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 Levothroid (levothyroxine sodium tablets, USP), 150 mcg cGMP deviations; After quality review of stability failures in previous lots, there is insufficient data to determine that other lots are not affected. Class IIFDA’s classMay 29, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedMay 29, 2013ClassClass IIStatusTerminatedWhereNationwide, and Missouri and Puerto Rico named
- Medicine recall Levothroid (levothyroxine sodium tablets, USP), 175 mcg cGMP deviations; After quality review of stability failures in previous lots, there is insufficient data to determine that other lots are not affected. Class IIFDA’s classMay 29, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedMay 29, 2013ClassClass IIStatusTerminatedWhereNationwide, and Missouri and Puerto Rico named
- Medicine recall Levothroid (levothyroxine sodium tablets, USP), 200 mcg cGMP deviations; After quality review of stability failures in previous lots, there is insufficient data to determine that other lots are not affected. Class IIFDA’s classMay 29, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedMay 29, 2013ClassClass IIStatusTerminatedWhereNationwide, and Missouri and Puerto Rico named
- Medicine recall Budesonide Capsules, 3 mg, Enteric Coated Failed Dissolution Specifications: Routine stability testing at the 12-month interval yielded an out-of-specification (OOS) result for dissolution testing. Class IIIFDA’s classMay 29, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 29, 2013ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Walmart Amlodipine Besylate Tablets, USP 10 mg Labeling: Label Error on Declared Strength-The recalled product has a misprint on the Amoldipine 10 mg label, 5 mg is listed in the USP description. Class IIFDA’s classMay 22, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 22, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Methylprednisolone Preservative Free 40 mg/ml Injectible Suspension, 1 mL Vials and 2 mL Vials and 1 mL… Non-Sterility: Green Valley Drugs received positive sterility results from their testing lab on two lots of Methylprednisolone Preservative Free 40 mg/mL… FDA Class I, its most serious class Class IFDA’s class (needs attention)May 22, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 22, 2013ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Cyanocobalamin 1000 mcg/ml, injection 30 mL, MDV, For Office Use Only, Green Valley Drugs Non-Sterility: Green Valley Drugs received positive sterility results from their testing lab on two lots of Methylprednisolone Preservative Free 40 mg/mL… FDA Class I, its most serious class Class IFDA’s class (needs attention)May 22, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 22, 2013ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Super Power capsules, Proprietary Blend 570 mg Marketed Without An Approved NDA/ANDA: This dietary supplement has been found to contain sildenafil, an FDA approved drug for the treatment of male erectile… FDA Class I, its most serious class Class IFDA’s class (needs attention)May 22, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 22, 2013ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Vistide (cidofovir) Injection, 375 mg Presence of Particulate Matter: Particulate matter was found in some vials of Vistide (cidofovir injection). FDA Class I, its most serious class Class IFDA’s class (needs attention)May 22, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 22, 2013ClassClass IStatusTerminatedWhereNationwide
- Medicine recall ROCK-IT MAN capsules, male sexual stimulant Marketed Without An Approved NDA/ANDA: FDA analysis found the product to contain hydroxythiohomosildenafil, an analogue of sildenafil which is an ingredient in… FDA Class I, its most serious class Class IFDA’s class (needs attention)May 22, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 22, 2013ClassClass IStatusTerminatedWhereNationwide
- Medicine recall a) Firminite 805 mg is Marketed Without an Approved NDA/ANDA: These products found to contain undeclared tadalafil. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 22, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedMay 22, 2013ClassClass IStatusTerminatedWhereNationwide, and Puerto Rico and US Virgin Islands named
- Medicine recall Mojo Nights, 1 capsule Marketed Without an Approved NDA/ANDA: The products were found to contain FDA approved ingredients and analogues of FDA approved ingredients used to treat male… FDA Class I, its most serious class Class IFDA’s class (needs attention)May 22, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 22, 2013ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Mojo Nights for Her, 1 capsule Marketed Without an Approved NDA/ANDA: The products were found to contain FDA approved ingredients and analogues of FDA approved ingredients used to treat male… FDA Class I, its most serious class Class IFDA’s class (needs attention)May 22, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 22, 2013ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Glenmark Gabapentin Tablets, a) 600mg, 500- count bottle (NDC 68462-126-05), b) 800 mg, 500- count bottle… Chemical Contamination: Gabapentin Sodium tablets is recalled due to complaints related to an off - odor described as moldy, musty or fishy in nature. Class IIIFDA’s classMay 22, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 22, 2013ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Glenmark Pravastatin Sodium Tablets ,40 mg, 90-count bottle (NDC 68462-197-90) Chemical Contamination: Pravastatin Sodium Tablets isbeing recalled due to complaints related to an off-odor described as moldy, musty or fishy in nature. Class IIIFDA’s classMay 22, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 22, 2013ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Glenmark Topiramate Tablets, 200 mg, 60-count bottle, (NDC 68462-110-60) Chemical Contamination: Topiramate Tablets is being recalled due to complaints related to an off - odor. Class IIIFDA’s classMay 22, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 22, 2013ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall libigrow capsules, PERFORMANCE ENHANCER, supplied Marketed Without an Approved NDA/ANDA: product may contain undeclared sildenafil, tadalafil and analogues of these FDA approved active ingredients, making them… FDA Class I, its most serious class Class IFDA’s class (needs attention)May 22, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 22, 2013ClassClass IStatusTerminatedWhereNationwide
- Medicine recall libigrow XXXTREME Capsules, MAXIMUM STRENGTH FORMULA, 1000 mg, supplied Marketed Without an Approved NDA/ANDA: product may contain undeclared sildenafil, tadalafil and analogues of these FDA approved active ingredients, making them… FDA Class I, its most serious class Class IFDA’s class (needs attention)May 22, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 22, 2013ClassClass IStatusTerminatedWhereNationwide
- Medicine recall BLUE Diamond Pill, supplied Marketed Without an Approved NDA/ANDA: product may contain undeclared sildenafil, tadalafil and analogues of these FDA approved active ingredients, making them… FDA Class I, its most serious class Class IFDA’s class (needs attention)May 22, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 22, 2013ClassClass IStatusTerminatedWhereNationwide
- Medicine recall BLUE Diamond PLATINUM Capsules, 1000 mg, supplied Marketed Without an Approved NDA/ANDA: product may contain undeclared sildenafil, tadalafil and analogues of these FDA approved active ingredients, making them… FDA Class I, its most serious class Class IFDA’s class (needs attention)May 22, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 22, 2013ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Mojo nights Capsules, Male Sexual Enhancer, supplied Marketed Without an Approved NDA/ANDA: product may contain undeclared sildenafil, tadalafil and analogues of these FDA approved active ingredients, making them… FDA Class I, its most serious class Class IFDA’s class (needs attention)May 22, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 22, 2013ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Mojo nights SUPREME Capsules, 1000 mg, Male Sexual Enhancer, supplied Marketed Without an Approved NDA/ANDA: product may contain undeclared sildenafil, tadalafil and analogues of these FDA approved active ingredients, making them… FDA Class I, its most serious class Class IFDA’s class (needs attention)May 22, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 22, 2013ClassClass IStatusTerminatedWhereNationwide
- Medicine recall CASANOVA Capsules, 450 mg, MALE SEXUAL ENHANCER, supplied i n1 count blister packs Marketed Without an Approved NDA/ANDA: product may contain undeclared sildenafil, tadalafil and analogues of these FDA approved active ingredients, making them… FDA Class I, its most serious class Class IFDA’s class (needs attention)May 22, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 22, 2013ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Acetylcysteine Injection, all strengths and all presentations including 100 mg/mL Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance… Class IIFDA’s classMay 22, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 22, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Alpha Lipoic Acid Injection, all strengths and all presentations including 25 mg/mL, 30 mL Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance… Class IIFDA’s classMay 22, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 22, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Amikacin Injection, all strengths and all presentations including 50, 30 mL Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance… Class IIFDA’s classMay 22, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 22, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Ascorbic Acid Injection, all strengths and all presentations including a) 500 mg/mL, b) corn source 500… Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance… Class IIFDA’s classMay 22, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 22, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Betamethasone Acetate and Betamethasone Sodium Injection, all strengths and all presentations including 6… Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance… Class IIFDA’s classMay 22, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 22, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Bacteriostatic Water for Injection, all presentations including 30 mL Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance… Class IIFDA’s classMay 22, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 22, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall B-Complex Injection, all strengths and all presentations including a) B-Complex Injection 30 mL Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance… Class IIFDA’s classMay 22, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 22, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Betamethasone Combination Injection, all strengths and all presentations including a) Beta combo 6 mg/mL, 3… Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance… Class IIFDA’s classMay 22, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 22, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall BET-ACE-LIDO-6-2 Injection, all strengths and all presentations including 7 mL syringe and Betameth Combo 6… Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance… Class IIFDA’s classMay 22, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 22, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Betamethasone Sodium Phosphate Injection, all strengths and all presentations including 6 mg/2 mL PF and 6… Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance… Class IIFDA’s classMay 22, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 22, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Betamethasone Combination with Lidocaine 1% and Bupivacaine 0.5 % Injection, all strengths and all… Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance… Class IIFDA’s classMay 22, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 22, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Biotin Injection, all strengths and all presentations including Biotin-15-30 mL Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance… Class IIFDA’s classMay 22, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 22, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Bupivacaine and Dexamethasone Injection, all strengths and all presentations including… Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance… Class IIFDA’s classMay 22, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 22, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Bupivacaine Injection, all strengths and all presentations including a) Bupivacaine Parabens Free 0.5% 50 mL,… Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance… Class IIFDA’s classMay 22, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 22, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Buprenorphine Injection, all strengths and all presentations including Buprenorphine-0.3 30 mL Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance… Class IIFDA’s classMay 22, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 22, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Vitamin D3 Injection, all strengths and all presentations including a) Cholecalciferol D3 50,000iu 30 mL, b)… Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance… Class IIFDA’s classMay 22, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 22, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Cyanocobalamin Injection, all strengths and all presentations including a) Cyanocobalamin 1000mcg, b)… Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance… Class IIFDA’s classMay 22, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 22, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Cyclosporine Injection, all strengths and all presentations including Cyclosporine 2% Aqueous Solution 15 mL Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance… Class IIFDA’s classMay 22, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 22, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Dexamethasone Sodium Phosphate Injection, all strengths and all presentations including a) Dexamethasone… Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance… Class IIFDA’s classMay 22, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 22, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Dexpanthenol Injection, all strengths and all presentations including Dexpanthenol 250 mg/30 mL Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance… Class IIFDA’s classMay 22, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 22, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Dimercapto-propane-sulfonic acid (DMPS) Injection, all strengths and all presentations including a) DMPS 50… Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance… Class IIFDA’s classMay 22, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 22, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Dimethyl Sulfoxide (DMSO) Injection, all strengths and all presentations including DMSO 99% 50 mL Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance… Class IIFDA’s classMay 22, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 22, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Edetate Disodium Injection, all strengths and all presentations including a) Edetate Disodium 150/30 mL and… Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance… Class IIFDA’s classMay 22, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 22, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Edetate Calcium Disodium Injection, all strengths and all presentations including a) Edetate Calcium Disodium… Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance… Class IIFDA’s classMay 22, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 22, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall ED Mix Injections, all strengths and all presentations including a) ED mix TM -at 2, b) ED-Mix BI-Mix 10 30… Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance… Class IIFDA’s classMay 22, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 22, 2013ClassClass IIStatusTerminatedWhereNationwide
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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