The Recall Desk

State

Puerto Rico product recalls

72,940 recalls have nationwide distribution and so reach Puerto Rico. 3,090 additional recalls listed Puerto Rico specifically in their distribution scope.

What the numbers show

Total
3,090
Critical
366
Severe
625
Most recent
2026-09-02

Of the 3,090 recalls naming Puerto Rico we have scored against our rubric, 366 (12%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 625 (20%) are Severe.

These figures cover only the 3,090 recalls whose distribution notice names Puerto Rico specifically. The 72,940 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

4601–4625 of 76030

  • ModerateFDA (Drugs)·D-0148-2026·2025-11-05

    Lisdexamfetamine 50 mg capsules recalled after failing dissolution at twelve month stability

    Sun Pharmaceutical Industries is recalling two lots of Lisdexamfetamine Dimesylate Capsules 50 mg after an out-of-specification dissolution result at the 12-month stability station.

    Product
    LISDEXAMFETAMINE DIMESYLATE — LISDEXAMFETAMINE DIMESYLATE (LISDEXAMFETAMINE DIMESYLATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0141-2026·2025-11-05

    Everolimus 10 mg tablets recalled after an out of specification impurity result

    Endo USA is recalling 935 cartons of Everolimus tablets 10 mg after results came back out of specification for impurity IP-C.

    Product
    Everolimus tablets 10 mg, 28 tablets (each carton contains 4 blister strips with 7 tablets each), Rx only, Manufactured by: Par Pharmaceutical Chestnut Ridge, NY 10977 NDC# 49884-128-91
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0145-2026·2025-11-05

    Lisdexamfetamine 20 mg capsules recalled after failing dissolution at twelve month stability

    Sun Pharmaceutical Industries is recalling two lots of Lisdexamfetamine Dimesylate Capsules 20 mg after an out-of-specification dissolution result at the 12-month stability station.

    Product
    LISDEXAMFETAMINE DIMESYLATE — LISDEXAMFETAMINE DIMESYLATE (LISDEXAMFETAMINE DIMESYLATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0396-2026·2025-11-05

    Refill three month all in one bundles recalled for lacking 510k clearance

    Daye is recalling 3,074 packs of its Refill 3 Month All in One Bundle because the product lacks 510(k) clearance.

    Product
    Refill 3 Month All in One Bundle; Model Number: FG-BNDL-PC-MM-REFAIO;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0404-2026·2025-11-05

    Three month trial tampon boxes recalled for lacking 510k clearance

    Daye is recalling 3,074 packs of the Initiation 3 Month Trial Tampon Box because the product lacks 510(k) clearance.

    Product
    Initiation 3 Month Trial Tampon Box; Model Number: FG-TMP-MM-IB09090909;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0401-2026·2025-11-05

    Mixed regular and super tampon packs recalled for lacking 510k clearance

    Daye is recalling 3,074 packs of Initiation 18 Coated Regular and 18 Coated Super Tampons because the product lacks 510(k) clearance.

    Product
    Initiation 18 Coated Regular and 18 Coated Super Tampons; Model Number: FG-TMP-MM-IB18180000;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0393-2026·2025-11-05

    Refill coated and nude regular tampons recalled for lacking 510k clearance

    Daye is recalling 3,074 packs of Refill 18 Coated Regular and 18 Nude Regular Tampons because the product lacks 510(k) clearance.

    Product
    Refill 18 Coated Regular and 18 Nude Regular Tampons; Model Number: FG-TMP-MM-REF18001800;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0392-2026·2025-11-05

    Refill regular and super tampon packs recalled for lacking 510k clearance

    Daye is recalling 3,074 packs of Refill 18 Coated Regular and 18 Coated Super Tampons because the product lacks 510(k) clearance.

    Product
    Refill 18 Coated Regular and 18 Coated Super Tampons; Model Number: FG-TMP-MM-REF18180000;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0394-2026·2025-11-05

    Refill coated and nude super tampons recalled for lacking 510k clearance

    Daye is recalling 3,074 packs of Refill 18 Coated Super and 18 Nude Super Tampons because the product lacks 510(k) clearance.

    Product
    Refill 18 Coated Super and 18 Nude Super Tampons; Model Number: FG-TMP-MM-REF00180018;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0391-2026·2025-11-05

    Refill coated super tampon packs recalled for lacking 510k clearance

    Daye is recalling 3,074 packs of Refill 36 Coated Super Tampons because the product lacks 510(k) clearance.

    Product
    Refill 36 Coated Super Tampons; Model Number: FG-TMP-MM-REF00360000;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0383-2026·2025-11-05

    Coated regular and super tampon packs recalled for lacking 510k clearance

    Daye is recalling 3,074 packs of 9 Coated Regular and 9 Coated Super Tampons because the product lacks 510(k) clearance.

    Product
    9 Coated Regular and 9 Coated Super Tampons; Model Number: FG-TMP-REF09090000;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0400-2026·2025-11-05

    Initiation 36 coated super tampons recalled for lacking 510k clearance

    Daye is recalling 3,074 packs of Initiation 36 Coated Super Tampons because the product lacks 510(k) clearance.

    Product
    Initiation 36 Coated Super Tampons; Model Number: FG-TMP-MM-IB00360000;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0146-2026·2025-11-05

    Lisdexamfetamine 30 mg capsules recalled after failing dissolution at twelve month stability

    Sun Pharmaceutical Industries is recalling two lots of Lisdexamfetamine Dimesylate Capsules 30 mg after an out-of-specification dissolution result at the 12-month stability station.

    Product
    LISDEXAMFETAMINE DIMESYLATE — LISDEXAMFETAMINE DIMESYLATE (LISDEXAMFETAMINE DIMESYLATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0384-2026·2025-11-05

    Coated and nude regular tampons recalled because product lacks 510k clearance

    Daye is recalling 3,074 packs of 9 Coated Regular and 9 Nude Regular Tampons because the product lacks 510(k) clearance.

    Product
    9 Coated Regular and 9 Nude Regular Tampons; Model Number: FG-TMP-REF09000900;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0395-2026·2025-11-05

    Refill three month trial tampon boxes recalled for lacking 510k clearance

    Daye is recalling 3,074 packs of its Refill 3 Month Trial Tampon Box because the product lacks 510(k) clearance.

    Product
    Refill 3 Month Trial Tampon Box; Model Number: FG-TMP-MM-REF09090909;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0379-2026·2025-11-05

    Coated and nude super tampon packs recalled for lacking 510k clearance

    Daye is recalling 3,074 packs of 9 Coated Super Tampons and 9 Nude Super Tampons because the product lacks 510(k) clearance.

    Product
    9 Coated Super Tampons and 9 Nude Super Tampons; Model Number: FG-TMP-RET00090009;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0402-2026·2025-11-05

    Initiation coated and nude regular tampons recalled for lacking 510k clearance

    Daye is recalling 3,074 packs of Initiation 18 Coated Regular and 18 Nude Regular Tampons because the product lacks 510(k) clearance.

    Product
    Initiation 18 Coated Regular and 18 Nude Regular Tampons; Model Number: FG-TMP-MM-IB18001800;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0149-2026·2025-11-05

    Lisdexamfetamine 60 mg capsules recalled after failing dissolution at twelve month stability

    Sun Pharmaceutical Industries is recalling two lots of Lisdexamfetamine Dimesylate Capsules 60 mg after an out-of-specification dissolution result at the 12-month stability station.

    Product
    LISDEXAMFETAMINE DIMESYLATE — LISDEXAMFETAMINE DIMESYLATE (LISDEXAMFETAMINE DIMESYLATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0142-2026·2025-11-05

    Everolimus 2.5 mg tablets recalled after an out of specification impurity result

    Endo USA is recalling 2,035 cartons of Everolimus tablets 2.5 mg after results came back out of specification for impurity IP-C.

    Product
    Everolimus tablets 2.5 mg, 28 tablets (each carton contains 4 blister strips with 7 tablets each), Rx only, Manufactured by: Par Pharmaceutical Chestnut Ridge, NY 10977 NDC# 49884-119-91
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0144-2026·2025-11-05

    Lisdexamfetamine 10 mg capsules recalled after failing dissolution at twelve month stability

    Sun Pharmaceutical Industries is recalling two lots of Lisdexamfetamine Dimesylate Capsules 10 mg after an out-of-specification dissolution result at the 12-month stability station.

    Product
    LISDEXAMFETAMINE DIMESYLATE — LISDEXAMFETAMINE DIMESYLATE (LISDEXAMFETAMINE DIMESYLATE)
    Category
    Drug
    Distribution
    Distributed nationwide