Browse Drug Recalls

1,056 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 1,056 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 1,056 FDA drug recalls.

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DateProductReasonClassFirm
Jun 24, 2024 Diflorasone Diacetate Ointment, USP, 0.05%, 60g tube, Rx only, Mfd. By: Lyne ... Failed Impurities/Degradation Specifications: The impurity results at 12 months stability testin... Class III Rising Pharma Holding, Inc.
Jun 18, 2024 Venlafaxine Hydrochloride, extended-release capsules, USP, 37.5mg, 10 x 10 bl... Failed dissolution specifications: out of specification result obtained during routine stability ... Class II The Harvard Drug Group LLC dba Major Pharmaceut...
May 7, 2024 Drug Vial Label: Zilretta¿ (triamcinolone acetonide extended-release injectab... Failed Stability Specifications - at 12 months 2-8 degrees C followed by 6 weeks at 25 degrees C. Class II PACIRA PHARMACEUTICALS INC
Mar 28, 2024 Isotretinoin Capsules, USP 40mg, 30-count 3x10 blister packs per carton, Rx O... Superpotent Drug: The 3-month stability result for assay was found to be above specification limit Class II Teva Pharmaceuticals USA, Inc
Mar 26, 2024 Diltiazem Hydrochloride Extended-Release Capsules, USP 120 mg, Twice-a-Day Do... Failed Dissolution Specifications: Out of Specification (OOS) was reported in test of dissolution... Class II Glenmark Pharmaceuticals Inc., USA
Mar 1, 2024 S.P.Labs, Thyroid, Full Strength, Rx only, For Manufacturing, Processing or R... Failed Stability Specifications Class II Specialty Process Labs LLC
Mar 1, 2024 S.P Labs, Thyroid, USP, Rx only, For Manufacturing, Processing or Repackaging... Failed Stability Specifications Class II Specialty Process Labs LLC
Feb 22, 2024 Tobramycin for Injection, USP, 1.2 grams per Pharmacy Bulk Package, Rx Only, ... Failed Stability Specification: Water determination was found not complying with specification. Class II Eugia US LLC
Feb 20, 2024 Clindamycin Phosphate Topical Solution USP, 1%, 60 mL bottle, Manufactured fo... Defective Container: Out of specification for weight due to a slow leakage at the 12-month stabil... Class III Contract Pharmaceuticals Limited Canada
Feb 20, 2024 Clindamycin Phosphate, Topical Solution USP, 1%, 60 mL, Rx Only, Manufactured... Defective Container: Out of specification for weight due to a slow leakage at the 12-month stabil... Class III Contract Pharmaceuticals Limited Canada
Feb 16, 2024 Broncochem Cold & Tea (acetaminophen, phenylephrine, HCl, chlorpheniramine ma... Stability testing failures for one or two of the four active pharmaceutical ingredients among the... Class II Global Corporation
Feb 16, 2024 Broncochem Cold & Flu Syrup Kids (acetaminophen, guaifenesin, phenylephrine H... Stability testing failures for one or two of the four active pharmaceutical ingredients among the... Class II Global Corporation
Feb 9, 2024 Telmisartan Tablets, USP 40mg, Rx Only, 30 Tablets per bottle, Manufactured b... Failed Stability Specifications: Out of specification for blend uniformity. Class II Micro Labs Limited
Feb 9, 2024 HydrALAZINE Hydrochloride Tablets, USP 10mg, packaged in 100-count (10x10 bli... an out of specification result obtained during routine stability testing for Impurities. There i... Class II The Harvard Drug Group LLC dba Major Pharmaceut...
Jan 11, 2024 Vasostrict (vasopressin in 5% Dextrose) Injection, 20 units per 100 mL (0.2 u... Superpotent Drug: Assay from the 3-month and 6-month stability intervals exceeded the upper speci... Class II Par Sterile Products LLC
Dec 13, 2023 Selenium Sulfide 2.25% Shampoo, 180mL bottle, Rx Only, Manufactured for: Bi-C... CGMP Deviations: Stability data does not support expiry date. Class II Private Label Partners, Inc.
Dec 8, 2023 Eprontia (topiramate) oral solution, 25 mg/mL, 473 mL Bottle, Rx only, Manufa... Failed Impurities/Degradation Specifications: Out of specification Impurity C (4,5-desisopropylid... Class III Azurity Pharmaceuticals, Inc.
Nov 6, 2023 VITRAKVI (larotractenib) oral solution, 20mg/mL, 100 mL bottle, Rx only, Manu... Microbial Contamination of Non-Sterile Products: microbial contamination identified as Penicilliu... Class I Bayer Healthcare Pharmaceuticals Inc.
Nov 6, 2023 Hydrocortisone 1% and Acetic Acid 2% Otic Solution USP, 10ml dropper bottle, ... Failed Impurities/Degradation Specifications:Out-of-Specification result for Hydrocortisone relat... Class III Taro Pharmaceuticals Inc.
Oct 23, 2023 Esomeprazole Magnesium Delayed-Release Capsules, USP 20mg, Packaged as (a) 30... Failed Impurities/Degradation Specifications:Out of Specification result reported for the test of... Class III Glenmark Pharmaceuticals Inc., USA
Aug 25, 2023 BD ChloraPrep Clear, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isoprop... Stability data does not support expiry: Shelf-life of the impacted lots of BD ChloraPrep" Clear 1... Class II CareFusion 213, LLC
Aug 16, 2023 Nexlizet (bempedoic acid and ezetimibe), 180ng/18mg, 30 tablets, Rx only, Man... Failed dissolution specifications: below specification results at stability 12-month Class III Esperion
Jul 18, 2023 Fosfomycin Tromethamine Granules for Oral Solution, 3 g single- dose sachet, ... Failed Impurities/Degradation Specifications: Out-of-specification results observed for the organ... Class III Ascend Laboratories, LLC
Jun 27, 2023 Amlodipine Besylate Tablets, USP 10 mg, 1000-count bottles, Rx only, Manufact... Subpotent Drug: Out-of-Specification test results observed in assay test at 21-month long term st... Class III Lupin Pharmaceuticals Inc.
Jun 26, 2023 Tizanidine Hydrochloride Tablet 4mg, packaged in a) 20 count-bottles (NDC 687... Failed Stability Specifications Class II Preferred Pharmaceuticals, Inc.
Jun 23, 2023 PANCREAZE (pancrelipase) Delayed-Release Capsules, 100-count bottles, Rx only... Failed Stability Specifications Class III Vivus, Inc.
Jun 23, 2023 Tydemy (drospirenone, ethinyl estradiol and levomefolate calcium tablets, 3 m... Failed Stability Specification and Failed Impurities/Degradation Specifications: out of specific... Class I Lupin Pharmaceuticals Inc.
Jun 21, 2023 Tizanidine Tablets USP, 4 mg, 1000-Count bottle, Rx Only, Manufactured by Dr.... Failed dissolution specification: Out of specification results observed in 24-month long term sta... Class II Dr Reddy's Laboratories Limited
May 9, 2023 buPROPrion Hydrochloride Extended-Release Tablets, USP (SR) 150 mg, 60 Tablet... Failed Dissolution Specifications; during stability testing Class II SUN PHARMACEUTICAL INDUSTRIES INC
Apr 26, 2023 Timolol Maleate Ophthalmic Solution, USP 0.5%, packaged in a) 2.5mL bottles, ... CGMP Deviations: Firm went out of business and could no longer continue stability studies. Class II Akorn, Inc.
Apr 26, 2023 Calcipotriene Topical Solution, 0.005% (Scalp Solution), 60 mL bottles, Rx O... CGMP Deviations: Firm went out of business and could no longer continue stability studies. Class II Akorn, Inc.
Apr 26, 2023 Midazolam Injection, USP, 50 mg/10mL (5mg/mL), For Intramuscular or Intraveno... CGMP Deviations: Firm went out of business and could no longer continue stability studies. Class II Akorn, Inc.
Apr 26, 2023 Lidocaine Ointment USP, 5%, 1 1/4 oz tubes, Rx Only, Manufactured for: HI-TEC... CGMP Deviations: Firm went out of business and could no longer continue stability studies. Class II Akorn, Inc.
Apr 26, 2023 Midazolam Injection, USP 2mg/2mL (1 mg/mL) For Intramuscular or Intravenous U... CGMP Deviations: Firm went out of business and could no longer continue stability studies. Class II Akorn, Inc.
Apr 26, 2023 Granisetron HCl Injection, USP, 1 mg/mL, packaged in a) 1mL and b) 4 mL vials... CGMP Deviations: Firm went out of business and could no longer continue stability studies. Class II Akorn, Inc.
Apr 26, 2023 Fluticasone Propionate Nasal Spray, 50mcg, 16 g bottles, Manufactured by: HI-... CGMP Deviations: Firm went out of business and could no longer continue stability studies. Class II Akorn, Inc.
Apr 26, 2023 Gonak Hypromellose Ophthalmic Solution 25mg/mL, 15 mL bottles, Rx Only, Manuf... CGMP Deviations: Firm went out of business and could no longer continue stability studies. Class II Akorn, Inc.
Apr 26, 2023 Olopatadine HCl Nasal Spray, 665 mcg, 30.5 g bottles, Rx Only, Manufactured b... CGMP Deviations: Firm went out of business and could no longer continue stability studies. Class II Akorn, Inc.
Apr 26, 2023 Oxcarbazepine Oral Suspension, USP, 300 mg/5 mL, 250 mL bottles, Rx Only, Dis... CGMP Deviations: Firm went out of business and could no longer continue stability studies. Class II Akorn, Inc.
Apr 26, 2023 Pilocarpine Hydrochloride Ophthalmic Solution, USP 1%, 15 mL bottles, Rx Only... CGMP Deviations: Firm went out of business and could no longer continue stability studies. Class II Akorn, Inc.
Apr 26, 2023 Albuterol Sulfate Syrup, 2mg (base), 16 fl oz (473 mL) per bottle, Rx only, D... CGMP Deviations: Firm went out of business and could no longer continue stability studies. Class II Akorn, Inc.
Apr 26, 2023 Calcitriol Injection 2 mcg/mL, 1 mL ampules Rx Only, Distributed by: Akorn Op... CGMP Deviations: Firm went out of business and could no longer continue stability studies. Class II Akorn, Inc.
Apr 26, 2023 DOCU LIQUID (docusate sodium, 50 mg/5 mL), packaged in 473mL bottles and b)10... CGMP Deviations: Firm went out of business and could no longer continue stability studies. Class II Akorn, Inc.
Apr 26, 2023 Acetic Acid Otic Solution, 15 mL per bottle, Rx only, Distributed by: Akorn O... CGMP Deviations: Firm went out of business and could no longer continue stability studies. Class II Akorn, Inc.
Apr 26, 2023 Neomycin & Polymyxin B Sulfates, and Bacitracin Zinc Ophthalmic Ointment, 3.5... CGMP Deviations: Firm went out of business and could no longer continue stability studies. Class II Akorn, Inc.
Apr 26, 2023 Tropicamide Ophthalmic Solution, USP 0.5%, 15 mL bottles, Rx only, Distribute... CGMP Deviations: Firm went out of business and could no longer continue stability studies. Class II Akorn, Inc.
Apr 26, 2023 Acyclovir Oral Suspension, 200mg/5mL, Rx only, Distributed by: Akorn Operatin... CGMP Deviations: Firm went out of business and could no longer continue stability studies. Class II Akorn, Inc.
Apr 26, 2023 Sufenta (Sufentanil Citrate Injection, USP) 50 mcg/mL, packaged in a)1 mL amp... CGMP Deviations: Firm went out of business and could no longer continue stability studies. Class II Akorn, Inc.
Apr 26, 2023 Lactulose Solution, USP (Oral), 10g/15 mL, packaged in a) 15mL bottles, b) 30... CGMP Deviations: Firm went out of business and could no longer continue stability studies. Class II Akorn, Inc.
Apr 26, 2023 Clobetasol Propionate Shampoo, 0.05%, 4oz (118 mL) bottles, Rx Only, Distrib... CGMP Deviations: Firm went out of business and could no longer continue stability studies. Class II Akorn, 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.