droplet® pen needles 32Gx4mmRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00857273002091), received between Feb 10, 2026 and May 15, 2026 — classified as 1 injury, 7 malfunctions.

The most frequently reported specific device problem is “No Flow” (8 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 15, 2026No Flow

  ON (B)(6) 2026 HTL-STREFA INC. RECEIVED A PHONE CALL COMPLAINT. CUSTOMER STATED SEVERAL PEN NEEDLES FAILED TO PRIME AND DISPENSE INSULIN. SHE SAID DROP OF INSULIN WAS NOT VISIBLE AT THE END OF THE PEN NEEDLE TIP. SHE CONFIRMED FOLLOWING THE IFU AND DID NOT SUFFER ANY HEALTH CONSEQUENCE FROM THE COMPLAINT. SHE USES TOUJEO AND NOVALOG INSULIN PENS AND CONFIRMED HAVING THE ISSUE WITH BOTH PENS. SHE SAID OVER 12 PEN NEEDLES HAVE FAILED OVER TWO BOXES. WE ARE PROVIDING REPLACEMENT SAMPLES AND THE CUSTOMER AGREED TO SUBMIT SAMPLES FOR INVESTIGATION ANALYSIS. SAMPLE UNDER COMPLAINT HAS NOT BEEN RETURNED FOR FURTHER EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25183959 ↗
• MalfunctionApr 3, 2026No Flow

  ON (B)(6) 2026 HTL-STREFA INC. RECEIVED A PHONE CALL COMPLAINT. CUSTOMER STATED SEVERAL PEN NEEDLES HAVE FAILED TO DISPENSE INSULIN. SHE HAS 10 FAILURES OUT OF HER CURRENT BOX. SHE USES LANTUS SOLOSTAR INJECTION PEN. SHE CONFIRMED THAT SHE FOLLOWS THE IFU AND DID NOT SUFFER ANY MIS DOSING OR HEALTH CONSEQUENCE. WE ARE PROVIDING REPLACEMENT SAMPLES AND THE CUSTOMER AGREED TO SUBMIT SAMPLES FOR INVESTIGATION ANALYSIS. SAMPLE UNDER COMPLAINT HAS NOT BEEN RETURNED FOR FURTHER EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24781234 ↗
• InjuryApr 3, 2026No Flow

  ON 03/16/2026 HTL-STREFA INC. RECEIVED A PHONE CALL COMPLAINT. CUSTOMER STATED HER PEN NEEDLES ARE FAILING TO DISPENSE FULL DOSE OF INSULIN. CUSTOMER SAID MOST OF THE PEN NEEDLES SHE HAS USED FROM HER CURRENT BOX HAVE FAILED TO DISPENS. CUSTOMER CONFIRMED THROUGH GLUCOSE FREESTYLE MONITORING SYSTEM THAT HER SUGAR HAD SPIKE TO 200 PLUS. SHE WAS ABLE TO REDUCE HER LEVELS WITH ANOTHER INJECTION. SHE DID NOT SEEK MEDICAL ATTENTION AND DID NOT SUFFER ANY MAJOR HEALTH CONSEQUENCE. SHE USES HUMALOG AND LANTUS SOLOSTAR PEN INJECTORS. CUSTOMER CONFIRMED PRIMING PEN NEEDLES PRIOR TO INJECTION AND FOLLOWS THE IFU. WE ARE PROVIDING REPLACEMENT SAMPLES AND THE CUSTOMER AGREED TO SUBMIT SAMPLES FOR INVESTIGATION ANALYSIS. SAMPLE UNDER COMPLAINT HAS NOT BEEN RETURNED FOR FURTHER EVALUATION.

  Patient problems: Hyperglycemia

  MAUDE report 24773757 ↗
• MalfunctionMar 26, 2026No Flow

  ON (B)(6) 2026 HTL-STREFA INC. RECEIVED A PHONE CALL COMPLAINT. CUSTOMER STATED SEVERAL PEN NEEDLES FAILED TO PRIME AND DISPENSE INSULIN. CUSTOMER USES THE LANTUS SOLOSTAR PEN INJECTOR. CUSTOMER DID NOT SUFFER ANY MIS DOSING FROM THE COMPLAINT. THE CUSTOMER STATED IT TAKES DIALING UNITS 2 TO 3 TIMES AND THEN THE INSULIN SHOOTS OUT OF THE PEN NEEDLE AS IF IT'S UNDER PRESSURE. WE ARE PROVIDING REPLACEMENT SAMPLES AND THE CUSTOMER AGREED TO SUBMIT SAMPLES FOR INVESTIGATION ANALYSIS. ON 2026-03-23 SAMPLE UNDER COMPLAINT HAS BEEN RETURNED FOR FURTHER EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24696137 ↗
• MalfunctionMar 16, 2026No Flow

  ON 02/26/2026 HTL-STREFA INC. RECEIVED AN EMAIL COMPLAINT. THE COMPLAINT HAS BEEN REGISTERED IN HTL-STREFA S. A COMPLIANT HANDLING SYSTEM ON 03/02/2026. CUSTOMER STATED: I AM WRITING TO EXPRESS CONCERN REGARDING THE QUALITY OF THE 0.23X4MM DROPLET PEN NEEDLES. I HAVE HAD 2 BOXES OF 100 NEEDLES FROM WHICH APPROXIMATELY 1 OUT OF 4 NEEDLES DOES NOT WORK. I DIDN'T SAVE THE LOT NUMBER FROM THE FIRST BOX BECAUSE I DIDN'T THINK I'D RUN INTO THE PROBLEM AGAIN BUT UNFORTUNATELY, I AM HAVING THE SAME PROBLEM WITH A SECOND BOX. THE LOT NUMBER IS F58A4. I AM ATTACHING A PICTURE OF THE LABEL ON THE END OF THE BOX THAT CONTAINS ALL THE IDENTIFYING INFORMATION. BOTH OF THESE BOXES WERE PURCHASED AT A WALGREENS DRUG STORE ON 12/15/2025. I USE EACH OF THESE NEEDLES ONLY ONCE FOR 4 INJECTIONS PER DAY. I USE A HUMALOG KWIKPEN 3 TIMES DAILY AND A LANTUS SOLOSTAR PEN 1 TIME DAILY. TO HAVE THE NEEDLES FAIL AS OFTEN AS THESE ARE FAILING IS FRUSTRATING AND COSTLY. I HAVE READ AND REREAD THE INSTRUCTIONS AND WHILE I HAVE HAD NEEDLES FAIL PREVIOUSLY, THEY HAVE NOT FAILED AS FREQUENTLY AS THEY ARE NOW. I BELIEVE THE PART OF THE NEEDLE THAT PIERCES THE MEMBRANE AT THE END OF THE INSULIN PENS BENDS SO NO INSUL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24603397 ↗
• MalfunctionMar 16, 2026No Flow

  ON 03/02/2026 HTL-STREFA INC. RECEIVED A PHONE CALL COMPLAINT. CUSTOMER STATED HER PEN NEEDLES ARE FAILING TO DISPENSE THE INSULIN DURING HER INJECTION. SHE HAS 20 CONFIRMED FAILED PEN NEEDLES OUT OF HER LAST 3 BOXES. CUSTOMER CONFIRMED THE PEN NEEDLE DID NOT BEND ON USER OR NON-USER END WHILE ATTACHING PEN NEEDLE TO INJECTOR PEN. SHE USES TRESIBA AND NOVALOG INJECTOR PENS. CUSTOMER CONFIRMED THAT SHE FOLLOWS THE IFU AND ROTATES INJECTION SITES. SHE DID NOT SUFFER ANY MIS DOSING OR SERIOUS INJURY FROM THE COMPLAINT. WE ARE PROVIDING REPLACEMENT SAMPLES AND THE CUSTOMER AGREED TO SUBMIT SAMPLES FOR INVESTIGATION ANALYSIS. SAMPLE UNDER COMPLAINT HAS NOT BEEN RETURNED FOR FURTHER EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24603265 ↗
• MalfunctionMar 16, 2026No Flow

  ON (B)(6) 2026 HTL-STREFA INC. RECEIVED A PHONE CALL COMPLAINT. CUSTOMER STATED SEVERAL PEN NEEDLES FAILED TO DISPENSE INSULIN. HE SAID THE INSULIN FAILED TO PRIME. HE ALSO SAID THE PEN NEEDLES ARE DIFFICULT TO REMOVE FROM THE PEN INJECTOR, STATING THE PROTECTIVE CAP FAILS TO REMOVE THE PEN NEEDLE FOLLOWING INJECTION. HE STATED 6 PEN NEEDLES HAVE FAILED OF THE 20 PEN NEEDLES USED OUT THE BOX OF 100. CUSTOMER CONFIRMED FOLLOWING THE IFU AND USES LANTUS SOLOSTAR PEN INJECTOR. HE DID NOT SUFFER MIS DOSING OR HEALTH CONSEQUENCE FROM THE COMPLAINT. WE ARE PROVIDING REPLACEMENT SAMPLES AND CUSTOMER AGREED TO SUBMIT SAMPLES FOR INVESTIGATION ANALYSIS. ON 2026-03-04 PRODUCT INVOLVED IN THE EVENT HAS BEEN RETURNED TO HTL-STREFA S.A. FOR FURTHER EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24603040 ↗
• MalfunctionFeb 10, 2026No Flow

  BETWEEN (B)(6) 2026, HTL-STREFA S.A. RECEIVED 10 COMPLAINTS FROM THE U.S. MARKET. ALL OF THE COMPLAINTS CONCERN THE F58A4 LOT, AND ALL INVOLVE USERS REPORTING PROBLEMS WITH CLOGGED NEEDLES AND PEN NEEDLES THAT FAIL TO DISPENSE INSULIN. THE FULL DESCRIPTION OF THE COMPLAINTS IS BELOW: "ON (B)(6) 2026 HTL-STREFA INC. RECEIVED AN EMAIL COMPLAINT. CUSTOMER STATED: I WAS TOLD BY A WALGREENS PHARMACY EMPLOYEE TO CONTACT THE MANUFACTURER ABOUT THE DEFECTIVE PEN NEEDLES I'VE ENCOUNTERED IN THE BOX THAT I PURCHASED AROUND CHRISTMAS TIME IN 2025. I MUST HAVE FOUND AT LEAST A DOZEN BAD NEEDLES SO FAR, THE DEFECT BEING THAT AS I CONTINUE TO DIAL IN THE INSULIN AT 2 UNITS AT A TIME, NOTHING COMES OUT. ANOTHER NEEDLE FIXES THE PROBLEM BUT I'M WASTING SEVERAL NEEDLES IN THE PROCESS." "ON (B)(6) 2026 HTL-STREFA INC. RECEIVED A PHONE CALL COMPLAINT. CUSTOMER SAID SEVERAL PEN NEEDLES HAVE FAILED TO DISPENSE INSULIN. CUSTOMER CONFIRMED FOLLOWING THE IFU AND DID NOT SUFFER ANY MIS DOSING OR HEALTH CONSEQUENCE FROM COMPLAINT. HE USES HUMALOG PEN INJECTOR.". "ON (B)(6) 2026 HTL-STREFA INC. RECEIVED A PHONE CALL COMPLAINT. CUSTOMER STATED HIS PEN NEEDLES ARE FAILING TO DISPENSE INSULIN. HE SAYS 1 OUT 3 P

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24302191 ↗