FDA daily for Wednesday, August 27, 2025
In this issue: 10 approvals, 14 drug recalls, 113 label changes and 69 food or supplement recalls. 2 items touch categories MedGrid carries, and they come first.
For MedGrid's categories
Items in this issue that name a product category sold on MedGrid. Each links to its full FDA record; the chip opens that category's federal and state rules.
- Earth Mama Baby Face Mineral Sunscreen Stick SPF 40
ZINC OXIDE · Eleeo Brands LLC · TOPICAL
Drug and biologic approvals
FDA date:On Wed, Aug 20 FDA approved 3 new applications (0 brand or biologic, 3 generic) and 7 supplements to existing ones.
- OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE
HANGZHOU BINJIANG · HYDROCHLOROTHIAZIDE, OLMESARTAN MEDOXOMIL
- MACITENTAN
MSN · MACITENTAN
- NICARDIPINE HYDROCHLORIDE
NANJING KING FRIEND · NICARDIPINE HYDROCHLORIDE
Drug recalls
FDA date:FDA's enforcement report dated Wed, Aug 20 lists 14 drug recalls: 14 Class II.
- 0.9% Sodium Chloride Injection USP, L 8000, 1000mL Excel Container, Rx Only, Sterile, nonpyrogenic, single dose container, B. Braun Medical…
B BRAUN MEDICAL INC · Lack of Assurance of Sterility; potential for fluid leakage at one of the weld sites.
- Carvedilol Tablets, USP, 12.5 mg, 500-count bottle, Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd, Colvale-Bardez, Goa, 403513, In…
Glenmark Pharmaceuticals Inc., USA · CGMP Deviations: Presence of a nitrosamine, N-Nitroso Carvedilol I Impurity above the current Acceptable Intake Level.
- Duloxetine Delayed-Release Capsules, USP, 60 mg, 1,000 Capsules per bottle, Rx Only, Manufactured by: Towa Pharmaceutical Europe, S.L., Mar…
Breckenridge Pharmaceutical, Inc. · CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
- Carvedilol Tablets, USP, 25 mg, 500 Tablets per carton, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Plot No. 2, Phase-2, Pharm…
Glenmark Pharmaceuticals Inc., USA · CGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above the FDA-recommended limit of NMT 4.0 ppm
- Lactated Ringer's Injection USP, L 7500, 1000mL Excel Container, Rx Only, Sterile, nonpyrogenic, single dose container, B. Braun Medical In…
B BRAUN MEDICAL INC · Lack of Assurance of Sterility; potential for fluid leakage at one of the weld sites.
- Carvedilol Tablets, USP, 12.5 mg, 500 Tablets per carton, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Plot No. 2, Phase-2, Pha…
Glenmark Pharmaceuticals Inc., USA · CGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above the FDA-recommended limit of NMT 4.0 ppm
- Amlodipine and Olmesartan Medoxomil Tablets, 5 mg/ 40 mg, 30-count bottle, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA; Distri…
Ascend Laboratories, LLC · Failed Dissolution Specifications: low dissolution results
- Theophylline extended-release tablets 400mg, 100-count bottle, Rx only, Manufactured by: Glenmark Pharmaceuticals Limited, Colvale-Bardez,…
Glenmark Pharmaceuticals Inc., USA · Failed Dissolution Specifications: Failure results (above) were reported for the Dissolution (by UV) test for commercial annual stability at the long-term shel…
- Carvedilol Tablets, USP, 3.125 mg, Packaged as: a)500-count bottle, NDC 68462-162-05; b) 100-count bottle, NDC 68462-162-01; Rx only, Manuf…
Glenmark Pharmaceuticals Inc., USA · CGMP Deviations: Presence of a nitrosamine, N-Nitroso Carvedilol I Impurity above the current Acceptable Intake Level.
- Metoprolol Tartrate Tablets, USP, 100 mg, 1000 Tablets, Rx Only, Manufactured by: Renata PLC (General Plant -2), Noyapara, Bhawal Mirzapur,…
Westminster Pharmaceuticals LLC · CGMP Deviations: Presence of a nitrosamine, N-nitroso-metoprolol above the established Acceptable Daily Intake (ADI) level.
- Metoprolol Tartrate Tablets, USP, 50 mg, 1000 Tablets, Rx Only, Manufactured by: Renata PLC (General Plant -2), Noyapara, Bhawal Mirzapur,…
Westminster Pharmaceuticals LLC · CGMP Deviations: Presence of a nitrosamine, N-nitroso-metoprolol above the established Acceptable Daily Intake (ADI) level.
Label updates
FDA date:113 drug labels took effect on Wed, Aug 13; 2 of the 25 read for this issue are for products in MedGrid's categories. Below: those, and labels carrying a boxed warning.
- Earth Mama Baby Face Mineral Sunscreen Stick SPF 40
ZINC OXIDE · Eleeo Brands LLC · TOPICAL
- Paroxetine
PAROXETINE HYDROCHLORIDE HEMIHYDRATE · NuCare Pharmaceuticals, Inc. · ORAL
- Paclitaxel protein-bound particles for injectable suspension (albumin-bound)
PACLITAXEL · BluePoint Laboratories · INTRAVENOUS
- MELOXICAM
MELOXICAM · PHOENIX RX LLC · ORAL
Food and supplement recalls
FDA date:FDA's enforcement report dated Wed, Aug 20 lists 69 food or supplement recalls: 23 Class I, 35 Class II, 11 Class III.
- Molly's Kitchens Tuna Salad, item 794599, net wt. 5lb. Foodservice item. Product is packaged in clear printed plastic tub with printed whit…
Reser's Fine Foods, Inc. · Tuna Salad products are recalled due to potential contamination with Listeria monocytogenes because products containing Newly Weds Foods recalled Japanese Styl…
- READY MEALS DUO TUNA SALAD W/ CRACKERS
Albertsons Companies LLC · Potential contamination with Listeria monocytogenes.
- Reser's Gourmet Tuna Salad, net wt. 5lb. Foodservice item. Product is packaged in clear printed plastic tub with white lid with white stick…
Reser's Fine Foods, Inc. · Tuna Salad products are recalled due to potential contamination with Listeria monocytogenes because products containing Newly Weds Foods recalled Japanese Styl…
- READY MEALS TUNA SALAD CROISSANT SANDWICH
Albertsons Companies LLC · Potential contamination with Listeria monocytogenes.
- READY MEALS TUNA SALAD SNACKER TRAY
Albertsons Companies LLC · Potential contamination with Listeria monocytogenes.
- Jewel Osco CLUB SANDWICHES WITH SALAD
Albertsons Companies LLC · Potential contamination with Listeria monocytogenes.
- Quesito El Establo brand Spanish Cheese QUESITO COLOMBIANO; INGREDIENTS: Milk, Cheese Cultures, Salt, Vitamins C and D; INGREDIENTES: Leche…
Quesito El Establo · Product was manufactured and held under insanitary conditions. Product may be contaminated with Listeria monocytogenes.
- Randalls SALAD SANDWICH 12 INCH TRAY
Albertsons Companies LLC · Potential contamination with Listeria monocytogenes.
- Reser's Tuna Salad, net wt. 5lb. Foodservice item. Product is packaged in white plastic tub and lid with sticker. Keep Refrigerated. This i…
Reser's Fine Foods, Inc. · Tuna Salad products are recalled due to potential contamination with Listeria monocytogenes because products containing Newly Weds Foods recalled Japanese Styl…
- Signature Cafe Premium Tuna Salad, net wt. 3lb (48oz). Foodservice item to be used by deli. Product is packaged in clear plastic tub with p…
Reser's Fine Foods, Inc. · Tuna Salad products are recalled due to potential contamination with Listeria monocytogenes because products containing Newly Weds Foods recalled Japanese Styl…
- READY MEALS QUAD TUNA SALAD
Albertsons Companies LLC · Potential contamination with Listeria monocytogenes.
- Randalls PREMIUM TUNA SALAD
Albertsons Companies LLC · Potential contamination with Listeria monocytogenes.
FDA did not answer for Clearances, Device recalls, Drug shortages while this issue was written; those sections will fill in on a later visit.
How the FDA daily is written
Every issue is written from FDA's public data (openFDA) and nothing else: the counts, names, firms and reasons are FDA's own. openFDA posts each kind of record on its own delay, so each section covers one FDA date and says which. Shortages cover yesterday; approvals, drug and device recalls, and food and supplement recalls cover a week ago; device clearances and label changes cover two weeks ago. Every FDA date appears in exactly one issue. Complete response letters appear the day after FDA publishes a batch.
Subscribe with any feed reader, or point an email tool at the RSS feed to send each issue as a newsletter. Search any drug, device or company across every FDA dataset in the FDA data explorer.
