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 6, 2026.
1,254of 1,254 medicine recallsshown with your filters
The list
- Medicine recall Plant Vigra, packaged in BIG BOX / (18 cans / 6 capsules per can / 108 capsules), Distributed by: R Thomas… Marketed Without An Approved NDA/ANDA FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 1, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 1, 2016ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Hard Ten Days Marketed Without An Approved NDA/ANDA FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 1, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 1, 2016ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Man King, packaged in BIG BOX (8 small boxes / 5 capsules per box / 40 capsules), Distributed by: R Thomas… Marketed Without An Approved NDA/ANDA FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 1, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 1, 2016ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Mojo Risen, packaged in BIG BOX (24 individual cards / 2 capsules per card/ 48 capsules), Distributed by: R… Marketed Without An Approved NDA/ANDA FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 1, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 1, 2016ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Night Man, packaged in SMALL BOX (6 capsules), Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467 Marketed Without An Approved NDA/ANDA FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 1, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 1, 2016ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Tiger King, packaged in BIG BOX (10 small bottles / 10 capsules per bottle / 100 capsules), Distributed by: R… Marketed Without An Approved NDA/ANDA FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 1, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 1, 2016ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Samurai-X, packaged in BIG BOX (24 individually wrapped capsules), Distributed by: R Thomas Marketing, LLC,… Marketed Without An Approved NDA/ANDA FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 1, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 1, 2016ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Super Hard, packaged in BIG BOX (20 small boxes / 6 capsules per box / 120 capsules), Distributed by: R… Marketed Without An Approved NDA/ANDA FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 1, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 1, 2016ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Zhen Gong Fu Marketed Without An Approved NDA/ANDA FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 1, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 1, 2016ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Licorice Coughing Liquid (guaifenesin), 5%, 3.38 fl Marketed Without An Approved NDA/ANDA: presence of undeclared morphine. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 1, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 1, 2016ClassClass IStatusTerminatedWhereNationwide
- Medicine recall SUPER HERBS 350 mg, 30 capsules per bottle. Marketed without an approved NDA/ANDA - presence of undeclared sibutramine, desmethylsibutramine (an active metabolite of sibutramine) and/or phenolphthalein. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 1, 2016in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJun 1, 2016ClassClass IStatusTerminatedWhereNo state named
- Medicine recall BETTER BRAIDS UN-BRAID (salicylic acid), Le Demelant Microbial Contamination of Non-Sterile Products: Failed S.aureus test. Class IIFDA’s classMay 25, 2016in FDA’s Enforcement Report2 statesnamed in where it went PublishedMay 25, 2016ClassClass IIStatusTerminatedWhereMaryland and New Jersey
- Medicine recall Magnesium Sulfate Inj., USP 50%, 10 g/20 mL Failed pH Specifications: Confirmed high out of specification (OOS) results for pH. Class IIIFDA’s classMay 25, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMay 25, 2016ClassClass IIIStatusOngoingWhereNationwide, and Puerto Rico named
- Medicine recall Renovo Patch (Capsaicin, 0.0375%, Menthol, USP 5.00%), 3-count patches per carton Marketed Without An Approved NDA/ANDA: product is an unapproved drug and additionally 3 lots were found to be subpotent. Class IIFDA’s classMay 25, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 25, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall col-rite (docusate sodium) stool softener softgels, 50 mg Superpotent Drug: High out of specification results for assay at the 6 month time point interval. Class IIIFDA’s classMay 25, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 25, 2016ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Paliperidone Extended-release Tablets, 1.5 mg, 30 count bottles Failed Dissolution Specifications; three month stability time point. Class IIFDA’s classMay 18, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 18, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Ondansetron Tablets USP, 4 mg, 30 count bottles Failed Impurities/Degradation Specifications; 12 month stability time point Class IIFDA’s classMay 18, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 18, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Dryses Aluminum Chlorohydrate Antiperspirant Solution, 3.4 fl cGMP Deviations; product does not comply with cGMP requirements Class IIFDA’s classMay 18, 2016in FDA’s Enforcement Report4 statesnamed in where it went PublishedMay 18, 2016ClassClass IIStatusOngoingWhereColorado, Florida, Georgia and Puerto Rico
- Medicine recall Salises Facial Moisturizing Acne Treatment Gel, (salicylic acid 1.5%), 1.7 fl cGMP Deviations; product does not comply with cGMP requirements Class IIFDA’s classMay 18, 2016in FDA’s Enforcement Report4 statesnamed in where it went PublishedMay 18, 2016ClassClass IIStatusOngoingWhereColorado, Florida, Georgia and Puerto Rico
- Medicine recall Repaskin 50 (octocrylene 7%, titanium dioxide 2%) Body Lotion Sunscreen gel cream, Broad Spectrum SPF 50, 6.8… cGMP Deviations; product does not comply with cGMP requirements Class IIFDA’s classMay 18, 2016in FDA’s Enforcement Report4 statesnamed in where it went PublishedMay 18, 2016ClassClass IIStatusOngoingWhereColorado, Florida, Georgia and Puerto Rico
- Medicine recall Repaskin 30 (octacrylene 4%, oxybenzone 3%, octisalate 3%, octinoxate 3% Avobenzone 3%) Body Lotion Sunscreen… cGMP Deviations; product does not comply with cGMP requirements Class IIFDA’s classMay 18, 2016in FDA’s Enforcement Report4 statesnamed in where it went PublishedMay 18, 2016ClassClass IIStatusOngoingWhereColorado, Florida, Georgia and Puerto Rico
- Medicine recall Dryses Aluminum Chlorohydrate Deodorant for Men Roll-on, 2.5 fl oz cGMP Deviations; product does not comply with cGMP requirements Class IIFDA’s classMay 18, 2016in FDA’s Enforcement Report4 statesnamed in where it went PublishedMay 18, 2016ClassClass IIStatusOngoingWhereColorado, Florida, Georgia and Puerto Rico
- Medicine recall Dryses Aluminum Chlorohydrate Deodorant for Women, Roll-on, 2.5 fl oz cGMP Deviations; product does not comply with cGMP requirements Class IIFDA’s classMay 18, 2016in FDA’s Enforcement Report4 statesnamed in where it went PublishedMay 18, 2016ClassClass IIStatusOngoingWhereColorado, Florida, Georgia and Puerto Rico
- Medicine recall Repaskin 50 (octocrylene 7%, titanium oxide 2%) Facial Sunscreen gel cream, Broad Spectrum SPF 50, 1.7 fl oz cGMP Deviations; product does not comply with cGMP requirements Class IIFDA’s classMay 18, 2016in FDA’s Enforcement Report4 statesnamed in where it went PublishedMay 18, 2016ClassClass IIStatusOngoingWhereColorado, Florida, Georgia and Puerto Rico
- Medicine recall Repaskin 30 (octacrylene 4%, oxybenzone 3%, octisalate 3%, octinoxate 3% Avobenzone 3%) Facial Sunscreen gel… cGMP Deviations; product does not comply with cGMP requirements Class IIFDA’s classMay 18, 2016in FDA’s Enforcement Report4 statesnamed in where it went PublishedMay 18, 2016ClassClass IIStatusOngoingWhereColorado, Florida, Georgia and Puerto Rico
- Medicine recall Screenses Color Sunscreen Tinted facial make-up compact, Broad Spectrum SPF 50, Brown, 0.35 oz cGMP Deviations; product does not comply with cGMP requirements Class IIFDA’s classMay 18, 2016in FDA’s Enforcement Report4 statesnamed in where it went PublishedMay 18, 2016ClassClass IIStatusOngoingWhereColorado, Florida, Georgia and Puerto Rico
- Medicine recall Screenses Color Sunscreen, Tinted facial make-up compact, Broad Spectrum SPF 50 Light, 0.35 oz cGMP Deviations; product does not comply with cGMP requirements Class IIFDA’s classMay 18, 2016in FDA’s Enforcement Report4 statesnamed in where it went PublishedMay 18, 2016ClassClass IIStatusOngoingWhereColorado, Florida, Georgia and Puerto Rico
- Medicine recall Brevibloc DOUBLE STRENGTH Premixed Injection, Esmolol Hydrochloride in Sodium Chloride, 2000mg/100mL Discoloration: presence of atypical yellow discoloration of the solution . Class IIFDA’s classMay 18, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 18, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Good Neighbor Pharmacy PEG-Phen Lubricant Eye Drops (Polyethylene Glycol 400 0.4% / Propylene Glycol 0.3%),… Presence of Particulate Matter Class IIFDA’s classMay 11, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 11, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Quelicin (Succinylcholine Chloride) Injection, USP 200 mg. Labeling: Incorrect or Missing Lot and/or Exp Date: Potential for the lot number and/or expiration date to be faded or missing from the primary label on the… Class IIIFDA’s classMay 11, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 11, 2016ClassClass IIIStatusOngoingWhereNationwide
- Medicine recall Venlafaxine 75 mg Tablet, Compare to Effexor 75 mg Tablet, a) 30-count bottle (NDC 636290-3324-2), b)… Labeling: Label Mix-Up: Bryant Ranch received Tevas venlafaxine hydrochloride extended-release tablets for repackaging, but labeled it incorrectly as the… Class IIIFDA’s classMay 11, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 11, 2016ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Oxycodone Hydrochloride Oral Solution, USP 5 mg/5 mL Defective Container: Excess lidding material accumulation between the seal and the cup resulting in the lid not properly adhering and allowing leakage. Class IIFDA’s classMay 11, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 11, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Acetaminophen & Codeine Phosphate Tablets, 300 mg/30 mg, 15-count plastic bottle Labeling: Not elsewhere classified - count on the label was incorrect. Class IIIFDA’s classMay 11, 2016in FDA’s Enforcement ReportVirginiathe one state its words name PublishedMay 11, 2016ClassClass IIIStatusTerminatedWhereVirginia
- Medicine recall SKY Aspirin Chewable Tablets, 81 mg, Unit Dose 750 tablets Labeling: Label mix-up -outer carton incorrectly labeled as aspirin chewable tablets. Class IIIFDA’s classMay 4, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 4, 2016ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Telmisartan Tablets, USP, 80 mg, 30-count Presence of Foreign Substance: Product complaint for the presence of foreign matter identified as silicone within the tablet. Class IIIFDA’s classApr 27, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 27, 2016ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Dextroamphetamine Sulfate Tablets USP, 10 mg, 100-count bottle Failed Impurities/Degradation Specifications Class IIFDA’s classApr 27, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 27, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Dextroamphetamine Sulfate Tablets USP, 5 mg, 100-count bottle Failed Impurities/Degradation Specifications Class IIFDA’s classApr 27, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 27, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Dextrose Injection, USP, 70% Chemical Contamination: Potential for contamination of the products with an aromatic hydrocarbon resin. Class IIFDA’s classApr 27, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 27, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Dextrose Injection, USP, 50% Chemical Contamination: Potential for contamination of the products with an aromatic hydrocarbon resin. Class IIFDA’s classApr 27, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 27, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Dextrose Injection, USP, 20% Chemical Contamination: Potential for contamination of the products with an aromatic hydrocarbon resin. Class IIFDA’s classApr 27, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 27, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Aminosyn-PF (amino acids) 7%, Sulfite-Free, 500 mL Bags Chemical Contamination: Potential for contamination of the products with an aromatic hydrocarbon resin. Class IIFDA’s classApr 27, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 27, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Mannitol I.V., 20%, USP Chemical Contamination: Potential for contamination of the products with an aromatic hydrocarbon resin. Class IIFDA’s classApr 27, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 27, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Potassium Chloride Injection 20 mEq, 400 mEq/L Chemical Contamination: Potential for contamination of the products with an aromatic hydrocarbon resin. Class IIFDA’s classApr 27, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 27, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Zemplar (paricalcitol) capsules, 1 mcg, 30-count bottle Failed Content Uniformity Specifications Class IIIFDA’s classApr 27, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 27, 2016ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Simvastatin Tablets, USP 5 mg Subpotent Drug Class IIIFDA’s classApr 20, 2016in FDA’s Enforcement Report3 statesnamed in where it went PublishedApr 20, 2016ClassClass IIIStatusTerminatedWhereCalifornia, Ohio and Pennsylvania
- Medicine recall Haloperidol Decanoate Injection, 50 mg/mL, 1 mL vial Failed Impurities/Degradation Specifications: Firm is recalling product due to an impurity out-of-specification result. Class IIIFDA’s classApr 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 20, 2016ClassClass IIIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Cisatracurium Besylate Injection, 20 mg per 10 mL Incorrect/ Undeclared Excipient: Firm is recalling product due to an incorrect statement of Preservative free on the individual carton label. Class IIFDA’s classApr 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 20, 2016ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Fenofibrate Capsules (Micronized) 134 mg, 500-count bottle Labeling: Incorrect or Missing Lot and/or Exp. Class IIIFDA’s classApr 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 20, 2016ClassClass IIIStatusTerminatedWhereNationwide
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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