Every drug recall in FDA enforcement reports from the last three years, plus older recalls that are still open. Filter by severity, status or medicine, and check the lot numbers on your package.
0 Class I (most serious) drug recalls reported in the last 30 days.
3,228 recalls
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Class II Ongoing
Adbry, (tralokinumab-ldrm) injection, 300 mg/2mL, Packaged as a) 1 x Single dose Autoinjector, SAMPLE NOT FOR SALE, NDC 50222-350-91; b) 2 x Single dose Autoinjectors, NDC 50222-350-02; Rx only, Manufactured by: LEO Phar…
Reason: Lack of Assurance of Sterility: due to the presence of particulate matter in one unit from the lot, which lab tests have identified as wool fiber.
Lots, distribution and details
- Product
- Adbry, (tralokinumab-ldrm) injection, 300 mg/2mL, Packaged as a) 1 x Single dose Autoinjector, SAMPLE NOT FOR SALE, NDC 50222-350-91; b) 2 x Single dose Autoinjectors, NDC 50222-350-02; Rx only, Manufactured by: LEO Pharma A/S. Industriparken 55, DK-2750 Ballerup, Denmark, Distributed by: LEO Pharma Inc., Madison, NJ 07940, USA,
- Lots / codes
- Lot: a) 003E24C, Exp 04/30/2027; b) 003E24A, Exp 04/30/2027.
- Distribution
- Nationwide in the USA
- Quantity
- 11,407 units
- Recall started
- February 10, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0339-2026
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Class I Ongoing
UDENYCA, pegfilgrastim-cbqv injection, 6 mg/0.6mL Single Dose Prefilled Syringe, Rx only, Manufactured by Accord BioPharma, Inc., 8041 Arco Corporate Drive, Suite 200, Raleigh, NC 27617, NDC 69448-025-63
Reason: Temperature Abuse. 116 cartons with specific serial numbers of Lot 2199821, were stored incorrectly in a controlled room temperature environment instead of the required refrigerated environment.
Lots, distribution and details
- Product
- UDENYCA, pegfilgrastim-cbqv injection, 6 mg/0.6mL Single Dose Prefilled Syringe, Rx only, Manufactured by Accord BioPharma, Inc., 8041 Arco Corporate Drive, Suite 200, Raleigh, NC 27617, NDC 69448-025-63
- Lots / codes
- Subset of Lot 2199821, Expires: 05/31/2027 Specific Serial Numbers being Recalled: 160R694TT06X; 1C74A686RPPG; 1W6A2M777N3V; 20825394KR8P; 242E2RK3EA92; 2DG49VH89EPG; 2WEA2ADK1P4H; 3KR2TVAG3VDH; 42M0V0G9PM84; 46E9XKDPTH1R; 4AM12WEAE48H; 4FGHR096DMNV; 4MWGWM991XNA; 4NEW8XD9DNM2; 4Y2PYDFN9YA1; 61EPX42R4K2A; 63FN9VW5CAV7; 69TG160DW2CV; 69XFP3TMTP7X; 6AWVDCNHTV61; 6CEFY72W5GPA; 6FHF1A59X0X4; 6GA64FNDVGXY; 6NW5FACPPWDW; 75V19CF2A0PA; 7HK7155YNAK3; 7R51VVA1WX9T; 7XCKXMH2EERC; 85D8MFVM66D4; 8F3Y5NFFHC64; 8RDWKPM53N5R; 8W1PVXC5NAFW; 9338DPED7P3R; 9A4CXFTGCPYN; 9FKN5NRDX99A; 9G79AR0RGAY4; 9K28G80GGYXN; 9NN7NXE40M13; A48PXEPE77YE; A8M168K58G64; AMR0RNWHTWMW; AR145NW8WTVX; AY19W6DEGRX4; C276HMDGRE49; CAY0ARAEGMCF; CKT370X2G4NP; D0DFAXCN6G5W; D54TXR8AD9Y8; DAK3XP1P3DMP; DH44AGKTX27F; E69E9K6C29VD; EK1D8P703RCH; EX947FYVW7Y6; F2K148YVNRDD; F4EVX8573F1V; FEXA7MENKWF1; FNDNMPAFH89D; G2W3WTMP5HK9; G5MN0F418FFY; G6XECANG6P01; G7FNVGWW3D72; GAHFFNX336GA; GKNTDP4AV6AA; GVPN5C4D23H6; GVPPYARK1FCD; GVXDAAA87GA1; GX7AP73W4HMH; HDTFT2W59K52; HDVG3W6VW59Y; HP703MKWGGM7; K8CGDV1301TP; KN6Y35T0A198; KVGC92YVC6XF; KYCP1Y7CK4R4; MEY2VW5MC0N9; MGH40F2679X3; N11XGETGDAVM; N9DGTY65NFGN; NH9VM1K2ECGP; NNCFT59RD1KF; NVFCXRWHX93N; P3XY0RNV0VPY; P609NH6W670V; P9Y7926YN82A; PA88CCXMWCMG; PKADTN18YR1X; PM0YHNNK6P4T; R11TYM5VE9CK; R45AXAEK4TTN; R6C3533P943P; RMW35MXX4R4K; RX75F9DA58W4; RXRCRP9272DG; RXTH041DMT5D; T2FW4C24F364; T442NHDFD7H8; TC3443DCR4F8; TK8TRR8NT92A; TT8K21TGYFWY; V255NE533X59; V6MYKEA7HN7P; V764DEYM4RYP; VCPTYV1EF0R1; VECGDTDV1Y3A; VEE09A07R9X5; VEER64AW2C51; VRN2TE3HPK5N; WF14WA03FNT2; WTP5TKRGNFGW; WWPMXV50FRM4; X1DKP0T2AE1W; X59C5AV3VDTG; XKG3T7811TD2; Y0CYY950EYK8; YCRW0EPK620Y; YNYA64T18DPW.
- Distribution
- Nationwide in the USA
- Quantity
- 116 cartons
- Recall started
- January 16, 2026 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0353-2026
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Class II Ongoing
Cetrorelix Acetate for Injection (Kit), 0.25 mg per vial, Single-Dose Kit, Rx Only, Mfd. for: Meitheal Pharmaceuticals, Chicago, IL NDC 71288-558-90.
Reason: Defective Delivery System: Missing or duplicated needles within the injection kit
Lots, distribution and details
- Product
- Cetrorelix Acetate for Injection (Kit), 0.25 mg per vial, Single-Dose Kit, Rx Only, Mfd. for: Meitheal Pharmaceuticals, Chicago, IL NDC 71288-558-90.
- Lots / codes
- Lot Q4E0112A, Exp.: 30 Apr 2027
- Distribution
- U.S. Nationwide
- Quantity
- 16,477 kits
- Recall started
- February 9, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0340-2026
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Class II Ongoing
Oxycodone Hydrochloride Tablets, USP (CII), 5 mg, 100-Count (10 x 10) blister cards per carton, Rx Only, The drug product contained in this package is from NDC # 10702-018, KVK-Tech Inc. Distributed by: American Health P…
Reason: Defective container: card seal defects (weak/non-existent seals), leading to the tablets falling out of their cavities.
Lots, distribution and details
- Product
- Oxycodone Hydrochloride Tablets, USP (CII), 5 mg, 100-Count (10 x 10) blister cards per carton, Rx Only, The drug product contained in this package is from NDC # 10702-018, KVK-Tech Inc. Distributed by: American Health Packaging, Columbus, Ohio 43217, Carton NDC 68084-354-01; Blister NDC 68084-354-11
- Lots / codes
- Lots #: 1027932, Exp Date 06/30/2027, 1028360, Exp Date 08/31/2027
- Distribution
- Nationwide in the USA
- Quantity
- 31,676 packages
- Recall started
- January 14, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0338-2026
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Class II Ongoing
vancomycin HCl, 2 grams, 2 grams added to 500 mL, 0.9% Sodium Chloride Injection, USP, Fagron Sterile Services, 20 Dan Road, Canton, MA 02021, NDC 71506-019-59.
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Lots / codes
- Lot # C274-000047611, Exp Date: 10-Feb-26; Lot # C274-000049633, Exp Date: 12-May-26.
- Distribution
- US Nationwide.
- Quantity
- N/A
- Recall started
- February 5, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0337-2026
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Class II Ongoing
vancomycin HCl, 1.5 grams, 1.5 grams added to 500 mL, 0.9% Sodium Chloride Injection, USP, Fagron Sterile Services, 20 Dan Road, Canton, MA 02021, NDC 71506-016-59
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Lots / codes
- Lot # C274-000049628, Exp Date: 3-May-26.
- Distribution
- US Nationwide.
- Quantity
- 1578 bags
- Recall started
- February 5, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0336-2026
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Class II Ongoing
thiamine HCl, 500 mg, 500 mg added to 100 mL, 0.9% Sodium Chloride Injection, USP, Fagron Sterile Services, 20 Dan Road, Canton, MA 02021, NDC 71506-079-56.
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Lots / codes
- Lot # C274-000047651, Exp Date: 7-Feb-26; Lot # C274-000048671, Exp Date: 30-Mar-26; Lot # C274-000048828, Exp Date: 7-Apr-26; Lot # C274-000049121, Exp Date: 19-Apr-26; Lot # C274-000049127, Exp Date: 21-Apr-26; Lot # C274-000049252, Exp Date: 26-Apr-26; Lot # C274-000049260, Exp Date: 28-Apr-26; Lot # C274-000049401, Exp Date: 3-May-26; Lot # C274-000049413, Exp Date: 5-May-26; Lot # C274-000049571, Exp Date: 10-May-26; Lot # C274-000049581, Exp Date: 12-May-26; Lot # C274-000049584, Exp Date: 13-May-26; Lot # C274-000049717, Exp Date: 17-May-26; Lot # C274-000049727, Exp Date: 18-May-26.
- Distribution
- US Nationwide.
- Quantity
- 10,548 bags
- Recall started
- February 5, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0335-2026
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Class II Ongoing
ketamine HCl, 1,000 mg, 1,000 mg per 100 mL (10 mg per mL) in Sodium Chloride Injection, Fagron Sterile Services, 20 Dan Road, Canton, MA 02021, NDC 71506-050-56
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Lots / codes
- Lot # C274-000047883, Exp Date: 17-Feb-26; Lot # C274-000048515, Exp Date: 22-Mar-26; Lot # C274-000048679, Exp Date: 31-Mar-26; Lot # C274-000049119, Exp Date: 19-Apr-26; Lot # C274-000049282, Exp Date: 27-Apr-26
- Distribution
- US Nationwide.
- Quantity
- 1410 bags
- Recall started
- February 5, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0334-2026
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Class II Ongoing
acyclovir sodium, 200 mg, 200mg added to 100 mL, 0.9% Sodium Chloride Injection, USP, For Intravenous Use, Single-Use Bag, Fagron Sterile Services, 20 Dan Road, Canton, MA 02021, NDC 71506-035-56
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Lots / codes
- Lot # C274-000049124, Exp Date: 28-Feb-26.
- Distribution
- US Nationwide.
- Quantity
- 1057 bags
- Recall started
- February 5, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0333-2026
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Class II Ongoing
Testosterone 100mg Anastrozole 4mg , 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-4104-32
Reason: Presence of Foreign substance – potential presence of metal particulate matter
Lots, distribution and details
- Lots / codes
- Lot#: 254000105, Exp. 05/28/2026, 254000110, Exp. 08/07/2026; 254000112, 254000113, Exp. 09/26/2026.
- Distribution
- Nationwide in the USA
- Quantity
- 1,464 pellets.
- Recall started
- January 26, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0331-2026
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Class II Ongoing
Testosterone 87.5mg, Triamcinolone Acetonide17.5 mcg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-6087-32.
Reason: Presence of Foreign substance – potential presence of metal particulate matter
Lots, distribution and details
- Lots / codes
- Lot#: 256000103, Exp. 07/28/2026.
- Distribution
- Nationwide in the USA
- Quantity
- 1,631 pellets
- Recall started
- January 26, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0330-2026
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Class II Ongoing
Testosterone 200mg, Triamcinolone Acetonide 40mcg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-6200-43.
Reason: Presence of Foreign substance – potential presence of metal particulate matter
Lots, distribution and details
- Lots / codes
- Lot#: 256000105, Exp. 09/19/2026.
- Distribution
- Nationwide in the USA
- Quantity
- 7,840 pellets
- Recall started
- January 26, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0329-2026
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Class II Ongoing
Testosterone 100mg, Triamcinolone Acetonide 20mcg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC:79559-6100-32.
Reason: Presence of Foreign substance – potential presence of metal particulate matter
Lots, distribution and details
- Lots / codes
- Lot#: 256000104, Exp. 07/30/2026. .
- Distribution
- Nationwide in the USA
- Quantity
- 4,599 pellets
- Recall started
- January 26, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0328-2026
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Class II Ongoing
Testosterone 75mg, Anastrozole 4mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-4079-32.
Reason: Presence of Foreign substance – potential presence of metal particulate matter
Lots, distribution and details
- Lots / codes
- Lot#: 254000107, Exp. 06/30/2026; 254000111, Exp. 08/07/2026. .
- Distribution
- Nationwide in the USA
- Quantity
- 670 pellets
- Recall started
- January 26, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0327-2026
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Class II Ongoing
Testosterone 100mg, Anastrozole 4mg (4.5), 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-4104-01.
Reason: Presence of Foreign substance – potential presence of metal particulate matter
Lots, distribution and details
- Lots / codes
- Lot#: 254000104, Exp. 05/27/2026
- Distribution
- Nationwide in the USA
- Quantity
- 100 pellets
- Recall started
- January 26, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0326-2026
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Class II Ongoing
Testosterone, 303 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-1303-01.
Reason: Presence of Foreign substance – potential presence of metal particulate matter
Lots, distribution and details
- Lots / codes
- Lot#: 251000124, Exp. 06/02/2026.
- Distribution
- Nationwide in the USA
- Quantity
- 1,015 pellets
- Recall started
- January 26, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0325-2026
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Class II Ongoing
Testosterone, 200 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-1200-43.
Reason: Presence of Foreign substance – potential presence of metal particulate matter
Lots, distribution and details
- Lots / codes
- Lot#: 251000127, Exp. 06/03/2026; 251000128, Exp. 06/05/2026; 251000133, 251000134, 251000135, Exp. 06/16/2026; 251000138, 251000139, 251000140, 251000141, Exp. 06/25/2026; 251000147, 251000148, 251000149, Exp. 07/28/2026; 251000156, 251000157, Exp. 08/08/2026; 251000164, 251000165, 251000166, Exp. 08/22/2026; 251000169, Exp. 08/29/2026; 251000171, 251000172, Exp. 09/03/2026; 251000180, Exp. 09/19/2026.
- Distribution
- Nationwide in the USA
- Quantity
- 194,336 pellets
- Recall started
- January 26, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0324-2026
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Class II Ongoing
Testosterone, 100 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC:79559-1100-32.
Reason: Presence of Foreign substance – potential presence of metal particulate matter
Lots, distribution and details
- Lots / codes
- Lot#: 251000132, Exp. 06/16/2026; 251000142, Exp. 06/30/2026; 251000144, Exp. 07/14/2026; 251000146, Exp. 07/21/2026; 251000162, 251000163, Exp. 08/16/2026; 251000167, Exp. 08/22/2026; 251000177, Exp. 09/12/2026.
- Distribution
- Nationwide in the USA
- Quantity
- 153,498 pellets
- Recall started
- January 26, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0323-2026
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Class II Ongoing
Testosterone, 87.5 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-1087-32.
Reason: Presence of Foreign substance – potential presence of metal particulate matter
Lots, distribution and details
- Lots / codes
- Lot#: 251000145, Exp. 07/14/2026; 251000161, Exp. 08/16/2026; 251000175, Exp. 09/08/2026. .
- Distribution
- Nationwide in the USA
- Quantity
- 62,581 pellets.
- Recall started
- January 26, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0322-2026
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Class II Ongoing
Testosterone, 62.5 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-1062-32.
Reason: Presence of Foreign substance – potential presence of metal particulate matter
Lots, distribution and details
- Lots / codes
- Lot#: 251000125, Exp. 06/02/2026.
- Distribution
- Nationwide in the USA
- Quantity
- 1,758 pellets.
- Recall started
- January 26, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0321-2026
-
Class II Ongoing
Testosterone, 50.0 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-1050-32.
Reason: Presence of Foreign substance – potential presence of metal particulate matter
Lots, distribution and details
- Lots / codes
- Lot#: 251000122, Exp. 04/01/2026; 251000151, Exp. 08/02/2026; 251000155, Exp. 08/08/2026; 251000173, Exp. 09/05/2026.
- Distribution
- Nationwide in the USA
- Quantity
- 70,959 pellets.
- Recall started
- January 26, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0320-2026
-
Class II Ongoing
Testosterone, 37.5 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-1037-32.
Reason: Presence of Foreign substance – potential presence of metal particulate matter
Lots, distribution and details
- Lots / codes
- Lot#: 251000131, Exp. 06/16/2026; 251000136, Exp. 08/02/2026; 251000150, Exp. 08/12/2026; 251000158, Exp. 08/14/2026; 251000159, Exp. 06/16/2026.
- Distribution
- Nationwide in the USA
- Quantity
- 60,868 pellets.
- Recall started
- January 26, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0319-2026
-
Class II Ongoing
Testosterone, 25.0 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-1025-32.
Reason: Presence of Foreign substance – potential presence of metal particulate matter
Lots, distribution and details
- Lots / codes
- Lot#: 251000130, Exp. 06/02/2026; 251000137, 06/19/2026; 251000152, Exp. 08/02/2026; 251000168, Exp. 08/29/2026; 251000170, Exp. 09/03/2026
- Distribution
- Nationwide in the USA
- Quantity
- 89,074 pellets
- Recall started
- January 26, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0318-2026
-
Class II Ongoing
Testosterone, 18.0 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-1018-32.
Reason: Presence of Foreign substance – potential presence of metal particulate matter
Lots, distribution and details
- Lots / codes
- Lot#: 251000126, Exp. 06/03/2026.
- Distribution
- Nationwide in the USA
- Quantity
- 146 pellets
- Recall started
- January 26, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0317-2026
-
Class II Ongoing
Testosterone, 12.5 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-1012-32.
Reason: Presence of Foreign substance – potential presence of metal particulate matter
Lots, distribution and details
- Lots / codes
- Lot#: 251000143, Exp. 07/07/2026; 251000160, Exp. 08/16/2026.
- Distribution
- Nationwide in the USA
- Quantity
- 3,871 pellets
- Recall started
- January 26, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0316-2026
Have this medicine at home? Compare the lot number and expiry date on your package with the recall. Do not stop taking a prescribed medicine on your own — stopping suddenly can be riskier than the recalled lot. Your pharmacist can check it and usually swap it for an unaffected one.
What the recall classes mean
- Class I Most serious: use could cause serious health problems or death.
- Class II Could cause temporary or medically reversible health problems; serious harm is unlikely.
- Class III Not likely to cause health problems — for example a labelling or packaging fault.
Source: FDA Enforcement Report, via openFDA. Updated here twice a day; last update November 1, 2026 14:40. openFDA data are not validated for clinical use — confirm with the FDA source or your pharmacist.