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Browse Drug Recalls

20 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 20 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 20 FDA drug recalls.

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DateProductReasonClassFirm
May 9, 2025 Phentermine Hydrochloride Capsules, USP 30mg, 100-count bottle, Rx Only, Mfd.... cGMP deviations Class II KVK Tech, Inc.
May 9, 2025 Indomethacin Extended-Release Capsules USP, 75 mg, 100-count bottle, Rx only,... cGMP deviations Class II KVK Tech, Inc.
Sep 20, 2023 Betaxolol Tablets, USP 10 mg, Rx Only, 100 count bottles, Mfd by: KVK Tech In... Presence of Foreign Tablets/Capsules: There is a potential presence of oxycodone HCl tablets, USP... Class I KVK-Tech, Inc.
Jul 2, 2021 Atovaquone Oral Suspension, USP, 750 mg/5 mL, 210 mL bottle, Rx Only, Mfd. By... Temperature abuse: the firm received customer complaints of unusual grittiness in the product. Class I KVK-Tech, Inc.
Apr 27, 2021 Hydrocodone Bitartrate and Homatropine Methlybromide tablets, USP, 5 mg/ 1.5 ... Failed Impurities/Degradation Specifications Class III KVK-Tech, Inc.
Dec 18, 2020 Benzhydrocodone and Acetaminophen Tablets, CII, 6.12mg/ 325mg, 100 Tablets, R... Failed Impurities/Degradation Specifications; out of specification results obtained for N-Oxide i... Class III KVK-Tech, Inc.
Nov 1, 2019 Hydrocodone Bitartrate and Homatropine Methlybromide Oral Solution 5 mg/1.5 m... Presence of Foreign Substance: Black particles were found in the lots during retain sample inspec... Class II KVK-Tech, Inc.
Oct 4, 2019 Methylphenidate Hydrochloride Oral Solution 5mg per 5mL, 500 mL Bottle, Sugar... Presence of Foreign Substance; Fiber particles. Class III KVK-Tech, Inc.
Dec 11, 2018 Oxybutynin Chloride Tablets, USP, 5 mg, 500-count bottle, Rx only, Mfd. By: K... Labeling: Wrong bar code Class II KVK-Tech, Inc.
Aug 11, 2017 Phentermine Capsules, 15 mg, a) 7-count bottle (NDC 55289-791-07), b) 14-cou... Failed Impurities/Degradation Specifications:Out of specification results for individual unknown ... Class III PD-Rx Pharmaceuticals, Inc.
Aug 3, 2017 Phentermine HCL Capsules, USP 15 mg, packaged in a) 100-count bottles (NDC 10... Failed Impurities/Degradation Specifications: out-of-specification results obtained for individua... Class III KVK-Tech, Inc.
May 5, 2016 Benzphetamine Hydrochloride Tablets, 50 mg, 30-count bottle, RX only, Mfd by:... Discoloration: presence of scuffing marks on tablets. Class III KVK-Tech, Inc.
Jul 14, 2015 Phentermine Hydrochloride Capsules, USP, 15 mg, packaged in a) 100-count bott... Failed Impurities/Degradation Specifications: out-of-specification results for individual unknown... Class III KVK-Tech, Inc.
Apr 7, 2015 Hydroxyzine Hydrochloride, oral solution, 10 mg per 5 mL, 16 fl oz (473 ml) b... Failed Impurities/Degradation Specifications Class II Akorn, Inc.
Apr 1, 2014 HydrOXYzine Hydrochloride Oral Solution, USP, 10 mg / 5mL, Net Wt 16 fl oz (4... Failed Impurity/Degradation Specification; out-of-specification result for one individual unknown... Class II Hi-Tech Pharmacal Co., Inc.
Jan 31, 2014 HydrOXYzine HCl Tablets, USP 50 mg, 100 Tablet Blister, Rx only Mfd by: KVK-... Good Manufacturing Practices Deviations: The product has an active pharmaceutical ingredient from... Class II American Health Packaging
Jan 31, 2014 HydrOXYzine HCl Tablets, USP 25 mg, 100 Tablet Blister, Rx only Mfd by: KVK-... Good Manufacturing Practices Deviations: The product has an active pharmaceutical ingredient from... Class II American Health Packaging
Dec 11, 2013 HydrOXYzine HCI Tablets USP 50 mg, 100, 500, and 1000 count bottles, Rx only.... Good Manufacturing Practices Deviations: The product has an Active Pharmaceutical Ingredient from... Class II KVK-Tech, Inc.
Dec 11, 2013 HydrOXYzine HCI Tablets USP 25 mg, 100, 500, and 1000 count bottles, Rx only.... Good Manufacturing Practices Deviations: The product has an Active Pharmaceutical Ingredient from... Class II KVK-Tech, Inc.
Dec 11, 2013 HydrOXYzine HCI Tablets USP 10 mg, 100 count bottles, Rx only. Mfd by KVK-TEC... Good Manufacturing Practices Deviations: The product has an Active Pharmaceutical Ingredient from... Class II KVK-Tech, 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.