FDA Recall
Terminated
Historical recordClass II
Sterile Diluent for Epoprostenol Sodium for Injection, 50 mL vial (NDC 0703-9258-01), packaged in 2X50ML per tray (NDC 0703-9258-09), Rx only, TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454.
by Teva Pharmaceuticals USA
- Reason
- Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility assurance for these sterile injectable products.
- Published
- March 3, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Desmopressin Acetate Injection USP, 4 mcg/mL, 1 mL Preserved Vial (NDC 0703-5051-01), packaged in 10X1 mL Vials per Tray (NDC 0703-5051-03), Rx only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454.
by Teva Pharmaceuticals USA
- Reason
- Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility assurance for these sterile injectable products.
- Published
- March 3, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Dacarbazine for Injection USP, 200 mg, Single Use Vial (NDC 0703-5075-01), packaged in 10X20 ML Single Use Vials per tray (NDC 0703-5075-03); Rx only, TEVA Pharmaceuticals USA, INC., North Wales, PA 19454.
by Teva Pharmaceuticals USA
- Reason
- Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility assurance for these sterile injectable products.
- Published
- March 3, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Cephalexin for Oral Suspension, USP 250 mg per 5 mL 200 ml (when mixed) Rx Only, Manufactured by: Alkem Laboratories, Ltd, Mumbai -400 013 INDIA Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054 NDC 67877-545-68
by Ascend Laboratories LLC
- Reason
- CGMP Deviations: Individual Unidentified impurities results of the product was found at higher side of the specification limit.
- Published
- February 24, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Cephalexin for Oral Suspension, USP 250 mg per 5 mL, 100 ml (when mixed) Rx Only, Manufactured by: Alkem Laboratories, Ltd, Mumbai -400 013 INDIA Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054 NDC 67877-545-88
by Ascend Laboratories LLC
- Reason
- CGMP Deviations: Individual Unidentified impurities results of the product was found at higher side of the specification limit.
- Published
- February 24, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Auryxia (ferric citrate) tablets, 210 mg*, 200 tablets bottle, RX ONLY, Manufactured for and distributed by: KERYX BIOPHARMACEUTICALS, INC., 245 First Street, Suite 1400, Cambridge, MA 02142, USA, NDC 59922-0631-01.
by Akebia Therapeutics dba Keryx Biopharmaceutials, Inc
- Reason
- Failed Dissolution Specifications
- Published
- February 24, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Sulfur Ointment 10%, Pomada de Azufre, 2.6 OZ (73.7g) jar; Manufactured by/ Fabricado por: De La Cruz Products, A Division of DLC Laboratories, Inc. Paramount, CA 9023 USA; UPC 024286150426
by DLC Laboratories, Inc
- Reason
- Labeling: Label Mix-Up. THe English label with Drug Facts panel for Camphor was incorrectly placed on product.
- Published
- February 24, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
OPTIMUS LUBRICANTS Instant Hand Sanitizer, (alcohol 70% v/v) 275 Gal (1040 L) tank with spout dispenser, Made in Mexico, Liq-E, S.A. DE C.V., Puerto Tampico No. 345 Col. La Fe San Nicolas de Los Garza, Nuevo Leon, Mexico. C.P. 66477.; UPC # 7 501799 118981
by Liq-E S.A. De C.V.
- Reason
- Chemical Contamination: Products contain methanol and were below the label claim for ethanol content
- Published
- February 24, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
OPTIMUS LUBRICANTS Instant Hand Sanitizer, (ethyl alcohol 70%) 1 Gal (3.78 L) bottle, Made in Mexico, Liq-E, S.A. DE C.V., Puerto Tampico No. 345 Col. La Fe San Nicolas de Los Garza, Nuevo Leon, Mexico. C.P. 66477; NDC: XXXXX-378-04, UPC # 7 501799 118837
by Liq-E S.A. De C.V.
- Reason
- Chemical Contamination: Products contain methanol and were below the label claim for ethanol content
- Published
- February 24, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
OPTIMUS LUBRICANTS Instant Hand Sanitizer, (alcohol 70% v/v) 55 Gal (208 L) drum, Made in Mexico, Liq-E, S.A. DE C.V., Puerto Tampico No. 345 Col.. La Fe San Nicolas de Los Garza, Nuevo Leon, Mexico. C.P. 66477.UPC # 7 501799 118998
by Liq-E S.A. De C.V.
- Reason
- Chemical Contamination: Products contain methanol and were below the label claim for ethanol content
- Published
- February 24, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
OPTIMUS LUBRICANTS Instant Hand Sanitizer, (ethyl alcohol 70%) 8.5 Fl. Oz. (250 mL) bottle, Made in Mexico, Liq-E, S.A. DE C.V., Puerto Tampico No. 345 Col. La Fe San Nicolas de Los Garza, Nuevo Leon, Mexico. C.P. 66477. UPC # 7 501799 115621
by Liq-E S.A. De C.V.
- Reason
- Chemical Contamination: Products contain methanol and were below the label claim for ethanol content
- Published
- February 24, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass I
Enoxaparin Sodium Injection, USP 120 mg/ 0.8 mL Single Dose Syringes with Automatic Safety Device For Subcutaneous Injection 10 x 0.8 mL Single Dose Syringes Rx Only,Manufactured by: Gland Pharma Ltd. Hyderabad, India Manufactured for: Apotex Corp. Weston, FL 33326 NDC 60505-0796-4 UPC 360505079543 (carton) NDC 60505-0796-0 UPC (01)10360505079602 (label)
by Apotex Corp.
- Reason
- Labeling; Label Mixup; syringe barrels may contain markings for 100 mg/mL (corresponding to 100 mg/mL strength) instead of 150 mg/mL (corresponding to 120 mg/0.8mL strength)
- Published
- February 17, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass I
Enoxaparin Sodium Injection, USP 100 mg/mL Single Dose Syringes with Automatic Safety Device For Subcutaneous Injection 10 x 1 mL Single Dose Syringes Rx Only, Manufactured by: Gland Pharma Ltd. Hyderabad, India Manufactured for: Apotex Corp. Weston, FL 33326 NDC 60505-0795-4 UPC 360505079544 (carton) NDC 60505-0795-1 UPC (01)10360505079510 (label)
by Apotex Corp.
- Reason
- Labeling; Label Mixup; syringe barrels may containing markings for 150 mg/mL (corresponding to 120 mg/0.8mL strength) instead of 100 mg/mL markings (corresponding to 100 mg/mL strength)
- Published
- February 17, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Lidocaine/Tetracaine (LIPO110)* 23%/7% Ointment 100 GMS per 4 ounce plastic ointment jar, Rx Only, Stanley Specialty Pharmacy 3120 Latrobe Dr. Suite 200 Charlotte, NC 28211
by Stanley Specialty Pharmacy Compounding and Wellness Center
- Reason
- Superpotent Drug. Lidocaine higher concentration than listed
- Published
- February 17, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Pantoprazole Sodium for Injection 40mg/vial For I.V. infusion only Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512 Manufactured by: Sun Pharmaceutical Industries Ltd. Halol-Baroda Highway, Halol-389 350, Gujarat, India NDC 62756-129-40
by SUN PHARMACEUTICAL INDUSTRIES INC
- Reason
- Failed Impurity/Degradation Specifications
- Published
- February 17, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Glycopyrrolate Injection, USP 0.4 mg/2 mL (0.2 mg/mL) 25 x 2 mL Single Dose Vials Rx Only, Manufactured for: Accord Healthcare, Inc. Durham, NC 27703, USA. Manufactured by: Intas Pharmaceuticals Limited, Ahmedabad-382 210, India NDC 16729-472-08 (Vial NDC 16729-472-30)
by ACCORD HEALTHCARE, INC.
- Reason
- Labeling; Label Mix-up; correctly labeled 2 mL vials were packaged into blister strips labeled for 1 mL vials
- Published
- February 17, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Glanbia Performance Nutrition (Manufacturing), Inc
- Product
- think! Protein + Fiber Oatmeal, Farmer's Market Berry Crumbl…
- Reason
- Undeclared ingredients including but not limited to pecans and almonds
- Published
- February 17, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Metformin Hydrochloride Extended-Release Tablets, USP, 750 mg, 100 Tablets per bottle, Rx Only, Manufactured by: Nostrum Laboratories, Inc., Kansas City, MO 64120. NDC: 29033-056-01
by Nostrum Laboratories Inc
- Reason
- CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level.
- Published
- February 10, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Acetaminophen Injection 1,000 mg per 100 mL (10 mg/mL), 100 mL Single Dose Vial, For Intravenous Use Only, Distributed by: AuroMedics Pharma LLC 279 Princeton-Hightstown Rd. E. Windsor, NJ 08520 Made in India NDC 55150-307-01
by AuroMedics Pharma LLC
- Reason
- Discoloration and failed pH specifications
- Published
- February 10, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Oseltamivir Phosphate for Oral Suspension, 6 mg/mL, 60 mL (usable volume after constitution), Rx only, Manufactured for:Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, Manufactured by: Lupin Limited Aurangabad, Maharashtra, India. NDC: 68180-678-01
by Lupin Pharmaceuticals Inc.
- Reason
- Failed Impurities/Degradation Specifications; Out-of-specification test results observed for Impurity C at 9 month long-term stability time point.
- Published
- February 10, 2021
- 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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