Medicines, 2017
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1,073 medicine recalls FDA’s Enforcement Report published in 2017, 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.
1,073of 1,073 medicine recallsshown with your filters
The list
- Medicine recall ENHANCED RETIN ANTI-WRINKLE CREAM, ENHANCED RETIN ANTI-WRINKLE CREAM 0.1%, ENHANCED RETIN 0.025% and 0.05% Lack of Assurance of Sterility: There are also CGMP Deviations. Class IIFDA’s classMar 22, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 22, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall HCG in all strength including: 2,400, 9600,12,000 UNIT POWDER VIAL DROPS, HCG 11,000/B-12 UNITS SOLUTION Lack of Assurance of Sterility: There are also CGMP Deviations. Class IIFDA’s classMar 22, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 22, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall HUMAN CHORIONIC GONADOTROPIN Lack of Assurance of Sterility: There are also CGMP Deviations. Class IIFDA’s classMar 22, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 22, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall HYDROQUINONE CREAM in all strengths including: 4%, 5%, 6%, 7%, 8%,10% Lack of Assurance of Sterility: There are also CGMP Deviations. Class IIFDA’s classMar 22, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 22, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall HYDROQUINONE 28% SOLUTION Lack of Assurance of Sterility: There are also CGMP Deviations. Class IIFDA’s classMar 22, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 22, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall TRETINOIN CREAM in all strengths including: 0.1%, 0.05%, TRETINOIN GEL in all strengths including 0.1% and… Lack of Assurance of Sterility: There are also CGMP Deviations. Class IIFDA’s classMar 22, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 22, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall TRETINOIN 0.02% IN OIL FREE CREAM Lack of Assurance of Sterility: There are also CGMP Deviations. Class IIFDA’s classMar 22, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 22, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall MELATONIN 1.5MG SPRAY Lack of Assurance of Sterility: There are also CGMP Deviations. Class IIFDA’s classMar 22, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 22, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall PURIFIED WATER Lack of Assurance of Sterility: There are also CGMP Deviations. Class IIFDA’s classMar 22, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 22, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall RETIN-A 0.05% CREAM Lack of Assurance of Sterility: There are also CGMP Deviations. Class IIFDA’s classMar 22, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 22, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall LIDOCAINE CREAM in all strengths including: 5%, 8%, 23%, 30%, LIDOCAINE / PRILOCAINE / MELYLEPHRINE 15% / 5%… Lack of Assurance of Sterility: There are also CGMP Deviations. Class IIFDA’s classMar 22, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 22, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall AZELAIC ACID 15% CREAM Lack of Assurance of Sterility: There are also CGMP Deviations. Class IIFDA’s classMar 22, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 22, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall METRONIDAZOLE 1% GEL, METRONIDAZOLE 1%/ NIACINAMIDE 4%/ AZELAIC CREAM 10% CREAM Lack of Assurance of Sterility: There are also CGMP Deviations. Class IIFDA’s classMar 22, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 22, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall HYDROCORTISONE 2.5% WITH ALOE VERA CREAM Lack of Assurance of Sterility: There are also CGMP Deviations. Class IIFDA’s classMar 22, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 22, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall SULFACETAMIDE 10%/HYDROCORTISONE 1% CREAM Lack of Assurance of Sterility: There are also CGMP Deviations. Class IIFDA’s classMar 22, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 22, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall SULFUR 5% CREAM Lack of Assurance of Sterility: There are also CGMP Deviations. Class IIFDA’s classMar 22, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 22, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall CUSTOM LIGHTENING/BRIGHTENING CREAM Lack of Assurance of Sterility: There are also CGMP Deviations. Class IIFDA’s classMar 22, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 22, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall GENTLE SUPREME BLEACHING CREAM Lack of Assurance of Sterility: There are also CGMP Deviations. Class IIFDA’s classMar 22, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 22, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall INTIMATE BLEACHING CREAM Lack of Assurance of Sterility: There are also CGMP Deviations. Class IIFDA’s classMar 22, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 22, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall KOJIC ACID 8%/AZELAIC ACID 15% CREAM Lack of Assurance of Sterility: There are also CGMP Deviations. Class IIFDA’s classMar 22, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 22, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Buffered Lidocaine, 1%, In Sodium Bicarbonate 8.4%, 1 mL Total Volume in a 3 mL syringe, Local anesthetic use Labeling; Label Mixup; outer packaging is incorrectly labeled as Buffered Lidocaine 1% instead of correctly as Buffered Lidocaine 0.9% Class IIIFDA’s classMar 22, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 22, 2017ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Mirtazapine Tablets, USP 45 mg, a) 30 count, b) 100 count and c) 500 count bottles Presence of Foreign Tablets/Capsules; possibility of Glipizide 10 mg tablet in bottle Class IIFDA’s classMar 15, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 15, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Mirtazapine Tablets, USP, 45 mg Presence of Foreign Tablets/Capsules; possibility of Glipizide 10 mg tablets commingled Class IIFDA’s classMar 15, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 15, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Calcipotriene Cream 0.0005% Incorrect/Undeclared excipients: inadvertent omission of a drug excipient from the the Authorized Generic label and also a warning regarding contact dermatitis… Class IIFDA’s classMar 15, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 15, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Risedronate Sodium Delayed-release Tablets, 35 mg, Once-a-Week, 1 tablet per blister (NDC 0093-5509-19) Failed Dissolution Specifications: low out of specification dissolution results found during stability testing. Class IIIFDA’s classMar 15, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 15, 2017ClassClass IIIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Edex (alprostadil for injection) 10mcg Lack of Assurance of Sterility: Defective container resulting in the lack of sterility assurance. Class IIFDA’s classMar 15, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 15, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Aspirin Chewable Tablets, 81 mg, (NSAID*) Presence of Foreign Substance: foreign material found in the bulk inventory. Class IIFDA’s classMar 15, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 15, 2017ClassClass IIStatusCompletedWhereNationwide
- Medicine recall Levofloxacin Ophthalmic Solution, 0.5%, Sterile Failed Impurities/ Degradation Specifications: OOS for related compound (levofloxacin n-oxide) at the 18 month stability time point. Class IIIFDA’s classMar 15, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 15, 2017ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Pioglitazone and Glimepiride Tablets, USP, 30 mg/4 mg, 30 count bottles Failed Dissolution Specifications Class IIFDA’s classMar 15, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 15, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall CycloSPORINE Capsules, USP, 100 mg, 30 count Failed Impurities/Degradations Specifications; out of specification results for Maximum Unknown Impurities and Total Impurities Class IIFDA’s classMar 8, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 8, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall glipiZIDE Extended-Release Tablets, 5 mg, 1000 count bottles Presence of Foreign Tablets/Capsules; bottles of Glipizide 5 mg tablets may contain Glipizide 10 mg tablets Class IIFDA’s classMar 8, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 8, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Domperidone capsules 10 mg, compounded, dispensed Marketed without an approved NDA/ANDA for which safety and efficacy has not been established. FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 8, 2017in FDA’s Enforcement ReportPennsylvaniathe one state its words name PublishedMar 8, 2017ClassClass IStatusTerminatedWherePennsylvania
- Medicine recall Duopa (carbidopa and levodopa enteral suspension), 4.63 mg/20 mg per mL, 100 mL cassette, 7 cassettes per… Failed Stability Specifications: confirmed out of specification results obtained during refrigerated material stability testing indicating that drug may settle… Class IIFDA’s classMar 8, 2017in FDA’s Enforcement Report2 statesnamed in where it went PublishedMar 8, 2017ClassClass IIStatusTerminatedWhereIllinois and Tennessee
- Medicine recall EYE WASH, 4 fl oz. Non-Sterility: Direct evidence of contamination for 2 lots based on FDA samples. FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 8, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 8, 2017ClassClass IStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Eye Irrigating Solution, 4 fl oz Lack of assurance of sterility Class IIFDA’s classMar 8, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 8, 2017ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Eye Wash, 4 fl oz Lack of assurance of sterility Class IIFDA’s classMar 8, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 8, 2017ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall EYE WASH, 4 fl oz. Lack of assurance of sterility Class IIFDA’s classMar 8, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 8, 2017ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall HealthA2Z CHEWABLE Aspirin (NSAID) 81 mg, Orange Flavor, 36 Chewable Tablets, a) cGMP deviations - presence of rubber particles found loose in the bulk product. Class IIFDA’s classMar 8, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 8, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Indocin (Indomethacin) suppositories, USP, 50 mg, laminate strips Failed Impurities/Degradation Specifications: Out of specification (OOS) for total impurity and out of trend for known impurity results encountered during… Class IIFDA’s classMar 8, 2017in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMar 8, 2017ClassClass IIStatusTerminatedWhereNo state named
- Medicine recall Alfuzosin Hydrochloride Extended-release Tablets, 10 mg, 100-count bottles Presence of Foreign Substance: consumer complaint for foreign matter embedded in the tablet identified as a broken piece of wire rope from the manufacturing… Class IIFDA’s classMar 8, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 8, 2017ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Salicylic Acid Shampoo, 6%, 177 mL bottle Failed Impurities/Degradation Specifications: The API for these products had an out of specification result for an organic impurity. Class IIIFDA’s classMar 8, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 8, 2017ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Salicylic Acid Cream, 6%, 400g bottle Failed Impurities/Degradation Specifications: The API for these products had an out of specification result for an organic impurity. Class IIIFDA’s classMar 8, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 8, 2017ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Nano PNC Water Marketed without an Approved NDA/ANDA and non-sterility: NANO PNC Water by nebulizer was sampled and found to contain variovorax paradoxus. FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 8, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 8, 2017ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Zenatane (isotretinoin) capsules, 40 mg Failed dissolution specifications - low dissolution results at S3 stage. Class IIIFDA’s classMar 8, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 8, 2017ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Zenatane (isotretinoin) capsules, 20 mg Failed dissolution specifications - low dissolution results at S3 stage. Class IIIFDA’s classMar 8, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 8, 2017ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Zenatane (isotretinoin) capsules, 30 mg Failed dissolution specifications - low dissolution results at S3 stage. Class IIIFDA’s classMar 8, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 8, 2017ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Zenatane (isotretinoin) capsules, 10 mg Failed dissolution specifications - low dissolution results at S3 stage. Class IIIFDA’s classMar 8, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 8, 2017ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall CycloSPORINE Capsules, USP, 100 mg, 30 count bottle Failed Impurities/Degradations Specifications; out of specification results for Maximum Unknown Impurities and Total Impurities. Class IIFDA’s classMar 1, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 1, 2017ClassClass 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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