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Browse Drug Recalls

837 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 837 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 837 FDA drug recalls in NC.

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DateProductReasonClassFirm
Feb 7, 2023 Atorvastatin Calcium Tablets USP 40 mg* Rx Only, Packaged as a) 90 Tablets ND... CGMP Deviations: recalling drug products following an FDA inspection. Class II Accord Healthcare, Inc.
Feb 7, 2023 Montelukast Sodium Tablets, USP, 10 mg* Rx Only, Packaged as: a) 30-count bot... CGMP Deviations: recalling drug products following an FDA inspection. Class II Accord Healthcare, Inc.
Feb 7, 2023 BusPIRone Hydrochloride Tablets USP 30 mg, 60-count bottle, Rx Only, Manufact... CGMP Deviations: recalling drug products following an FDA inspection. Class II Accord Healthcare, Inc.
Feb 7, 2023 Atorvastatin Calcium Tablets USP 80 mg* Rx Only, Packaged as a) 90 Tablets ND... CGMP Deviations: recalling drug products following an FDA inspection. Class II Accord Healthcare, Inc.
Feb 7, 2023 Dofetilide Capsules 250 mcg (0.25 mg) 60-count bottle, Rx only, Manufactured ... CGMP Deviations: recalling drug products following an FDA inspection. Class II Accord Healthcare, Inc.
Jan 12, 2023 Allopurinol Tablets USP, 100 mg, 100-count bottle, Rx Only, Manufactured for:... Presence of Foreign Substance: Presence of a small piece of green plastic embedded in the crack t... Class II Accord Healthcare, Inc.
Nov 29, 2022 Daptomycin for Injection 350 mg/vial 1 Single-dose vial, Rx only, Manufacture... Labeling mixup: cartons labeled as Daptomycin 350 mg/vial were found to contain vials of Daptomyc... Class I Accord Healthcare, Inc.
Nov 28, 2022 8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL) 50 mL Single D... Defective Container: Complaints received of vial breakage and glass flying when pressurized while... Class I Exela Pharma Sciences LLC
Nov 28, 2022 8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL) 50 mL Single D... Defective Container: Complaints received of vial breakage and glass flying when pressurized while... Class I Exela Pharma Sciences LLC
Oct 4, 2022 8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL) 50 mL Single D... Defective Container: Complaints received of vial breakage and glass flying when pressurized while... Class I Exela Pharma Sciences LLC
Oct 4, 2022 8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL) 50 mL Single D... Defective Container: Complaints received of vial breakage and glass flying when pressurized while... Class I Exela Pharma Sciences LLC
Jun 9, 2022 Clonidine Transdermal System, USP 0.3 mg/day, 4 Patches (NDC 51862-455-01) pe... Defective Delivery System: Out of specification for release liner removal force results at the 3... Class II Mayne Pharma Inc
May 13, 2022 Tivicay (dolutegravir) Tablets 50 mg, 30-count Bottle, Rx Only, Manufactured ... Labeling: incorrect or missing lot and/or expiration date. An incorrect expiration date was print... Class III GlaxoSmithKline LLC
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
Jan 14, 2022 Lexette (halobetasol propionate) Topical Foam, 0.05% 50 g canisters, Rx ONLY,... CGMP Deviation: Difficulty dispensing/does not dispense or dispensing liquid instead of foam. Class II Mayne Pharma Inc
Jan 11, 2022 8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL), 50 mL vials, ... Lack of Assurance of Sterility Class II Exela Pharma Sciences LLC
Aug 18, 2021 X RATED HONEY FOR MEN, packaged in 15g packets, 4 packets per box, UPC 6 1368... Marketed without an approved NDA/ANDA: Product found to be tainted with Tadalafil. Class I Phe Inc
Mar 10, 2021 heal the world, moisturizing original hand sanitizer, Non-Sterile Solution, A... Labeling Not Elsewhere Classified: Hand sanitizer packaged in containers resembling drinking wate... Class I PNHC, LLC.
Jan 28, 2021 Glycopyrrolate Injection, USP 0.4 mg/2 mL (0.2 mg/mL) 25 x 2 mL Single Dose V... Labeling; Label Mix-up; correctly labeled 2 mL vials were packaged into blister strips labeled fo... Class III Accord Healthcare, Inc.
Jan 21, 2021 Lidocaine/Tetracaine (LIPO110)* 23%/7% Ointment 100 GMS per 4 ounce plastic o... Superpotent Drug. Lidocaine higher concentration than listed Class II Stanley Specialty Pharmacy Compounding and Well...
Dec 9, 2020 Vumerity (diroximel fumarate) delayed-release capsule, 231 mg, packaged in a... Failed dissolution specifications: out-of-specification test results observed during the buffer s... Class II Biogen MA Inc.
Aug 7, 2020 Always Be Clean Hand Sanitizer (73% Alcohol) 0.04 FL OZ (1.2 mL) packaged in ... Labeling Not Elsewhere Classified: Product labeled to contain methanol Class II Open Book Extracts
Aug 7, 2020 Just Hand Sanitizer (Ethyl Alcohol 73%) Single Use-Packs 100-count NDC 78065-... Labeling Not Elsewhere Classified: Product labeled to contain methanol Class II Open Book Extracts
Aug 6, 2020 Hydromorphone HCl 1 mg/mL 250 mL bags, Rx only, Family Pharmacy of Statesvill... Lack of Assurance of Sterility Class II Family Pharmacy of Statesville
Aug 6, 2020 Trimix (Alprostadil/Papaverine/Phentolamine) 20 mcg/30 mg/0.5 mg Injectable 5... Lack of Assurance of Sterility Class II Family Pharmacy of Statesville
Aug 6, 2020 Vancomycin14 mg/mL Fortified Ophthalmic Solution in 5 mL bottles, Rx only, Fa... Lack of Assurance of Sterility Class II Family Pharmacy of Statesville
Aug 6, 2020 Hydromorphone HCl 5 mg/mL Infusion in 250 mL bags, Rx only, Family Pharmacy o... Lack of Assurance of Sterility Class II Family Pharmacy of Statesville
Aug 6, 2020 Hydromorphone HCl 0.1 mg/mL Infusion in 1000 mL bags, Rx only, Family Pharmac... Lack of Assurance of Sterility Class II Family Pharmacy of Statesville
Aug 6, 2020 Hydromorphone HCl 2 mg/mL Infusion 250 mL bags, Rx only, Family Pharmacy of S... Lack of Assurance of Sterility Class II Family Pharmacy of Statesville
Aug 6, 2020 Ketamine 50 mg Infusion (LV 1) Solution in 250 mL bags, Rx only, Family Pharm... Lack of Assurance of Sterility Class II Family Pharmacy of Statesville
Aug 6, 2020 Morphine Sulfate 6 mg/mL Infusion in 250 mL bag, Rx only, Family Pharmacy of... Lack of Assurance of Sterility Class II Family Pharmacy of Statesville
Aug 6, 2020 Fentanyl 150 mcg/mL Infusion Solution in 250 mL bags, Rx only, Family Pharmac... Lack of Assurance of Sterility Class II Family Pharmacy of Statesville
Aug 6, 2020 Methylcobalamin 1 mg/mL Injectable in 1 mL syringes, Rx only, Family Pharmacy... Lack of Assurance of Sterility Class II Family Pharmacy of Statesville
Aug 6, 2020 Trimix (Alprostadil/Papaverine/Phentolamine) 10 mcg/20 mg/1 mg Injectable 5 m... Lack of Assurance of Sterility Class II Family Pharmacy of Statesville
Aug 6, 2020 Lorazepam 1 mg/mL Infusion Solution in 250 mL bags, Rx only, Family Pharmacy ... Lack of Assurance of Sterility Class II Family Pharmacy of Statesville
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.
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
Mar 19, 2020 Dermatone (avobenzone, homosalate, octisalate, and octocrylene) Sunscreen Lot... Microbial contamination of non-sterile products: positive test for yeast and bacteria. Class II Filltech USA, LLC
Mar 19, 2020 Dermatone (avobenzone, homosalate, octisalate, and octocrylene) Sunscreen Lot... Microbial contamination of non-sterile products: positive test for yeast and bacteria. Class II Filltech USA, LLC
Mar 2, 2020 Carbidopa and Levodopa Tablets, USP 25 mg/250mg, 100 ct bottle, Rx Only, Mayn... Product Mix-Up: A foreign tablet was found in bottle. Class II Mayne Pharma Inc
May 31, 2019 ZYFLO CR (zileuton) extended-release tablets, 600 mg, 120-count bottles, Rx o... Failed Dissolution Specifications: Out of specification result for dissolution. Class II Chiesi USA, Inc.
May 31, 2019 Zileuton Extended-Release Tablets, 600 mg, 120-count bottles, Rx only, Distri... Failed Dissolution Specifications: Out of specification result for dissolution. Class II Chiesi USA, Inc.
Apr 12, 2019 Diltiazem 250 mg in NS 250 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Ac... Lack of sterility assurance. Class II CMC Enterprise Pharmacy
Apr 12, 2019 CeFAZolin 1 GM a) in NS 100 mL bag; b) 100 mg/mL (10 mL) syringe, Made by: En... Lack of sterility assurance. Class II CMC Enterprise Pharmacy
Apr 12, 2019 Phenylephrine 20 mg NS 250 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Ac... Lack of sterility assurance. Class II CMC Enterprise Pharmacy
Apr 12, 2019 Vancomycin 1000 mg in NS 250 mL bag, Made by: Enterprise Pharmacy, 4400 Golf ... Lack of sterility assurance. Class II CMC Enterprise Pharmacy
Apr 12, 2019 Vancomycin 1750 mg in 0.9% Sodium Chloride 500 mL bag, Made by: Enterprise Ph... Lack of sterility assurance. Class II CMC Enterprise Pharmacy
Apr 12, 2019 Magnesium Sulfate 1 GM in NS 50 mL bag, Made by: Enterprise Pharmacy, 4400 Go... Lack of sterility assurance. Class II CMC Enterprise Pharmacy
Apr 12, 2019 Sodium Citrate 4%, 40 mg/mL, 3 mL syringe, Flush Syringe, Made by: Enterpris... Lack of sterility assurance. Class II CMC Enterprise Pharmacy
Apr 12, 2019 Vancomycin 1500 mg in NS 250 mL bag, Made by: Enterprise Pharmacy, 4400 Golf ... Lack of sterility assurance. Class II CMC Enterprise Pharmacy

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.