consumer Healthcare Holdings |
| Apr 20, 2020 | ChapStick Total Hydration Moisture + Tint + SPF15 Pretty in Pink Net Wt. 0.08... | Labeling: Not elsewhere classified: Observed separation in the secondary packaging in the blister... | Class III | Glaxosmithkline Consumer Healthcare Holdings |
| Apr 20, 2020 | ChapStick Total Hydration Moisture + Tint + SPF15 Very Berry Net Wt. 0.08 OZ... | Labeling: Not elsewhere classified: Observed separation in the secondary packaging in the blister... | Class III | Glaxosmithkline Consumer Healthcare Holdings |
| Mar 25, 2020 | Fentanyl Citrate Injection, USP, 100 mcg/2 mL (50 mcg/mL), 10 Ampules per car... | Failed impurities/degradation specification: Out-of-Specification result for total impurity at 4.... | Class III | Akorn Inc |
| Mar 23, 2020 | Tacrolimus Capsules, USP 5mg, 100-count bottle, Rx only, Mylan Pharmaceutical... | Presence of foreign tablet/capsule - Potential presence of commingled one Tacrolimus 1 mg capsule... | Class III | Mylan Pharmaceuticals Inc. |
| Mar 9, 2020 | Bekyree (desogestrel and ethinyl estradiol tablets USP, 0.15 mg/0.02 mg and e... | Failed Content Uniformity Specifications: Out Of Specification test results observed for content ... | Class III | Lupin Pharmaceuticals Inc. |
| Mar 4, 2020 | PrediniSONE Tablets, USP 5 mg, 48-count bottle, Rx only, Distributed by: Par... | Labeling: Incorrect or Missing Exp Date - An incorrect expiration date has been identified on Pre... | Class III | Par Pharmaceutical Inc. |
| Feb 27, 2020 | Quetiapine Fumarate Extended-Release Tablets, 150 mg, 100 tablets per unit do... | Labeling; Incorrect or Missing Package Insert: Product was packaged with the package insert for Q... | Class III | The Harvard Drug Group |
| Feb 27, 2020 | Quetiapine Fumarate Extended-Release Tablets, 200 mg, 100 tablets per unit do... | Labeling; Incorrect or Missing Package Insert: Product was packaged with the package insert for Q... | Class III | The Harvard Drug Group |
| Feb 27, 2020 | Quetiapine Fumarate Extended-Release Tablets, 300 mg, 100 tablets per unit do... | Labeling; Incorrect or Missing Package Insert: Product was packaged with the package insert for Q... | Class III | The Harvard Drug Group |
| Feb 27, 2020 | Quetiapine Fumarate Extended-Release Tablets, 50 mg, 100 tablets per unit dos... | Labeling; Incorrect or Missing Package Insert: Product was packaged with the package insert for Q... | Class III | The Harvard Drug Group |
| Feb 24, 2020 | Zoledronic Acid Injection 5 mg/100 mL (0.05 mg/mL), Solution for Intravenous ... | Failed Impurities/Degradation Specifications: Out-of-specification results obtained for impuritie... | Class III | Breckenridge Pharmaceutical, Inc |
| Feb 21, 2020 | CVS Health Sodium Chloride Ophthalmic Ointment USP, 5%, 3.5 g tubes, Distribu... | Presence of Particulate Matter: Brown spots observed on the inside of the tube of product, identi... | Class III | Akorn, Inc. |
| Feb 21, 2020 | Sodium Chloride Ophthalmic Ointment USP, 5%, 3.5 g tubes, Manufactured by: A... | Presence of Particulate Matter: Brown spots observed on the inside of the tube of product, identi... | Class III | Akorn, 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.