Inopak Ltd recalls Mild Health Care Antibacterial Hand Soap, .6% P.C.M.X., packaged in a) 1000 ml Disc Pump pouches, 8 x 1000 ml Disc Pump
Inopak recalls mild antibacterial hand soap with CGMP deviations. Products may not meet safety standards due to manufacturing issues. Consumers should check batch numbers and contact Inopak for details.
Recall notice
CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing practices.
Contact the company & request your remedy
What happened, in plain English
Inopak is recalling mild antibacterial hand soap that was not produced under current good manufacturing practices. This means the soap might not meet safety standards, potentially posing risks to users. Read more at govinfonow.com/recall/38884-inopak-mild-health-care-antibacterial-hand-soap-recall-cgmp-deviations.
Source Summary by GovInfoNow · govinfonow.com/recall/38884-inopak-mild-health-care-antibacterial-hand-soap-recall-cgmp-deviations · Updated October 5, 2026 · FDA enforcement record: FDA #D-1316-2019
Cite this page
“Inopak Mild Health Care Antibacterial Hand Soap Recall: CGMP Deviations.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/38884-inopak-mild-health-care-antibacterial-hand-soap-recall-cgmp-deviations. Based on FDA recall #D-1316-2019 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1316-2019%22&limit=1).
Why it’s dangerous
The hand soap was not made following current good manufacturing practices. This could mean the product does not meet safety standards, but the specific risks are not clearly described in the recall.
Who’s affected
Anyone who owns or uses the recalled hand soap products. People using the soap for hand hygiene are most at risk due to potential manufacturing issues.
How to tell if you have this one
Check for batch numbers 6656, 6959, or 7008 on the product. The products include 1000 ml Disc Pump pouches, 2000 ml Disc Pump pouches, 800 ml Universal Valve pouches, and 1 gallon bottles.
- Brand
Inopak- Category
Drug
All 10 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Terminated- Distribution
Nationwide in the USA
| Recall number | Product, codes & lots |
|---|---|
| D-1310-2019 | ANTIBACTERIAL Foaming Hand Wash With Moisturizers labeled as Antibacterial Foaming Soap, ACTIVE:P.C.M.X, packaged in a) 18 oz bottles, 12/18 oz bottles per case, 5063-432-02; b) 1 gallon bottles, 4/1 gallon bottles per case, 5063-420-03; c) Options Systems Antibacterial Foaming Hand Wash with .3% PCMX, packaged in 1000mL pouches, 6/1000ML pouches per case, 5063-OS1000; d) INOFOAM Antibacterial Foaming Hand Wash with .3% PCMX, packaged in 1000mL pouches, 6-1000ml pouches per case, 5063-FL1000, Inopak LTD., 24 Executive Parkway, Ringwood, NJ 07456.; Batch #: 6657, 6666, 6671, 6679, 6687, 6695, 6702, 6718, 6730, 6744, 6754, 6760, 6772, 6773, 6784, 6793, 6804, 6812, 6819, 6838, 6846, 6856, 6862, 6877, 6890, 6896, 6902, 6910, 6919, 6938, 6944, 6953, 6971, 6985, 6990, 6998, 7005, 7012, 7018, 7028, 7033, 7039, 7043, 7053, 7060, 7068, 7080, 7092, 7101, 7110, 7116, 7126, 7143, 7153, 7161, 7167, 7175, 7188, 7204, 7208, 7213, 7221, 7232, 7242, 7248, 7267, 7275, 7284, 7287, 7295, 7308, 7314, 7324, 7329, 7336, 7348, 7357, 7363, 7372, 7382, 7389, 7397, 7403, and 7411 |
| D-1311-2019 | AQUACIL instant foaming hand sanitizer, alcohol free formula, benzalkonium chloride 0.1% (w/w), packaged in a) 18 FL OZ (532 mL) bottles, 12/18OZ bottles per case, Product Code BIO-5075-432-02; b) 1000 ML pouches, 6/1000 ML pouches per case, Product Code BIO575-OS1000, Biocentris Pharmaceuticals (Division of Inopak).; Batch #: 6736, 6826 |
| D-1312-2019 | Instant Waterless Hand Sanitizer, Ethyl Alcohol, 62%, packaged as a) DermaGel Instant Waterless Hand Sanitizing Gel with Moisturizers, with Aloe Vera & Vitamin E, packaged in a) 1000 ml Disc Pump pouches (NDC 58575-340), 8 x 1000 ml Disc Pump pouches per case, Product Code 5025-L1000; b) 2 fl. oz. bottles, 80/2 oz bottles per case, 5025-480-02; c) 18 fl. oz. bottles (NDC 58575-340), 16/18 oz bottles per case, 5025-430-02; d) 8 FL OZ. bottle, 24/8 oz bottle per case, 5025-440-03; e) 4 fl. oz. bottles, 24 x 4oz. Bottles per case, 5025-450-03; f) 800 ml pouches, 12 x 800 ml Universal Valve pouches per case, 5025-404-NB; g) 1 Gallon bottles, 4/1 gallon bottles per case, 5025-4202-02; Inopak LTD., Ringwood, NJ 07456. SaniTyze Hand Sanitizer with Aloe Vera, Vitamin E & Keratin, packaged as h) 8 fl oz (237 ml) bottles, 24/ 8 Oz. bottles per case; Manufactured for Crosstex International, Inc., 10 Rarick Road, Hauppague, NY 11788-4209.; Batch #: 7069, 6648, 6649, 6652, 6654, 6667, 6669, 6675, 6677, 6684, 6686, 6692, 6694, 6703, 6704, 6710, 6717, 6719, 6726, 6727, 6731, 6733, 6739, 6743, 6748, 6751, 6752, 6759, 6763, 6767, 6769, 6771, 6775, 6776, 6780, 6782, 6787, 6788, 6801, 6805, 6808, 6811, 6814, 6815, 6821, 6824, 6825, 6830, 6831, 6836, 6843, 6845, 6852, 6859, 6860, 6874, 6878, 6880, 6881, 6884, 6889, 6897, 6900, 6903, 6905, 6912, 6920, 6922, 6926, 6928, 6931, 6940, 6945, 6948, 6951, 6954, 6962, 6967, 6969, 6972, 6975, 6980, 6986, 6989, 6995, 7002, 7015, 7023, 7029, 7030, 7035, 7044, 7047, 7048, 7051, 7059, 7062, 7066, 7072, 7073, 7079, 7081, 7084, 7085, 7088, 7090, 7095, 7096, 7099, 7102, 7105, 7112, 7113, 7115, 7124, 7125, and 7128. |
| D-1313-2019 | INODERM Antiseptic Hand Soap (E-2), .6% (incorrectly labeled on bags as 75%) PCMX, 800ml/27fl.oz.pouches (NDC 058575-110), 12 x 800 Bag-N-Box pouches per case (NDC 058575-110-80), 5014-404-NB; INOPAK, 24 Executive PKWY, Ringwood, NJ 07456.; Batch #: 7074 |
| D-1314-2019 | INOFOAM Foaming E-2 Food Handling Wash with .6% PCMX, 1000mL pouch (NDC 058575-110-11), 6/1000 ML pouches per case (NDC 058575-110-80), 5064-FL1000, Inopak, LTD.; Batch #: 7304, 7180, 6707, 7065 |
| D-1315-2019 | Antibacterial Hand Soap, Healthcare 2000, labeled as a) DERMA System CARE SaniClenz Antimicrobial Skin Cleanser (Chlorhexidine Gluconate), 4 x (1 gallon containers), Reorder/REF #JSCG; Manufactured for Crosstex International, Inc.; b) MEDI-WASH CHG Anti-Microbial Hand Wash with Chlorhexidine Gluconate; 1000ML pouches, 8/1000ML pouches per case, Walter G. Legge Co Inc, 444 Central AVE, Peekskill, NY 10566; Batch #: 6802, 6803, 6909, 6655 |
| D-1316-2019 | Mild Health Care Antibacterial Hand Soap, .6% P.C.M.X., packaged in a) 1000 ml Disc Pump pouches, 8 x 1000 ml Disc Pump pouches per case, 5013-L1000, b) 2000 ml. Disc Pump pouches, 4 x 2000 ml Disc Pump pouches per case, 5013-XL2000, c) 800 ml Universal Valve pouches, 12 x 800 ml Universal Valve pouches per case, 5013-404, d) 1 gallon bottles, 4/1 gallon bottles per case, 5013-420-02, INOPAK, LTD., 24 Executive Parkway, Ringwood, NJ 07456.; Batch #: 6656, 6959, 7008 |
| D-1317-2019 | Sani-Guard-SF Waterless Foam Hand Sanitizer, Ethyl Alcohol 70%, packaged in a) 6/1000 ml pouches per case, 5068-FL1000, b) 1000 ml cartridge pouch, 6/1000 ml .8ml Option Cartridge pouches per case, 5068-OS1000, Inopak LTD; Batch #: 6668, 6721 |
| D-1318-2019 | Antibacterial Hand Soap, .3% P.C.M.X, labeled as STYLE Antibacterial Hand Soap with moisturizers, a) 1000 ml pouches, 10/1000 ML. Large Valve pouches per case, 5031-404-LN, b) 1000 ml pouches, 8/1000 ML. Disc Pumps pouches per case, 5031-L1000, c) 800 ML Universal Valve pouches, 12/800 ML Universal Valve pouches per case, 5031-404, d) 800 ml pouches, 12/800 ML Presspak pouches per case, "B", 5031-403-1B, e) 800 ml pouches, 12 x 800ML. KC Valve pouches per case, 5031-404-KC, f) 800 ml pouches, 12/800 ML Universal Valve pouches per case, 5031-404, g) 800 ml pouches, 12/800 ML Presspak pouches per case, "B", 5031-403-1B, h) 500 ml pouches, 6/500 ML. KC Valve pouches per case, 5031-404-500-6, i) 500 ml pouches, 18/500 ML. KC Valve pouches per case, 5031-404-500, j) 500 ml pouches, 6/500 ML. KC Valve pouches per case, 5031-404-500-6, k) 8 oz. bottles, 24/8 OZ. bottles with pumps per case, 5031-440-03, l) 18 oz. bottles, 16 x 18 OZ. Bottles with Pumps per case, 5031-430-02, m) 1000 ml pouches, 10/1000 ML. Large Valve pouches per case, 5031-404-LN, n) 1000 ml pouches, 8/1000ML. Disc Pumps pouches per case, 5031-L1000; Choice Antibacterial Hand Soap, packaged as o) 800 ml/27fl.oz. pouches, 12/800 ml Universal Valve pouches per case, 5031-404UV-CH, Manufactured by Inopak LTD., Ringwood, NJ.; Batch #: 6660, 6664, 6676, 6682, 6685, 6698 ,6701, 6725, 6732, 6742, 6744, 6746, 6756, 6762, 6770, 6777, 6792, 6798, 6807, 6813, 6816, 6820, 6829, 6839, 6868, 6872, 6875, 6891, 6892, 6904, 6906, 6914, 6916, 6923, 6932, 6939, 6952, 6958, 6963, 6970, 6978, 6982, 6987, 6993, 6997, 7004, 7006, 7024, 7038, 7049, 7054, 7056, 7058, 7078, 7087, 7098, 7104, 7108, 7111, 7129, 7132, 7134, 7138, 7145, 7152, 7157, 7160, 7164, 7170, 7177, 7184, 7190, 7192, 7203, 7207, 7220, 7224, 7231, 7235, 7237, 7243, 7247, 7252, 7258, 7260, 7269, 7281, 7285, 7291, 7296, 7301, 7306, 7311, 7312, 7319, 7322, 7326, 7335, 7338, 7340, 7347, 7351, 7353, 7368, 7377, 7384, 7387, 7394 and 7399 |
| D-1319-2019 | Unison Hand Care Products, WHITE PEARLIZED Anti-Bacterial Hand Cleaner with Triclosan, #4302, with exclusive Bajan fragrance, packaged in 800 ML (27 FL OZ) pouch containers, 12-800 ml containers/12-27 FL. OZ. container pouches per case, National Chemical Laboratories, Inc., 401 North 10th Street, Philadelphia, PA 19123.; Batch # 6827 |
What to do — step by step
Check Product Details
Look for batch numbers 6656, 6959, or 7008 on the product.
Questions people ask
What products are being recalled?
Mild Health Care Antibacterial Hand Soap with .6% P.C.M.X., including 1000 ml Disc Pump pouches, 2000 ml Disc Pump pouches, 800 ml Universal Valve pouches, and 1 gallon bottles with batch numbers 6656, 6959, or 7008.
Why is this product being recalled?
The hand soap was not produced under current good manufacturing practices, which may mean it does not meet safety standards.
What should I do if I have the recalled product?
Check the product for batch numbers 6656, 6959, or 7008. Contact Inopak for further instructions.
Contact Inopak
We’ve drafted a message you can send Inopak to request your refund or repair — edit it as you like.
Subject: Recall D-1316-2019 — Inopak Inopak Hello, I own a Inopak that is covered by recall D-1316-2019 from Inopak. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
Similar recalls
Keep exploring
From people who’ve dealt with this
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-1316-2019 (April 22, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1316-2019 to see it in context.
- Plain-language summary written by qwen3:4b on October 5, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.