Browse Drug Recalls
1,020 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 1,020 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 1,020 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jan 10, 2025 | Granix (tbo-filgrastim) Injection 300 mcg/0.5 mL, Single Dose prefilled syrin... | Failed Stability Specifications - 12-month stability test result for one of the known peptides is... | Class II | Teva Pharmaceuticals USA, Inc |
| Jan 8, 2025 | babyganics, Sheer Blend, SPF 50 Mineral Sunscreen Fragrance Free (zinc oxide ... | Failed stability specifications: during routine stability monitoring quality concerns were identi... | Class II | Johnson, S C and Son, Inc |
| Dec 23, 2024 | Cardura XL (doxazosin) extended release tablets 4 mg, 30 -count bottle, Rx on... | Failed Impurities/Degradation Specifications: Out of specification results observed for the impur... | Class II | Viatris Inc |
| Dec 23, 2024 | Cardura XL (doxazosin) extended release tablets 8 mg, 30-count bottle, Rx onl... | Failed Impurities/Degradation Specifications: Out of specification results observed for the impur... | Class II | Viatris Inc |
| Dec 20, 2024 | Levothyroxine Sodium Tablets, Lupin, 75 mcg (0.075mg), 1000 Tablets, Rx Only,... | Failed Impurities/Degradation Specifications: Out of specifications result observed in the drug s... | Class II | Lupin Pharmaceuticals Inc. |
| Dec 18, 2024 | Colchicine Capsules 0.6 mg, 30-count bottles, Rx only, Manufactured by: Granu... | Failed Dissolution Specifications: Out of specification observed during the accelerated stability... | Class II | Granules Pharmaceuticals Inc. |
| Nov 22, 2024 | Kit for the Preparation of Technetium Tc 99m Sulfur Colloid Injection, 10 mL ... | Failed Stability Specifications | Class II | Jubilant Draximage Inc., dba Jubilant Radiopharma |
| Nov 5, 2024 | Hydralazine HCl Tablets, USP, 25mg, Rx only, 100 tablets per carton, Distribu... | Failed Impurities/Degradation Specifications; during routine stability testing for impurities. | Class III | The Harvard Drug Group LLC dba Major Pharmaceut... |
| Oct 21, 2024 | Chlorpheniramine Maleate 4 mg tablets, 24-count bottle, Manufactured For: Ath... | Superpotent Drug: Stability failure for assay at 6 months test time-point. | Class II | BLI International, Inc. |
| Oct 11, 2024 | Triamcinolone Acetonide Cream USP, 0.025%, 1 LB (454 g) per jar, Rx Only, Man... | Subpotent and Superpotent Drug. Out of specification assay results recorded as part of Uniformity... | Class III | Padagis US LLC |
| Aug 21, 2024 | Cefixime for Oral Suspension USP, 100 mg/5 mL, 50 mL bottle, Rx only, Manufac... | Subpotent Drug- An out of specification ( OOS ) result observed in assay test during 18-month lon... | Class II | Lupin Pharmaceuticals Inc. |
| Aug 9, 2024 | Ibuprofen 800mg, Generic for: Motrin, Each tablet contains: Ibuprofen, USP 80... | Failed Impurities/Degradation Specifications: Product failed impurity specifications at the 18-mo... | Class II | Direct Rx |
| Aug 8, 2024 | Ibuprofen Tablets, USP 400mg, Generic for Motrin, Pkg Size: 30 tablets per bo... | Failed Impurities/Degradation Specifications - at 18-month Stability testing | Class II | Preferred Pharmaceuticals, Inc. |
| Aug 7, 2024 | Hydrocortisone 1% & Acetic Acid 2% Otic Solution, 10 mL bottle, Rx only, Mfg ... | Failed Impurities/Degradation Specifications: Out-of-specification results obtained for related i... | Class III | Taro Pharmaceuticals U.S.A., Inc. |
| 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. |
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.