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Browse Drug Recalls

27 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 27 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 27 FDA drug recalls.

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DateProductReasonClassFirm
Dec 31, 2025 Levothyroxine Sodium Tablets, USP, Thyro-Tabs, 150mcg, 1000 Tablets, Rx only,... Product Mix-Up: A single bottle of this lot was reported by a pharmacy to contain 88 mcg tablets ... Class II Alvogen, Inc
Jan 31, 2025 Fentanyl Transdermal System CII, 25mcg/h, packaged in a pouch, further packag... Defective delivery system - patches could be multi-stacked, adhered one on top of the other, in a... Class I Alvogen, Inc
Feb 6, 2023 Levothyroxine Sodium Tablets, USP 112 mcg, 90 tablets per bottle, Rx Only, Ma... Sub-Potent Drug: Out of specification for assay at the 24 month interval. Class II Alvogen, Inc
Jan 26, 2022 RIVASTIGMINE TRANSDERMAL SYSTEM, Delivers 4.6 mg/24 hours, 30 systems per box... CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage co... Class II CARDINAL HEALTHCARE
Mar 15, 2021 Oseltamivir Phosphate for Oral Suspension 6 mg/mL* *Each mL contains 6 mg ose... CGMP Deviations: Intermittent exposure to temperature excursion during storage. Class II Cardinal Health Inc.
Mar 15, 2021 Nitrofurantoin Macrocrystals Capsules 25 mg 100 Capsules Rx Only NDC 47781-30... CGMP Deviations: Intermittent exposure to temperature excursion during storage. Class II Cardinal Health Inc.
Feb 26, 2021 Buprenorphine and Naloxone Sublingual Film 2mg/0.5mg, 30 pouches each contain... Subpotent drug: Out of specification for assay of naloxone and buprenorphine (low) Class II Alvogen, Inc
Jul 24, 2019 Nitrofurantoin Monohydrate/Macrycrystals Capsules, 100 mg, 100-count bottle, ... Failed dissolution specifications Class II Alvogen, Inc
Jul 24, 2019 Macrobid Urinary Tract Anitbacterial, 100 mg, 100-count bottle, Rx Only, Mfg... Failed dissolution specifications Class II Alvogen, Inc
Apr 19, 2019 FENTANYL Transdermal System, 12 mcg/h, five (12 mcg/h) systems per carton, Rx... Product Mix-Up: Customer complaint that their carton labeled as Fentanyl Transdermal Systems, 12 ... Class I Alvogen, Inc
Mar 15, 2019 Clindamycin Injection, USP, 300 mg/ 2 mL (150 mg/mL), 2 mL vials, Rx only, Di... Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demons... Class III Pfizer Inc.
Mar 15, 2019 Clindamycin Injection, USP, 900 mg/6 mL (150 mg/mL), 6 mL vial, Rx only, Dist... Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demons... Class III Pfizer Inc.
Mar 15, 2019 Clindamycin Injection, USP, 600 mg/ 4 mL (150 mg/mL), 4 mL vials, Rx only, Di... Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demons... Class III Pfizer Inc.
Jun 16, 2017 Clindamycin Injection USP; 900 mg/6 mL (150 mg/mL). 6 mL Single-dose ADD-VANT... Lack of Assurance of Sterility Class II Alvogen, Inc
Jun 16, 2017 Clindamycin Injection USP; 300 mg/2 mL (150 mg/mL). 2 mL Single-dose ADD-VANT... Lack of Assurance of Sterility Class II Alvogen, Inc
Jun 16, 2017 Clindamycin Injection USP; 600 mg/4 mL (150 mg/mL). 4 mL Single-dose ADD-VANT... Lack of Assurance of Sterility Class II Alvogen, Inc
Mar 7, 2017 Adalat CC (nifedipine) Extended-Release Tablets, 90 mg, 100-count bottles, Rx... Cross Contamination with another product:residual powder found in inlet air duct identified as so... Class III Alvogen, Inc
Mar 7, 2017 Adalat CC (nifedipine) Extended-Release Tablets, 60 mg, 100-count bottles, Rx... Cross Contamination with another product:residual powder found in inlet air duct identified as so... Class III Alvogen, Inc
Mar 7, 2017 Adalat CC (nifedipine) Extended-Release Tablets, 90 mg, 100-count bottles, Rx... Cross Contamination with another product:residual powder found in inlet air duct identified as so... Class III Alvogen, Inc
Mar 7, 2017 Adalat CC (nifedipine) Extended-Release Tablets, 30 mg, 100-count bottles, Rx... Cross Contamination with another product:residual powder found in inlet air duct identified as so... Class III Alvogen, Inc
Mar 7, 2017 Nifedipine Extended-Release Tablets, 30 mg, 100-count bottles, Rx Only, Manuf... Cross Contamination with another product:residual powder found in inlet air duct identified as so... Class III Alvogen, Inc
Mar 7, 2017 Adalat CC (nifedipine) Extended Release Tablets, 60 mg, 100- count bottles, ... Cross Contamination with another product:residual powder found in inlet air duct identified as so... Class III Alvogen, Inc
Mar 7, 2017 Adalat CC (nifedipine) Extended Release Tablets 30 mg, 100-count bottles, Rx ... Cross Contamination with another product:residual powder found in inlet air duct identified as so... Class III Alvogen, Inc
Mar 7, 2017 Nifedipine Extended-Release Tablets, 60 mg, 100-count bottles, Rx Only, Manuf... Cross Contamination with another product:residual powder found in inlet air duct identified as so... Class III Alvogen, Inc
Mar 7, 2017 Nifedipine Extended-Release Tablets, 90 mg, 100-count bottles, Rx Only, Manuf... Cross Contamination with another product:residual powder found in inlet air duct identified as so... Class III Alvogen, Inc
Apr 21, 2015 NITROFURANTOIN MONOHYDRATE/MACROCRYSTALS CAPSULES, 100 mg, 100 count bottle, ... Failed Dissolution Specification; 6 month time point Class II Alvogen, Inc
Aug 28, 2014 Oxycodone and Acetaminophen Tablets USP 10 mg/325 mg 100 count bottles Rx Onl... Failed Content Uniformity Specifications - The lot failed to meet the acceptance criteria for Uni... Class II Alvogen, 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.