FDA Recall
Terminated
Historical recordClass III
Olanzapine Orally Disintegrating Tablets, 5 mg, 30 count (3x10 unit dose) blister pack, Rx only, Manufactured by: Jubilant Generics, Ltd., Roorkee, India, Marketed by: Jubilant Cardista Pharmaceuticals, Inc., Salisbury, MD NDC 59746-0306-32
by Jubilant Cadista Pharmaceuticals, Inc.
- Reason
- Subpotent
- Published
- November 11, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Fluocinonide Ointment USP 0.05%, packaged in: a) 15 gm tube, NDC 52565-0040-15, b) 30 gm tube, NDC 52565-0040-30 c) 60 gram tube, NDC 52565-0040-60, Rx only, Manufactured by: Teligent Pharma, Inc., Buena, New Jersey 08310
by Teligent Pharma, Inc.
- Reason
- Failed Impurities/Degradation - Out-of-specification results for Fluocinolone Acetonide impurity.
- Published
- November 11, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Time-Cap Labs, Inc. Metformin Hydrochloride Extended Release Tablets USP 750 mg, 100 count bottles, Rx Only Manufactured for: Time-Cap Labs, Inc. 7 Michael Avenue Farmingdale, NY 11735, USA Manufactured by: Marksans Pharma Ltd. Plot No. L-82, L-83, Verna Indl. Estate. Verna Goa-403 722 India NDC 49483-624-01
by Marksans Pharma Limited
- Reason
- CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
- Published
- November 11, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Time-Cap Labs, Inc. Metformin Hydrochloride Extended-Release Tablets USP 500 mg, a) 90 count (NDC 49483-623-09) b) 100 count (49483-623-01) c) 500 count (NDC 49483-623-50) and d) 1000 count (NDC 49483-623-10) bottles, Rx Only Manufactured for: Time-Cap Labs, Inc. 7 Michael Avenue Farmingdale, NY 11735, USA, Manufactured by: Marksans Pharma Ltd. Plot No. L-82, L-83, Verna Indl. Estate. Verna Goa-403 722 India NDC 49483-623-50
by Marksans Pharma Limited
- Reason
- CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
- Published
- November 11, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Metformin Hydrochloride Extended-Release Tablets, USP 500 mg, a) 30 count (NDC 70934-309-30); b) 60 count (NDC 70934-309-60); c) 90 count (70934-309-90); d) 120 count (NDC 70934-309-98) bottles, Rx Only, Time-Cap Labs Inc. Repackaged by Northwind Pharmaceuticals North Blenheim, NY 12131
by Denton Pharma, Inc.
- Reason
- CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level (per manufacturer)
- Published
- November 11, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Metformin Hydrochloride Extended-Release Tablets USP 750 mg, 30 Tablets bottle, Rx Only, Time-Cap Labs, Inc., Repackaged By: Northwind Pharmaceuticals North Blenheim NY 12131 NDC 70934-334-30
by Denton Pharma, Inc.
- Reason
- CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level (per manufacturer)
- Published
- November 11, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Spring Glen Fresh Foods
- Product
- Rice Pudding 5lb plastic containers. UPC: 4428421260. Refr…
- Reason
- Undeclared egg and milk due to mis-labeling.
- Published
- November 11, 2020
- Distribution
- Distributed to distributors in Maryland,…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Lidl US TRADING
- Product
- Lidl Organic Butter Microwave Popcorn, 3 x 3.3oz, 10 boxes p…
- Reason
- Lidl US, LLC has initiated a recall of Lidl Organic Butter Microwave Popcorn, 3 x 3.3oz, 10 boxes per case and 3 popcorn bags per box. Best by/Lot Codes: JUL192021N2, JUL232021N2, AUG182021N2 because the raw ingredient supplier for the popcorn has initiated a recall due to foreign material.
- Published
- November 11, 2020
- Distribution
- States were stores are located: VA, MD,…
View recall →
FDA Recall
Terminated
Historical recordClass II
N-A-C (N-Acetyl-L-Cysteine, 500 mg, 100 capsules; Veggie Caps, white HDPE bottle with RED label Product # 107002 UPC: 790011070023
by Jarrow Formulas Inc
- Reason
- Mislabeling of SUS (N-A-C Sustain 600 mg 100 tab) with N-A-C N-Acetyl-L-Cysteine 500 mg, 100 cap.
- Published
- November 4, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Hydrocortisone butyrate Cream, 0.1%, 15-gram tubes, Rx Only, Manufactured for Oceanside Pharmaceuticals a division of Valeant Pharmaceuticals North America LLC Bridgewater, NJ 08807 USA, By: Ferndale Laboratories, Inc. Ferndale, MI 48220, NDC 68682-270-15
by Bausch Health Companies, Inc.
- Reason
- SUBPOTENT DRUG
- Published
- November 4, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Catapres (clonidine hydrochloride, USP) 0.3 mg, tablet, 100-count bottle, Rx only, Dist. by: Boehringer Ingelheim Pharmaceuticals, Inc. Ridgefield, CT 06877, Made in Germany, NDC, 0597-0011-01
by Boehringer Ingelheim Pharmaceuticals, Inc.
- Reason
- An extraneous peak was observed for dissolution testing.
- Published
- November 4, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Catapres (clonidine hydrochloride, USP) 0.2 mg, tablet, 100-count bottle, Rx only, Dist. by: Boehringer Ingelheim Pharmaceuticals, Inc. Ridgefield, CT 06877, Made in Germany, NDC, 0597-0007-01
by Boehringer Ingelheim Pharmaceuticals, Inc.
- Reason
- An extraneous peak was observed for dissolution testing.
- Published
- November 4, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Catapres (clonidine hydrochloride, USP) 0.1 mg, tablet, 100-count bottle, Rx only, Dist. by: Boehringer Ingelheim Pharmaceuticals, Inc. Ridgefield, CT 06877, Made in Germany, NDC, 0597-0006-01
by Boehringer Ingelheim Pharmaceuticals, Inc.
- Reason
- An extraneous peak was observed for dissolution testing.
- Published
- November 4, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Capital Seaboard
- Product
- Gracie's Pointe frozen raw shrimp. 1. 8/12 Count Per Pound…
- Reason
- Frozen raw shrimp in import alert inadvertently released for distribution.
- Published
- November 4, 2020
- Distribution
- Distributed to 287 restaurants in MD, VA…
View recall →
FDA Recall
🇺🇸 United States
Ongoing
Historical recordClass II
Nurture Inc. dba Happy Family
- Product
- Happy Kid Gluten Free Fruit & Oat Bar Organic Blueberry & Ra…
- Reason
- Recall due to mold growth observed (Eurotium spp., Aspergillus niger, and Xeromyces bisporus).
- Published
- November 4, 2020
- Distribution
- AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA,…
View recall →
FDA Recall
🇺🇸 United States
Ongoing
Historical recordClass II
Nurture Inc. dba Happy Family
- Product
- Happy Tot Superfoods Gluten Free Oat Bar Organic Bananas, St…
- Reason
- Recall due to mold growth observed (Eurotium spp., Aspergillus niger, and Xeromyces bisporus).
- Published
- November 4, 2020
- Distribution
- AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA,…
View recall →
FDA Recall
🇺🇸 United States
Ongoing
Historical recordClass II
Nurture Inc. dba Happy Family
- Product
- Happy Tot Superfoods Gluten Free Oat Bar Organic Blueberries…
- Reason
- Recall due to mold growth observed (Eurotium spp., Aspergillus niger, and Xeromyces bisporus).
- Published
- November 4, 2020
- Distribution
- AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA,…
View recall →
FDA Recall
Terminated
Historical recordClass III
Candesartan Cilexetil and Hydrochlorothiazide Tablets, USP 32 mg/12.5 mg, packaged in a) 90-count bottles (NDC 0378-3002-77) and b) 500-count bottles (NDC 0378-3002-05), Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A.
by Mylan Pharmaceuticals Inc.
- Reason
- Out-of-specification organic impurity results obtained during routine stability testing.
- Published
- October 28, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate (Mixed Salts of A Single-Entity Amphetamine Product) Extended-Release Capsules, 30 mg, 100-count bottle, Rx Only, Mfd. for: Amerigen Pharmaceuticals, Inc. Lyndhurst, NJ 07071 NDC 43975-282-10
by ANI Pharmaceuticals, Inc.
- Reason
- Labeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-months.
- Published
- October 28, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate (Mixed Salts of A Single-Entity Amphetamine Product) Extended-Release Capsules, 25 mg, 100-count bottle, Rx Only, Mfd. for: Amerigen Pharmaceuticals, Inc. Lyndhurst, NJ 07071 NDC 43975-281-10
by ANI Pharmaceuticals, Inc.
- Reason
- Labeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-months.
- Published
- October 28, 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.
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