DrugMar 22, 2017
Synergy Rx MINOXADIL all strength including 2%, 5% and MINOXIDIL / RETINOIC ACID 5% / 0.025 recall — FDA D-0528-2017
Lack of Assurance of Sterility: There are also CGMP Deviations.
Class IIFDA: TerminatedSynergy Rx
10,690drug recall records
953FDA Class I records
8firms with 5+ records
Aidapak Services, LLC537 records
Database records
Records — page 249
10,690 detailed records are currently available in this category.
DrugMar 22, 2017
Synergy Rx LIDOCAINE CREAM in all strengths including: 5%, 8%, 23%, 30%, LIDOCAINE / recall — FDA D-0593-2017
Lack of Assurance of Sterility: There are also CGMP Deviations.
Class IIFDA: TerminatedSynergy Rx
DrugMar 22, 2017
Synergy Rx SUPREME CREAM recall — FDA D-0572-2017
Lack of Assurance of Sterility: There are also CGMP Deviations.
Class IIFDA: TerminatedSynergy Rx
DrugMar 22, 2017
Synergy Rx RETINOIC ACID all strengths including 0.025%, 0.05% and 0.1% CREAM, RETINOIC ACID recall — FDA D-0541-2017
Lack of Assurance of Sterility: There are also CGMP Deviations.
Class IIFDA: TerminatedSynergy Rx
DrugMar 22, 2017
Synergy Rx ADAPALENE 0.1%, BENZOYL PEROXIDE 2.5% GEL, ADAPELENE 0.3%, BENZOYL PEROXIDE 2,5% recall — FDA D-0530-2017
Lack of Assurance of Sterility: There are also CGMP Deviations.
Class IIFDA: TerminatedSynergy Rx
DrugMar 22, 2017
Synergy Rx RETINOIC ACID SOLUTION in all strengths including 0.3%, 0.4%, 0.5%, 1%, RETINOIC recall — FDA D-0542-2017
Lack of Assurance of Sterility: There are also CGMP Deviations.
Class IIFDA: TerminatedSynergy Rx
DrugMar 22, 2017
Synergy Rx TCA PEEL SOLUTION in all strengths including: 5%, 10%, 15%, 18%, and 20%, TCA recall — FDA D-0573-2017
Lack of Assurance of Sterility: There are also CGMP Deviations.
Class IIFDA: TerminatedSynergy Rx
DrugMar 15, 2017
Teva Pharmaceuticals USA Risedronate Sodium Delayed-release Tablets, 35 mg, Once-a-Week, 1 recall — FDA D-0511-2017
Failed Dissolution Specifications: low out of specification dissolution results found during stability testing.
Class IIIFDA: TerminatedTeva Pharmaceuticals USA
DrugMar 15, 2017
Edex recall — FDA D-0512-2017
Lack of Assurance of Sterility: Defective container resulting in the lack of sterility assurance. ok thanks
Class IIFDA: TerminatedEndo Pharmaceuticals, Inc.
DrugMar 15, 2017
Mckesson Packaging Services Aspirin Chewable Tablets, 81 mg, (NSAID*) recall — FDA D-0513-2017
Presence of Foreign Substance: foreign material found in the bulk inventory.
Class IIFDA: CompletedMckesson Packaging Services
DrugMar 15, 2017
Calcipotriene Cream 0.0005% recall — FDA D-0510-2017
Incorrect/Undeclared excipients: inadvertent omission of a drug excipient from the the Authorized Generic label and also a warning regarding contact dermatitis from the brand product…
Class IIFDA: TerminatedLEO PHARMA Inc.
DrugMar 8, 2017
Zenatane (isotretinoin) capsules, 10 mg recall — FDA D-0509-2017
Failed dissolution specifications - low dissolution results at S3 stage.
Class IIIFDA: TerminatedDr. Reddy's Laboratories, Inc.
DrugMar 8, 2017
Dr. Reddy's Laboratories Zenatane (isotretinoin) capsules, 30 mg recall — FDA D-0508-2017
Failed dissolution specifications - low dissolution results at S3 stage.
Class IIIFDA: TerminatedDr. Reddy's Laboratories, Inc.
DrugMar 8, 2017
L. Perrigo Company Salicylic Acid Cream, 6%, 400g bottle recall — FDA D-0504-2017
Failed Impurities/Degradation Specifications: The API for these products had an out of specification result for an organic impurity.
Class IIIFDA: TerminatedL. Perrigo Company
DrugMar 8, 2017
Duopa recall — FDA D-0495-2017
Failed Stability Specifications: confirmed out of specification results obtained during refrigerated material stability testing indicating that drug may settle within drug cassettes nearing…
Class IIFDA: TerminatedAbbVie Inc.
DrugMar 8, 2017
L. Perrigo Company Salicylic Acid Shampoo, 6%, 177 mL bottle recall — FDA D-0503-2017
Failed Impurities/Degradation Specifications: The API for these products had an out of specification result for an organic impurity.
Class IIIFDA: TerminatedL. Perrigo Company
DrugMar 8, 2017
Pacific Medical Solutions Nano PNC Water recall — FDA D-0505-2017
Marketed without an Approved NDA/ANDA and non-sterility: NANO PNC Water by nebulizer was sampled and found to contain variovorax paradoxus.
Class IFDA: TerminatedPacific Medical Solutions
DrugMar 8, 2017
G & W Laboratories Indocin (Indomethacin) suppositories, USP, 50 mg, laminate strips packed recall — FDA D-0501-2017
Failed Impurities/Degradation Specifications: Out of specification (OOS) for total impurity and out of trend for known impurity results encountered during stability testing.
Class IIFDA: TerminatedG & W Laboratories, Inc.
DrugMar 8, 2017
Alfuzosin Hydrochloride Extended-release Tablets, 10 mg, 100-count bottles recall — FDA D-0502-2017
Presence of Foreign Substance: consumer complaint for foreign matter embedded in the tablet identified as a broken piece of wire rope from the manufacturing equipment.
Class IIFDA: TerminatedSun Pharmaceutical Industries, Inc.
DrugMar 8, 2017
Allegiant Health HealthA2Z CHEWABLE Aspirin (NSAID) 81 mg, Orange Flavor, 36 Chewable recall — FDA D-0500-2017
cGMP deviations - presence of rubber particles found loose in the bulk product.
Class IIFDA: TerminatedAllegiant Health
DrugMar 8, 2017
Zenatane (isotretinoin) capsules, 40 mg recall — FDA D-0506-2017
Failed dissolution specifications - low dissolution results at S3 stage.
Class IIIFDA: TerminatedDr. Reddy's Laboratories, Inc.
DrugMar 8, 2017
Zenatane (isotretinoin) capsules, 20 mg recall — FDA D-0507-2017
Failed dissolution specifications - low dissolution results at S3 stage.
Class IIIFDA: TerminatedDr. Reddy's Laboratories, Inc.
DrugMar 1, 2017
Sandoz Transderm Scop (scopolamine) Transdermal System, 1.5 mg, 1 patch per pouch recall — FDA D-0481-2017
Labeling: Incorrect Instructions:outer carton contains the incorrect instructions for Step 2 stating "Do cut the patch" rather than the correct instructions of "Do not cut the patch". The…
Class IIFDA: TerminatedSandoz Inc.
DrugMar 1, 2017
CycloSPORINE Capsules, USP, 100 mg, 30 count bottle recall — FDA D-0475-2017
Failed Impurities/Degradations Specifications; out of specification results for Maximum Unknown Impurities and Total Impurities.
Class IIFDA: TerminatedApotex Inc.
How to use this drug recall index
A drug recall record can include the reason for recall, firm, status, distribution pattern, quantity and FDA classification. This site does not provide medical advice; it organizes public recall information and links users back to official sources.
Recall Lookup USA keeps the last complete source record available when an official data service is temporarily unavailable. When a source provides only a few fields, we show only those known facts rather than padding the page with generic text.
What the database can and cannot tell you
This database is designed for discovery and reference. It can help you locate a relevant recall record, identify the recalling firm or NHTSA campaign, compare dates and classifications, and follow the official source. It is not a substitute for a VIN-specific NHTSA check, a manufacturer notice, medical advice or instructions issued by the recalling company.