FDA Recall
🇺🇸 United States
TerminatedTerminated: June 20, 2018Historical recordClass II
Midwest International Corp
- Product
- Dai Yu, 80g, Hairtail, NET WT: 2.8 oz (80g), Item #D526
- Reason
- The product is an acidified food without a registered manufacturer and scheduled process
- Published
- December 14, 2016
- Distribution
- FL, GA, IN, IL, MD, MA, VA, TX & MN
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: January 25, 2017Historical recordClass I
Calbee North America, LLC
- Product
- HARVEST SNAPS, SNAPEA CRISPS, BLACK PEPPER FLAVORED GREEN PE…
- Reason
- One lot of black pepper flavored green pea crisps may contain wasabi ranch flavored green pea crisps which contain milk which is not declared on the black pepper flavored product.
- Published
- December 14, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: August 1, 2017Historical recordClass III
Safecor Health, LLC
- Product
- Safecor Vitamin B-1 (THIAMINE) 100 mg tablets NDC: 48433-01…
- Reason
- Box labeled Thiamine Hydrochloride instead of Thiamine Mononitrate
- Published
- December 14, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: June 19, 2018Historical recordClass I
OLMA-XXI INC.
- Product
- SALMON, TURBOT, BUTTERFISH, smoked sliced, Net Weight: 8oz (…
- Reason
- Products have the potential to be contaminated with Listeria monocytogenes
- Published
- December 14, 2016
- Distribution
- NY, NJ, MD, PA, MA, CA VA, FL, CT, TX, I…
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: June 19, 2018Historical recordClass I
OLMA-XXI INC.
- Product
- Premium Norwegian Salmon, Smoked, slice 8oz (227g), UPC # 85…
- Reason
- Products have the potential to be contaminated with Listeria monocytogenes
- Published
- December 14, 2016
- Distribution
- NY, NJ, MD, PA, MA, CA VA, FL, CT, TX, I…
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: May 2, 2017Historical recordClass II
Greencore USA, Inc.
- Product
- Double Smoked Bacon, Cheddar and Egg on Croissant Bun, 5.2 o…
- Reason
- Product may contain metal foreign material in the Croissant Bun.
- Published
- December 14, 2016
- Distribution
- FL, GA, LA, MD, NC, OH, and TX.
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: May 2, 2017Historical recordClass II
Greencore USA, Inc.
- Product
- Slow Roasted Ham and Swiss Croissant, 5.6 oz.
- Reason
- Product may contain metal foreign material in the Croissant Bun.
- Published
- December 14, 2016
- Distribution
- FL, GA, LA, MD, NC, OH, and TX.
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: August 9, 2019Historical recordClass II
SSI-GoPicnic LLC
- Product
- GoPicnic Turkey Slices & Cheddar Cheese; 4 Individually Pack…
- Reason
- Bagel chips containing wheat gluten included in a meal labeled "gluten free."
- Published
- December 14, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: May 17, 2018Historical recordClass II
Phenazopyridine Hydrochloride Tablets, USP, 200 mg, 100 count bottles, Rx only, Manufactured for: Nationwide Laboratories LLC, Iselin, New Jersey 08830, NDC 42937-702-10.
by Nationwide Laboratories, LLC
- Reason
- CGMP Deviations: manufactured under practices which may result in assay or content uniformity failures.
- Published
- December 7, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: May 17, 2018Historical recordClass II
Phenazopyridine Hydrochloride Tablets, USP, 100 mg, 100 count bottles, Rx only, Manufactured for: Nationwide Laboratories LLC, Iselin, New Jersey 08830, NDC 42937-701-10.
by Nationwide Laboratories, LLC
- Reason
- CGMP Deviations: manufactured under practices which may result in assay or content uniformity failures.
- Published
- December 7, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: May 17, 2018Historical recordClass II
Salsalate Tablets, USP, 750 mg, packaged in a) 100 count bottles (NDC 42937-704-10); b) 500 count bottles (NDC 42937-704-18); and c) 1000 count bottles (NDC 42937-704-20); Rx only, Manufactured for: Nationwide Laboratories LLC, Iselin, New Jersey 08830.
by Nationwide Laboratories, LLC
- Reason
- CGMP Deviations: manufactured under practices which may result in assay or content uniformity failures.
- Published
- December 7, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: May 17, 2018Historical recordClass II
Salsalate Tablets, USP, 500 mg, packaged in a) 500 count bottles (NDC 42937-703-18); b) 100 count bottles (NDC 42937-703-10); and c) 1000 count bottles (NDC 42937-703-20); Rx only, Manufactured for: Nationwide Laboratories LLC, Iselin, New Jersey 08830.
by Nationwide Laboratories, LLC
- Reason
- CGMP Deviations: manufactured under practices which may result in assay or content uniformity failures.
- Published
- December 7, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: August 14, 2017Historical recordClass II
Phenazopyridine Hydrochloride Tablets, USP, 200 mg, 100 count bottles, Rx only, Manufactured for: Burel Pharmaceuticals, Inc., Richland, MS --- NDC 35573-306-10
by Burel Pharmaceuticals Inc
- Reason
- CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures
- Published
- December 7, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: August 14, 2017Historical recordClass II
Phenazopyridine Hydrochloride Tablets, USP, 100 mg, 100 count bottles, Rx only, Manufactured for: Burel Pharmaceuticals, Inc., Richland, MS --- NDC 35573-304-10
by Burel Pharmaceuticals Inc
- Reason
- CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures
- Published
- December 7, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: August 14, 2017Historical recordClass II
Indiomin MB URINARY ANTISEPTIC, ANTISPASMODIC Capsules, Each capsule contains: Methenamine 120 mg, Monobasic Sodium Phosphate 40.8 mg, Methylene Blue, 10 mg; Hyoscyamine Sulfate, 0.12 mg, 100 count, Rx only, Manufactured for: BUREL PHARMACEUTICALS, NDC 35573-315-10
by Burel Pharmaceuticals Inc
- Reason
- CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures
- Published
- December 7, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: August 14, 2017Historical recordClass II
AZUPHEN MB URINARY ANTISEPTIC Capsules, Each capsule contains: Methenamine 120 mg, Monobasic Sodium Phosphate 40.8 mg, Phenyl Salicylate 36 mg, Methylene Blue 10 mg, Hyoscyamine Sulfate, 0.12 mg, 100 count bottles, Rx only, Manufactured for: BUREL PHARMACEUTICALS, Richland, MS --- NDC 35573-314-10
by Burel Pharmaceuticals Inc
- Reason
- CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures
- Published
- December 7, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: August 14, 2017Historical recordClass II
UROPHEN MB URINARY ANTISEPTIC Tablets, Each tablet contains: Methenamine 81.6 mg, Benzoic Acid 9.0 mg, Phenyl Salicylate 36 mg, Methylene Blue 10.8 mg, Hyoscyamine Sulfate 0.12 mg, 100 count bottles, Rx only, Manufactured for: BUREL PHARMACEUTICALS, Richland, MS --- NDC 35573-307-10
by Burel Pharmaceuticals Inc
- Reason
- CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures
- Published
- December 7, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: August 14, 2017Historical recordClass II
URAMIT MB URINARY ANTISEPTIC Capsules, Each capsule contains: Methenamine 118 mg, Monobasic Sodium Phosphate 40.8 mg, Phenyl Salicylate 36 mg, Methylene Blue 10 mg, Hyoscyamine Sulfate, 0.12 mg, 100 count bottles, Rx only, Manufactured for: BUREL PHARMACEUTICALS, Richland, MS --- NDC 35573-300-10
by Burel Pharmaceuticals Inc
- Reason
- CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures
- Published
- December 7, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: August 14, 2017Historical recordClass II
UROLET MB URINARY ANTISEPTIC, ANTISPASMODIC Tablets, Each tablet contains: Methenamine 81.6 mg, Monobasic Sodium Phosphate 40.8 mg, Phenyl Salicylate 36 mg, Methylene Blue, 10.8 mg; Hyoscyamine Sulfate, 0.12 mg, (a) 30 count (NDC 35573-302-30) and (b) 100 count bottles (NDC 35573-302-10), Rx only, Manufactured for: BUREL PHARMACEUTICALS, Richland, MS
by Burel Pharmaceuticals Inc
- Reason
- CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures
- Published
- December 7, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: August 14, 2017Historical recordClass II
Hyolev MB URINARY ANTISEPTIC Tablets, Each tablet for oral administration contains: Hyoscyamine Sulfate 0.12 mg, Methenamine 81 mg, Methylene Blue 10.8 mg, Phenyl Salicylate 32.4 mg, Sodium Phosphate Monobasic 40.8 mg, 90 count bottles, Rx only, Manufactured for: BUREL PHARMACEUTICALS, Richland, MS --- NDC 35573-301-90
by Burel Pharmaceuticals Inc
- Reason
- CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures
- Published
- December 7, 2016
- 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.