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Browse Drug Recalls

399 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 399 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 399 FDA drug recalls in N/A.

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DateProductReasonClassFirm
Apr 2, 2026 Lidocaine HCl Injection, USP, 2%, 100 mg/5mL (20 mg/mL), 5 mL Single-Dose Via... Lack of Assurance of Sterility Class II Huons Co., Ltd.
Apr 2, 2026 Lidocaine HCl injection, USP, 1% 50mg/5mL (10 mg/mL), 5 mL Single Dose Vials,... Lack of Assurance of Sterility Class II Huons Co., Ltd.
Apr 2, 2026 Bupivacaine Hydrochloride 0.75% in 8.25% Dextrose Injection, USP (15 mg/2 mL)... Lack of Assurance of Sterility Class II Huons Co., Ltd.
Apr 2, 2026 0.9% Sodium Chloride Injection, USP, 10 mL Ampules, Rx only, Single Dose, Pre... Lack of Assurance of Sterility Class II Huons Co., Ltd.
Mar 26, 2026 Pantoprazole Sodium, Delayed-Release Tablets, USP, 40 mg, 1000-count bottle, ... Discoloration: Firm received five (5) complaints stating that, "Tablets discolored darker than no... Class II Hetero Labs Limited (Unit V)
Mar 20, 2026 QC Quality Choice, Menthol- Cough Suppressant Oral Anesthetic, Cough Drops, C... This recall is being initiated following FDA's recommendation based on certain observations noted... Class II Xiamen Kang Zhongyuan Biotechnology Co., Ltd.
Mar 20, 2026 MGC Health, Menthol- Cough Suppressant, Oral Anesthetic, Cough Drops, Honey L... This recall is being initiated following FDA's recommendation based on certain observations noted... Class II Xiamen Kang Zhongyuan Biotechnology Co., Ltd.
Mar 20, 2026 QC Quality Choice, Menthol-Cough Suppressant Oral Anesthetic, Cough Drops, Me... This recall is being initiated following FDA's recommendation based on certain observations noted... Class II Xiamen Kang Zhongyuan Biotechnology Co., Ltd.
Mar 20, 2026 caring mill, Menthol Cough Suppressant Oral Anesthetic, Cough Drops, Cherry, ... This recall is being initiated following FDA's recommendation based on certain observations noted... Class II Xiamen Kang Zhongyuan Biotechnology Co., Ltd.
Mar 20, 2026 QC Quality Choice, Menthol-Cough Suppressant Oral Anesthetic, Cough Drops, Va... This recall is being initiated following FDA's recommendation based on certain observations noted... Class II Xiamen Kang Zhongyuan Biotechnology Co., Ltd.
Mar 20, 2026 exchange select, Menthol- Cough Suppressant Oral Anesthetic, Cough Drops, Men... This recall is being initiated following FDA's recommendation based on certain observations noted... Class II Xiamen Kang Zhongyuan Biotechnology Co., Ltd.
Mar 20, 2026 QC Quality Choice, Pectin Oral Demulcent, Throat Soothing Drops, Creamy Straw... This recall is being initiated following FDA's recommendation based on certain observations noted... Class II Xiamen Kang Zhongyuan Biotechnology Co., Ltd.
Mar 20, 2026 QC Quality Choice, Menthol- Cough Suppressant Oral Anesthetic, Cough Drops, S... This recall is being initiated following FDA's recommendation based on certain observations noted... Class II Xiamen Kang Zhongyuan Biotechnology Co., Ltd.
Mar 20, 2026 QC Quality Choice, Menthol-Cough Suppressant Oral Anesthetic, Cough Drops, Ho... This recall is being initiated following FDA's recommendation based on certain observations noted... Class II Xiamen Kang Zhongyuan Biotechnology Co., Ltd.
Mar 20, 2026 Discount Drug Mart Food Market, Cough Drops, Menthol- Cough Suppressant Anest... This recall is being initiated following FDA's recommendation based on certain observations noted... Class II Xiamen Kang Zhongyuan Biotechnology Co., Ltd.
Mar 20, 2026 QC Quality Choice, Menthol-Cough Suppressant Oral Anesthetic, Cough Drops, Su... This recall is being initiated following FDA's recommendation based on certain observations noted... Class II Xiamen Kang Zhongyuan Biotechnology Co., Ltd.
Mar 20, 2026 exchange select, Menthol -Cough Suppressant Oral Anesthetic, Honey Lemon Flav... This recall is being initiated following FDA's recommendation based on certain observations noted... Class II Xiamen Kang Zhongyuan Biotechnology Co., Ltd.
Mar 20, 2026 Discount Drug Mart Food Market, Cough Drops, Menthol -Cough Suppressant Anest... This recall is being initiated following FDA's recommendation based on certain observations noted... Class II Xiamen Kang Zhongyuan Biotechnology Co., Ltd.
Mar 20, 2026 MGC Health, Menthol- Cough Suppressant, Oral Anesthetic, Cough Drops, Sugar F... This recall is being initiated following FDA's recommendation based on certain observations noted... Class II Xiamen Kang Zhongyuan Biotechnology Co., Ltd.
Mar 20, 2026 MGC Health, Menthol- Cough Suppressant, Oral Anesthetic, Cough Drops, Honey L... This recall is being initiated following FDA's recommendation based on certain observations noted... Class II Xiamen Kang Zhongyuan Biotechnology Co., Ltd.
Feb 13, 2026 Semaglutide, For Rx compounding use only, packaged in a) 1g, NDC 84385-106-01... CGMP Deviations This recall has been initiated due to failing to complete process validation and ... Class II Harbin Jixianglong Biotech Co., Ltd.
Feb 13, 2026 Semaglutide, For Rx compounding use only, packaged in a) 1g, NDC 84385-106-0... CGMP Deviations This recall has been initiated due to failing to complete process validation and ... Class II Harbin Jixianglong Biotech Co., Ltd.
Feb 3, 2026 Pitavastatin Tablets, 2 mg, packaged in 90-count bottles, Rx only, Manufactur... Presence of foreign tablets/capsules: one Pitavastatin tablet 1mg found in bottle of Pitavastatin... Class III Annora Pharma Private Limited
Dec 31, 2025 CHNaO Fluorescein Sodium Ophthalmic Strips, USP 1mg, packaged as a) 100-count... Lack of Assurance of Sterility: Products have not been manufactured in conformance with current g... Class II Wizcure Pharmaa Private Limited
Dec 31, 2025 Vista Meibo Tears Propylene Glycol 0.6% w/v Eye Drops Advanced Dry Eye Relief... Lack of Assurance of Sterility: Products have not been manufactured in conformance with current g... Class II Wizcure Pharmaa Private Limited
Dec 31, 2025 Vista Gonio Eye Lubricant, Hypromellose Ophthalmic Solution USP (Sterile Drop... Lack of Assurance of Sterility: Products have not been manufactured in conformance with current g... Class II Wizcure Pharmaa Private Limited
Dec 31, 2025 Vista Gel Hypromellose USP 0.3% w/v, Eye Drops Dry Eye Relief Lubricating Gel... Lack of Assurance of Sterility: Products have not been manufactured in conformance with current g... Class II Wizcure Pharmaa Private Limited
Dec 31, 2025 Vista Tears Polyethylene Glycol 400 0.4% w/v, Propylene Glycol 0.3% w/v Eye D... Lack of Assurance of Sterility: Products have not been manufactured in conformance with current g... Class II Wizcure Pharmaa Private Limited
Dec 31, 2025 Bio Glo Fluorescein Sodium Ophthalmic Strips USP, 300 diagnostic strips, Manu... Lack of Assurance of Sterility: Products have not been manufactured in conformance with current g... Class II Wizcure Pharmaa Private Limited
Dec 31, 2025 BioGlo Fluorescein Sodium Ophthalmic Strips USP, 100 diagnostic strips, Manuf... Lack of Assurance of Sterility: Products have not been manufactured in conformance with current g... Class II Wizcure Pharmaa Private Limited
Dec 19, 2025 INON ACE Antacid tablets (magnesium aluminosilicate, magnesium hydroxide and ... Failed Disintegration Specifications: above the time expected. Class II Sato Pharmaceutical Co., Ltd
Oct 10, 2025 HADLIMA (adalimumab-bwwd) injection, 40mg/0.8 mL, 2 Single-dose Prefilled Syr... Lack of Assurance of Sterility. Class II Samsung Bioepis Co., Ltd.
Aug 22, 2025 Ultra Violette, Velvet Screen SPF 50, Blurring Mineral Skinscreen, Zinc Oxide... Subpotent/Super-potent Product: Testing of the SPF 50 sunscreen revealed inconsistency in SPF res... Class II GRACE & FIRE PTY LTD
Aug 22, 2025 Ultra Violette Mini SPF Mates kit includes: Velvet Screen SPF 50 Blurring Min... Subpotent/Super-potent Product: Testing of the SPF 50 sunscreen revealed inconsistency in SPF res... Class II GRACE & FIRE PTY LTD
Jul 25, 2025 Doxepin Hydrochloride Capsules, USP, 10 mg, 100 Capsules, Rx only, Manufactur... CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed inter... Class II Alembic Pharmaceuticals Limited
Jul 22, 2025 BZK Antiseptic Towelette, Sterile, For External Use Only, benzalkonium chlori... Lack of Assurance of Sterility. Class II Taizhou Kangping Medical Science And Technology...
Jul 21, 2025 Quick Touch Alcohol Prep Pads(Isopropyl Alcohol 70%), 100 Sterile Pads per ca... cGMP Deviations Class II YANGZHOU YULOU PAPER PRODUCTS CO., LTD
Jun 11, 2025 Famciclovir Tablets, USP 500 mg, 30-count bottles, Rx Only, Manufactured for:... Presence of Foreign Substance- Black hair strand found attached to a tablet in a sealed bottle. Class III Macleods Pharmaceuticals Ltd
May 7, 2025 Bromfenac Ophthalmic Solution 0.09%, 1.7 mL bottle, Rx only, Sterile, Manufac... Failed Impurities/Degradation Specifications Class II Alembic Pharmaceuticals Limited
May 6, 2025 ENDURANCE BOOST WITH HORNY GOAT WEED, 500mg, 20 capsules per carton, VEPEMVA... Marketed without approved NDA/ANDA: The product has been found to be tainted with Sildenafil and... Class I EnShiShiXiangNiShangMaoYouXianGongSi
Apr 24, 2025 CURA HONGOS, Antifungal, 1% Clotrimazole, Topical Lotion, 0.76 fl oz (22.5 mL... CGMP Deviations Class II KENIL HEALTHCARE PRIVATE LIMITED
Apr 24, 2025 Cinnafresh anticavity gel toothpaste, sodium fluoride 0.22%, Bold Cinnamon Fl... CGMP Deviations Class II KENIL HEALTHCARE PRIVATE LIMITED
Apr 24, 2025 KOFAL, Athletes, Penetrating Pain Relief, External Analgesic Ointment (methyl... CGMP Deviations Class II KENIL HEALTHCARE PRIVATE LIMITED
Apr 24, 2025 Rapidol, Triple Antibiotic First Aid Ointment, Bacitracin Zinc/ Neomycin Sulf... CGMP Deviations Class II KENIL HEALTHCARE PRIVATE LIMITED
Apr 24, 2025 KOFAL Original, Penetrating Pain Relieving Ointment (methyl salicylate 12% - ... CGMP Deviations Class II KENIL HEALTHCARE PRIVATE LIMITED
Apr 24, 2025 CURA HONGOS, Antifungal Cream, Clotrimazole 1%, Net Wt/ Peso Neto 2 oz (56.7g... CGMP Deviations Class II KENIL HEALTHCARE PRIVATE LIMITED
Apr 24, 2025 Nature Mint, Anticavity Fluoride Toothpaste, Sodium monofluorophosphate 0.76%... CGMP Deviations Class II KENIL HEALTHCARE PRIVATE LIMITED
Apr 24, 2025 Nature Mint, Anticavity Fluoride Toothpaste, Sodium monofluorophosphate 0.76%... CGMP Deviations Class II KENIL HEALTHCARE PRIVATE LIMITED
Apr 24, 2025 Maximum Security, Anticavity Gel Toothpaste, Sodium Fluoride 0.22%, Fresh Min... CGMP Deviations Class II KENIL HEALTHCARE PRIVATE LIMITED
Apr 24, 2025 Maximum Security, Anticavity Gel Toothpaste, Sodium Fluoride 0.22%, Fresh Min... CGMP Deviations Class II KENIL HEALTHCARE PRIVATE LIMITED

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.