Browse Drug Recalls

534 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 534 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 534 FDA drug recalls in 2012.

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Date	Product	Reason	Class	Firm
Apr 17, 2012	Loxapine Capsules USP, 5mg, 100 count bottle, Rx only Manufactured By: Watson...	Labeling: Incorrect or Missing Package Insert: An outdated version of a patient outsert was used...	Class III	Watson Laboratories Inc
Apr 16, 2012	Multihance Multipack (gadobenate dimeglumine) injection, 529 mg/mL, Pharmacy ...	Lack of Assurance of Sterility; Product recalled due to displacement of the aluminum crimp cap du...	Class II	Bracco Diagnostics Inc
Apr 16, 2012	Bracco Diagnostics multihance (gadobenate dimeglumine) injection, 529 mg/mL, ...	Short Fill: The product is being recalled due to a potential underfill of the affected vials.	Class III	Bracco Diagnostics Inc
Apr 13, 2012	Fosphenytoin Sodium Injection, USP, 100 mg PE per 2 mL (50 mg PE per mL), 2 m...	Presence of Particulate Matter: This product is being recalled due to the discovery of particles ...	Class II	West-ward Pharmaceutical Corp.
Apr 13, 2012	Fosphenytoin Sodium Injection, USP, 500 mg PE per 10 mL (50 mg PE per mL), 10...	Presence of Particulate Matter: This product is being recalled due to the discovery of particles ...	Class II	West-ward Pharmaceutical Corp.
Apr 11, 2012	Propofol Injectable Emulsion, 1%, (10mg/mL), packaged in a) 200 mg/20 mL, 5 U...	Presence of Particulate Matter: A single visible particulate was observed in a retention sample b...	Class II	Hospira, Inc.
Apr 10, 2012	Carbon Dioxide, USP, Medical Gas, packaged in a) size EA aluminum, CGA940 (CD...	Impurities/Degradation Products: Out Of Specification levels of nitrogen dioxide.	Class II	Airgas Inc
Apr 9, 2012	Dr. Reddy's Ciprofloxacin Tablets, USP 500 mg*, 500 Tablets, Rx only, Mfd. By...	Adulterated Presence of Foreign Tablets: Dr. Reddy's Laboratories has received complaints of misl...	Class II	Dr. Reddy's Laboratories, Inc.
Apr 9, 2012	Dr. Reddy's Amlodipine Besylate and Benazepril Hydrochloride 5 mg*/20 mg, 50...	Adulterated Presence of Foreign Tablets: Dr. Reddy's Laboratories has received complaints of misl...	Class II	Dr. Reddy's Laboratories, Inc.
Apr 5, 2012	Meloxicam Tablets, USP, 15 mg, Rx Only, 100 Tablets per Bottle, Manufactured ...	Tablet Thickness: Recall was initiated due to the presence of one slightly oversized tablet in a ...	Class II	Apotex Corp.
Apr 5, 2012	Magnesium Sulfate in Water for Injection, 40 mg/mL (0.325 mEq Mg++/mL), 2 g t...	Superpotent (Single Ingredient) Drug: Above specification assay results for percentage of magnesi...	Class III	Hospira, Inc.
Apr 2, 2012	Mefloquine HCL Tablets, 250 mg, 5 tablets per blister pack; 5 Blister packs p...	Tablet Thickness: Product is being recalled due to the potential of being underweight or overweight.	Class II	Teva Pharmaceuticals USA, Inc.
Mar 29, 2012	buPROPion Hydrochloride Extended-Release Tablets (XL), 150 mg, UD 100 Tablets...	Failed USP Dissolution Test Requirements: Possible out-of-specification dissolution results at th...	Class III	McKesson Packaging Services
Mar 29, 2012	buPROPion Hydrochloride Extended-Release Tablets (XL), 300 mg, UD 100 Tablets...	Failed USP Dissolution Test Requirements: Possible out-of-specification dissolution results at th...	Class III	McKesson Packaging Services
Mar 22, 2012	Daytrana (Methylphenidate) Transdermal System Patch, Delivers 20 mg over 9 ho...	Miscalibrated/Defective Delivery System; exceeded the specification for both mechanical peel forc...	Class II	Noven Pharmaceuticals, Inc.
Mar 20, 2012	DermaZinc Spray, 0.25% zinc pyritione, topical OTC, 4 fl oz bottle Distribut...	Subpotent (Single Ingredient Drug): The firm is recalling the product because the product is subp...	Class III	Quadrant Chemical Corporation
Mar 16, 2012	Balnetar Therapeutic Tar Bath, Coal Tar USP 2.5% (from Coal Tar USP Solution,...	Subpotent (Single Ingredient Drug): out-of-specification result for coal tar content assay.	Class III	Ranbaxy Inc.
Mar 14, 2012	Metformin Hydrochloride Tablets, USP, 1000 mg, Rx only, 1000 count tablets pe...	Presence of Foreign Substance(s): A product complaint was received from a pharmacist who discover...	Class II	Zydus Pharmaceuticals USA Inc
Mar 10, 2012	Blue Male Enhancement Pill, bulk product, by The Menz Club, Ridgeland, MS	Marketed without an Approved NDA/ANDA; product found to contain sulfoaildenafil, an analogue of s...	Class I	The Menz Club, LLC
Mar 9, 2012	Ciprofloxacin Tablets, USP, 500 mg, Rx Only, 100 Tablets per Bottle, Manufact...	Labeling Illegible: Missing Label; The voluntary recall of the aforementioned batch of product is...	Class III	Pack Pharmaceuticals
Mar 9, 2012	Northstar Zolpidem Tartrate Tablets USP 10 mg. Manufactured for Northstar RX...	Adulterated Presence of Foreign Tablets: This product is being recalled becaiuse 30 valacyclovir ...	Class II	Aurobindo Pharma LTD
Mar 8, 2012	Nisoldipine Extended Release Tablets, 17mg, 100 count bottle, Rx only, Manuf...	Failed USP Dissolution Test Requirements: Out of Specification dissolution result at 18 month tim...	Class II	Shionogi Inc.
Feb 24, 2012	Levothroid (levothyroxine sodium tablets, USP), 75 mcg., 100-count bottles, R...	Subpotent (Single Ingredient Drug): Low assay at the 6-month test interval.	Class II	Lloyd Inc
Feb 24, 2012	Thyro-Tab.075 mg., packaged in bulk drums for repackaging. The firm name on t...	Subpotent (Single Ingredient Drug): Low assay at the 6-month test interval.	Class II	Lloyd Inc
Feb 23, 2012	Hard Ten Days Capsule, 4500 mg, boxes of 6 packets, OTC, Developed by: Ameri...	Marketed Without an Approved ANDA/NDA: presence of sildenafil	Class I	www.vitaminbestbuy.com
Feb 23, 2012	Man King Capsules, 2800 mg, boxes of 5 packets, OTC, Developed by: American ...	Marketed Without an Approved ANDA/NDA: presence of sildenafil.	Class I	www.vitaminbestbuy.com
Feb 23, 2012	Japan Weight Loss Blue Capsules, 9 g (300 mg), 30 count box, Green algae lipo...	Marketed Without an Approved ANDA/NDA: presence of sibutramine	Class I	www.vitaminbestbuy.com
Feb 20, 2012	PHYSICIANS TOTAL CARE, TETRACYCLINE, 500 mg, 30 CAPSULES, bottle MFG. BY: TEV...	Presence of Foreign Substance(s): There is a potential for foreign particulate matter in the API.	Class II	Physicians Total Care, Inc.
Feb 20, 2012	PHYSICIANS TOTAL CARE, TETRACYCLINE, 250 mg, 30 CAPSULES, bottle MFG. BY: TEV...	Presence of Foreign Substance(s): There is a potential for foreign particulate matter in the API.	Class II	Physicians Total Care, Inc.
Feb 8, 2012	Lipitor (Atorvastatin calcium); 40 mg, 30 TABLETS, Rx only, Repacked & distri...	Chemical Contamination: Complaints of an uncharacteristic odor identified as 2,4,6 tribromoanisole.	Class II	Physicians Total Care, Inc.
Feb 6, 2012	Eloxatin (OXALIplatin injection) 5 mg/mL injection, 100 mg, Rx only, Mfd. fo...	CGMP Deviations: Eloxatin was manufactured by Ben Venue Laboratories, a contract manufacturer, w...	Class II	sanofi-aventis US, Inc.
Feb 6, 2012	Eloxatin (OXALIplatin injection) 5 mg/mL Injection, 50 mg, Rx only, Mfd. for:...	CGMP Deviations: Eloxatin was manufactured by Ben Venue Laboratories, a contract manufacturer, w...	Class II	sanofi-aventis US, Inc.
Feb 3, 2012	Levothroid (levothyroxine sodium tablets, USP), 50 mcg., packaged in 100-ct. ...	Subpotent (Single Ingredient Drug): Low assay at the 9-month test interval.	Class II	Lloyd Inc
Feb 3, 2012	Thyro-Tab 0.050mg., packaged in bulk drums for repackaging. The firm name on...	Subpotent (Single Ingredient Drug): Low assay at the 9-month test interval.	Class II	Lloyd 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.