Medicines, 2013
Shortlist up to four to read them side by side.
1,376 medicine recalls FDA’s Enforcement Report published in 2013, newest first; 18,075 in all since 2012.
FDA’s medicine recalls, as its Enforcement Report classifies them, from June 2012. Lists of FDA’s records can’t be saved for alerts: openFDA asks that its data not be used to alert the public (openFDA); FDA’s own emails do that. Copied Nov 6, 2026.
1,376of 1,376 medicine recallsshown with your filters
The list
- Medicine recall Venlafaxine Hydrochloride Tablets, 75 mg*, 100-count tablets per bottle Failed Tablet/Capsule Specifications: Pharmacist complaint of an excessive amount of broken and/or chipped tablets in the bottle. Class IIFDA’s classApr 3, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 3, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Lactated Ringer’s Injection, USP, 1000 mL CGMP Deviations: Shipment of product not approved for release. Class IIIFDA’s classApr 3, 2013in FDA’s Enforcement ReportNorth Carolinathe one state its words name PublishedApr 3, 2013ClassClass IIIStatusTerminatedWhereNorth Carolina
- Medicine recall PE Daytime Cold/Flu LiqGel, Multi Symptom Relief, Acetaminophen/Dextromethorphan HBr/Phenylephrine HCL… Subpotent; 12 month time point for the active ingredient Phenylephrine HCl. Class IIIFDA’s classApr 3, 2013in FDA’s Enforcement ReportArkansasthe one state its words name PublishedApr 3, 2013ClassClass IIIStatusTerminatedWhereArkansas
- Medicine recall Derma-Smoothe/FS (fluocinolone acetonide), 0.01% Topical Oil (Body Oil) Subpotent; 12 month stability timepoint Class IIIFDA’s classApr 3, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 3, 2013ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Derma-Smoothe/FS (fluocinolone acetonide) 0.01% Topical Oil(SCALP OIL) Subpotent; 22 month stability timepoint Class IIIFDA’s classApr 3, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 3, 2013ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall TORISEL Kit (temsirolimus) injection, 25 mg/mL, CONCENTRATED Lack of Assurance of Sterility; potential that a low level of endotoxins may be present in the diluent vials. Class IIIFDA’s classApr 3, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 3, 2013ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Ciprofloxacin Tablets USP, 500 mg, 100-count bottle Presence of Foreign Substance(s): A complaint was received for a rubber-like material in a 500 mg Ciprofloxacin tablet. Class IIFDA’s classApr 3, 2013in FDA’s Enforcement Report2 statesnamed in where it went PublishedApr 3, 2013ClassClass IIStatusTerminatedWhereArkansas and Georgia
- Medicine recall PHYSICIANS TOTAL CARE, TETRACYCLINE, 250 mg, 30 CAPSULES, bottle MFG Presence of Foreign Substance(s): There is a potential for foreign particulate matter in the API. Class IIFDA’s classApr 3, 2013in FDA’s Enforcement Report10 statesnamed in where it went PublishedApr 3, 2013ClassClass IIStatusTerminatedWhereColorado, Florida, Georgia, Kansas, Louisiana, Missouri, North Carolina, South Carolina, Texas and Virginia
- Medicine recall PHYSICIANS TOTAL CARE, TETRACYCLINE, 500 mg, 30 CAPSULES, bottle MFG Presence of Foreign Substance(s): There is a potential for foreign particulate matter in the API. Class IIFDA’s classApr 3, 2013in FDA’s Enforcement Report10 statesnamed in where it went PublishedApr 3, 2013ClassClass IIStatusTerminatedWhereColorado, Florida, Georgia, Kansas, Louisiana, Missouri, North Carolina, South Carolina, Texas and Virginia
- Medicine recall Propofol Injectable Emulsion, 1% Presence of Particulate Matter: Visible particulate embedded in vials was observed and confirmed in a sample bottle during retain inspection. Class IIFDA’s classApr 3, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 3, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall SEPP 70% Isopropanol (isopropyl alcohol) 70% v/v, USP, 200-count applicators (net 0.67 mL each) per carton Labeling: Not Elsewhere Classified: This product is misbranded because the product is not sterile and the labeling is misleading in relation to sterility… Class IIFDA’s classApr 3, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedApr 3, 2013ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico and US Virgin Islands named
- Medicine recall SEPP 2% Iodine Tincture USP Labeling: Not Elsewhere Classified: This product is misbranded because the product is not sterile and the labeling is misleading in relation to sterility… Class IIFDA’s classApr 3, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedApr 3, 2013ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico and US Virgin Islands named
- Medicine recall SEPP 10% Povidone Iodine Solution USP Labeling: Not Elsewhere Classified: This product is misbranded because the product is not sterile and the labeling is misleading in relation to sterility… Class IIFDA’s classApr 3, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedApr 3, 2013ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico and US Virgin Islands named
- Medicine recall Blood Culture Prep Kit II containing 1 FREPP Labeling: Not Elsewhere Classified: This product is misbranded because the product is not sterile and the labeling is misleading in relation to sterility… Class IIFDA’s classApr 3, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedApr 3, 2013ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico and US Virgin Islands named
- Medicine recall Donor Prep Kit containing 1 FREPP Labeling: Not Elsewhere Classified: This product is misbranded because the product is not sterile and the labeling is misleading in relation to sterility… Class IIFDA’s classApr 3, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedApr 3, 2013ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico and US Virgin Islands named
- Medicine recall FREPP/SEPP Kit containing 1 FREPP (povidone iodine 2% aqueous solution), Net 1.1 mL and 1 SEPP (povidone… Labeling: Not Elsewhere Classified: This product is misbranded because the product is not sterile and the labeling is misleading in relation to sterility… Class IIFDA’s classApr 3, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedApr 3, 2013ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico and US Virgin Islands named
- Medicine recall Carisoprodol Tablets, USP, 350 mg Labeling: Not elsewhere classified: On 12/12/11, DEA published a final rule in the Federal Register making this product a schedule IV (C-IV)controlled… Class IIIFDA’s classMar 27, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 27, 2013ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Meprobamate, Tablets USP, 200 mg, 100 tablets Failed Impurities/Degradation Specifications: Watson Laboratories Inc. Class IIFDA’s classMar 27, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 27, 2013ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Meprobamate; Tablets USP, 400 mg, 100 tablets; Rx only; Manufactured By: Watson Laboratories, Inc., Corona,… Failed Impurities/Degradation Specifications: Watson Laboratories Inc. Class IIFDA’s classMar 27, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 27, 2013ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall ZARAH¿ Drospirenone/ Ethinyl Estradiol Tablets, 3.0 mg/0.03 mg Failed Tablet/Capsule Specification; tablet breakage while pushing through the blister pack (dispenser) . Class IIFDA’s classMar 27, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 27, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall METRONIDazole Injection, USP 500 mg Lack of Assurance of Sterility: There is the potential for the solution to leak from the administrative port to the fill tube seal. Class IIFDA’s classMar 27, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 27, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Myoflex (trolamine salicylate) 10%, Pain Relieving Cream, a) 2-oz tube, b) 4-oz Labeling: Incorrect or Missing Lot and/or Exp Date. Class IIIFDA’s classMar 27, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 27, 2013ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Nupercainal, Dibucaine, Hemorrhoidal & Topical Analgesic Ointment, a) 1-oz Labeling: Incorrect or Missing Lot and/or Exp Date. Class IIIFDA’s classMar 27, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 27, 2013ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall 4 way Nasal Decongestant Fast Acting Nasal Spray, containing phenylephrine hydrochloride 1%, a) 1/2-fl Labeling: Incorrect or Missing Lot and/or Exp Date. Class IIIFDA’s classMar 27, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 27, 2013ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall 4 way Nasal Decongestant Menthol Nasal Spray, containing phenylephrine hydrochloride 1%, a) 1/2-fl Labeling: Incorrect or Missing Lot and/or Exp Date. Class IIIFDA’s classMar 27, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 27, 2013ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall 4 way Saline Moisturizing Mist with Eucalyptol & Menthol, 1-fl Labeling: Incorrect or Missing Lot and/or Exp Date. Class IIIFDA’s classMar 27, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 27, 2013ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Levothyroxine Tablets, USP (levothyroxine sodium), 0.175 mg, 30 count bottles, Rx, Repacked & Subpotent; 15 month stability (by mfr) Class IIFDA’s classMar 27, 2013in FDA’s Enforcement Report2 statesnamed in where it went PublishedMar 27, 2013ClassClass IIStatusTerminatedWhereGeorgia and Ohio
- Medicine recall Medi-bolic Booster Injectable (methionine 8.3 mg/mL, choline chloride 16.6 mg/mL, inositol 16.6 mg/mL,… CGMP Deviations: Pharmaceutical for injection was not manufactured according to Good Manufacturing Procedures. Class IIFDA’s classMar 20, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 20, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Eye Drops advanced relief (Dextran 70 0.1%, Polyethylene glycol 400 1%, Povidone 1%, Tetrahydrozoline HCl… Labeling: Label Mix-Up: Incorrect back labeling of the immediate container of eye drops (unit carton and front label are correct) which do not list three… Class IIFDA’s classMar 20, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 20, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Terazosin Hydrochloride Capsules, 2 mg Presence of Foreign Tablets/Capsules: Recall is being conducted due to a foreign capsule found in one bottle. Class IIFDA’s classMar 20, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 20, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall PIRACETAM COGNITION ENHANCING AGENT Dietary Supplement PHARMACEUTICAL GRADE 800 mg 240 Capsules per bottle… Marketed Without an Approved NDA/ANDA: The product is an unapproved new drug. Class IIFDA’s classMar 20, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 20, 2013ClassClass IIStatusTerminatedWhereNationwide, and Texas named
- Medicine recall PIRACETAM POWDER COGNITION ENHANCING AGENT Dietary Supplement CTD 500 grams PHARMACEUTICAL GRADECTD Labs… Marketed Without an Approved NDA/ANDA: The product is an unapproved new drug. Class IIFDA’s classMar 20, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 20, 2013ClassClass IIStatusTerminatedWhereNationwide, and Texas named
- Medicine recall ANIRACETAM FAST ACTING NOOTROPIC Dietary Supplement PHARMACEUTICAL GRADE 750mg 60 Capsules per bottle CTD… Marketed Without an Approved NDA/ANDA: The product is an unapproved new drug. Class IIFDA’s classMar 20, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 20, 2013ClassClass IIStatusTerminatedWhereNationwide, and Texas named
- Medicine recall Mercuroclear Antiseptic Anesthetic First Aid Helps prevent infection and relieves pain and itching of minor… Microbial Contamination of Non-Sterile Product(s): The product has the potential to be contaminated with Bulkholderia gladioli. Class IIFDA’s classMar 20, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 20, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall PULMICORT RESPULES 0.25 mg/2 ml Budesonide Inhalation Suspension Does Not Meet Monograph: Budesonide may be slightly above or below the specification range. Class IIIFDA’s classMar 20, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 20, 2013ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall PULMICORT RESPULES 0.5 mg/2 ml Does Not Meet Monograph: Budesonide may be slightly above or below the specification range. Class IIIFDA’s classMar 20, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 20, 2013ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall CALCIUM GLUCONATE INJECTION, USP, 10% Labeling: Missing label Class IIIFDA’s classMar 20, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 20, 2013ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall ABILIFY (aripiprazole) Tablets, 30 mg CGMP Deviations: A drum of Abilify 30 mg Tablets rejected during the compression stage was not segregated from the other portion of the lot and was… Class IIFDA’s classMar 13, 2013in FDA’s Enforcement Report3 statesnamed in where it went PublishedMar 13, 2013ClassClass IIStatusTerminatedWhereCalifornia, Louisiana and Tennessee
- Medicine recall Montelukast Sodium Tablets, 10 mg (base) Chemical Contamination: The recall has been initiated based on multiple complaints received from pharmacists and consumers reporting that they detected an… Class IIIFDA’s classMar 13, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 13, 2013ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall 0.9% Sodium Chloride Injection USP, 100 mL Hospira, Inc., Lake Forest, IL 60045 Lack of Assurance of Sterility: There is the potential for solution to leak from the administrative port to the fill tube seal. Class IIFDA’s classMar 13, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 13, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall HEXTEND 6% Hetastarch in Lactated Electrolyte Injection, 500 mL Lack of Assurance of Sterility: There is the potential for the solution to leak from the seal of the fill tube to the bag. Class IIFDA’s classMar 13, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 13, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Well at Walgreens Wal-Tussin CF Max, MAXIMUM STRENGTH ADULT NON-DROWSY, Multi-Symptom Cold, (dextromethorphan… Presence of Precipitate; white substance confirmed as Guaifenesin, an active ingredient was observed in some bottles. Class IIIFDA’s classMar 13, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 13, 2013ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Rite Aid Maximum Strength Tussin Cough & Cold Mucus Relief CF, (dextromethorphan HBr 10 mg, guaifenesin 200… Presence of Precipitate; white substance confirmed as Guaifenesin, an active ingredient was observed in some bottles. Class IIIFDA’s classMar 13, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 13, 2013ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Select Brand Cough Control CF Max, Maximum Strength for MUCUS RELIEF, (dextromethorphan HBr 10 mg,… Presence of Precipitate; white substance confirmed as Guaifenesin, an active ingredient was observed in some bottles. Class IIIFDA’s classMar 13, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 13, 2013ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Wal-Mart Equate Tussin CF Adult Maximum Strength, Multi-Symptom Cold, (dextromethorphan HBr 10 mg,… Presence of Precipitate; white substance confirmed as Guaifenesin, an active ingredient was observed in some bottles. Class IIIFDA’s classMar 13, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 13, 2013ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall VERSAPHARM Ethambutol Tablets, USP,400 mg Discoloration: Ethambutol Tablets USP 400 mg have tablets cores that may be discolored. Class IIFDA’s classMar 13, 2013in FDA’s Enforcement ReportGeorgiathe one state its words name PublishedMar 13, 2013ClassClass IIStatusTerminatedWhereGeorgia
- Medicine recall Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, Amphetamine… Failed Dissolution Specification: This product recall is due to the product lot # 50077231 exceeding dissolution specifications. Class IIIFDA’s classMar 13, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 13, 2013ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall EXPAREL (bupivacaine liposome injectable suspension), 1.3%, 266 mg/20 mL Subpotent; bupivacaine Class IIFDA’s classMar 6, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 9 states named PublishedMar 6, 2013ClassClass IIStatusTerminatedWhereNationwide, and Arizona, District of Columbia, Florida, Georgia, Massachusetts, New Jersey, New York, Ohio and Texas named
Nothing matches all of these.
Remove a filter to see more. Each one is a fact FDA’s record publishes, so a recall can be left out because its record is silent on it.
Source:
FDA, Drug recall enforcement reports. Released Nov 3, 2026. Updated weekly.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.”
Your shortlist0 of 4
Add one more to compare.