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Browse Drug Recalls

1,392 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 1,392 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 1,392 FDA drug recalls in 2022.

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DateProductReasonClassFirm
May 9, 2022 Dexpanthenol 250 mg/mL Multi-Dose 30 mL Rx Only, Olympia Pharmaceuticals, 670... Lack of assurance of sterility. Class II Olympia Compounding Pharmacy dba Olympia Pharmacy
May 9, 2022 Methylcobalamin 5 mg/mL, Packaged as a) Multi-Dose 10mL vial, NDC 73198-0051-... Lack of assurance of sterility. Class II Olympia Compounding Pharmacy dba Olympia Pharmacy
May 9, 2022 SB-5 Papaverine 30 mg/mL Phentolamine 3 mg/mL PGE 50 mcg/mL, Multi-Dose 10 mL... Lack of assurance of sterility. Class II Olympia Compounding Pharmacy dba Olympia Pharmacy
May 9, 2022 Formula F9 Papaverine 0.9 mg/mL Phentolamine 0.1 mg/mL PGE 20 mcg/mL Atropine... Lack of assurance of sterility. Class II Olympia Compounding Pharmacy dba Olympia Pharmacy
May 9, 2022 Lipostat-Plus Methionine 25 mg/mL Inositol 50 mg/mL Choline Chloride 50 mg/mL... Lack of assurance of sterility. Class II Olympia Compounding Pharmacy dba Olympia Pharmacy
May 9, 2022 Pyridoxine 100 mg/mL, Multi-Dose 30 mL vial, Rx Only, Olympia Pharmaceuticals... Lack of assurance of sterility. Class II Olympia Compounding Pharmacy dba Olympia Pharmacy
May 9, 2022 Cyanocobalamin 2 mg/mL, Multi-Dose 10 mL vial, Rx Only, Olympia Pharmaceutica... Lack of assurance of sterility. Class II Olympia Compounding Pharmacy dba Olympia Pharmacy
May 9, 2022 Alpha Lipoic Acid 25 mg/mL, Multi-Dose 30 mL vial, Rx Only, Olympia Pharmaceu... Lack of assurance of sterility. Class II Olympia Compounding Pharmacy dba Olympia Pharmacy
May 9, 2022 Vitamin D3 (50,000 IU/mL)Multi-Dose 30 mL vial, Rx Only, Olympia Pharmaceutic... Lack of assurance of sterility. Class II Olympia Compounding Pharmacy dba Olympia Pharmacy
May 9, 2022 Phenylephrine 1 mg/mL, Multi-Dose 5 mL vial, Rx Only, Olympia Pharmaceuticals... Lack of assurance of sterility. Class II Olympia Compounding Pharmacy dba Olympia Pharmacy
May 9, 2022 Diluent for Reconstitution Multi-Dose 10 mL vial, Rx Only, Olympia Pharmaceut... Lack of assurance of sterility. Class II Olympia Compounding Pharmacy dba Olympia Pharmacy
May 9, 2022 Sodium Tetradecyl Sulfate 0.3% Injection, Multi-Dose 30 mL vial, Rx Only, Ol... Lack of assurance of sterility. Class II Olympia Compounding Pharmacy dba Olympia Pharmacy
May 9, 2022 Bimix-3 Papaverine 30 mg/mL Phentolamine 3 mg/mL, Packaged as a) 2.5 mL Multi... Lack of assurance of sterility. Class II Olympia Compounding Pharmacy dba Olympia Pharmacy
May 9, 2022 NB-343 Papaverine 30 mg/mL Phentolamine 3 mg/mL PGE 30 mcg/mL, Multi-Dose 10 ... Lack of assurance of sterility. Class II Olympia Compounding Pharmacy dba Olympia Pharmacy
May 9, 2022 Magnesium Chloride, 200 mg/mL, Multi-Dose 30 mL vial, Rx Only, Olympia Pharma... Lack of assurance of sterility. Class II Olympia Compounding Pharmacy dba Olympia Pharmacy
May 9, 2022 Pyridoxine HCL 100 mg/mL, Multi-Dose 30 mL vial, Rx Only, Olympia Pharmaceuti... Lack of assurance of sterility. Class II Olympia Compounding Pharmacy dba Olympia Pharmacy
May 9, 2022 QM-4 Papaverine 30 mg/mL Phentolamine 3 mg/mL Alprostadil 300 mcg/mL Atropine... Lack of assurance of sterility. Class II Olympia Compounding Pharmacy dba Olympia Pharmacy
May 9, 2022 Sodium Selenite 200 mg/mL, Multi-Dose 30 mL vial, Rx Only, Olympia Pharmaceu... Lack of assurance of sterility. Class II Olympia Compounding Pharmacy dba Olympia Pharmacy
May 9, 2022 T-106 Papaverine 30 mg/mL Phentolamine 1 mg/mL Alprostadil 25 mcg/mL, Package... Lack of assurance of sterility. Class II Olympia Compounding Pharmacy dba Olympia Pharmacy
May 9, 2022 Lidocaine 2% (20 mg/mL), Multi-Dose 30 mL vial , Rx Only, Olympia Pharmaceuti... Lack of assurance of sterility. Class II Olympia Compounding Pharmacy dba Olympia Pharmacy
May 9, 2022 Sodium Bicarbonate 8.4% MDV Injection, Multi-Dose 30 mL vial, Rx Only, Olymp... 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 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 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 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 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 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 3, 2022 Sirolimus Oral Solution, 1 mg/mL, 60 mL bottle, Rx Only, Manufactured by: Apo... Failed Dissolution Specifications: Sirolimus Oral Solution recalled due to lot RZ1598 exceeded th... Class III Apotex Corp.
May 3, 2022 Nitrofurantoin Capsules, USP (Monohydrate/Macrocrystals), 100 mg, 100 Capsule... Failed Dissolution Specifications: Nitrofurantoin Capsules recalled due to dissolution failure at... Class III American Health Packaging
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 29, 2022 buPROPion Hydrochloride Extended-Release Tablet, USP (SR), 150 mg packaged in... Presence Of Foreign Substance: Customer complaint for the presence of dark, gritty substance foun... Class III SUN PHARMACEUTICAL INDUSTRIES INC
Apr 29, 2022 buPROPion Hydrochloride Extended-Release Tablet, USP (SR), 200 mg, 60-count b... Presence Of Foreign Substance: Customer complaint for the presence of dark, gritty substance foun... Class III SUN PHARMACEUTICAL INDUSTRIES INC
Apr 29, 2022 Higher Education Make Out Ready Vegan Lip Balm, SPF 15, Net Wt. 0.15 oz (4.25... Mislabeling: The active ingredient list on the label does not match the product's actual ingredie... Class III Eco Lips, 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 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 27, 2022 GaviLyte -C (Polyethylene Glycol 3350, 240 g) and electrolytes for Oral Solut... Failed Stability Specification Class II Lupin Pharmaceuticals Inc.
Apr 27, 2022 Open Nature Cough Drops Menthol-Cough Suppressant/Oral Anesthetic Peppermint ... Subpotent drug: Low OOS for menthol content at the three month room temperature. Class III Bestco LLC
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, 100 mg, packaged in: a) 100-count bottle (NDC 68462... cGMP deviations Class II Glenmark Pharmaceuticals Inc., USA
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 Norepinephrine 8mg in 0.9% Sodium Chloride 250 mL bag, Rx only, SCA Pharmaceu... CGMP Deviations Class II SCA Pharmaceuticals
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

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.