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Browse Drug Recalls

1,681 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 1,681 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 1,681 FDA drug recalls in 2018.

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DateProductReasonClassFirm
Aug 27, 2018 Levonorgestrel and Ethinyl Estradiol Tablets, USP 0.15 mg/0.03 mg, Rx Only, 3... Labeling: Not Elsewhere Classified-Incorrect NDC and product name identified on blister packs. Class III Mylan Pharmaceuticals Inc.
Aug 24, 2018 Cortaid 12-Hour Advanced Anti-itch Cream (1% hydrocortisone), NET WT 1.5 oz. ... CGMP deviations: Notice received from supplier of a voluntary recall of all their nasal products ... Class II Valeant Pharmaceuticals North America LLC
Aug 24, 2018 Amlodipine/Valsartan HCTZ 10 mg/320 mg/25 mg tablets, HDPE 90 cc bottles in c... CGMP Deviations: Detection of trace amounts of NDMA, a possible impurity or contaminant in an act... Class II RemedyRepack Inc.
Aug 24, 2018 Ethosuximide Capsules, USP, 250 mg, 100 capsules per bottle, Rx only, Mfg For... Failed Impurities/Degradation Specifications: Out of specification (OOS) results for unspecified ... Class II Akorn, Inc.
Aug 24, 2018 Cortaid Maximum Strength Cream (1% hydrocortisone), 1 OZ (28 g) tube, OTC, Di... CGMP deviations: Notice received from supplier of a voluntary recall of all their nasal products ... Class II Valeant Pharmaceuticals North America LLC
Aug 24, 2018 Cortaid Intensive Therapy Cooling Spray (1% hydrocortisone), 2 FL OZ (59 mL) ... CGMP deviations: Notice received from supplier of a voluntary recall of all their nasal products ... Class II Valeant Pharmaceuticals North America LLC
Aug 24, 2018 Thyroid Powder, USP, 25kg/drum, Rx Only, Sichuan Friendly Pharmaceutical Co.,... CGMP Deviations: Thyroid Powder has inconsistent levels of the active ingredients levothyroxine a... Class II LGM Pharma LLC
Aug 23, 2018 Cefuroxime 10mg/mL INJ 0.5 mg, SDV, Rx only, Pacific Compounding, Stockton, CA Presence of Particulate Matter: Particulate matter was reported in one lot of Cefuroxime by a phy... Class II Pacific Compounding Pharmacy & Consultations Inc
Aug 23, 2018 Thyroveev, Homeopathic (OTC Medicine), 2 fl oz (59 mL) per bottle, Mftd for: ... Microbial Contamination of Non Sterile Products; Products contaminated with microoganisms, includ... Class I Hellolife
Aug 23, 2018 Neuroveen, Homeopathic (OTC Medicine), 2 fl oz (59 mL) per bottle, Mftd for: ... Microbial Contamination of Non Sterile Products; Products contaminated with microoganisms, includ... Class I Hellolife
Aug 23, 2018 Compulsin, Homeopathic (OTC Medicine), 2 fl oz (59 mL) per bottle, Mftd for: ... Microbial Contamination of Non Sterile Products; Products contaminated with microoganisms, includ... Class I Hellolife
Aug 23, 2018 Children s Advil Suspension Ibuprofen Oral Suspension, 100 mg per 5mL, 4 FL O... Labeling Error: Not elsewhere classified. product has a dosage cup marked in teaspoons and the i... Class II Pfizer Global Supply
Aug 23, 2018 Morphine Sulfate Extended-Release Tablets, 30 mg, 100-count bottle, Rx only, ... Failed Impurities/Degradation Specifications: Morphine Sulfate Extended Release Tablets are being... Class III LUPIN SOMERSET
Aug 23, 2018 Respitrol, Homeopathic (OTC Medicine), 2 fl oz (59 mL) per bottle, Mftd for: ... Microbial Contamination of Non Sterile Products; Products contaminated with microoganisms, includ... Class I Hellolife
Aug 22, 2018 THYROID POWDER USP, Full Strength (Levothyroxine labeled range of 103-125mcg/... CGMP Deviations: Recall notice received from supplier that Thyroid Powder has inconsistent levels... Class II Syntec Pharma Corp
Aug 22, 2018 THYROID POWDER USP (Levothyroxine labeled range of 34.2-41.8mcg/grain; Liothy... CGMP Deviations: Recall notice received from supplier that Thyroid Powder has inconsistent levels... Class II Syntec Pharma Corp
Aug 21, 2018 Calcium Gluconate injectable, 10%, 50 ml Single Dose vial, Rx only, Central D... Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of pro... Class II Auro Pharmacies, Inc.
Aug 21, 2018 Methyl-Cobalamin injectable, 10 mg/mL, 30 mL Multiple Dose vial, Rx only, Cen... Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of pro... Class II Auro Pharmacies, Inc.
Aug 21, 2018 Folic Acid injectable, 10 mg/ml, 30 ml Multiple Dose vial, Rx only, Central ... Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of pro... Class II Auro Pharmacies, Inc.
Aug 21, 2018 Testosterone Enanthate/Cypionate injectable, 126/54 mg/mL, packaged in a) 3 m... Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of pro... Class II Auro Pharmacies, Inc.
Aug 21, 2018 Methyl-Cobalamin injectable, 2 mg/mL, 30 ml Multiple Dose vial, Rx only, Cen... Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of pro... Class II Auro Pharmacies, Inc.
Aug 21, 2018 Testosterone Cypionate/Enanthate injectable, 126/54 mg/mL, packaged in a) 3 m... Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of pro... Class II Auro Pharmacies, Inc.
Aug 21, 2018 CoEnzyme-Q10 injectable, 20 mg/mL, 10 mL Multiple Dose vial, Rx only, Central... Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of pro... Class II Auro Pharmacies, Inc.
Aug 21, 2018 Dexpanthenol injectable, 250 mg/mL, 10 mL Single Dose vial, Rx only, Central ... Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of pro... Class II Auro Pharmacies, Inc.
Aug 21, 2018 Thyroid Powder 25kg/drum, US Pharmacopoeia, Sichuan Friendly Pharmaceutical C... CGMP Deviations: Thyroid Powder has inconsistent levels of the active ingredients levothyroxine... Class II Sichuan Friendly Pharmaceutical Co.,Ltd.
Aug 21, 2018 Glutathione injectable, 200 mg/mL, 30 mL Multiple Dose vial, Rx only, Central... Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of pro... Class II Auro Pharmacies, Inc.
Aug 21, 2018 Testosterone Cypionate/Enanthate injectable, 200/50 mg/mL, packaged in a) 5 m... Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of pro... Class II Auro Pharmacies, Inc.
Aug 21, 2018 Methyl-Cobalamin injectable, 5 mg/mL, 30 mL Multiple Dose vial, Rx only, Cent... Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of pro... Class II Auro Pharmacies, Inc.
Aug 21, 2018 0.9% Sodium Chloride Injection USP 100 mL bags, Rx only, Baxter Healthcare Co... CGMP Deviations Class II Baxter Healthcare Corporation
Aug 21, 2018 Hydrochlorothiazide Tablets USP, 12.5 mg, 100-count bottle, Rx Only, Manufact... Product Mix-Up: customer complaint that a sealed bottle labeled as Hydrochlorothiazide Tablets US... Class I Accord Healthcare, Inc.
Aug 21, 2018 Oxycodone and Acetaminophen Tablets, USP, 5 mg*/325 mg, 100-count bottle, Rx ... Labeling: Incorrect or Missing Lot and/or Exp Date: Lot FG10517 is mislabeled on the primary cont... Class III Mayne Pharma Inc
Aug 21, 2018 Methyl-Cobalamin injectable, 1 mg/mL, packaged in a) 5 mL and b) 30 mL Multi... Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of pro... Class II Auro Pharmacies, Inc.
Aug 20, 2018 Amlodipine/Valsartan/HCTZ 10mg/320mg/25mg Tablet, Rx Only (HDPE 90cc Bottles ... CGMP Deviations: Detection of trace amounts of NDMA, a possible impurity or contaminant in an act... Class II RemedyRepack Inc.
Aug 20, 2018 Montelukast Sodium Tablets, 10 mg*, 30-count bottles, Rx Only, By: Hetero, H... Discoloration: A complaint was received from a pharmacist for the presence of blue specks on tabl... Class II Hetero Labs Limited Unit V
Aug 17, 2018 Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP, 10 mg/160 mg/12.5... CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Class II Torrent Pharma Inc.
Aug 17, 2018 Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP, 10 mg/160 mg/25 m... CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Class II Torrent Pharma Inc.
Aug 17, 2018 Amlodipine and Valsartan Tablets, USP, 10 mg/160mg, 30 tablets per bottle, Rx... CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Class II Torrent Pharma Inc.
Aug 17, 2018 Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP, 10 mg/320 mg/25 m... CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Class II Torrent Pharma Inc.
Aug 17, 2018 Valsartan Tablets USP, 80mg, 90 tablets per bottle, Rx Only, Manufactured by:... CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Class II Torrent Pharma Inc.
Aug 17, 2018 Valsartan Tablets USP, 320mg, 90 tablets per bottle, Rx Only, Manufactured by... CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Class II Torrent Pharma Inc.
Aug 17, 2018 Amlodipine and Valsartan Tablets, USP, 5 mg/160 mg, 30 tablets per bottle, Rx... CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Class II Torrent Pharma Inc.
Aug 17, 2018 Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP, 5 mg/160 mg/12.5 ... CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Class II Torrent Pharma Inc.
Aug 17, 2018 Valsartan Tablets USP, 160mg, 90 tablets per bottle, Rx Only, Manufactured by... CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Class II Torrent Pharma Inc.
Aug 17, 2018 Amlodipine and Valsartan Tablets, USP, 10 mg/320 mg, 30 tablets per bottle, R... CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Class II Torrent Pharma Inc.
Aug 17, 2018 Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP, 5 mg/160 mg/25 mg... CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Class II Torrent Pharma Inc.
Aug 17, 2018 Amlodipine and Valsartan Tablets, USP, 5 mg/320 mg, 30 tablets per bottle, Rx... CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Class II Torrent Pharma Inc.
Aug 15, 2018 Valsartan Tablets USP 320 mg, 90-count, plastic child resistant bottle, Rx On... CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Class II Preferred Pharmaceuticals, Inc
Aug 15, 2018 Montelukast Sodium Tablets 10 mg, 30-count bottle, Rx Only, By: Hetero Hetero... Labeling: Label Mix-Up - One lot labeled Montelukast Sodium Tablets 10 mg tablets may contain 90 ... Class I Hetero Labs Limited Unit V
Aug 14, 2018 Megestrol Acetate Oral Suspension, USP 400 mg/mL, 10 mL (10 mL UD cups in box... Supterpotent Drug Class II Mckesson Corporation
Aug 14, 2018 Valsartan Tablets, USP 80 mg Rx Only 50 Tablets (5x10) Unit Dose NDC 50268-78... CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Class II AVKARE 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.