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Browse Drug Recalls

6 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 6 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 6 FDA drug recalls.

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DateProductReasonClassFirm
Oct 9, 2025 FentaNYL Citrate PF, 500mcg/50 mL (10mcg/mL) in NACL, Injection for IV use, 5... Labeling: Incorrect or Missing Lot and/or Exp Date Class III STAQ Pharma, Inc.
Oct 9, 2025 Hydromorphone HCL PF, 10mg/50 mL (0.2mg/mL) in NACL, Injection for IV use, 50... Labeling: Incorrect or Missing Lot and/or Exp Date Class III STAQ Pharma, Inc.
Oct 9, 2025 Ketamine Hydrochloride, 50mg/5 mL (10mg/mL), Injection for IV use, 50 mL syri... Labeling: Incorrect or Missing Lot and/or Exp Date Class III STAQ Pharma, Inc.
Nov 29, 2023 ROPivacaine HCl 0.2% PF in Sodium Chloride 1,000 mg/500 mL (2 mg per mL) Inje... STAQ Pharma Inc. received consumer complaints related to leaking bags and other potential bag con... Class II STAQ Pharma, Inc.
Feb 3, 2022 Morphine Sulfate PF 25 mg/25mL (1 mg/mL) in NaCl, 25 mL in 30 mL Single Dose ... Labeling: Label Mix up; A limited number of syringes containing HYDROmorphone HCl PF were incorre... Class I STAQ Pharma, Inc.
Feb 3, 2022 HYDROmorphone HCl PF 10 mg/50 mL (0.2mg/mL) in NaCl, 50 mL in 50 mL Single Do... Labeling: Label Mix up; A limited number of syringes containing HYDROmorphone HCl PF were incorre... Class I STAQ Pharma, Inc.

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.