Medicines, 2015
Shortlist up to four to read them side by side.
2,020 medicine recalls FDA’s Enforcement Report published in 2015, 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.
2,020of 2,020 medicine recallsshown with your filters
The list
- Medicine recall Fenofibric Acid Tablets, 35 mg, 30-count bottles, labeled as a) FIBRICOR (fenofibric acid) Tablets Chemical Contamination: The product may contain trace amounts of benzophenone, a component of the label varnish that may leach through the bottle and into the… Class IIIFDA’s classOct 21, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 21, 2015ClassClass IIIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Fenofibric Acid Tablets 105 mg Chemical Contamination: The product may contain trace amounts of benzophenone, a component of the label varnish that may leach through the bottle and into the… Class IIIFDA’s classOct 21, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 21, 2015ClassClass IIIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall WellPatch¿ Capsaicin Pain Relief Patch, 0.025% Natural Capsaicin, External Analgesic, 4 Large Patches Labeling: Incorrect Instructions; The word not is missing from the following sentences “do bandage tightly or cover with any type of wrap except clothing and… Class IIFDA’s classOct 21, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 21, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall QC Quality Choice Loratadine Orally Disintegrating Tablets, USP 10 mg, 10-count tablets per box Superpotent Drug: Out Of Specification (OOS) result for Assay. Class IIIFDA’s classOct 21, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 21, 2015ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Rite Aid Pharmacy loratadine orally disintegrating tablets USP, 10 mg Superpotent Drug: Out Of Specification (OOS) result for Assay. Class IIIFDA’s classOct 21, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 21, 2015ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Health Best Choice Care, Loratadine Orally Disintegrating Tablets, USP, 10 mg, 10-count tablets per box,… Superpotent Drug: Out Of Specification (OOS) result for Assay. Class IIIFDA’s classOct 21, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 21, 2015ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall CareOne Original Prescription Strength, Allergy Relief, Loratadine Orally Disintegrating Tablets, USP, 10 mg Superpotent Drug: Out Of Specification (OOS) result for Assay. Class IIIFDA’s classOct 21, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 21, 2015ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall CVS Pharmacy, Original Prescription Strength, LORATADINE ORALLY DISINTEGRATING TABLETS, USP, 10 mg Superpotent Drug: Out Of Specification (OOS) result for Assay. Class IIIFDA’s classOct 21, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 21, 2015ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Discount Drug Mart Food Fair, Original Prescription Strength, Loratadine Orally Disintegrating Tablets, USP,… Superpotent Drug: Out Of Specification (OOS) result for Assay. Class IIIFDA’s classOct 21, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 21, 2015ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Equaline Original Prescription Strength, loratadine orally disintegrating tablets, USP, 10 mg Superpotent Drug: Out Of Specification (OOS) result for Assay. Class IIIFDA’s classOct 21, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 21, 2015ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Fred’s Loratadine Orally Disintegrating Tablets, USP, 10 mg, 30-counts tablets per box Superpotent Drug: Out Of Specification (OOS) result for Assay. Class IIIFDA’s classOct 21, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 21, 2015ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Good Neighbor Pharmacy Loratadine Orally Disintegrating Tablets, USP, 10 mg Superpotent Drug: Out Of Specification (OOS) result for Assay. Class IIIFDA’s classOct 21, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 21, 2015ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Health Mart Pharmacy loratadine orally disintegrating tablets, USP, 10 mg, 10-count tablets per box Superpotent Drug: Out Of Specification (OOS) result for Assay. Class IIIFDA’s classOct 21, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 21, 2015ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall HEB Loratadine Orally Disintegrating Tablets, USP, 10 mg, 10-count tablets per box, Made with pride & care… Superpotent Drug: Out Of Specification (OOS) result for Assay. Class IIIFDA’s classOct 21, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 21, 2015ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Leader Loratadine Orally Disintegrating Tablets, USP, 10 mg, 30-count tablets per box Superpotent Drug: Out Of Specification (OOS) result for Assay. Class IIIFDA’s classOct 21, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 21, 2015ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Major loratadine orally disintegrating tablets, USP, 10 mg, 10-count tablets per box Superpotent Drug: Out Of Specification (OOS) result for Assay. Class IIIFDA’s classOct 21, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 21, 2015ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Ohm Loratadine Orally Disintegrating Tablets, USP, 10 mg, 30-count tablets Superpotent Drug: Out Of Specification (OOS) result for Assay. Class IIIFDA’s classOct 21, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 21, 2015ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Premier Value Loratadine Orally Disintegrating Tablets, USP, 10 mg, 30-count tablets per box Superpotent Drug: Out Of Specification (OOS) result for Assay. Class IIIFDA’s classOct 21, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 21, 2015ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Safeway Care Loratadine Orally Disintegrating Tablets, USP, 10 mg Superpotent Drug: Out Of Specification (OOS) result for Assay. Class IIIFDA’s classOct 21, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 21, 2015ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall TopCare LORATIDINE ORALLY DISINTEGRATING TABLETS, , USP, 10 mg Superpotent Drug: Out Of Specification (OOS) result for Assay. Class IIIFDA’s classOct 21, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 21, 2015ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Up&Up loratadine orally disintegrating tablets, USP, 10 mg, 30-count tablets per box Superpotent Drug: Out Of Specification (OOS) result for Assay. Class IIIFDA’s classOct 21, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 21, 2015ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Sunmark loratadine Orally Disintegrating Tablets, USP, 10 mg Superpotent Drug: Out Of Specification (OOS) result for Assay. Class IIIFDA’s classOct 21, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 21, 2015ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Wal-itin Loratadine Orally Disintegrating Tablets, USP, 10 mg Superpotent Drug: Out Of Specification (OOS) result for Assay. Class IIIFDA’s classOct 21, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 21, 2015ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Meijer Loratadine Orally Disintegrating Tablets, USP, 10 mg, 30-count tablets per box, Dist Superpotent Drug: Out Of Specification (OOS) result for Assay. Class IIIFDA’s classOct 21, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 21, 2015ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Methylcobalamin (preservative Free) 1 mg/mL Injection, Bedford Pharmacy, 209 Route 101, Bedford, NH 03110 Lack of assurance of sterility Class IIFDA’s classOct 21, 2015in FDA’s Enforcement Report2 statesnamed in where it went PublishedOct 21, 2015ClassClass IIStatusTerminatedWhereMassachusetts and New Hampshire
- Medicine recall P-P-P (COBAL) 30-1-20/mL, Injection, Bedford Pharmacy, 209 Route 101, Bedford, NH 03110 Lack of assurance of sterility Class IIFDA’s classOct 21, 2015in FDA’s Enforcement Report2 statesnamed in where it went PublishedOct 21, 2015ClassClass IIStatusTerminatedWhereMassachusetts and New Hampshire
- Medicine recall P-P (COBAL) 30-2 /mL, Injection, Bedford Pharmacy, 209 Route 101, Bedford, NH 03110 Lack of assurance of sterility Class IIFDA’s classOct 21, 2015in FDA’s Enforcement Report2 statesnamed in where it went PublishedOct 21, 2015ClassClass IIStatusTerminatedWhereMassachusetts and New Hampshire
- Medicine recall Methylcobalamin (Bacteriostatic) 1 mg/mL Injection, Bedford Pharmacy, 209 Route 101, Bedford, NH 03110 Lack of assurance of sterility Class IIFDA’s classOct 21, 2015in FDA’s Enforcement Report2 statesnamed in where it went PublishedOct 21, 2015ClassClass IIStatusTerminatedWhereMassachusetts and New Hampshire
- Medicine recall Hydroxocobalamin 20 mg/mL Injection, Bedford Pharmacy, 209 Route 101, Bedford, NH 03110 Lack of assurance of sterility Class IIFDA’s classOct 21, 2015in FDA’s Enforcement Report2 statesnamed in where it went PublishedOct 21, 2015ClassClass IIStatusTerminatedWhereMassachusetts and New Hampshire
- Medicine recall Acetylcysteine 10% Opthalmic Solution, Bedford Pharmacy, 209 Route 101, Bedford, NH 03110 Lack of assurance of sterility Class IIFDA’s classOct 21, 2015in FDA’s Enforcement Report2 statesnamed in where it went PublishedOct 21, 2015ClassClass IIStatusTerminatedWhereMassachusetts and New Hampshire
- Medicine recall Testosterone Cypionate (Complete Formula) 100 mg/mL, Injection, Bedford Pharmacy, 209 Route 101, Bedford, NH… Lack of assurance of sterility Class IIFDA’s classOct 21, 2015in FDA’s Enforcement Report2 statesnamed in where it went PublishedOct 21, 2015ClassClass IIStatusTerminatedWhereMassachusetts and New Hampshire
- Medicine recall Testosterone Cypionate (Complete Formula) 200 mg/mL, Injection, Bedford Pharmacy, 209 Route 101, Bedford, NH… Lack of assurance of sterility Class IIFDA’s classOct 21, 2015in FDA’s Enforcement Report2 statesnamed in where it went PublishedOct 21, 2015ClassClass IIStatusTerminatedWhereMassachusetts and New Hampshire
- Medicine recall P-P-P (COBAL) 30-1-5/mL, Injection,Bedford Pharmacy, 209 Route 101, Bedford, NH 03110 Lack of assurance of sterility Class IIFDA’s classOct 21, 2015in FDA’s Enforcement Report2 statesnamed in where it went PublishedOct 21, 2015ClassClass IIStatusTerminatedWhereMassachusetts and New Hampshire
- Medicine recall P-P-P (COBAL) 30-4-40/mL, Injection, Bedford Pharmacy, 209 Route 101, Bedford, NH 03110 Lack of assurance of sterility Class IIFDA’s classOct 21, 2015in FDA’s Enforcement Report2 statesnamed in where it went PublishedOct 21, 2015ClassClass IIStatusTerminatedWhereMassachusetts and New Hampshire
- Medicine recall P-P-P (COBAL) 30-2- 30/mL, Injection, Bedford Pharmacy, 209 Route 101, Bedford, NH 03110 Lack of assurance of sterility Class IIFDA’s classOct 21, 2015in FDA’s Enforcement Report2 statesnamed in where it went PublishedOct 21, 2015ClassClass IIStatusTerminatedWhereMassachusetts and New Hampshire
- Medicine recall P-P (COBAL)30-0.5/mL, Injection, Bedford Pharmacy, 209 Route 101, Bedford, NH 03110 Lack of assurance of sterility Class IIFDA’s classOct 21, 2015in FDA’s Enforcement Report2 statesnamed in where it went PublishedOct 21, 2015ClassClass IIStatusTerminatedWhereMassachusetts and New Hampshire
- Medicine recall P-P (COBAL) 300-30/mL, Injection, Bedford Pharmacy, 209 Route 101, Bedford, NH 03110 Lack of assurance of sterility Class IIFDA’s classOct 21, 2015in FDA’s Enforcement Report2 statesnamed in where it went PublishedOct 21, 2015ClassClass IIStatusTerminatedWhereMassachusetts and New Hampshire
- Medicine recall Sermorelin 6mg/6mL Lyophilized Powder, Sterile Compound for Subcutaneous Injection, Diabetes Corporation of… Lack of Assurance of Sterility: A recent FDA inspection found that this product was not being compounded in an area appropriate for lyophilization which may… Class IIFDA’s classOct 14, 2015in FDA’s Enforcement Report3 statesnamed in where it went PublishedOct 14, 2015ClassClass IIStatusTerminatedWhereKentucky, Ohio and Tennessee
- Medicine recall Vytorin (ezetimibe and simvastatin) tablets, 10 mg/20 mg, each tablet contains 10 mg ezetimibe and 20 mg… Presence of Foreign Tablet/Capsule: Vytorin 10 mg/40 mg tablets were found in bottles of Vytorin 10 mg/20 mg tablets. Class IIFDA’s classOct 14, 2015in FDA’s Enforcement Report3 statesnamed in where it went PublishedOct 14, 2015ClassClass IIStatusTerminatedWhereKentucky, Mississippi and Ohio
- Medicine recall Daytrana (methylphenidate transdermal system), 30 mg over 9 Hour Patches Defective Delivery System: Out of specification for z-statistic related to mechanical peel force. Class IIFDA’s classOct 14, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 14, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Rodan & Fields Proactiv Solution, Sheer Finish Compact Foundation, salicylic acid acne treatment, FAIR, 7… Subpotent Drug: Salicylic acid is subpotent. Class IIIFDA’s classOct 7, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedOct 7, 2015ClassClass IIIStatusTerminatedWhereNationwide, and Guam and Puerto Rico named
- Medicine recall Rodan & Fields Proactiv Solution, Sheer Finish Compact Foundation, salicylic acid acne treatment, LIGHT, 7… Subpotent Drug: Salicylic acid is subpotent. Class IIIFDA’s classOct 7, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedOct 7, 2015ClassClass IIIStatusTerminatedWhereNationwide, and Guam and Puerto Rico named
- Medicine recall Rodan & Fields Proactiv Solution, Sheer Finish Compact Foundation, salicylic acid acne treatment, MEDIUM, 7… Subpotent Drug: Salicylic acid is subpotent. Class IIIFDA’s classOct 7, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedOct 7, 2015ClassClass IIIStatusTerminatedWhereNationwide, and Guam and Puerto Rico named
- Medicine recall Rodan & Fields Proactiv Solution, Sheer Finish Compact Foundation, salicylic acid acne treatment, TAN, 7… Subpotent Drug: Salicylic acid is subpotent. Class IIIFDA’s classOct 7, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedOct 7, 2015ClassClass IIIStatusTerminatedWhereNationwide, and Guam and Puerto Rico named
- Medicine recall Rodan & Fields Proactiv Solution, Sheer Finish Compact Foundation, salicylic acid acne treatment, DARK, 7… Subpotent Drug: Salicylic acid is subpotent. Class IIIFDA’s classOct 7, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedOct 7, 2015ClassClass IIIStatusTerminatedWhereNationwide, and Guam and Puerto Rico named
- Medicine recall Prolotherapy with Phenol (Dextrose 25%, Glycerin 10%, Lidocaine HCl 10%, Bupivacaine HCl 0.625%, Phenol 1%,… Non-Sterility: Hartley Medical Center Pharmacy, Inc. FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 7, 2015in FDA’s Enforcement Report2 statesnamed in where it went PublishedOct 7, 2015ClassClass IStatusTerminatedWhereCalifornia and Nevada
- Medicine recall Prolotherapy with Phenol (Dextrose 25%, Glycerin 25%, Phenol 2.5%, QS SWI), 100 mL vial Non-Sterility: Hartley Medical Center Pharmacy, Inc. FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 7, 2015in FDA’s Enforcement Report2 statesnamed in where it went PublishedOct 7, 2015ClassClass IStatusTerminatedWhereCalifornia and Nevada
- Medicine recall METOCLOPRAMIDE ORAL SOLUTION, USP 10 mg/10 mL, 10 mL cups Defective Container: Lids on unit dose cups are not fully qualified. Class IIIFDA’s classOct 7, 2015in FDA’s Enforcement Report6 statesnamed in where it went PublishedOct 7, 2015ClassClass IIIStatusTerminatedWhereCalifornia, Illinois, Louisiana, Ohio, Pennsylvania and South Carolina
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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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