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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Drug
Medications & Supplements/Over-the-Counter

US Pharmaceuticals Inc.: Various Glycerin Suppositories and Topicals Recalled for Water Contamination

Agency Publication Date: August 13, 2019
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Summary

Approximately 17,307 units of various over-the-counter medications, including glycerin suppositories, hydrocortisone creams, and pain relief gels, have been recalled by US Pharmaceuticals Inc. due to deviations from manufacturing standards. Specifically, the purified water used to make these products failed quality tests for microbial counts and organic carbon levels. The recall affects several store brands, including CVS Health and Walgreens, sold nationwide between 2017 and 2021. Consumers should stop using these products and consult a healthcare professional, especially if they have used them on broken skin or sensitive areas.

Risk

The use of products manufactured with contaminated water can lead to infections, particularly in vulnerable populations, children, or when applied to damaged skin. While no specific injuries have been reported in this data, the presence of excessive microbial levels in topical and rectal products poses a risk of illness or adverse skin reactions.

What You Should Do

  1. Immediately check your medicine cabinet for affected CVS Health, Walgreens, Medline, CRYO-273, Unipack, Dee Cee Laboratories, or Wonder Laboratories products.
  2. Verify the lot numbers and expiration dates on the packaging. For example, check CVS Glycerin Suppositories (50-count) for lots 52J17 through 60J17 with expiration 07/2019, or Walgreens Hydrocortisone Cream with Aloe for lot 63J17.
  3. Stop using any products that match the affected lot numbers and expiration dates listed in the product section.
  4. Contact your healthcare provider or pharmacist for guidance if you have recently used these products and have concerns about your health.
  5. Return any unused product to the pharmacy or place of purchase for a full refund.
  6. Contact US Pharmaceuticals Inc. or the distributor listed on your product packaging for further instructions regarding the return process.
  7. For additional questions, call the FDA Consumer Complaint hotline at 1-888-723-3332 or visit www.fda.gov/safety/recalls.

Your Remedy Options

💰Full Refund

Return for refund

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: CVS Health Glycerin Suppositories (50-count box)
Model:
Recall #: D-1724-2019
UPC Codes:
050428331064
Lot Numbers:
52J17 (Exp 07/2019)
53J17 (Exp 07/2019)
54J17 (Exp 07/2019)
55J17 (Exp 07/2019)
59J17 (Exp 07/2019)
60J17 (Exp 07/2019)
Date Ranges: EXP 07/2019
Product: Eczema Lotion Hydrocortisone 1% / Anti-Itch Lotion (3.5 oz)
Model:
NDC 0363-0670-04
Recall #: D-1725-2019
UPC Codes:
311917193083
Lot Numbers:
36P17 (Exp 11/2019)
Date Ranges: EXP 11/2019
Product: CVS Therapeutic Menthol Gel (8 FL OZ)
Model:
Recall #: D-1726-2019
UPC Codes:
050428481363
Lot Numbers:
28L17 (Exp 09/2019)
31L17 (Exp 09/2019)
36L17 (Exp 09/2019)
40L17 (Exp 09/2019)
44L17 (Exp 09/2019)
05M17 (Exp 10/2019)
09M17 (Exp 10/2019)
12M17 (Exp 10/2019)
13M17 (Exp 10/2019)
23M17 (Exp 10/2019)
69P17 (Exp 11/2019)
72P17 (Exp 11/2019)
42S17 (Exp 12/2019)
46S17 (Exp 12/2019)
85C18 (Exp 03/2020)
86C18 (Exp 03/2020)
31J18 (Exp 07/2020)
43J18 (Exp 07/2020)
55J18 (Exp 07/2020)
58J18 (Exp 07/2020)
18L18 (Exp 07/2020)
Date Ranges: September 2019 - July 2020
Product: Children Glycerin Suppositories Laxative (25-count)
Model:
NDC 0363-0440-25
Recall #: D-1727-2019
Lot Numbers:
88J17 (Exp 07/2019)
Date Ranges: EXP 07/2019
Product: Adult Glycerin Suppositories (25-count)
Model:
NDC 0363-0445-25
Recall #: D-1728-2019
Lot Numbers:
01K17 (Exp 08/2019)
02K17 (Exp 08/2019)
Date Ranges: EXP 08/2019
Product: Adult Glycerin Suppositories (50-count)
Model:
NDC 0363-0441-50
Recall #: D-1729-2019
Lot Numbers:
39P17 (Exp 11/2019)
42P17 (Exp 11/2019)
43P17 (Exp 11/2019)
44P17 (Exp 11/2019)
Date Ranges: EXP 11/2019
Product: Adult Glycerin Suppositories (100-count)
Model:
NDC 0363-0441-00
Recall #: D-1730-2019
Lot Numbers:
68J17 (Exp 07/2019)
71J17 (Exp 07/2019)
72J17 (Exp 07/2019)
73J17 (Exp 07/2019)
77J17 (Exp 07/2019)
78J17 (Exp 07/2019)
79J17 (Exp 07/2019)
81J17 (Exp 07/2019)
82J17 (Exp 07/2019)
27P17 (Exp 11/2019)
28P17 (Exp 11/2019)
29P17 (Exp 11/2019)
30P17 (Exp 11/2019)
31P17 (Exp 11/2019)
32P17 (Exp 11/2019)
33P17 (Exp 11/2019)
37P17 (Exp 11/2019)
38P17 (Exp 11/2019)
Date Ranges: July 2019 - November 2019
Product: Hydrocortisone Cream With Aloe (1 oz)
Model:
NDC 0363-0620-03
Recall #: D-1731-2019
UPC Codes:
311917179353
Lot Numbers:
63J17 (Exp 07/2019)
11P17 (Exp 11/2019)
Date Ranges: July 2019 - November 2019
Product: Hydrocortisone Cream With Aloe (2 oz)
Model:
NDC 0363-0620-04
Recall #: D-1732-2019
UPC Codes:
311917179346
Lot Numbers:
11P17 (Exp 11/2019)
20P17 (Exp 11/2019)
Date Ranges: EXP 11/2019
Product: Hydrocortisone Cream Anti-Itch (1 oz)
Model:
NDC 0363-0638-03
Recall #: D-1733-2019
UPC Codes:
311917182452
Lot Numbers:
56J17 (Exp 07/2019)
Date Ranges: EXP 07/2019
Product: Hydrocortisone Cream Anti-Itch (2 oz)
Model:
NDC 0363-0638-04
Recall #: D-1734-2019
UPC Codes:
311917182476
Lot Numbers:
56J17 (Exp 07/2019)
Date Ranges: EXP 07/2019
Product: Soothe&Cool Protect Moisture Guard Skin Protectant (3.5 oz)
Model:
NDC 53329-303-22
Recall #: D-1735-2019
Lot Numbers:
57J17 (Exp 07/2019)
Date Ranges: EXP 07/2019
Product: CVS Health Glycerin Suppositories (100-count box)
Model:
Recall #: D-1736-2019
UPC Codes:
050428427385
Lot Numbers:
61J17 (Exp 07/2019)
62J17 (Exp 07/2019)
65J17 (Exp 07/2019)
66J17 (Exp 07/2019)
67J17 (Exp 07/2019)
83J17 (Exp 07/2019)
86J17 (Exp 07/2019)
87J17 (Exp 07/2019)
06P17 (Exp 11/2019)
08P17 (Exp 11/2019)
09P17 (Exp 11/2019)
10P17 (Exp 11/2019)
12P17 (Exp 11/2019)
13P17 (Exp 11/2019)
15P17 (Exp 11/2019)
16P17 (Exp 11/2019)
17P17 (Exp 11/2019)
18P17 (Exp 11/2019)
19P17 (Exp 11/2019)
21P17 (Exp 11/2019)
22P17 (Exp 11/2019)
23P17 (Exp 11/2019)
24P17 (Exp 11/2019)
26P17 (Exp 11/2019)
Date Ranges: July 2019 - November 2019
Product: CRYO-273 Cold Pain Relieving Gel Roll-On (3 FL. OZ.)
Model:
Recall #: D-1737-2019
UPC Codes:
815290015296
Lot Numbers:
09K17 (Exp 08/2019)
13K17 (Exp 08/2019)
Date Ranges: EXP 08/2019
Product: Cool Hot Ice Analgesic Gel (8 oz)
Model:
Recall #: D-1738-2019
UPC Codes:
751393006086
Lot Numbers:
14L18 (Exp 09/2020)
Date Ranges: EXP 09/2020
Product: Kool Comfort Cooling Pain Relief 5% Menthol (Various Sizes)
Model:
Recall #: D-1739-2019
UPC Codes:
052301359035
052301365043
052301365326
052301365166
052301365128
Lot Numbers:
27H18 (Exp 06/2021)
32H18 (Exp 06/2021)
42H18 (Exp 06/2021)
21J18 (Exp 07/2021)
Date Ranges: June 2021 - July 2021
Product: Wonder Freeze Pain Relieving Gel with ILEX 5% Menthol (Various Sizes)
Model:
Recall #: D-1740-2019
UPC Codes:
099528359035
099528315048
099528315161
Lot Numbers:
21J18 (Exp 07/2021)
42H18 (Exp 06/2021)
32H18 (Exp 06/2021)
Date Ranges: June 2021 - July 2021
Product: CRYO-273 Cold Pain Relieving Gel (128 FL. OZ.)
Model:
Recall #: D-1741-2019
UPC Codes:
815290015502
Lot Numbers:
13K17 (Exp 08/2019)
03L17 (Exp 09/2019)
74H18 (Exp 06/2020)
18J18 (Exp 06/2020)
Date Ranges: August 2019 - June 2020

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 83316
Status: Resolved
Manufacturer: US Pharmaceuticals Inc.
Sold By: CVS Pharmacy; Walgreens; Medline Industries; CRYO-273.com; Unipack Inc; Dee Cee Laboratories; Wonder Laboratories
Manufactured In: United States
Units Affected: 18 products (144 cases; 533 cases; 5017 cases; 76 cases; 98 cases; 196 cases; 880 cases; 3114 cases; 1223 cases; 305 cases; 651 cases; 830 tubes; 1174 cases; 167 cases; 246 cases; 2192 cases; 147 cases; 314 cases)
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.