Browse Drug Recalls
14,449 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 14,449 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 14,449 FDA drug recalls, Class II.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| May 9, 2022 | Testosterone Cypionate 200 mg/mL in Sesame Oil, Packaged in a) 5 mL Multi-Dos... | Lack of assurance of sterility. | Class II | Olympia Compounding Pharmacy dba Olympia Pharmacy |
| May 9, 2022 | NAD+ Nicotinamide Adenine Dinucleotide, Lyophilized powder for reconstitution... | Lack of assurance of sterility. | Class II | Olympia Compounding Pharmacy dba Olympia Pharmacy |
| May 9, 2022 | Zinc Chloride (0.5 mg/mL), Multi-Dose 30 mL vial, Rx Only, Olympia Pharmaceut... | Lack of assurance of sterility. | Class II | Olympia Compounding Pharmacy dba Olympia Pharmacy |
| May 9, 2022 | Lipo-Mino-Mix Pyridoxine HCL (B6) 2 mg/mL Methionine 12.4 mg/mL Inositol 25 m... | Lack of assurance of sterility. | Class II | Olympia Compounding Pharmacy dba Olympia Pharmacy |
| May 9, 2022 | Sermorelin Acetate Lyophilized powder for reconstitution 9 mg Per Multi-Dose ... | Lack of assurance of sterility. | Class II | Olympia Compounding Pharmacy dba Olympia Pharmacy |
| May 6, 2022 | medroxyPROGESTERone Acetate Injectable Suspension, USP, 1 mL Prefilled Syring... | Lack of assurance of sterility | Class II | SUN PHARMACEUTICAL INDUSTRIES INC |
| May 6, 2022 | Daytrana (methylphenidate transdermal system) Delivers 10 mg over 9 hours (1.... | Defective Delivery System: customer complaints exceeded respective action limits. | Class II | Noven Pharmaceuticals Inc |
| May 6, 2022 | medroxyPROGESTERone Acetate Injectable Suspension, USP, 1 mL Prefilled Syring... | Lack of assurance of sterility | Class II | SUN PHARMACEUTICAL INDUSTRIES INC |
| May 6, 2022 | medroxyPROGESTERone Acetate Injectable Suspension, USP, 1 mL Single-Dose Vial... | Lack of assurance of sterility | Class II | SUN PHARMACEUTICAL INDUSTRIES INC |
| May 6, 2022 | medroxyPROGESTERone Acetate Injectable Suspension, USP, 1 mL Prefilled Syring... | Lack of assurance of sterility | Class II | SUN PHARMACEUTICAL INDUSTRIES INC |
| May 6, 2022 | medroxyPROGESTERone Acetate Injectable Suspension, USP, 25 x 1 mL Single-Dose... | Lack of assurance of sterility | Class II | SUN PHARMACEUTICAL INDUSTRIES INC |
| May 5, 2022 | Losartan Pot./HCTZ 100/12.5 mg Packaged and Distributed By: Direct Rx Dawsonv... | CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits | Class II | Direct Rx |
| May 5, 2022 | Equate Tartar Control Plus (Eucalyptol 0.092%, Menthol 0.042%, Methyl salicyl... | Superpotent Drug: product complaint for milky blue appearance and consistency, further investigat... | Class II | Vi-Jon, LLC |
| May 4, 2022 | Losartan HCTZ 50/12.5 mg, 90 count bottle Original NDC# 33342-0050-10 Repac... | CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits | Class II | RemedyRepack Inc. |
| May 3, 2022 | Losartan Potassium & HCTZ Tablets 50mg/12.5 mg, hydrochlorothiazide USP 12.5,... | CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits | Class II | Preferred Pharmaceuticals, Inc. |
| May 3, 2022 | Losartan Potassium & HCTZ Tablets 50mg/12.5 mg, hydrochlorothiazide USP 12.5 ... | CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits | Class II | Preferred Pharmaceuticals, Inc. |
| May 2, 2022 | MVASI (bevacizumab-awwb), Injection, For Intravenous Infusion After Dilution,... | Defective container: loose crimp defect, potential loss of container integrity. | Class II | Amgen, Inc. |
| May 2, 2022 | Losartan HCTZ 100/12.5 mg, 90 count bottles NDC# 70518-2564-00 Repackaged ND... | CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits. | Class II | RemedyRepack Inc. |
| May 2, 2022 | Losartan HCTZ 100/25 mg, 90 count bottles NDC# 70518-2578-00 Repackaged NDC ... | CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits. | Class II | RemedyRepack Inc. |
| Apr 28, 2022 | alprazolam XR extended-release tablets, 3 mg, 60-count bottle, Rx only, Distr... | Failed Dissolution Specifications: low out-of-specification dissolution test results observed. | Class II | Viatris Inc |
| Apr 28, 2022 | Xanax XR (alprazolam) extended-release tablets, 3 mg, 60-count bottle, Rx onl... | Failed Dissolution Specifications: low out of specification results for dissolution. | Class II | Viatris Inc |
| Apr 27, 2022 | GaviLyte -C (Polyethylene Glycol 3350, 240 g) and electrolytes for Oral Solut... | Failed Stability Specification | Class II | Lupin Pharmaceuticals Inc. |
| Apr 25, 2022 | Zonisamide Capsules, USP, 100 mg, packaged in: a) 100-count bottle (NDC 68462... | cGMP deviations | Class II | Glenmark Pharmaceuticals Inc., USA |
| Apr 25, 2022 | Fentanyl 2mcg/ml and Bupivacaine 0.125% in 0.9% Sodium Chloride 100 mL bags, ... | CGMP Deviations | Class II | SCA Pharmaceuticals |
| Apr 25, 2022 | Zonisamide Capsules USP, 25 mg, packaged in 100-count bottles, Rx Only, Manuf... | cGMP deviations | Class II | Glenmark Pharmaceuticals Inc., USA |
| Apr 25, 2022 | Zonisamide Capsules, USP, 50 mg, packaged in 100-count bottles, Rx only, Manu... | cGMP deviations | Class II | Glenmark Pharmaceuticals Inc., USA |
| Apr 25, 2022 | Vancomycin HCl 1.5 g in 0.9% Sodium Chloride, 500 mL bags, Rx only, SCA Pharm... | CGMP Deviations | Class II | SCA Pharmaceuticals |
| Apr 25, 2022 | Norepinephrine 8mg in 0.9% Sodium Chloride 250 mL bag, Rx only, SCA Pharmaceu... | CGMP Deviations | Class II | SCA Pharmaceuticals |
| Apr 22, 2022 | Accupril (Quinapril HCl Tablets) 40 mg, 90 Tablets, Rx only NDC 0071-0535-23... | CGMP Deviations: Contains N-nitrosoquinapril above the acceptable limits. | Class II | Pfizer Inc. |
| Apr 22, 2022 | Accupril (Quinapril HCl Tablets) 20 mg, 90 Tablets, Rx only NDC 0071-0532-23... | CGMP Deviations: Contains N-nitrosoquinapril above the acceptable limits. | Class II | Pfizer Inc. |
| Apr 22, 2022 | Accupril (Quinapril HCl Tablets) 10 mg, 90 Tablets Rx only NDC 0071-0530-23 ... | CGMP Deviations: Contains N-nitrosoquinapril above the acceptable limits. | Class II | Pfizer Inc. |
| Apr 21, 2022 | Lidocaine Prilocaine Cream USP, 2.5%/2.5% Net Wt. 30 gram tube, Rx Only, Dist... | CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Te... | Class II | McKesson Corporation dba McKesson Drug Company |
| Apr 21, 2022 | Halobetasol Propionate Ointment 0.05% Net Wt., 50 gram tube, Rx Only, Manufac... | CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Te... | Class II | McKesson Corporation dba McKesson Drug Company |
| Apr 21, 2022 | Lidocaine Hydrochloride Topical Solution USP 4% (40 mg/mL), 50 mL bottle, Rx ... | CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Te... | Class II | McKesson Corporation dba McKesson Drug Company |
| Apr 21, 2022 | Erythromycin Topical Gel USP, 2%, Net Wt 60 g tube, Rx only, Manufactured by:... | CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Te... | Class II | McKesson Corporation dba McKesson Drug Company |
| Apr 21, 2022 | Betamethasone Dipropionate Ointment USP, 0.05%* (Augmented) (Potency expresse... | CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Te... | Class II | McKesson Corporation dba McKesson Drug Company |
| Apr 21, 2022 | TORCO RACING FUELS HAND SANITIZER, Alcohol Antiseptic 80% Topical Solution, H... | CGMP Deviations: FDA analysis found product to contain acetaldehyde and acetal above specificatio... | Class II | Torco Race Fuels |
| Apr 15, 2022 | Lansoprazole Delayed-Release Orally Disintegrating Tablets, 30 mg, 10 Packs o... | Failed Dissolution Specifications | Class II | Dr. Reddy's Laboratories, Inc. |
| Apr 15, 2022 | Losartan Potassium & Hydrochlorothiazide Tablets, USP, 100 mg/12.5 mg, a) 30-... | CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits | Class II | Macleods Pharma Usa Inc |
| Apr 15, 2022 | Lidocaine 2.5% and Prilocaine 2.5% Cream, USP, packaged in a) 5 g tubes (NDC... | cGMP Deviations | Class II | Teva Pharmaceuticals USA Inc |
| Apr 15, 2022 | Losartan Potassium & Hydrochlorothiazide Tablets, USP, 100 mg/25 mg, a) 30-co... | CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits | Class II | Macleods Pharma Usa Inc |
| Apr 15, 2022 | Losartan Potassium Tablets, USP, 50 mg, a) 30-count bottles (NDC # 33342-045-... | CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits | Class II | Macleods Pharma Usa Inc |
| Apr 15, 2022 | Losartan Potassium Tablets, USP, 25 mg, a) 90-count bottles (NDC # 33342-044-... | CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits | Class II | Macleods Pharma Usa Inc |
| Apr 15, 2022 | Losartan Potassium & Hydrochlorothiazide Tablets, USP, 50 mg/12.5 mg, a) 30-c... | CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits | Class II | Macleods Pharma Usa Inc |
| Apr 15, 2022 | Losartan Potassium Tablets, USP, 100 mg, a) 30-count bottles (NDC # 33342-046... | CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits | Class II | Macleods Pharma Usa Inc |
| Apr 13, 2022 | ClomiPHENE Citrate Tablets, USP 50 mg, 30-count bottle, Rx only, MFG: PAR Pha... | cGMP deviations: Temperature abuse | Class II | Mckesson Medical-Surgical Inc. Corporate Office |
| Apr 13, 2022 | Thrombin JMI, Vial 5,000IU 2/diluent, kit, Rx only, MFG: Pfizer NDC 60793-2... | cGMP deviations: Temperature abuse | Class II | Mckesson Medical-Surgical Inc. Corporate Office |
| Apr 13, 2022 | Lidocaine Patch 5%, 30-count box, Rx only, MFG: Teva Pharma USA, NDC 0591-352... | cGMP deviations: Temperature abuse | Class II | Mckesson Medical-Surgical Inc. Corporate Office |
| Apr 13, 2022 | MethyLPREDNISolone Acetate Injectable Suspension, USP, 200mg/5mL (40 mg/mL), ... | cGMP deviations: Temperature abuse | Class II | Mckesson Medical-Surgical Inc. Corporate Office |
| Apr 13, 2022 | Cefazolin for injection USP, and Dextrose Injection, USP, 2 g, 50 mL duplex c... | cGMP deviations: Temperature abuse | Class II | Mckesson Medical-Surgical Inc. Corporate Office |
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.