Weekly Safety Pulse: FAERS & Recalls

If you work anywhere near an ED, ICU, infusion center, pharmacy, or poison center, you already know the vibe: the hazards are rarely “new molecules” and almost always human systems + labeling + supply chain chaos.

Here’s a clean roundup of the latest FDA postings that intersect with overdose, toxic exposure, poisoning risk, or “this will absolutely become a consult.”

Already covered on MedicalToxic.com (Public Health Warnings & Recalls):

• FDA Issues Critical Age Limits for Scopolamine Patch Safety: https://medicaltoxic.com/news/fda-issues-critical-age-limits-for-scopolamine-patch-safety

• MedWatch Recall: Lead-Contaminated Rheumacare Capsules: https://medicaltoxic.com/news/medwatch-recall-lead-contaminated-rheumacare-capsules

• FDA Safety Alert: Nicotine Pouches and Pediatric Poisoning Risk: https://medicaltoxic.com/news/fda-safety-alert-nicotine-pouches-and-pediatric-poisoning-r

1) Latest FAERS quarterly “Potential Signals” posting (July–September 2025; content current as of Dec 31, 2025)

Medication error signal: Wrong drug administered
FAERS flagged a medication-error signal involving Septocaine (articaine HCl + epinephrine injection) and mepivacaine hydrochloride injection (a particular generic product) with the potential signal: “Wrong drug administered.” FDA notes it is evaluating the need for regulatory action. [2]

Toxicology lens: This is the kind of “simple” wrong-drug event that can produce very non-simple outcomes (local anesthetic systemic toxicity risk, unexpected hemodynamic effects from epinephrine-containing products, etc.). Packaging/workflow often starts the fire.

“Rising adverse-event reports” (severe allergic-type presentations): IGIV/IGSC lot-specific hypersensitivity
In the same quarter, FAERS highlighted increased hypersensitivity reactions tied to specific immune globulin lots and linked to an FDA safety communication. [2] FDA reports increased FAERS reporting of allergic/hypersensitivity reactions after infusion of certain IGIV/IGSC lots, including severe cases requiring epinephrine, steroids, and/or ED/hospital care, and recommends ceasing use immediately if affected lots are in stock. [3]

Affected lots:

• Asceniv lot #239825

• Bivigam lot #237452 [3]

2) FDA Drug Safety Communications (DSCs): newest items

Jan 13, 2026: GLP-1 RA labeling change request (not an overdose topic, but newest DSC)
The FDA requested removal of suicidal ideation/behavior language from labeling for Saxenda (liraglutide), Wegovy (semaglutide), and Zepbound (tirzepatide) after a comprehensive review found no increased risk of SI/B with GLP-1 RAs. [5] The DSC index is here. [4]

Jul 31, 2025: Opioid pain medicines labeling updates (most overdose-relevant, class-wide DSC)
FDA required labeling updates emphasizing long-term risks including fatal and non-fatal overdose, and reinforced that higher doses increase risk and risks persist over time. [6,7]

3) MedWatch / Safety Alerts & Recalls most relevant to overdose/toxic exposure (recent)

Potassium chloride overdose risk (labeling mix-up)
The FDA posted a recall notice for 20 mEq potassium chloride injection where the overwrap may incorrectly identify it as 10 mEq, warning overdose may lead to hyperkalemia, dysrhythmias, and cardiac arrest (FDA publish date Nov 3, 2025). [10]

Undeclared drug(s) in supplement (overdose/tox risk): Modern Warrior Ready
The FDA posted a recall stating testing identified undeclared tianeptine, 1,4-DMAA, and aniracetam (FDA publish date Jan 9, 2026). The notice highlights serious toxicity/overdose risks and cardiovascular risk from stimulant ingredients. [11]

Undeclared NSAID exposure: Silintan (meloxicam)
The FDA posted a recall stating Silintan contained undeclared meloxicam, with risks including serious harms and drug–drug interaction concerns (FDA publish date Jan 9, 2026). [12]

Counterfeit injectable product warning: counterfeit Ozempic
FDA updated its warning that counterfeit Ozempic (semaglutide) injection has been found in the U.S. supply chain, emphasizing sourcing only through state-licensed pharmacies and reporting events to MedWatch. [13]

Helpful navigation:

• MedWatch gateway. [8]

• FDA Drug Recalls page. [9]

Practical takeaways (the part people pretend they don’t need, then desperately need)

• Inventory triage beats heroics: check stock for the IGIV lots and pull/quarantine immediately if present. [3]

• High-alert med + mislabeled overwrap = predictable disaster: push a rapid internal alert for the KCl 20 mEq mislabeled as 10 mEq recall. [10]

• Supplements remain the Wild West: undeclared tianeptine/1,4-DMAA/aniracetam and hidden meloxicam are exactly the kind of “mystery tox” behind tachycardia, seizures, GI bleed, AKI, and odd tox screens. [11,12]

• Counterfeit injectables are a supply-chain problem with bedside consequences: reinforce legitimate sourcing and lot/packaging checks when FDA posts updates. [13]

• Remember what FAERS is (and isn’t): “Potential Signals” are not causality, but they’re useful smoke detectors. [1]

References:

1. U.S. Food and Drug Administration. Potential Signals of Serious Risks/New Safety Information Identified from the FDA Adverse Event Reporting System (FAERS) [Internet]. Silver Spring (MD): FDA; content current as of 2025 Dec 31 [cited 2026 Jan 21]. Available from: https://www.fda.gov/drugs/fdas-adverse-event-reporting-system-faers/potential-signals-serious-risksnew-safety-information-identified-fda-adverse-event-reporting-system

2. U.S. Food and Drug Administration. July - September 2025 | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS) [Internet]. Silver Spring (MD): FDA; content current as of 2025 Dec 31 [cited 2026 Jan 21]. Available from: https://www.fda.gov/drugs/fdas-adverse-event-reporting-system-faers/july-september-2025-potential-signals-serious-risksnew-safety-information-identified-fda-adverse

3. U.S. Food and Drug Administration. Immune Globulin Intravenous (IGIV) and/or Immune Globulin Subcutaneous (IGSC) Lots with Increased Reports of Allergic/Hypersensitivity Reactions [Internet]. Silver Spring (MD): FDA; 2025 Oct 28 [cited 2026 Jan 21]. Available from: https://www.fda.gov/vaccines-blood-biologics/immune-globulin-intravenous-igiv-andor-immune-globulin-subcutaneous-igsc-lots-increased-reports

4. U.S. Food and Drug Administration. Drug Safety Communications [Internet]. Silver Spring (MD): FDA; content current as of 2026 Jan 13 [cited 2026 Jan 21]. Available from: https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications

5. U.S. Food and Drug Administration. FDA Requests Removal of Suicidal Behavior and Ideation Warning from Glucagon-Like Peptide-1 Receptor Agonist (GLP-1 RA) Medications [Internet]. Silver Spring (MD): FDA; 2026 Jan 13 [cited 2026 Jan 21]. Available from: https://www.fda.gov/drugs/drug-safety-and-availability/fda-requests-removal-suicidal-behavior-and-ideation-warning-glucagon-peptide-1-receptor-agonist-glp

6. U.S. Food and Drug Administration. FDA is requiring opioid pain medicine manufacturers to update prescribing information regarding long-term use [Internet]. Silver Spring (MD): FDA; 2025 Jul 31 [cited 2026 Jan 21]. Available from: https://www.fda.gov/drugs/drug-safety-and-availability/fda-requiring-opioid-pain-medicine-manufacturers-update-prescribing-information-regarding-long-term

7. U.S. Food and Drug Administration. FDA Requires Major Changes to Opioid Pain Medication Labeling to Emphasize Risks [Internet]. Silver Spring (MD): FDA; 2025 Jul 31 [cited 2026 Jan 21]. Available from: https://www.fda.gov/news-events/press-announcements/fda-requires-major-changes-opioid-pain-medication-labeling-emphasize-risks

8. U.S. Food and Drug Administration. MedWatch: The FDA Safety Information and Adverse Event Reporting Program [Internet]. Silver Spring (MD): FDA; content current as of 2026 Jan 16 [cited 2026 Jan 21]. Available from: https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program

9. U.S. Food and Drug Administration. Drug Recalls [Internet]. Silver Spring (MD): FDA [cited 2026 Jan 21]. Available from: https://www.fda.gov/drugs/drug-safety-and-availability/drug-recalls

10. U.S. Food and Drug Administration. Otsuka ICU Medical LLC Issues Voluntary Nationwide Recall of 20 mEq Potassium Chloride Injection Due To Overwrap Mislabeled As 10 mEq Potassium Chloride Injection [Internet]. Silver Spring (MD): FDA; FDA publish date 2025 Nov 03 [cited 2026 Jan 21]. Available from: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/otsuka-icu-medical-llc-issues-voluntary-nationwide-recall-20-meq-potassium-chloride-injection-due

11. U.S. Food and Drug Administration. Modern Warrior Recalls “Modern Warrior Ready” Dietary Supplement Due to Undeclared 1,4-DMAA and Aniracetam, as Well as Tianeptine, Which has Not Been Approved for Supplement Use by the FDA [Internet]. Silver Spring (MD): FDA; 2026 Jan 09 [cited 2026 Jan 21]. Available from: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/modern-warrior-recalls-modern-warrior-ready-dietary-supplement-due-undeclared-14-dmaa-and-aniracetam

12. U.S. Food and Drug Administration. Anthony Trinh, 123Herbals LLC (123HERBALS.COM) Issues Nationwide Recall of Silintan Capsules Due to the Presence of Undeclared Meloxicam [Internet]. Silver Spring (MD): FDA; 2026 Jan 09 [cited 2026 Jan 21]. Available from: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/anthony-trinh-123herbals-llc-123herbalscom-issues-nationwide-recall-silintan-capsules-due-presence

13. U.S. Food and Drug Administration. FDA warns consumers not to use counterfeit Ozempic (semaglutide) found in U.S. drug supply chain [Internet]. Silver Spring (MD): FDA; updated 2025 Dec 05 [cited 2026 Jan 21]. Available from: https://www.fda.gov/drugs/drug-safety-and-availability/fda-warns-consumers-not-use-counterfeit-ozempic-semaglutide-found-us-drug-supply-chain