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 3, 2017 | bupPROPion HCL Extended-Release Tablets, USP (XL) 300 mg, 500-count bottle, R... | Failed Impurities/Degradation Specifications: Mylan Pharmaceuticals Inc. is conducting a voluntar... | Class III | Mylan Pharmaceuticals Inc. |
| Oct 30, 2017 | Doan's Pain Relieving Cream with 4% Lidocaine Plus Menthol, (lidocaine 4%, me... | Labeling: Incorrect or Missing Lot and/or Exp Date; lot number on the secondary packaging doesnt... | Class III | Dr. Reddy's Laboratories, Inc. |
| Oct 30, 2017 | Meclizine hydrochloride tablets USP, 12.5 mg, 100 count HDPE bottle, Rx only,... | Marketed without an approved NDA/ANDA: Bottles were released prior to final approval. | Class III | Jubilant Cadista Pharmaceuticals, Inc. |
| Oct 19, 2017 | Combigan (brimonidine tartrate/timolol maleate ophthalmic solution) 0.2%/0.5%... | Failed Impurities/Degradation Specifications. | Class III | Allergan Sales, LLC |
| Oct 19, 2017 | Lumigan (bimatoprost ophthalmic solution) 0.01%, 2.5 mL bottle, Rx only, All... | Failed Impurities/Degradation Specifications. | Class III | Allergan Sales, LLC |
| Oct 17, 2017 | Methylphenidate Hydrochloride Tablets USP, 20 mg, 100-count bottles, Rx only,... | Failed Dissolution Specifications: Low out of specification results for dissolution. | Class III | Teva Pharmaceuticals USA |
| Oct 13, 2017 | Clofarabine injection, 20 mg/20 mL, 20 mL Single-Use Vial, Rx only, Mfd by: T... | Labeling: Incorrect or Missing Package Insert: authorized generic product was packaged with the i... | Class III | Sanofi-Aventis U.S. LLC |
| Oct 12, 2017 | Clolar (clofarabine) 20 mg/20 mL (1 mg/mL) Injection, for intravenous use, R... | Labeling: Incorrect or Missing Package Insert. | Class III | Genzyme Corporation |
| Oct 3, 2017 | Famotidine tablets, 10 mg, packaged in 30-count bottle, OTC, labeled as a) CV... | Failed impurities/degradation specifications: Famotodine has an out of specification result for a... | Class III | Dr. Reddy's Laboratories, Inc. |
| Sep 26, 2017 | morphine Sulfate in 0.9% Sodium Chloride Injection 1 mL Total Volume 2 mg per... | Labeling: Incorrect or Missing Lot and/or Exp. Date | Class III | Pharmedium Services, LLC |
| Sep 26, 2017 | morphine Sulfate in 0.9% Sodium Chloride Injection 2 mL Total Volume 1 mg per... | Labeling: Incorrect or Missing Lot and/or Exp. Date | Class III | Pharmedium Services, LLC |
| Sep 26, 2017 | HYDROmorphone HCl in 0.9% Sodium Chloride Injection, 1 mL Total Volume 1 mg p... | Labeling: Incorrect or Missing Lot and/or Exp. Date | Class III | Pharmedium Services, LLC |
| Sep 25, 2017 | Carbamazepine Oral Suspension USP, 100 mg/5 mL, 5 mL Unit Dose Cups (NDC 6809... | Subpotent Drug: low out of specification results. | Class III | Precision Dose Inc. |
| Sep 25, 2017 | Esterified Estrogens & Methyltestosterone Tablets, USP 1.25 mg/2.5 mg, 100-c... | Subpotent Drug: Out of specification assay result in Esterified Estrogen and Methyltestosterone t... | Class III | Amneal Pharmaceuticals, Inc. |
| Sep 25, 2017 | Ampicillin for Injection, USP, 500 mg per vial, single vial (NDC 0781-3407-78... | Labeling: Missing Label: customer complaint that some vials of ampicillin within the shrink wrap ... | Class III | Sandoz Inc |
| Sep 25, 2017 | Esterified Estrogens & Methyltestosterone Tablets, USP 0.625 mg/1.25 mg, 100... | Subpotent Drug: Out of specification assay result in Esterified Estrogen and Methyltestosterone t... | Class III | Amneal Pharmaceuticals, Inc. |
| Sep 22, 2017 | Mobic (meloxicam) tablets, 15 mg, package in 100-count bottle, Rx only, Dist.... | Labeling: Incorrect or missing package insert. One lot of Mobic Tablets is packaged with an incor... | Class III | Boehringer Ingelheim Pharmaceuticals, Inc. |
| Sep 20, 2017 | Fluocinonide Gel USP, 0.05%, 15 g tube, Rx Only, Mfd. by: Taro Pharmaceutical... | Cross contamination with other products: traces of Dapsone were found in the finished product. | Class III | Taro Pharmaceuticals U.S.A., Inc. |
| Sep 13, 2017 | Magnesium Citrate Oral Solution Cherry Flavor, 1.745 g per fl oz, packaged in... | Failed Impurities/Degradation Specifications. | Class III | Vi-Jon, Inc. |
| Sep 13, 2017 | Equate Beauty Clarifying Face Daily Moisturizer 4 fl. oz. (118 mL) Distribute... | Failed Stability Specifications | Class III | Vi-Jon, Inc. |
| Sep 13, 2017 | Magnesium Citrate Oral Solution Lemon Flavor, 1.745g per fl oz, packaged in ... | Failed Impurities/Degradation Specifications. | Class III | Vi-Jon, Inc. |
| Sep 8, 2017 | AndroGel (testosterone gel) 1.62%, 40.5mg in 2.5g aluminum foil packet, 30 Pa... | Temperature Abuse: Prolonged exposure to temperatures outside of labeled storage conditions. | Class III | AbbVie Inc. |
| Sep 8, 2017 | AndroGel (testosterone gel) 1.62%, 88 gm metered-dose pump, 20.25 mg of testo... | Temperature Abuse: Prolonged exposure to temperatures outside of labeled storage conditions. | Class III | AbbVie Inc. |
| Sep 5, 2017 | Phentermine, USP Capsules, 15 mg, 30 count bottles, Rx only, Packaged By: Aid... | Failed Impurities/Degradation Specification; out-of-specification results for individual unknown ... | Class III | Aidarex Pharmaceuticals LLC |
| Sep 5, 2017 | ENALAPRIL MALEATE Tablets, USP, 5MG, 90-count bottles, Rx only, MFG: Wockhard... | Failed Impurities/Degradation Specifications: manufacturer of product recalled this repackaged lo... | Class III | Aidarex Pharmaceuticals LLC |
| Aug 29, 2017 | Enalapril Maleate Tablets, USP, 5 mg, 100 Tablets (10 x 10), Rx Only. Packag... | Failed Stability Specifications | Class III | Amerisource Health Services |
| Aug 28, 2017 | Propafenone Hydrochloride tablets, 150 mg, packaged in 10 x 10 unit dose card... | Failed moisture limits: Out of specification for moisture content. | Class III | Mckesson Packaging Services |
| Aug 22, 2017 | Enalapril Maleate tablets, USP, 5mg, 1000-count bottles, Rx only, Manufacture... | Failed Impurities/Degradation Specifications: 5mg strength being recalled for out of specificatio... | Class III | Wockhardt Usa Inc. |
| Aug 17, 2017 | Hydrocodone Bitartrate and Acetaminophen Oral Solution 7.5 mg/325 mg per 15 m... | Labeling: Not Elsewhere Classified; product is incorrectly labeled as Class III controlled substa... | Class III | VistaPharm, Inc. |
| Aug 11, 2017 | Phentermine Capsules, 15 mg, a) 7-count bottle (NDC 55289-791-07), b) 14-cou... | Failed Impurities/Degradation Specifications:Out of specification results for individual unknown ... | Class III | PD-Rx Pharmaceuticals, Inc. |
| Aug 4, 2017 | Quillivant XR methylphenidate HCl, for extended-release oral suspension, 750m... | Failed Dissolution Specifications | Class III | Pfizer Inc. |
| Aug 4, 2017 | Quillivant XR methylphenidate HCl, for extended-release oral suspension, 600 ... | Failed Dissolution Specifications | Class III | Pfizer Inc. |
| Aug 3, 2017 | Phentermine HCL Capsules, USP 15 mg, packaged in a) 100-count bottles (NDC 10... | Failed Impurities/Degradation Specifications: out-of-specification results obtained for individua... | Class III | KVK-Tech, Inc. |
| Aug 2, 2017 | Glipizide Extended-Release Tablets (anti-diabetic agent), 5 mg, packaged in 3... | Failed Moisture Limits: out of specification test results for water content obtained during stabi... | Class III | Teva Pharmaceuticals USA |
| Jul 25, 2017 | Albuterol Sulfate Inhalation Solution, 0.021% (0.63 mg/3mL), packaged in 5 po... | Failed Impurities/Degradation Specifications: high out of specification results for related compo... | Class III | Teva Pharmaceuticals USA |
| Jul 19, 2017 | Voriconazole Tablets, 200 mg, 20-count cartons (4 x 5) Unit Dose, Rx only, Ma... | Failed impurities/degradation specifications: Out of specification for a related compound C. | Class III | AVKARE Inc. |
| Jul 17, 2017 | Beautipharm Body Moisturizing Balm SPF 10 (Octocrylene 4% and Octyl methoxyci... | Subpotent Drug: products are labeled as having SPF 10 protection; however, this claim cannot be 1... | Class III | Linde Eckstein Gmbh + Co KG |
| Jul 17, 2017 | Make Up Transparent sand (Titanium Dioxide) SPF 10 liquid make-up, 1 oz. Net ... | Subpotent Drug: products are labeled as having SPF 10 protection; however, this claim cannot be 1... | Class III | Linde Eckstein Gmbh + Co KG |
| Jul 17, 2017 | Make Up Transparent ivory (Titanium Dioxide) SPF 10 liquid make-up, 1 oz. Net... | Subpotent Drug: products are labeled as having SPF 10 protection; however, this claim cannot be 1... | Class III | Linde Eckstein Gmbh + Co KG |
| Jul 17, 2017 | Make Up Perfect ivory (Titanium Dioxide) SPF 10 liquid make-up, 1 oz. Net Wt.... | Subpotent Drug: products are labeled as having SPF 10 protection; however, this claim cannot be 1... | Class III | Linde Eckstein Gmbh + Co KG |
| Jul 17, 2017 | Make Up Transparent pastel (Titanium Dioxide) SPF 10 liquid make-up, 1 oz. Ne... | Subpotent Drug: products are labeled as having SPF 10 protection; however, this claim cannot be 1... | Class III | Linde Eckstein Gmbh + Co KG |
| Jul 17, 2017 | Make Up Transparent terra (Titanium Dioxide) SPF 10 liquid make-up, 1 oz. Net... | Subpotent Drug: products are labeled as having SPF 10 protection; however, this claim cannot be 1... | Class III | Linde Eckstein Gmbh + Co KG |
| Jul 17, 2017 | Make Up Transparent dark tan (Titanium Dioxide) SPF 10 liquid make-up, 1 oz. ... | Subpotent Drug: products are labeled as having SPF 10 protection; however, this claim cannot be 1... | Class III | Linde Eckstein Gmbh + Co KG |
| Jul 17, 2017 | Make Up Perfect sand (Titanium Dioxide) SPF 10 liquid make-up, 1 oz. Net Wt. ... | Subpotent Drug: products are labeled as having SPF 10 protection; however, this claim cannot be 1... | Class III | Linde Eckstein Gmbh + Co KG |
| Jul 17, 2017 | Make Up Perfect pastel (Titanium Dioxide) SPF 10 liquid make-up, 1 oz. Net Wt... | Subpotent Drug: products are labeled as having SPF 10 protection; however, this claim cannot be 1... | Class III | Linde Eckstein Gmbh + Co KG |
| Jul 17, 2017 | Beautipharm All Day Moisturizing Balm SPF 10 (Octocrylene 4% and Octyl methox... | Subpotent Drug: products are labeled as having SPF 10 protection; however, this claim cannot be 1... | Class III | Linde Eckstein Gmbh + Co KG |
| Jul 17, 2017 | Make Up Perfect terra (Titanium Dioxide) SPF 10 liquid make-up, 1 oz. Net Wt.... | Subpotent Drug: products are labeled as having SPF 10 protection; however, this claim cannot be 1... | Class III | Linde Eckstein Gmbh + Co KG |
| Jul 17, 2017 | Beautipharm Eye Care Balm SPF 10 (Octocrylene 4% and Octyl methoxycinnamide 4... | Subpotent Drug: products are labeled as having SPF 10 protection; however, this claim cannot be 1... | Class III | Linde Eckstein Gmbh + Co KG |
| Jul 17, 2017 | Make Up Perfect dark tan (Titanium Dioxide) SPF 10 liquid make-up, 1 oz. Net ... | Subpotent Drug: products are labeled as having SPF 10 protection; however, this claim cannot be 1... | Class III | Linde Eckstein Gmbh + Co KG |
| Jul 17, 2017 | Make Up Perfect caramel (Titanium Dioxide) SPF 10 liquid make-up, 1 oz. Net W... | Subpotent Drug: products are labeled as having SPF 10 protection; however, this claim cannot be 1... | Class III | Linde Eckstein Gmbh + Co KG |
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.