Vehicle Safety
Recalls Search 320,000+ NHTSA safety recalls Complaints 2.1M+ consumer safety complaints TSBs 4.7M technical service bulletins VIN Lookup Decode any vehicle VIN instantly OBD Codes 12,000+ diagnostic trouble codes Fuel Economy EPA MPG data for all vehicles Statistics Recall trends & safety analysis
Consumer Safety
Product Safety 9,700+ CPSC product recalls Food Safety 28,600+ FDA food recalls Pet Safety 1.3M FDA animal adverse events Drug Safety 17,500+ FDA drug recalls Device Safety 38,400+ FDA device recalls Workplace Safety 102,900+ OSHA injury reports
Infrastructure
Bridge Safety 624,000 bridge inspections Aviation Safety 30,000+ NTSB aviation events Dam Safety 92,600 dam safety records Water Safety 433,000+ public water systems Railroad Safety 438,000+ rail crossings Pipeline Safety 8,800+ pipeline incidents
Public Health
Nursing Homes 14,700 CMS rated facilities Environmental 80,000+ hazardous sites & releases

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.

Clear
DateProductReasonClassFirm
May 21, 2012 TRIAMCINOLONE ACETONIDE 4MG/ML (0.4MG/0.1ML) INJECTABLE 10 ML 5 ML TRIAMC... Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs d... Class II Franck's Lab Inc., d.b.a. Franck's Compounding Lab
May 21, 2012 STRONTIUM 1 MG/ML INJECTABLE 30 ML 60 ML (2 DIFFERENT PRODUCTS) Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs d... Class II Franck's Lab Inc., d.b.a. Franck's Compounding Lab
May 21, 2012 TESTOSTERONE CYP/ESTRADIOL CYP 50MG/2MG/ML INJECTABLE 5 ML; TESTOSTERONE CYP... Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs d... Class II Franck's Lab Inc., d.b.a. Franck's Compounding Lab
May 21, 2012 MANNITOL 20% INJECTABLE 1250 ML 250 ML 2500 ML 400 ML; MAN... Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs d... Class II Franck's Lab Inc., d.b.a. Franck's Compounding Lab
May 21, 2012 LIDOCAINE HCL (STERILE) 4% JELLY 120 ML 30 ML; LIDOCAINE H... Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs d... Class II Franck's Lab Inc., d.b.a. Franck's Compounding Lab
May 21, 2012 LISSAMINE GREEN SOLUTION 1% OPHTHALMIC 10 ML (1 PRODUCT) Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs d... Class II Franck's Lab Inc., d.b.a. Franck's Compounding Lab
May 21, 2012 TOBRAMYCIN 1.4% (14MG/ML) OPHTHALMIC 15 ML 3 ML 7 ML; TOBRAMYCI... Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs d... Class II Franck's Lab Inc., d.b.a. Franck's Compounding Lab
May 18, 2012 Copaxone (glatiramer acetate injection), 20mg/mL, 1 mL , Rx only, Marketed b... Presence of Foreign Substance: Recall is being initiated due to the presence of a foreign particl... Class II Teva Pharmaceuticals USA, Inc.
May 18, 2012 a) Firminite 805 mg is packaged in 2 count, 4 count, and 10 count capsules bl... Marketed Without an Approved NDA/ANDA: These products found to contain undeclared tadalafil. Tada... Class I InSo-Independent Contractor for West Coast Nutr...
May 17, 2012 Imodium Multi-Symptom Relief Caplets, Loperamide HCl 2 mg/Simethicone 125 mg,... Defective Container; damaged blister units Class III Mcneil Consumer Healthcare, Div Of Mcneil-ppc, ...
May 16, 2012 Metoprolol Tartrate Tablets USP 50 mg, 1000 count bottle, Rx only, Manufactur... Tablet Thickness: Potential for some tablets not conforming to weight specifications (under and o... Class II Teva Pharmaceuticals USA, Inc.
May 14, 2012 Zemplar (paricalcitol) Injection, 5 mcg/mL in 2 mL multi-dose vials, 25 vial ... CGMP Deviations: There is potential that Abbott's third party manufacturer, Hospira, may have app... Class II Abbott Laboratories
May 12, 2012 HYDROmorphone HCl Injection, USP, 1 mg/mL, 1 mL fill in a 2.5 mL Carpuject pr... Superpotent (Single Ingredient) Drug: Some of the prefilled cartridge units have been found to be... Class I Hospira Inc.
May 9, 2012 Dent's Extra Strength Toothache Gum, (benzocaine 20%), Net Wt. .035 Oz.. (1 g... Superpotent; benzocaine Class II Grandpa Brands Co
May 8, 2012 Derma-Smoothe/FS (Fluocinolone Acetonide) 0.01%, Body Oil, 4 fl. oz. (118.28m... Subpotent; fluocinolone acetonide Class III Hill Dermaceuticals, Inc.
May 8, 2012 Derma-Smoothe/FS (Fluocinolone Acetonide) 0.01% Topical Oil (Scalp Oil), 4 fl... Subpotent; fluocinolone acetonide Class III Hill Dermaceuticals, Inc.
May 8, 2012 Estradiol Hemihydrate M20 EP/USP Powder, packaged in a) 1.5 kg and b) 2.5 kg ... Cross Contamination w/Other Products: This active pharmaceutical ingredient is being recalled due... Class II Bayer HealthCare Pharmaceuticals Inc.
May 8, 2012 Morton, Sodium Chloride, USP, Granular, packaged in kraft paper bags, fiber d... Impurities/Degradation Products: The product was found to contain a slightly out of specification... Class III Morton Salt Co.
May 7, 2012 Rodan & Fields Proactiv Solution, Sheer Finish Compact Foundation, salicylic ... Subpotent Drug: Salicylic acid is subpotent. Class III Guthy-Renker LLC
May 7, 2012 Rodan & Fields Proactiv Solution, Sheer Finish Compact Foundation, salicylic ... Subpotent Drug: Salicylic acid is subpotent. Class III Guthy-Renker LLC
May 7, 2012 Rodan & Fields Proactiv Solution, Sheer Finish Compact Foundation, salicylic ... Subpotent Drug: Salicylic acid is subpotent. Class III Guthy-Renker LLC
May 7, 2012 Rodan & Fields Proactiv Solution, Sheer Finish Compact Foundation, salicylic ... Subpotent Drug: Salicylic acid is subpotent. Class III Guthy-Renker LLC
May 7, 2012 Endocet (oxycodone and acetaminophen) tablets, USP, 10 mg/650 mg, 100-count t... Adulterated Presence of Foreign Tablets: Customer complaint that some Endocet 10 mg/325 mg tablet... Class III Endo Pharmaceuticals, Inc.
May 7, 2012 Rodan & Fields Proactiv Solution, Sheer Finish Compact Foundation, salicylic ... Subpotent Drug: Salicylic acid is subpotent. Class III Guthy-Renker LLC
May 4, 2012 1.5% Glycine Irrigation, USP, 3000 mL, Rx Only, Hospira, Inc., Lake Forest, I... Lack of Assurance of Sterility: Hospira, Inc is voluntarily recalling the products due to possibl... Class II Hospira Inc.
May 4, 2012 5% Dextrose and 0.45% Sodium Chloride Injection, USP, 1000 mL VisIV Container... Lack of Assurance of Sterility: Hospira, Inc is voluntarily recalling the products due to possibl... Class II Hospira Inc.
May 4, 2012 LifeGas OXYGEN COMPRESSED UN1072 USP, Distributed by: Linde CGMP Deviations: The pressure gages, vacuum gages, and thermometer had surpassed the calibration ... Class II Linde Gas LLC
May 4, 2012 0.45% Sodium Chloride Injection, USP, Rx Only, 250 mL, by Hospira, Inc., Lake... Lack of Assurance of Sterility: Hospira, Inc is voluntarily recalling the products due to possibl... Class II Hospira Inc.
May 4, 2012 70% Dextrose Injection USP, 2000 mL, Rx Only, by Hospira, Inc., Lake Forest, ... Lack of Assurance of Sterility: Hospira, Inc is voluntarily recalling the products due to possibl... Class II Hospira Inc.
May 4, 2012 0.9% Sodium Chloride Injection, USP, Polyolefin Flexible Container, a) 500 mL... Lack of Assurance of Sterility: Hospira, Inc is voluntarily recalling the products due to possibl... Class II Hospira Inc.
May 4, 2012 20% Dextrose Injection, USP, a) 500 mL in 1000 mL Partial-Fill Container (NDC... Lack of Assurance of Sterility: Hospira, Inc is voluntarily recalling the products due to possibl... Class II Hospira Inc.
May 4, 2012 5% Dextrose Injection USP, a) 250 mL (NDC 0409-7922-02), b) 500 mL (NDC 0409-... Lack of Assurance of Sterility: Hospira, Inc is voluntarily recalling the products due to possibl... Class II Hospira Inc.
May 4, 2012 0.9% Sodium Chloride Injection, USP, a) 50 mL (NDC 0409-7984-13), b) 50 mL (N... Lack of Assurance of Sterility: Hospira, Inc is voluntarily recalling the products due to possibl... Class II Hospira Inc.
May 4, 2012 0.9% Sodium Chloride Irrigation, USP, 3000 mL, Rx Only, Hospira, Inc., Lake F... Lack of Assurance of Sterility: Hospira, Inc is voluntarily recalling the products due to possibl... Class II Hospira Inc.
May 2, 2012 Zeosa (norethindrone and ethinyl estradiol tablets USP, (chewable), 0.4 mg/0.... Impurities/Degradation: This recall is being carried out due to the potential for some lots not ... Class II Teva Pharmaceuticals USA, Inc.
May 1, 2012 Midazolam HCl Injection, 5 mg/mL, 1 mL single use vials, packaged in 10 x 1 m... Short Fill: These products are being recalled because there is potential that vials with low fill... Class II Ben Venue Laboratories Inc
May 1, 2012 Octreotide Acetate Injection, 50 mcg/mL (0.05 mg/mL), 1 mL single dose vials,... Short Fill: These products are being recalled because there is potential that vials with low fill... Class II Ben Venue Laboratories Inc
Apr 30, 2012 Dorzolamide HCI/Timolol Maleate Ophthalmic Solution 22.3mg/6.8mg per mL, 10mL... Presence of Particulate Matter: Lots identified in this recall notification may contain small pa... Class II Apotex Inc.
Apr 26, 2012 Midol Complete, Acetaminophen, Caffeine, Pyrilamine Maleate, Caplets, OTC, a)... Labeling: Label Mix-up: This recall was initiated after identifying that the label statement on t... Class III Bayer Healthcare, LLC
Apr 26, 2012 Midol Complete, Acetaminophen, Caffeine, Pyrilamine Maleate, Gelcaps 24 ct. b... Labeling: Label Mix-up: This recall was initiated after identifying that the label statement on t... Class III Bayer Healthcare, LLC
Apr 24, 2012 Epinephrine Injection, USP, 1:1000 (1 mg/mL), 25 x 1 mL Ampules, For SC and I... Presence of Particulate Matter Class II Luitpold Pharmaceuticals, Inc.
Apr 24, 2012 CABERGOLINE Tablets, 0.5 mg, RX only, 8 count bottles, Manufactured For: TEVA... Impurities/Degradation Products: This lot of product will not meet the impurity specification ove... Class III Teva Pharmaceuticals USA, Inc.
Apr 23, 2012 Jolessa (levonorgestrel/ethinyl estradiol tablets, USP) 0.15 mg/0.03 mg, each... Contraceptive Tablets Out of Sequence: This recall has been initiated due to the potential that s... Class III Teva Pharmaceuticals USA, Inc.
Apr 23, 2012 ChloraPrep One-Step (2% w/v chlorhexidine gluconate and 70% v/v isopropyl alc... Lack of Assurance of Sterility: Firm mistakenly released quarantined, non conforming material tha... Class II Carefusion 213, Llc
Apr 21, 2012 X-ROCK For Men, Dietary Supplement, Manufactured by CRM Laboratories, Distri... Marketed Without an Approved NDA/ANDA: product tested positive for PDE-5 Sildenafil and PDE-5 Hyd... Class I XRock Industries, LLC
Apr 17, 2012 Loxitane Capsules, Loxapine Succinate Capsules, 10mg base, 100 count bottle,... Labeling: Incorrect or Missing Package Insert: An outdated version of a patient outsert was used... Class III Watson Laboratories Inc
Apr 17, 2012 Loxapine Capsules USP, 25mg, 100 count bottle, Rx only, Manufactured By: Wats... Labeling: Incorrect or Missing Package Insert: An outdated version of a patient outsert was used... Class III Watson Laboratories Inc
Apr 17, 2012 Morphine Sulfate Injection, USP, 4mg/mL, 1 mL fill in 2.5 mL Carpuject Cartr... Superpotent; Cartridges labeled to contain 1 mL found to contain 2.2 mL Class I Hospira Inc.
Apr 17, 2012 Loxapine Capsules USP, 10mg, 100 count bottle, Rx only, Manufactured By: Wats... Labeling: Incorrect or Missing Package Insert: An outdated version of a patient outsert was used... Class III Watson Laboratories Inc
Apr 17, 2012 Loxapine Capsules USP, 50mg, 100 count bottle, Rx only Manufactured By: Watso... Labeling: Incorrect or Missing Package Insert: An outdated version of a patient outsert was used... Class III Watson Laboratories 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.