Browse Drug Recalls
2,085 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 2,085 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 2,085 FDA drug recalls in 2013.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Apr 10, 2013 | Sodium Bicarbonate Injection, all strengths and all presentations including: ... | Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by t... | Class II | FVS Holdings, Inc. dba. Green Valley Drugs |
| Apr 9, 2013 | Lisinopril Tablets, USP, 30 mg, Rx only, 100 tablets, NDC 65862-041-01 Manufa... | Labeling: Label Error on Declared Strength: Incorrect strength on side display panel of label | Class III | Aurobindo Pharma USA Inc |
| Apr 9, 2013 | 3M Tekk Brand Industrial/Construction First Aid Kit, Total Resources Int'l Wa... | CGMP Deviations: The first aid kits that are subject to the voluntary recall is being initiated d... | Class II | Total Resources Intl |
| Apr 9, 2013 | (No Brand) First Aid Kit, 326 Piece Kit. Product labeling reads in part: B... | CGMP Deviations: The first aid kits that are subject to the voluntary recall is being initiated d... | Class II | Total Resources Intl |
| Apr 9, 2013 | Medi-First Brand First Aid Kit, MEDI-FIRST 61 Piece Kit, Home, Workplace Trav... | CGMP Deviations: The first aid kits that are subject to the voluntary recall is being initiated d... | Class II | Total Resources Intl |
| Apr 8, 2013 | Propofol Injectable Emulsion, 1%, 200 mg/20 mL (10 mg/mL), 20 mL Single patie... | Presence of Particulate Matter: A single visible particulate was identified during a retain sampl... | Class II | Hospira Inc. |
| Apr 8, 2013 | BUCALSEP (R) ORAL SOLUTION, (Benzocaine, 600 mg, Cetylpyridinum Chloride 30 m... | Subpotent; Cetylpyridinum Chloride | Class III | Hi-Tech Pharmacal Co., Inc. |
| Apr 5, 2013 | Glenmark Gabapentin Tablets, a) 600mg, 500- count bottle (NDC 68462-126-05)... | Chemical Contamination: Gabapentin Sodium tablets is recalled due to complaints related to an off... | Class III | Glenmark Generics Inc., USA |
| Apr 5, 2013 | Glenmark Pravastatin Sodium Tablets ,40 mg, 90-count bottle (NDC 68462-197-90... | Chemical Contamination: Pravastatin Sodium Tablets isbeing recalled due to complaints related to ... | Class III | Glenmark Generics Inc., USA |
| Apr 5, 2013 | Glenmark Topiramate Tablets, 200 mg, 60-count bottle, (NDC 68462-110-60), Rx... | Chemical Contamination: Topiramate Tablets is being recalled due to complaints related to an off ... | Class III | Glenmark Generics Inc., USA |
| Apr 4, 2013 | Rite Aid brand Maximum Strength Tussin Cough & Cold Mucus Relief CF, (dextrom... | Presence of Precipitate; white substance confirmed as Guaifenesin, an active ingredient was obser... | Class III | Aaron Industries Inc |
| Apr 3, 2013 | Oxcarbazepine Oral Suspension, 300 mg/5 mL, 250 mL bottle, Rx only, Boehringe... | Resuspension Problems: Recalled lot did not meet resuspendability requirements. | Class II | Boehringer Ingelheim Roxane Inc |
| Apr 2, 2013 | Cetacaine Liquid Topical Anesthetic, Rx Only, a) 14 g bottle (NDC 10223-0202... | Subpotent Drug: Cetacaine Topical Anesthetic Liquid is being recalled because one of the three ac... | Class II | Cetylite Industries, Inc. |
| Apr 1, 2013 | Lloyd Thyro-Tab 0.050 mg., packaged in 150,000-tablet bulk drums (2/75,000-ta... | cGMP deviations; After quality review of stability failures in previous lots, there is insufficie... | Class II | Lloyd Inc. of Iowa |
| Apr 1, 2013 | Lloyd Thyro-Tab 0.150 mg., packaged in 150,000-tablet bulk drums (2/75,000-ta... | cGMP deviations; After quality review of stability failures in previous lots, there is insufficie... | Class II | Lloyd Inc. of Iowa |
| Apr 1, 2013 | Levothroid (levothyroxine sodium tablets, USP), 137 mcg, RX only, 100 tablets... | cGMP deviations; After quality review of stability failures in previous lots, there is insufficie... | Class II | Lloyd Inc. of Iowa |
| Apr 1, 2013 | Levothroid (levothyroxine sodium tablets, USP), 112 mcg, RX only, 100 tablets... | cGMP deviations; After quality review of stability failures in previous lots, there is insufficie... | Class II | Lloyd Inc. of Iowa |
| Apr 1, 2013 | Levothroid (levothyroxine sodium tablets, USP), 150 mcg, RX only, 100 tablets... | cGMP deviations; After quality review of stability failures in previous lots, there is insufficie... | Class II | Lloyd Inc. of Iowa |
| Apr 1, 2013 | Levothroid (levothyroxine sodium tablets, USP) , 50 mcg, RX only, 100 tablets... | cGMP deviations; After quality review of stability failures in previous lots, there is insufficie... | Class II | Lloyd Inc. of Iowa |
| Apr 1, 2013 | ROCK-IT MAN capsules, male sexual stimulant, packaged in 1-count (UPC 8 53447... | Marketed Without An Approved NDA/ANDA: FDA analysis found the product to contain hydroxythiohomos... | Class I | Consumer Concepts, Inc. |
| Apr 1, 2013 | Levothroid (levothyroxine sodium tablets, USP), 88 mcg, RX only, 100 tablets ... | cGMP deviations; After quality review of stability failures in previous lots, there is insufficie... | Class II | Lloyd Inc. of Iowa |
| Apr 1, 2013 | Levothroid (levothyroxine sodium tablets, USP), 200 mcg, RX only, 100 tablets... | cGMP deviations; After quality review of stability failures in previous lots, there is insufficie... | Class II | Lloyd Inc. of Iowa |
| Apr 1, 2013 | Lloyd Thyro-Tab 0.075 mg., packaged in 150,000-tablet bulk drums (2/75,000-ta... | cGMP deviations; After quality review of stability failures in previous lots, there is insufficie... | Class II | Lloyd Inc. of Iowa |
| Apr 1, 2013 | Lloyd Thyro-Tab 0.112 mg., packaged in 150,000-tablet bulk drums (2/75,000-ta... | cGMP deviations; After quality review of stability failures in previous lots, there is insufficie... | Class II | Lloyd Inc. of Iowa |
| Apr 1, 2013 | Levothroid (levothyroxine sodium tablets, USP), 100 mcg, RX only, 100 tablets... | cGMP deviations; After quality review of stability failures in previous lots, there is insufficie... | Class II | Lloyd Inc. of Iowa |
| Apr 1, 2013 | Levothroid (levothyroxine sodium tablets, USP) , 75 mcg, RX only, 100 tablets... | cGMP deviations; After quality review of stability failures in previous lots, there is insufficie... | Class II | Lloyd Inc. of Iowa |
| Apr 1, 2013 | Lloyd Thyro-Tab 0.088 mg., packaged in 150,000-tablet bulk drums (2/75,000-ta... | cGMP deviations; After quality review of stability failures in previous lots, there is insufficie... | Class II | Lloyd Inc. of Iowa |
| Apr 1, 2013 | Lloyd Thyro-Tab 0.125 mg., packaged in 150,000-tablet bulk drums (2/75,000-ta... | cGMP deviations; After quality review of stability failures in previous lots, there is insufficie... | Class II | Lloyd Inc. of Iowa |
| Apr 1, 2013 | Lloyd Thyro-Tab 0.100 mg., packaged in 150,000-tablet bulk drums (2/75,000-ta... | cGMP deviations; After quality review of stability failures in previous lots, there is insufficie... | Class II | Lloyd Inc. of Iowa |
| Apr 1, 2013 | Levothroid (levothyroxine sodium tablets, USP) , 125 mcg, RX only, 100 tablet... | cGMP deviations; After quality review of stability failures in previous lots, there is insufficie... | Class II | Lloyd Inc. of Iowa |
| Apr 1, 2013 | Lloyd Thyro-Tab 0.137 mg., packaged in 150,000-tablet bulk drums (2/75,000-ta... | cGMP deviations; After quality review of stability failures in previous lots, there is insufficie... | Class II | Lloyd Inc. of Iowa |
| Apr 1, 2013 | Lloyd Thyro-Tab 0.175 mg., packaged in 150,000-tablet bulk drums (2/75,000-ta... | cGMP deviations; After quality review of stability failures in previous lots, there is insufficie... | Class II | Lloyd Inc. of Iowa |
| Apr 1, 2013 | Levothroid (levothyroxine sodium tablets, USP), 175 mcg, RX only, 100 tablets... | cGMP deviations; After quality review of stability failures in previous lots, there is insufficie... | Class II | Lloyd Inc. of Iowa |
| Apr 1, 2013 | Lloyd Thyro-Tab 0.200 mg., packaged in 150,000-tablet bulk drums (2/75,000-ta... | cGMP deviations; After quality review of stability failures in previous lots, there is insufficie... | Class II | Lloyd Inc. of Iowa |
| Mar 29, 2013 | 0.9% Sodium Chloride Injection, USP, 1000 mL flexible container, Rx only, Hos... | Presence of Particulate Matter: reports of small grey/brown particles found in the primary contai... | Class I | Hospira Inc. |
| Mar 28, 2013 | Levoxyl (levothyroxine sodium) tablets, USP 75 mcg, packaged in a) 100-count... | Chemical contamination: emission of strong odor after package was opened. | Class II | Pfizer Inc. |
| Mar 28, 2013 | Levoxyl (levothyroxine sodium) tablets, USP 150 mcg, packaged in a) 100-count... | Chemical contamination: emission of strong odor after package was opened. | Class II | Pfizer Inc. |
| Mar 28, 2013 | Levoxyl (levothyroxine sodium) tablets, USP 88 mcg, packaged in a) 100-count ... | Chemical contamination: emission of strong odor after package was opened.. | Class II | Pfizer Inc. |
| Mar 28, 2013 | Levoxyl (levothyroxine sodium) tablets, USP 125 mcg, packaged in a) 100-coun... | Chemical contamination: emission of strong odor after package was opened | Class II | Pfizer Inc. |
| Mar 28, 2013 | Levoxyl (levothyroxine sodium) tablets, USP 25 mcg, packaged in a) 100-count ... | Chemical contamination: emission of strong odor after package was opened.. | Class II | Pfizer Inc. |
| Mar 28, 2013 | Methylcobalamin (Buffered) Injection,1 mg/mL, 30 mL vial, Stock# 11126, Prese... | Lack of Assurance of Sterility; reports of adverse events after injection | Class II | NuVision Pharmacy, Inc. |
| Mar 28, 2013 | Levoxyl (levothyroxine sodium) tablets, USP 100 mcg, packaged in a) 100-count... | Chemical contamination: emission of strong odor after package was opened.. | Class II | Pfizer Inc. |
| Mar 28, 2013 | Levoxyl (levothyroxine sodium) tablets, USP 50 mcg, packaged in a) 100-count ... | Chemical contamination: emission of strong odor after package was opened. | Class II | Pfizer Inc. |
| Mar 28, 2013 | Levoxyl (levothyroxine sodium) tablets, USP 112 mcg, packaged in a) 100-count... | Chemical contamination: emission of strong odor after package was opened. | Class II | Pfizer Inc. |
| Mar 28, 2013 | Levoxyl (levothyroxine sodium) tablets, USP 137 mcg, packaged in a) 100-count... | Chemical contamination: emission of strong odor after package was opened. | Class II | Pfizer Inc. |
| Mar 28, 2013 | Levoxyl (levothyroxine sodium) tablets, USP 175 mcg, packaged in a) 100-count... | Chemical contamination: emission of strong odor after package was opened. | Class II | Pfizer Inc. |
| Mar 28, 2013 | Levoxyl (levothyroxine sodium) tablets, USP 200 mcg, packaged in a) 100-count... | Chemical contamination: emission of strong odor after package was opened. | Class II | Pfizer Inc. |
| Mar 27, 2013 | Lorazepam, 0.5 mg tablets, 100 count, RX only, Distributed by Major Pharmaceu... | Labeling: Incorrect or Missing Lot and/or Exp Date: Lorazepam Lot # L-04009 | Class III | Legacy Pharmaceutical Packaging LLC |
| Mar 25, 2013 | HCG Chorionic Gonadotropin, compounded by Pallimed Solutions Pharmacy, Woburn... | Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with qu... | Class II | Pallimed Solutions |
| Mar 25, 2013 | Vancomycin Ophthalmic PF, compounded by Pallimed Solutions Pharmacy, Wobrun, MA | Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with qu... | Class II | Pallimed Solutions |
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.