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 →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Aldi Inc
- Product
- Simply Nature Organic Green Lentils, 16 oz bag, UPC 04149829…
- Reason
- Product may contain undeclared wheat
- Published
- May 13, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
Ceftazidime for Injection USP and Dextrose for Injection USP, 2 g, 50 mL Duplex Container, RX only, B Braun Medical Inc., Bethlehem, PA 18018-3524, NDC 0264-3145-11
by B. Braun Medical Inc
- Reason
- Failed Stability Specifications: Out-of-Specification (OOS) results for High Molecular Weight Polymers.
- Published
- May 6, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Esomeprazole Magnesium Delayed Release Capsules USP, 40 mg*, 1000-count bottles, Rx only, Mfd. By: Dr. Reddy's Laboratories Limited Bachupally - 500 090 INDIA, NDC 43598-510-10
by Dr. Reddy's Laboratories, Inc.
- Reason
- Discoloration: product contains brown pellets
- Published
- May 6, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Nizatidine Oral Solution, 15 mg/mL (75 mg/5mL) USP 480 mL bottles, Rx Only Distributed by: Gemini Laboratories, LLC Bridgewater, NJ 08807 NDC 60846-301-15
by Amneal Pharmaceuticals of New York, LLC
- Reason
- CGMP Deviations: potential N-Nitrosodimethylamine (NDMA) amounts above levels established by the FDA.
- Published
- May 6, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Cefixime for Oral Suspension USP, 100mg/5mL, Rx Only, Manufactured for: Lupin Pharmaceutical, Inc. Baltimore, Maryland 21202 United States, Manufactured by: Lupin Limited Mandideep 462 046 INDIA, NDC 68180-405-01
by Lupin Pharmaceuticals Inc.
- Reason
- Subpotent Drug: low out of specification (OOS) test result observed in long term stability study.
- Published
- April 29, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
PEPPERMINT LIP MOISTURIZER (oxybenzone (4%) and Octinoxate (7%) SPF 15, 4.2 g tube, labeled as a) Bimark Inc., bimark.com; b) NOCO TRAIL REPORT, www.NoCoTrailReport.org; c) Herbruck's, d) St. Mark's Outpatient Surgery Center, 1250 East 3900 South Suite 100, Salt Lake City, UT 84124, e) Trust Company Oklahoma, trustok.com, f) Creekside Dental, www.creeksidedentalkennewick.com, g) Children's Healthcare of Atlanta Hughes Spalding, h) Great Smiles Orthodontics, Dr. Savage & Dr. Weissman, Crestline. Inverness.Turssville, www.bracebygreatsmiles.com, i) Acceleration station, j) The Children's Therapy & Learning Center, www.childrenstlc.com. FLAVORED LIP MOISTURIZER (oxybenzone (4%) and Octinoxate (7%) SPF 15, 4.2 g tube labeled as a) Gregory P. Miller DDS FAGD, 1140 South Avenue North Mankato, MN 56003, www.gregmillerdds.com, b) Shelby, c) Carolina Custom Traders, Wake Forest, North Carolina, c) Palm Springs Dental Associates Jonathan W. Preble, DMD, 499 E. Central Parkway, Suite 200, Altamonte Springs, FL 32701, www.drjpreble.com. LIP MOISTURIZER (oxybenzone (4%) and Octinoxate (7%) SPF 15, 4.2 g tube labeled as Family Dental of Thronton, 12889 Quebec St, Thornton, CO 80602, www.FamilyDentalofThornton.com.
by Yusef Manufacturing Laboratories, LLC
- Reason
- Superpotent drug: This lot of SPF containing lip balm contains up to 150% of the label claim for active ingredient Oxybenzone.
- Published
- April 29, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Lisinopril Tablets USP, 20 mg, 1000-count bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore MD 21202, Manufactured by: Lupin Limited Pithampur (M.P.) 454 775, India. NDC 68180-0981-03
by Lupin Pharmaceuticals Inc.
- Reason
- Product Mix-Up: a complaint received indicating mix-up of 10 mg Lisinopril tablets inside of 2 sealed bottles of 20 mg/1000 count bottles.
- Published
- April 29, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Daytrana (methylphenidate transdermal system) Delivers 30 mg over 9 hours (3.3 mg/hr) 30-count box, Rx only, Manufactured for Noven Therapeutics, LLC Miami, FL 33186, NDC 68968-5555-3
by Noven Therapeutics, LLC
- Reason
- Defective Delivery System: Out of specification for mechanical peel and shear.
- Published
- April 29, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Daytrana (methylphenidate transdermal system) Delivers 20 mg over 9 hours (2.2 mg/hr) 30-count box, Rx only, Manufactured for Noven Therapeutics, LLC Miami, FL 33186, NDC 68968-5554-3
by Noven Therapeutics, LLC
- Reason
- Defective Delivery System: Out of specification for mechanical peel and shear.
- Published
- April 29, 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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