Browse Drug Recalls
5 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 5 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 5 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jan 20, 2026 | Medi-First Antiseptic Wipes (BZK)(Benzalkonium Chloride 0.13%), 100 wipes per... | CGMP Deviations | Class II | ACME UNITED CORPORATION |
| Jan 24, 2022 | Back Pain-Off (caffeine 50mg, magnesium salicylate 290mg) Tablets 2-count pac... | cGMP deviations | Class II | Ultra Seal Corporation |
| Dec 6, 2021 | Medique Pain-Off (Acetaminophen 250 mg, Aspirin (NSAID*) 250 mg, Caffeine 65 ... | CGMP Deviations: manufacturer recalled after an FDA inspection noted that these products were not... | Class II | Medique Products |
| Dec 6, 2021 | Extra Strength Headache (acetaminophen 250 mg, aspirin 250 mg, caffeine 65 mg... | CGMP Deviations: manufacturer recalled after an FDA inspection noted that these products were not... | Class II | Medique Products |
| Dec 6, 2021 | Physicians CARE Extra Strength PAIN RELIEVER [Acetaminophen, Aspirin (NSAID),... | CGMP Deviations: manufacturer recalled after an FDA inspection noted that these products were not... | Class II | Medique Products |
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.