Browse Drug Recalls
24 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 24 FDA drug recall enforcement actions. Each entry includes the product description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.
Drug Safety Recalls
Browse 24 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Nov 19, 2020 | CVS Health Hydrating Healing Ointment (Petrolatum 41%), Net Wt 3 OZ (85g), Di... | Lack Of CGMP:s Low weight fill tubes were identified in one lot of CVS Healing Ointment. | Class II | US Pharmaceuticals Inc. |
| Jul 11, 2019 | Children Glycerin Suppositories Laxative for ages 2 to 5. Package Size 25-cou... | CGMP Deviations: Out of Specification results for either total microbial count or total organic c... | Class II | US Pharmaceuticals Inc. |
| Jul 11, 2019 | CVS Health Glycerin Suppositories, 50-count box, Distributed by: CVS Pharmacy... | CGMP Deviations: Out of Specification results for either total microbial count or total organic c... | Class II | US Pharmaceuticals Inc. |
| Jul 11, 2019 | Adult Glycerin Suppositories, Package Size 25-count suppositories, Distribute... | CGMP Deviations: Out of Specification results for either total microbial count or total organic c... | Class II | US Pharmaceuticals Inc. |
| Jul 11, 2019 | CVS Therapeutic Menthol Gel, 8 FL OZ (227 g) Distributed by: CVS Pharmacy, In... | CGMP Deviations: Out of Specification results for either total microbial count or total organic c... | Class II | US Pharmaceuticals Inc. |
| Jul 11, 2019 | Hydrocortisone Cream, Hydrocortisone 1% / Anti-Itch Cream, 2 OZ (56 g) tube. ... | CGMP Deviations: Out of Specification results for either total microbial count or total organic c... | Class II | US Pharmaceuticals Inc. |
| Jul 11, 2019 | Soothe&Cool Protect Moisture Guard Skin Protectant, 3.5 oz. (99 g), tube, Man... | CGMP Deviations: Out of Specification results for either total microbial count or total organic c... | Class II | US Pharmaceuticals Inc. |
| Jul 11, 2019 | Hydrocortisone Cream With Aloe, Hydrocortisone 1% / Anti-Itch Cream with Aloe... | CGMP Deviations: Out of Specification results for either total microbial count or total organic c... | Class II | US Pharmaceuticals Inc. |
| Jul 11, 2019 | Hydrocortisone Cream, Hydrocortisone 1% / Anti-Itch Cream, 1 OZ (28 g) tube. ... | CGMP Deviations: Out of Specification results for either total microbial count or total organic c... | Class II | US Pharmaceuticals Inc. |
| Jul 11, 2019 | Eczema Lotion Hydrocortisone 1% / Anti-Itch Lotion, 3.5 oz (99.2 g) Distribut... | CGMP Deviations: Out of Specification results for either total microbial count or total organic c... | Class II | US Pharmaceuticals Inc. |
| Jul 11, 2019 | CVS Health Glycerin Suppositories, 100- count box, Distributed by:Distributed... | CGMP Deviations: Out of Specification results for either total microbial count or total organic c... | Class II | US Pharmaceuticals Inc. |
| Jul 11, 2019 | Hydrocortisone Cream With Aloe, Hydrocortisone 1% / Anti-Itch Cream with Aloe... | CGMP Deviations: Out of Specification results for either total microbial count or total organic c... | Class II | US Pharmaceuticals Inc. |
| Jul 11, 2019 | Wonder Freeze Pain Releiving Gel with ILEX, Menthol 5%, packaged in a) 3 OZ /... | CGMP Deviations: Out of Specification results for either total microbial count or total organic c... | Class II | US Pharmaceuticals Inc. |
| Jul 11, 2019 | Kool Comfort Cooling Pain Relief, 5% Menthol, Packaged in a) 3 OZ./85 g (UPC... | CGMP Deviations: Out of Specification results for either total microbial count or total organic c... | Class II | US Pharmaceuticals Inc. |
| Jul 11, 2019 | Cool Hot Ice Analgesic Gel, 8 oz (227 g) Distributed by: Unipack Inc. Pittsbu... | CGMP Deviations: Out of Specification results for either total microbial count or total organic c... | Class II | US Pharmaceuticals Inc. |
| Jul 11, 2019 | CRYO-273 Cold Pain Relieving Gel Roll-On 3 FL. OZ. (89 mL) Distributed By: CR... | CGMP Deviations: Out of Specification results for either total microbial count or total organic c... | Class II | US Pharmaceuticals Inc. |
| Jul 11, 2019 | Adult Glycerin Suppositories, Package Size 50-count suppositories, Distribute... | CGMP Deviations: Out of Specification results for either total microbial count or total organic c... | Class II | US Pharmaceuticals Inc. |
| Jul 11, 2019 | Adult Glycerin Suppositories, Package Size 100-count suppositories, Distribut... | CGMP Deviations: Out of Specification results for either total microbial count or total organic c... | Class II | US Pharmaceuticals Inc. |
| Jul 11, 2019 | CRYO-273 Cold Pain Relieving Gel 128 FL. OZ. Distributed By: CRYO-273.com Ta... | CGMP Deviations: Out of Specification results for either total microbial count or total organic c... | Class II | US Pharmaceuticals Inc. |
| Dec 7, 2018 | Hydrocortisone Cream 1% MS Anti itch Cream with Intensive Healing 2 oz tubes,... | GMP Deviations: Out of specification results for Total Aerobic Microbial count in excipient purif... | Class II | US Pharmaceuticals Inc. |
| Dec 7, 2018 | Medline Remedy Essential Barrier Skin Protectant Ointment (petrolatum 59%) pa... | GMP Deviations: Out of specification results for Total Aerobic Microbial count in excipient purif... | Class II | US Pharmaceuticals Inc. |
| Dec 7, 2018 | Soothe & Cool Protect Moisture Guard Skin Protectant (petrolatum 59%),3.5 oz ... | GMP Deviations: Out of specification results for Total Aerobic Microbial count in excipient purif... | Class II | US Pharmaceuticals Inc. |
| May 26, 2016 | Remeven Cream, (50% Urea in a Cream Base), a) 5.0 oz (142 g) and b) 9.0 oz ... | Crystallization; Complaints that cream appears to have crystallized | Class III | Stratus Pharmaceuticals Inc |
| Jul 1, 2013 | Benztropine Mesylate Injection, USP, 2 mg/2 mL (1 mg/1 mL), 2 mL Single Dose ... | Presence of particulate matter: characterized as thin colorless flakes that are visually and che... | Class II | Fresenius Kabi USA, LLC |
Frequently Asked Questions
When a drug safety issue is identified — through FDA inspections, laboratory testing, adverse event reports, or manufacturer quality checks — the responsible company issues a recall to remove the affected products from the market. Pharmacies pull the product from shelves, and consumers are advised to contact their healthcare provider for alternatives.
The leading causes include cGMP deviations, impurity contamination (including nitrosamines like NDMA), failed dissolution or stability testing, sterility issues, potency problems, labeling errors, and foreign particle contamination.
Use the search and filter tools on this page to look up specific medications, active ingredients, or manufacturers. Each recall entry includes the product description, lot numbers, and distribution details.