Medicines, 2016
Shortlist up to four to read them side by side.
1,254 medicine recalls FDA’s Enforcement Report published in 2016, 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 5, 2026.
1,254of 1,254 medicine recallsshown with your filters
The list
- Medicine recall Fluconazole Injection, USP, 200 mg/100 mL Lack of Assurance of Sterility: confirmed customer complaints of leaking bags. Class IIFDA’s classDec 28, 2016in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 28, 2016ClassClass IIStatusTerminatedWhereNo state named
- Medicine recall BuPROPion Hydrochloride Extended-Release Tablets (XL), 300 mg Failed Dissolution Specifications; 6 month time point Class IIIFDA’s classDec 28, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 28, 2016ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall C-PAV/PHENTOL/PGE1, All strengths, All sizes Lack of Assurance of Sterility; sterility concerns with all injectable drug products that were made with sterilized filtered stock solutions. Class IIFDA’s classDec 28, 2016in FDA’s Enforcement Report2 statesnamed in where it went PublishedDec 28, 2016ClassClass IIStatusTerminatedWhereNew Jersey and New York
- Medicine recall C-PAV/PHENTOL/ATROP/PGE1, All strengths, All sizes Lack of Assurance of Sterility; sterility concerns with all injectable drug products that were made with sterilized filtered stock solutions. Class IIFDA’s classDec 28, 2016in FDA’s Enforcement Report2 statesnamed in where it went PublishedDec 28, 2016ClassClass IIStatusTerminatedWhereNew Jersey and New York
- Medicine recall Ultimate Body Tox PRO capsules, Proprietary Blend, 350 mg, 45 count bottle Marketed Without An Approved NDA/ANDA: The product contains undeclared sibutramine. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 28, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedDec 28, 2016ClassClass IStatusTerminatedWhereNationwide, and North Carolina named
- Medicine recall Lidocaine HCL/ Sodium Bicarb, 1%/0.5% 0.5 mL SYR PF Non-Sterility: failed sterility test result. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 28, 2016in FDA’s Enforcement ReportTexasthe one state its words name PublishedDec 28, 2016ClassClass IStatusTerminatedWhereTexas
- Medicine recall Hyoscyamine Sulfate, Sublingual Tablets, 0.125 mg, 100-count bottle Failed Content Uniformity Specifications: resulting in both superpotent and subpotent tablets. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 28, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedDec 28, 2016ClassClass IStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Hyoscyamine Sulfate, Orally Disintegrating Tablets, 0.125 mg, 100-count bottles Failed Content Uniformity Specifications: resulting in both superpotent and subpotent tablets. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 28, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedDec 28, 2016ClassClass IStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Hyoscyamine Sulfate, USP Tablets, 0.125 mg, 100-count tablets per bottle Failed Content Uniformity Specifications: resulting in both superpotent and subpotent tablets. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 28, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedDec 28, 2016ClassClass IStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Lamotrigine Orally Disintegrating Tablets (ODT), 200 mg, 30 Tablets 3 blisters containing 10 tablets each Labeling; Label Mixup; box labeled to contain 200 mg blister packs but actually contain 100 mg blister packs FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 28, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 28, 2016ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Honeywell eyesaline Eyewash Sterile Isotonic Solution, sterile water 99%, 32 fl Non Sterility; contaminated with Klebsiella pneumoniae FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 28, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 28, 2016ClassClass IStatusTerminatedWhereNationwide
- Medicine recall GlucaGen HypoKit (glucagon [rDNA origin] for injection), 1 mg per vial, Single use only Defective delivery system: detached needles on the syringe in the kit. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 28, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 28, 2016ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Bupivacaine Hydrochloride Inj., USP Presence of particulate matter: Confirmed customer report for the presence of particulate matter within a single vial. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 28, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 28, 2016ClassClass IStatusOngoingWhereNationwide
- Medicine recall Docusate Oral 10 mg/mL Oral Syringe Microbial Contamination of Non-Sterile Products; microbial contamination with B. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 28, 2016in FDA’s Enforcement ReportTexasthe one state its words name PublishedDec 28, 2016ClassClass IStatusTerminatedWhereTexas
- Medicine recall BLACK LABEL X capsules, 60-count bottles Marketed without an approved NDA/ANDA - presence of undeclared sildenafil. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 28, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 28, 2016ClassClass IStatusTerminatedWhereNationwide
- Medicine recall BLACK GOLD X ADVANCED capsules, 60-count bottles Marketed without an approved NDA/ANDA - presence of undeclared sibutramine. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 28, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 28, 2016ClassClass IStatusTerminatedWhereNationwide
- Medicine recall 3rd DEGREE capsules, 60-count bottles Marketed without an approved NDA/ANDA - presence of undeclared sibutramine. Class IIFDA’s classDec 28, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 28, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Skinny Bee Diet capsules, 500 mg Marketed without an approved NDA/ANDA: presence of undeclared sibutramine, desmethylsibutramine (an active metabolite of sibutramine) and phenolphthalein. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 28, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 28, 2016ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Duloxetine Delayed-release Capsules USP 30 mg 30-count bottles Failed Tablet/Capsule Specifications: Capsule shell (s) opening inside the bottle The Initial reports stated one or two capsules in a bottle count of 30s… Class IIFDA’s classDec 28, 2016in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 28, 2016ClassClass IIStatusTerminatedWhereNo state named
- Medicine recall Toms of Maine Naturally Dry Natural Powder Antiperspirant Stick Labeling: Label Mix Up- Incorrect back label applied to the product. Class IIIFDA’s classDec 28, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 28, 2016ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall AMGEN Kyprolis (carfilzomib) for injection, 30 mg per vial, Discard unused portion, For Intravenous… Lack of Assurance of Sterility: Potential cracks in glass vials Class IIFDA’s classDec 28, 2016in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedDec 28, 2016ClassClass IIStatusTerminatedWherePuerto Rico
- Medicine recall Phenylephrine 2.5% + Tropicamide 1% Compounded Eye Drops Solution, 5 mL bottles, Meta Pharmacy Services Lack of Sterility Assurance Class IIFDA’s classDec 28, 2016in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 28, 2016ClassClass IIStatusTerminatedWhereNo state named
- Medicine recall Sermorelin/GHRP-6 Injection 6 mg-3 mg Lyophylized I, 2 mL vial, Rx, Town and Country Compounding and… Non-Sterility; microbial contamination identified as Bacillus circulans FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 28, 2016in FDA’s Enforcement Report4 statesnamed in where it went PublishedDec 28, 2016ClassClass IStatusTerminatedWhereFlorida, Massachusetts, New Jersey and New York
- Medicine recall COMFORT SHIELD (dimethicone) Barrier Cream Cloths, 3% Microbial Contamination of Non-Sterile Products: contamination with the bacteria, Burkholderia cepacia. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 28, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedDec 28, 2016ClassClass IStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall COMFORT SHIELD (dimethicone) Barrier Cream Cloths, 3% CGMP Deviations: potential contamination of products manufactured on the same equipment and lines as the contaminated product. Class IIFDA’s classDec 28, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedDec 28, 2016ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall 2% Chlorhexidine Gluconate* Cloth, 2 disposable cloths per package, further CGMP Deviations: potential contamination of products manufactured on the same equipment and lines as the contaminated product. Class IIFDA’s classDec 28, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedDec 28, 2016ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Calcium Chloride 1 g/50 mL* Added to 5% Dextrose Lack of Assurance of Sterility - the firm is recalling select sterile drug products. Class IIFDA’s classDec 21, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 21, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Phenylephrine HCl 1 mg/10 mL Lack of Assurance of Sterility - the firm is recalling select sterile drug products. Class IIFDA’s classDec 21, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 21, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Calcium Chloride Lack of Assurance of Sterility - the firm is recalling select sterile drug products. Class IIFDA’s classDec 21, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 21, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Calcium Chloride Lack of Assurance of Sterility - the firm is recalling select sterile drug products. Class IIFDA’s classDec 21, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 21, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Fentanyl Citrate 1,500 mcg Lack of Assurance of Sterility - the firm is recalling select sterile drug products. Class IIFDA’s classDec 21, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 21, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Fentanyl Citrate 2,500 mcg Lack of Assurance of Sterility - the firm is recalling select sterile drug products. Class IIFDA’s classDec 21, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 21, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Fentanyl Citrate 2 mcg/mL & Bupivacaine HCl 0.125% Lack of Assurance of Sterility - the firm is recalling select sterile drug products. Class IIFDA’s classDec 21, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 21, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Glycopyrrolate 1 mg/5 mL Lack of Assurance of Sterility - the firm is recalling select sterile drug products. Class IIFDA’s classDec 21, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 21, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Heparin Sodium, 1 USP Unit/2 mL Lack of Assurance of Sterility - the firm is recalling select sterile drug products. Class IIFDA’s classDec 21, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 21, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Heparin Sodium 5,000 USP Units Added to 0.9% Sodium Chloride 1,000 mL* Bag Lack of Assurance of Sterility - the firm is recalling select sterile drug products. Class IIFDA’s classDec 21, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 21, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall HYDROmorphone HCl 6 mg/30 mL Lack of Assurance of Sterility - the firm is recalling select sterile drug products. Class IIFDA’s classDec 21, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 21, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall HYDROmorphone HCl 50 mg/50 mL Lack of Assurance of Sterility - the firm is recalling select sterile drug products. Class IIFDA’s classDec 21, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 21, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Hydromorphone HCl 1 mg/mL Lack of Assurance of Sterility - the firm is recalling select sterile drug products. Class IIFDA’s classDec 21, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 21, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Lidocaine HCl 1%, 10 mL Syringe, Hospital/Office Use Only Lack of Assurance of Sterility - the firm is recalling select sterile drug products. Class IIFDA’s classDec 21, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 21, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Midazolam HCl 50 mg/50 mL Lack of Assurance of Sterility - the firm is recalling select sterile drug products. Class IIFDA’s classDec 21, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 21, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Morphine Sulfate 1 mg/mL Lack of Assurance of Sterility - the firm is recalling select sterile drug products. Class IIFDA’s classDec 21, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 21, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Neostigmine Methylsulfate 5 mg/5 mL Injection Solution, 5 mL Lack of Assurance of Sterility - the firm is recalling select sterile drug products. Class IIFDA’s classDec 21, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 21, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Oxytocin 30 USP Units Added to 0.9% Sodium Chloride, 500 mL Bag, Single-Dose Bag, Injection Solution for IV… Lack of Assurance of Sterility - the firm is recalling select sterile drug products. Class IIFDA’s classDec 21, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 21, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Rocuronium Bromide 50 mg/5 mL Injection Solution, 5 mL Lack of Assurance of Sterility - the firm is recalling select sterile drug products. Class IIFDA’s classDec 21, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 21, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Ropivacaine HCl 0.25% Lack of Assurance of Sterility - the firm is recalling select sterile drug products. Class IIFDA’s classDec 21, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 21, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Succinylcholine Chloride 200 mg/10 mL Injection Solution 10 mL Lack of Assurance of Sterility - the firm is recalling select sterile drug products. Class IIFDA’s classDec 21, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 21, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Methylprednisolone Tablets, USP, 16 mg, 50-count bottles Labeling: Incorrect or Missing Lot and/or Exp Date: incorrect expiration date of 02/0218 is printed on the container label instead of the correct expiration… Class IIIFDA’s classDec 21, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedDec 21, 2016ClassClass IIIStatusTerminatedWhereNationwide, and Puerto Rico 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.”
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