Public Health Trace republishes official recall, outbreak, and surveillance data from CDC, FDA, USDA,
WHO, and other public sources. It is an independent information service, not a medical provider, and
not a substitute for professional medical advice or your local public health department's own guidance.
Policy version 2026-07-21, effective July 21, 2026.
If you are experiencing a medical emergency, call your local emergency services immediately. For food
recalls and disease investigations, always refer to the official CDC, FDA, USDA, WHO, or your local
public health authority for the most current information.
Every FDA drug enforcement recall Public Health Trace has on record, republished from
openFDA's official drug enforcement database. See Health
Alerts for current, active recalls alongside outbreaks and advisories.
Drug recall information is sourced from the FDA's structured openFDA Enforcement
Reports. Newly announced recalls may appear on FDA.gov before they become available in
the structured dataset. See Methodology for how Public
Health Trace imports and refreshes this data.
Filters
Showing 7,661–7,680 of 17,964 drug recalls
Drug RecallTerminatedHistorical recordClass II
Temozolomide Capsules, 180 mg, packaged in a) 5-count bottle (NDC 67877-541-07), b) 14-count bottle (NDC 67877-541-14), Rx only, Manufactured by: Deva Holding A.S., 1 Merkez Mahallesi, Istanbul, Turkey 34303, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054.
by Deva Holding AS - Cerkezkoy Subesi
Reason
CGMP Deviations: product was manufactured that did not prevent possible cross contamination with beta lactam products.
Workvie Instant Pain Relieving Roll On (Lidocaine HCL 4% + Menthol 1% & Arnica), 2.5oz (71 g) roll on bottle, Exclusively Distributed by: Marketite, LLC., Coral Gables, FL 33134, NDC 72393-201-25.
by Pharma-Natural Inc.
Reason
CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing practice violations.
Recall initiated
June 21, 2019
Reported by FDA
July 31, 2019
Distribution
Consignees in FL and TX who may have further distributed Nationwide in the USA and Puerto Rico.
NEOGEN-D (Dextromethorphan HBr, 30 mg; Guaifenesin, 200 mg; Phenylephrine HCl, 7.5 mg) in each 5 mL tsp, Raspberry Flavor, 16 fl oz (473 mL) bottle, Manufactured in the USA for Kramer Novis, San Juan, PR 00917, NDC 52083-699-16.
by Pharma-Natural Inc.
Reason
CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing practice violations.
Recall initiated
June 21, 2019
Reported by FDA
July 31, 2019
Distribution
Consignees in FL and TX who may have further distributed Nationwide in the USA and Puerto Rico.
SORBUGEN NR (Dextromethorphan HBr, 15 mg; Glyceryl Guaiacolate (Guaifenesin), 150 mg) in each 7.5 mL 1 1/2 tsp), GRAPE FLAVOR, 16 Fl.oz. (473 mL) bottle, Manufactured in the USA for Kramer Novis, San Juan, PR 00917, NDC 52083-660-16.
by Pharma-Natural Inc.
Reason
CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing practice violations.
Recall initiated
June 21, 2019
Reported by FDA
July 31, 2019
Distribution
Consignees in FL and TX who may have further distributed Nationwide in the USA and Puerto Rico.
TUSSLIN (Dextromethorphan HBr, 28 mg; Guaifenesin, 388 mg; Phenylephrine HCl, 10 mg) in each 5 mL tsp, Grape Flavor, 16 Fl.oz. (474 mL) bottle, Kramer Novis, San Juan, PR 00917, NDC 52083-622-16.
by Pharma-Natural Inc.
Reason
CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing practice violations.
Recall initiated
June 21, 2019
Reported by FDA
July 31, 2019
Distribution
Consignees in FL and TX who may have further distributed Nationwide in the USA and Puerto Rico.
Dayma SUPER FORTE XL10 (Camphor 0.5%, Menthol 2%, Methyl Salicylate 2%) Pain Relieving Topical Analgesic Gel, 4 Oz (113.4 g) jar, Distributed by: Biosfera International Distribution, LLC., Miami Lakes, FL 33016, NDC 63788-118-04.
by Pharma-Natural Inc.
Reason
CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing practice violations.
Recall initiated
June 21, 2019
Reported by FDA
July 31, 2019
Distribution
Consignees in FL and TX who may have further distributed Nationwide in the USA and Puerto Rico.
Lid O Creme (Lidocaine HCL 4% and Menthol 1%) Topical Analgesic Cream, 2.5 Oz (71 g) roll on bottle, Manufactured & Distributed by: Pharma Natural, Inc. Hialeah, FL 33016, NDC 63788-111-25.
by Pharma-Natural Inc.
Reason
CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing practice violations.
Recall initiated
June 21, 2019
Reported by FDA
July 31, 2019
Distribution
Consignees in FL and TX who may have further distributed Nationwide in the USA and Puerto Rico.
CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing practice violations.
Recall initiated
June 21, 2019
Reported by FDA
July 31, 2019
Distribution
Consignees in FL and TX who may have further distributed Nationwide in the USA and Puerto Rico.
CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing practice violations.
Recall initiated
June 21, 2019
Reported by FDA
July 31, 2019
Distribution
Consignees in FL and TX who may have further distributed Nationwide in the USA and Puerto Rico.
LidoAID (Lidocaine HCL 4%) portable pain relieving TOPICAL ANALGESIC GEL, 0.17 Oz (4 g) roll on bottle, Distributed by: Diabetic Supply of Suncoast, Inc., dba Advocate Diabetes, PO Box 2102, Vega Alta, PR 00692, NDC 63788-114-04.
by Pharma-Natural Inc.
Reason
CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing practice violations.
Recall initiated
June 21, 2019
Reported by FDA
July 31, 2019
Distribution
Consignees in FL and TX who may have further distributed Nationwide in the USA and Puerto Rico.
DOUBLE TUSSIN DM (Dextromethorphan Hbr 20 mg, Guaifenesin 300 mg) in each 5ml teaspoon, 4 FL OZ (120 mL) bottle, Distributed by: Pamby Dist., Miami, FL 33414, NDC 63708-121-04.
by Pharma-Natural Inc.
Reason
CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing practice violations.
Recall initiated
June 21, 2019
Reported by FDA
July 31, 2019
Distribution
Consignees in FL and TX who may have further distributed Nationwide in the USA and Puerto Rico.
GENCONTUSS (Chlorpheniramine Maleate, 2mg; Dextromethorphan HBr, 10 mg; Phenylephrine HCl, 5 mg) in each 5 mL tsp, Cherry Flavor, 16 fl oz (474 mL) bottle, Manufactured in the USA for Kramer Novis, San Juan, PR 00917, NDC 52083-650-16.
by Pharma-Natural Inc.
Reason
CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing practice violations.
Recall initiated
June 21, 2019
Reported by FDA
July 31, 2019
Distribution
Consignees in FL and TX who may have further distributed Nationwide in the USA and Puerto Rico.
ARMY HEALTH Pain Reliever Gel With CURCUMIN (Menthol 3.00%), 0.5 OZ jar, Manufactured exclusively for: Manufactured exclusively for: Crossover Telecom, LLC., P.O. Box 520248, Miami, FL 33122, UPC 8 50993 00461 1.
by Pharma-Natural Inc.
Reason
CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing practice violations.
Recall initiated
June 21, 2019
Reported by FDA
July 31, 2019
Distribution
Consignees in FL and TX who may have further distributed Nationwide in the USA and Puerto Rico.
CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing practice violations.
Recall initiated
June 21, 2019
Reported by FDA
July 31, 2019
Distribution
Consignees in FL and TX who may have further distributed Nationwide in the USA and Puerto Rico.
ARMY HEALTH With CURCUMIN (Menthol 3.00%) Pain Reliever Roll-On, 2.5 FL OZ (73ML) roll on bottle, Manufactured exclusively for: Crossover Telecom, LLC., P.O. Box 520248, Miami, FL 33122, UPC 8 50993 00408 6.
by Pharma-Natural Inc.
Reason
CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing practice violations.
Recall initiated
June 21, 2019
Reported by FDA
July 31, 2019
Distribution
Consignees in FL and TX who may have further distributed Nationwide in the USA and Puerto Rico.
CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing practice violations.
Recall initiated
June 21, 2019
Reported by FDA
July 31, 2019
Distribution
Consignees in FL and TX who may have further distributed Nationwide in the USA and Puerto Rico.
This information is republished from FDA's Recall Enterprise System through openFDA. Public Health Trace
does not verify or supplement it, is not affiliated with the FDA, and does not provide medical advice --
always follow the guidance of your pharmacist, physician, or the recalling company for any medication you take.
Read the full medical disclaimer.
