FDA Recall
Ongoing
Historical recordClass II
Maximum Strength Lidocaine Cold & Hot Patch (lidocaine 4%, menthol 1%), 5 patches per box, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895; NDC 66902-218-05.
by Wuhan Bingbing Pharmaceutical Co., Ltd.
- Reason
- CGMP Deviations: due to the loss of product manufacturing records and retain product samples, there is no assurance that the product will remain within specification through the labeled expiration date.
- Published
- June 3, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Mencaine (lidocaine 4.5%, menthol 5%) Patch, 1 patch per pouch, Manufactured For: Terrain Pharmaceuticals, Reno, NV 89501; NDC 53225-1090-1.
by Wuhan Bingbing Pharmaceutical Co., Ltd.
- Reason
- CGMP Deviations: due to the loss of product manufacturing records and retain product samples, there is no assurance that the product will remain within specification through the labeled expiration date.
- Published
- June 3, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
LidoPro (lidocaine 4%, menthol 5%, methyl salicylate 4%) patch, 15 Patches per box, Manufactured For: Terrain Pharmaceuticals, Reno, NV 89501; NDC 53225-1023-1.
by Wuhan Bingbing Pharmaceutical Co., Ltd.
- Reason
- CGMP Deviations: due to the loss of product manufacturing records and retain product samples, there is no assurance that the product will remain within specification through the labeled expiration date.
- Published
- June 3, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
LidoPatch (lidocaine HCl 3.6%, menthol 1.25%) Pain Relief Patch, packaged in 1 patch/box (NDC 10882-527-01); 30 patches/box (NDC 10882-527-02 and 10882-527-04), Manufactured for: JAR Laboratories, Elmhurst, IL.
by Wuhan Bingbing Pharmaceutical Co., Ltd.
- Reason
- CGMP Deviations: due to the loss of product manufacturing records and retain product samples, there is no assurance that the product will remain within specification through the labeled expiration date.
- Published
- June 3, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Doxycycline Hyclate tablets USP, 100 mg, packaged in bottles a) 6-count (NDC 55289-866-06), b) 10-count (NDC 55289-866-10), c) 14-count (NDC 55289-866-14), d) 20-count (NDC 55289-866-20), e) 28-count (NDC 55289-866-28), f) 30-count (NDC 55289-866-30), g) 60-count (NDC 55289-866-60), h) 120-count (NDC 55289-866-98), i) 210-count (NDC 55289-866-71), j) 300-count (NDC 55289-866-87), k) 400-count (NDC 55289-866-74), Rx only, PD-Rx Pharmaceuticals Incorporated Oklahoma City, OK 73127
by PD-Rx Pharmaceuticals, Inc.
- Reason
- Failed dissolution specifications
- Published
- June 3, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Doxycycline Hyclate Tablets USP, 100 mg, packaged in a) 50-count bottle (NDC 0143-2112-50), b) 500-count bottle (NDC 0143-2112-05), Rx only, Mfd. by: West-Ward Pharmaceuticals Corp., Eatontown, NJ 07724.
by West-Ward Columbus Inc
- Reason
- Failed dissolution specification: The dissolution test at the 24 month time point (end of shelf life) yielded an out of specification result.
- Published
- June 3, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Jindilli Beverages LLC
- Product
- Milkadamia Salted Buttery Spread 8 ounces packaged in plasti…
- Reason
- Potential to contain mold
- Published
- June 3, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Jindilli Beverages LLC
- Product
- Milkadamia Unsalted Buttery Spread 8 ounces packaged in plas…
- Reason
- Potential to contain mold
- Published
- June 3, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
GARZA FOOD VENTURES
- Product
- Siete Grain Free Cashew Flour Tortillas NET WT 7 OZ (200g) 8…
- Reason
- Potential to contain foreign material.
- Published
- June 3, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Ethacrynic Acid Tablets USP, 25 mg, 100 Tablets per Bottle, Rx only, Distr. by: West-Ward Pharmaceuticals Corp., Eatontown, NJ 07724, NDC: 0054-0415-25.
by West-Ward Columbus Inc
- Reason
- Failed Impurities/Degradation Specifications: Out of Specification for impurity 6 and total degradants.
- Published
- May 27, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Gabapentin Tablets USP, 600 mg, Rx Only, 500-count bottle, Manufactured for: Exelan Pharmaceuticals, Inc., Lawrenceville, GA 30046, Manufactured by: InvaGen Pharmaceuticals, Inc., Hauppauge, NY 11788, NDC 76282-405-05.
by InvaGen Pharmaceuticals, Inc.
- Reason
- Failed Impurities/Degradation Specifications; failure of Impurity A test at the 12-month long-term stability testing.
- Published
- May 27, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Aloprim (allopurinol sodium) for Injection, 500 mg Single-Dose Vial, Rx only, Manufactured for: Mylan Institutional LLC, Rockford, IL 61103 USA. NDC: 67457-187-50
by Mylan Institutional LLC
- Reason
- Discoloration: Out-of-specification results for appearance obtained during routine stability testing at the end of shelf-life for the parameters Appearance and Color of Solution.
- Published
- May 27, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
LACTATED RINGER'S Injection, USP 1000 mL flexible container, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7953-09
by ICU Medical Inc
- Reason
- Presence of Particulate Matter: confirmed customer complaint for the presence of particulate matter identified as iron oxide.
- Published
- May 27, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
Finasteride Plus 1.25 mg Capsule, a) 30-count bottle, b) 90-count bottle, Compounded Product Not for Resale, MasterPharm, 115-02 Liberty Ave, Richmond Hill, NY 11419.
by MasterPharm LLC
- Reason
- Cross Contamination with Other Products; Finasteride Plus 1.25mg capsules were found to contain minoxidil.
- Published
- May 20, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
ChapStick Total Hydration Moisture + Tint + SPF15 Pretty in Pink Net Wt. 0.08 OZ (2.2g) Marketed by: Pfizer, Madison, NJ 07940 USA NDC 0573-0873-08
by Glaxosmithkline Consumer Healthcare Holdings
- Reason
- Labeling: Not elsewhere classified: Observed separation in the secondary packaging in the blister and the backer card
- Published
- May 20, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
ChapStick Total Hydration Moisture + Tint + SPF15 Very Berry Net Wt. 0.08 OZ (2.2g) Marketed by: Pfizer, Madison, NJ 07940 USA NDC 0573-0872-08
by Glaxosmithkline Consumer Healthcare Holdings
- Reason
- Labeling: Not elsewhere classified: Observed separation in the secondary packaging in the blister and the backer card
- Published
- May 20, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
ChapStick Total Hydration Moisture + Tint + SPF15 Peachy Keen Net Wt. 0.08 OZ (2.2g) Marketed by: Pfizer, Madison, NJ 07940 USA, NDC 0573-0871-08
by Glaxosmithkline Consumer Healthcare Holdings
- Reason
- Labeling: Not elsewhere classified: Observed separation in the secondary packaging in the blister and the backer card
- Published
- May 20, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Infuvite PEDiatric Pharmacy, kit in 1 carton (40 mL fill in a 50 mL) vial 1 and (10 mL) in vial 2, Rx Only, Distributed by: Baxter Healthcare Corporation Clintec Nutrition Division Deerfield, IL 60015 USA, NDC 54643-5647-0
by Sandoz, Inc
- Reason
- Defective Container: Sub-optimal crimping in vial of Pediatric Infuvite Multiple Vitamins
- Published
- May 13, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Jason Pharmaceuticals, Inc. t/a Medifast
- Product
- Optavia, Old Fashioned Maple & Brown Sugar Oatmeal . 1.13 o…
- Reason
- The product contains undeclared milk.
- Published
- May 13, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Aldi Inc
- Product
- Simply Nature Organic Red Split Lentils, 16 oz bag, UPC 0414…
- Reason
- Product may contain undeclared wheat
- Published
- May 13, 2020
- Distribution
- Nationwide
View recall →
Recall records are summarized from official FDA and USDA sources. Notices may be updated, reclassified, terminated, or withdrawn. Always review the linked official notice for the most current instructions.
Read the full medical disclaimer.