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 5, 2026.
1,376of 1,376 medicine recallsshown with your filters
The list
- Medicine recall Sodium Bicarbonate Powder, CAS-144-55-8, Arm & Hammer, labeled as a) USP2 Grade Presence of Foreign Substance: raw material recalled due to stainless steel and other contamination. Class IIFDA’s classJul 24, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 24, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Sodium Bicarbonate Powder, CAS-144-55-8, Arm & Hammer, labeled as a) USP3 Grade Presence of Foreign Substance: raw material recalled due to stainless steel and other contamination. Class IIFDA’s classJul 24, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 24, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Sodium Bicarbonate Powder, CAS-144-55-8, Arm & Hammer, Sodium Bicarbonate U.S.P Presence of Foreign Substance: raw material recalled due to stainless steel and other contamination. Class IIFDA’s classJul 24, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 24, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Sodium Bicarbonate Powder, CAS-144-55-8, Arm & Hammer, labeled as a) USP5 Grade Presence of Foreign Substance: raw material recalled due to stainless steel and other contamination. Class IIFDA’s classJul 24, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 24, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall QUETIAPINE Fumarate Tablets 25mg 100 Tablets Failed Dissolution Test Requirements: During analysis of long term stability studies at 3 months time point, an OOS was reported for Quetiapine Fumarate… Class IIFDA’s classJul 24, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 24, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Amoxicillin for Oral Suspension, USP 200 mg/5 mL, a) 75 mL bottle Discoloration: This recall is being carried out due to an orange to brown discolored Amoxicillin powder on the inner foil seal of the bottles. Class IIIFDA’s classJul 24, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 24, 2013ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Oxytocin Injection, USP, (Synthetic), 10 USP Units/mL, for IV Infusion or IM Use Subpotent Drug; 15-month stability test station Class IIFDA’s classJul 24, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 24, 2013ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Estarylla (Norgestimate and Ethinyl Estradiol) Tablets Contraceptive Tablets out of Sequence: A placebo tablet was found in a row of active tablets. Class IIFDA’s classJul 24, 2013in FDA’s Enforcement ReportIndianathe one state its words name PublishedJul 24, 2013ClassClass IIStatusTerminatedWhereIndiana
- Medicine recall Piperacillin and Tazobactam for Injection, USP, 40.5 grams per Pharmacy Bulk Package vial Crystallization: Potential to exhibit precipitation/crystallization in IV bag or IV line upon reconstitution. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 24, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 24, 2013ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Medroxyprogesterone acetate, micronized (EP, USP) active pharmaceutical ingredient Failed Stability Specifications: Out of specification results for particle size were obtained at the 60 month test point. Class IIIFDA’s classJul 24, 2013in FDA’s Enforcement Report2 statesnamed in where it went PublishedJul 24, 2013ClassClass IIIStatusTerminatedWhereCalifornia and New York
- Medicine recall Lessina(R) (Levonorgestrel and ethinyl estradiol tablets, USP) 0.1 mg/0.02 mg, 28 day regimen Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) was detected during impurity testing Class IIIFDA’s classJul 17, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 17, 2013ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Junel(TM) Fe 1.5/30 (norethindrone acetate and ethinyl estradiol tablets, USP and ferrous fumarate tablets),… Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) was detected during impurity testing Class IIIFDA’s classJul 17, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 17, 2013ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Jolessa(R) (levonorgestrel/ethinyl estradiol tablets, USP) 0.15 mg/0.03 mg, 91 day regimen Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) was detected during impurity testing Class IIIFDA’s classJul 17, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 17, 2013ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Balziva(TM) (norethindrone and ethinyl estradiol tablets, USP) 0.15 mg/0.03 mg, 28 day regimen Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) was detected during impurity testing Class IIIFDA’s classJul 17, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 17, 2013ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Benztropine Mesylate Injection, USP, 2 mg/2 mL Presence of particulate matter: characterized as thin colorless flakes that are visually and chemically consistent with glass delamination observed in reserve… Class IIFDA’s classJul 17, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 17, 2013ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Gentamicin Sulfate Injection USP 80 mg/2 mL(40 mg/mL as Gentamicin), 2 mL Single-dose Fliptop Vial, (NDC… Presence of Particulate Matter: visible particles were identified floating in the primary container. Class IIFDA’s classJul 17, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 17, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Nimodipine Capsules 30 mg Crystallization; crystallized nimodipine Class IIFDA’s classJul 17, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 17, 2013ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Folic Acid Injection, USP, 5 mg/mL, For IM, IV or SC Use, 10 mL, Multiple Dose Vial Failed Impurities/Degradation Specification Class IIIFDA’s classJul 17, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 17, 2013ClassClass IIIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Errin (norethindrone tablets, USP), 0.35 mg, 6 blister cards per carton, 28 tablets each, 28 day regimen Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) was detected during impurity testing Class IIIFDA’s classJul 17, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 17, 2013ClassClass IIIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Camila (norethindrone tablets, USP), 0.35 mg, 6 blister cards per carton, 28 tablets each, 28 day regimen Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) was detected during impurity testing Class IIIFDA’s classJul 17, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 17, 2013ClassClass IIIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Nicardipine Hydrochloride Injection 25 mg/10 mL Failed Impurity/Degradation Specifications; out of specification value for impurity Nitrophenylpuridine Derivative (NPP-D) Class IIIFDA’s classJul 17, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 17, 2013ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Acetyl-D-Glucosamine w/Chondroitin 200 mg/ml, compounded by Olympia Pharmacy, Orlando, FL Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes Class IIFDA’s classJul 17, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 17, 2013ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medicine recall Acepromazine 25 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes Class IIFDA’s classJul 17, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 17, 2013ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medicine recall Adenosine-Mono-Phosphate Injection, 200 mg/ml, compounded by Olympia Pharmacy, Orlando, FL Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes Class IIFDA’s classJul 17, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 17, 2013ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medicine recall Alprostadil 2000 mcg/ml, compounded by Olympia Pharmacy, Orlando, FL Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes Class IIFDA’s classJul 17, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 17, 2013ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medicine recall Altrenogest 50 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes Class IIFDA’s classJul 17, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 17, 2013ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medicine recall Amikacin Sulfate 250 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes Class IIFDA’s classJul 17, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 17, 2013ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medicine recall Aminocaproic Acid 250 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes Class IIFDA’s classJul 17, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 17, 2013ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medicine recall Aminocaproic Acid 0.5mg/ml Injection,compounded by Olympia Pharmacy, Orlando, FL Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes Class IIFDA’s classJul 17, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 17, 2013ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medicine recall Aminophylline 2.5% Injection, compounded by Olympia Pharmacy, Orlando, FL Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes Class IIFDA’s classJul 17, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 17, 2013ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medicine recall Atipamezole 10 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes Class IIFDA’s classJul 17, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 17, 2013ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medicine recall Atropine Sulfate 50 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes Class IIFDA’s classJul 17, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 17, 2013ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medicine recall Beta Alanine 100 mg/ml / l-carnosine 100 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes Class IIFDA’s classJul 17, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 17, 2013ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medicine recall Betamethasone Sodium Phosphate 12 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes Class IIFDA’s classJul 17, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 17, 2013ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medicine recall Betamethasone Phosphate/Acetate 6 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes Class IIFDA’s classJul 17, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 17, 2013ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medicine recall Bi mix, compounded by Olympia Pharmacy, Orlando, FL Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes Class IIFDA’s classJul 17, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 17, 2013ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medicine recall BNP/Dexamethasone Eye Ointment, compounded by Olympia Pharmacy, Orlando, FL Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes Class IIFDA’s classJul 17, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 17, 2013ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medicine recall Buprenorphine 0.3 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes Class IIFDA’s classJul 17, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 17, 2013ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medicine recall Caco/Copper 6. 2 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes Class IIFDA’s classJul 17, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 17, 2013ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medicine recall Calcium Gluconate 23%, compounded by Olympia Pharmacy, Orlando, FL Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes Class IIFDA’s classJul 17, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 17, 2013ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medicine recall Cal-Phos 1000 Injection, compounded by Olympia Pharmacy, Orlando, FL Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes Class IIFDA’s classJul 17, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 17, 2013ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medicine recall Ceftiofur GM vial 50 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes Class IIFDA’s classJul 17, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 17, 2013ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medicine recall Chlorpromazine HCL 100 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes Class IIFDA’s classJul 17, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 17, 2013ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medicine recall Clenbuterol 0.03mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes Class IIFDA’s classJul 17, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 17, 2013ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medicine recall Cre-O-Pan Injection, compounded by Olympia Pharmacy, Orlando, FL Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes Class IIFDA’s classJul 17, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 17, 2013ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medicine recall Deslorelin 15 mg vial, compounded by Olympia Pharmacy, Orlando, FL Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes Class IIFDA’s classJul 17, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 17, 2013ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medicine recall Detomidine 10 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes Class IIFDA’s classJul 17, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 17, 2013ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medicine recall Detomidine w/Xylazine 100 mg/mg Injection, compounded by Olympia Pharmacy, Orlando, FL Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes Class IIFDA’s classJul 17, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 17, 2013ClassClass IIStatusOngoingWhereNationwide, 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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