FDA Recall
Terminated
Historical recordClass II
Shine & Clean Hand Sanitizer gel, (Ethyl Alcohol 70%), 33.81 fl oz (1L) bottle, Made in Mexico By: Maquiladora Miniara S.A. de C.V. Carrerera Teoloyucan Huehuetoca km: 22 S/N La Planada Mexico C.P.: 54665 NDC 76753-001-01
by Maquiladora Miniara Sa De Cv
- Reason
- CGMP Deviations: Products manufactured at the same site were FDA testing found below the label claim for ethanol content and the presence of undeclared methanol.
- Published
- September 16, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Just Hand Sanitizer (Ethyl Alcohol 73%) Single Use-Packs 100-count NDC 78065-2020-2 UPC 703123998598 (Single packs NDC 78065-2020-1 UPC 703123998659) Distributed by: Just Hand Sanitizer
by Open Book Extracts
- Reason
- Labeling Not Elsewhere Classified: Product labeled to contain methanol
- Published
- September 16, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Always Be Clean Hand Sanitizer (73% Alcohol) 0.04 FL OZ (1.2 mL) packaged in a) Single snaps (NDC 75091-2020-1 UPC 375091202016); b) 100-count boxes (NDC 75091-2020-2 UPC 375091202023); c) 25-count boxes (NDC 75091-2020-3 UPC 375091202030)
by Open Book Extracts
- Reason
- Labeling Not Elsewhere Classified: Product labeled to contain methanol
- Published
- September 16, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Cephalexin for Oral Suspension, USP 250 mg per 5 mL, For Reconstitution, For Oral Use Only, Rx Only, a) 100 mL bottle when mixed, NDC 0093-4177-73, b) 200 mL bottle when mixed, NDC 0093-4177-74, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454.
by Teva Pharmaceuticals USA
- Reason
- CGMP deviations; there is a possibility that some bottles in these lots may have the active ingredient above and/or below specification limits.
- Published
- September 16, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Cephalexin for Oral Suspension, USP 125 mg per 5 mL, For Reconstitution, For Oral Use Only, Rx Only, a) 100 mL bottle when mixed, NDC 0093-4175-73, b) 200 mL bottle when mixed, NDC 0093-4175-74, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454.
by Teva Pharmaceuticals USA
- Reason
- CGMP deviations; there is a possibility that some bottles in these lots may have the active ingredient above and/or below specification limits.
- Published
- September 16, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Kader Exports Pvt. Ltd.
- Product
- Cooked, Peeled and Deveined, Tail-on, Shrimp. AQUA STAR…
- Reason
- Frozen cooked shrimp is possibly contaminated with Salmonella.
- Published
- September 16, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Treehouse Foods
- Product
- Signature Select Chewy Granola Bars, Chocolate Chip, Family…
- Reason
- Product may contain undeclared peanut butter.
- Published
- September 16, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
Tranexamic Acid Injection, USP, 1000 mg/10 mL (100 mg/mL), 10 mL Single-Dose Vial (NDC 67457-197-00); 10 x 10 mL Single-Dose Vials per carton (NDC 67457-197-10), Rx only, Manufactured by: Mylan Institutional, Galway, Ireland; Manufactured for: Mylan Institutional LLC, Rockford, IL 61103.
by Mylan Institutional LLC
- Reason
- Labeling: Label Mix-Up; potential for cartons labeled as Tranexamic Acid Injection, USP to contain vials of Amiodarone HCl Injection, USP and cartons labeled as Amiodarone HCl Injection, USP to contain vials of Tranexamic Acid Injection, USP.
- Published
- September 9, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
Amiodarone Hydrochloride Injection, USP, 450 mg/9 mL (50 mg/mL), 9 mL Single-Dose Vial (NDC 67457-153-99); 10 x 9 mL Single-Dose Vials per carton (NDC 67457-153-09), Rx only, Manufactured by: Mylan Institutional, Galway, Ireland; Manufactured for: Mylan Institutional LLC, Rockford, IL 61103.
by Mylan Institutional LLC
- Reason
- Labeling: Label Mix-Up; potential for cartons labeled as Tranexamic Acid Injection, USP to contain vials of Amiodarone HCl Injection, USP and cartons labeled as Amiodarone HCl Injection, USP to contain vials of Tranexamic Acid Injection, USP.
- Published
- September 9, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
Skin Guard 24 All-Day Hand Sanitizer 1 4"x6" Hand Sanitizing Towelette packaged in 2.5 x 3.75 packets, Dist by: SG24 LLC, Bolingbroke, GA 31004
by SG24 LLC
- Reason
- Marketed without an Approved NDA/ANDA; product labeled to contain 0.56% methanol making it an unapproved new drug
- Published
- September 9, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
Skin Guard 24 All-Day Hand Sanitizer 10 mL Pocket Pen Dist by: SG24 LLC, Bolingbroke, GA 31004 UPC 793573147097
by SG24 LLC
- Reason
- Marketed without an Approved NDA/ANDA; product labeled to contain 0.56% methanol making it an unapproved new drug
- Published
- September 9, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
SkinGuard 24 All-Day Hand Sanitizer 8 oz. bottle with foam pump, Dist by: SG24 LLC, Bolingbroke, GA 31004 UPC 793573147125
by SG24 LLC
- Reason
- Marketed without an Approved NDA/ANDA; product labeled to contain 0.56% methanol making it an unapproved new drug
- Published
- September 9, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
SkinGuard 24 All-Day Hand Sanitizer 2.67 oz. bottle with foam pump, Dist by: SG24 LLC, Bolingbroke, GA 31004 UPC 793573147103
by SG24 LLC
- Reason
- Marketed without an Approved NDA/ANDA; product labeled to contain 0.56% methanol making it an unapproved new drug
- Published
- September 9, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
bio aaa Advance Hand Sanitizer Ethyl Alcohol 70%, Unscented, 16.23 Oz (480 mL), Distributed By: Payless Janitorial Corporation 1341 SW 21 Terrance, Fort Lauderdale, Florida Exported By: E. Audicode S.A. de C.V. Manufactured By: AAA Cosmetica S.A. de C.V. UPC 7 502272 12111 5
by AAA Cosmetica, SA de CV
- Reason
- Chemical Contamination: Product contains methanol.
- Published
- September 9, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
bio aaa Advance Hand Sanitizer Ethyl Alcohol 70%, Unscented, 16.23 Oz (480 mL), Distributed By: Payless Janitorial Corporation 1341 SW 21 Terrance, Fort Lauderdale, Florida Exported By: E. Audicode S.A. de C.V. Manufactured By: AAA Cosmetica S.A. de C.V. UPC 7 502272 12111 5
by AAA Cosmetica, SA de CV
- Reason
- CGMP Deviations
- Published
- September 9, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Command Brands GelAnti Bac Instant Hand Sanitizer, 70% Alcohol, , 8 FL OZ 250mL bottle, Roqueplast S.A. de C.V. Cda. Adolfo Manfredi #7 Altizapan de Zaragoza CP 52958 Edo de Mexico UPC 8 52239 00689 2
by ROQUE PLAST, S.A. DE C.V.
- Reason
- CGMP Deviation: Potential contamination with undeclared methanol.
- Published
- September 9, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
UltraCruz Hand Sanitizing Gel Antimicrobial (70% Isopropyl Alcohol), packaged in 3 Fluid Oz./89 mL bottes, Manufactured By Santa Cruz Biotechnology, Inc. 10410 Finnell St. Dallas, TX 75220
by Santa Cruz Biotechnology, Inc
- Reason
- Subpotent drug
- Published
- September 9, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Jaloma Antiseptic Hand Sanitizer, Ethyl Alcohol 62% with Vitamin E, packaged in a) 16.9 Fl. Oz. (1.06 pint, 500 mL), NDC# 65055-600-02, UPC# 759684515033, b) 4 Fl. Oz.(120 mL), NDC# 65055-600-01, UPC# 75968455026, Laboratorios Jaloma S.A. DE C.V., Aquiles Serdan 438, Z.P. 44380, Guadalajara, Jalisco, Mexico, Made in Mexico.
by Laboratorios Jaloma S.A. de C.V.
- Reason
- cGMP deviations
- Published
- September 9, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
WHOLE FOODS MARKET
- Product
- Whole Foods Market AGRIFORM PIAVE VECCHIO PLU 29336200000 I…
- Reason
- Undeclared lysozyme (from egg whites)
- Published
- September 9, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
WHOLE FOODS MARKET
- Product
- Whole Foods Market Mitica Mahon PLU 29341800000 Individual s…
- Reason
- Undeclared lysozyme (from egg whites)
- Published
- September 9, 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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